Menopause

Hormone therapy should not be used to prevent chronic conditions in postmenopausal women, according to updated recommendations from the U.S. Preventive Services Task Force. The recommendations were published online Dec. 12 in JAMA.

In the latest recommendation statement, the USPSTF issued D recommendations against using combination estrogen and progestin to prevent chronic conditions in postmenopausal women and against using estrogen only to prevent chronic conditions in postmenopausal women who have undergone hysterectomies (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.18261). A grade D recommendation is defined as “The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”

Judith Flacke/Thinkstock

[email protected]

Hormone therapy should not be used to prevent chronic conditions in postmenopausal women, according to updated recommendations from the U.S. Preventive Services Task Force. The recommendations were published online Dec. 12 in JAMA.

In the latest recommendation statement, the USPSTF issued D recommendations against using combination estrogen and progestin to prevent chronic conditions in postmenopausal women and against using estrogen only to prevent chronic conditions in postmenopausal women who have undergone hysterectomies (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.18261). A grade D recommendation is defined as “The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”

Judith Flacke/Thinkstock

[email protected]

Hormone therapy should not be used to prevent chronic conditions in postmenopausal women, according to updated recommendations from the U.S. Preventive Services Task Force. The recommendations were published online Dec. 12 in JAMA.

In the latest recommendation statement, the USPSTF issued D recommendations against using combination estrogen and progestin to prevent chronic conditions in postmenopausal women and against using estrogen only to prevent chronic conditions in postmenopausal women who have undergone hysterectomies (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.18261). A grade D recommendation is defined as “The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”

Judith Flacke/Thinkstock

[email protected]

Recorded at the 2017 meeting of the North American Menopause Society

Recorded at the 2017 meeting of the North American Menopause Society

Recorded at the 2017 meeting of the North American Menopause Society

Bone health remains one of the most important health care concerns in the United States today. In 2004, the Surgeon General released a report on bone health and osteoporosis. According to the report’s introduction:

This first-ever Surgeon General’s Report on bone health and osteoporosis illustrates the large burden that bone disease places on our Nation and its citizens. Like other chronic diseases that disproportionately affect the elderly, the prevalence of bone disease and fractures is projected to increase markedly as the population ages. If these predictions come true, bone disease and fractures will have a tremendous negative impact on the future well-being of Americans. But as this report makes clear, they need not come true: by working together we can change the picture of aging in America. Osteoporosis and fractures…no longer should be thought of as an inevitable part of growing old. By focusing on prevention and lifestyle changes, including physical activity and nutrition, as well as early diagnosis and appropriate treatment, Americans can avoid much of the damaging impact of bone disease.¹

Related article:
2016 Update on bone health

Although men also experience osteoporosis as they age, in women the rapid loss of bone at menopause makes their disease burden much greater. As women’s health care providers, we stand at the front line for preventing, diagnosing, and treating osteoporosis to reduce the impact of this disease. In this Update I focus on important information that has emerged in the past year.

Read about new ACP guidelines to assess fracture risk

Guidelines for therapy: How to assess fracture risk and when to treat

American College of Obstetricians and Gynecologists Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin No. 129: Osteoporosis. Obstet Gynecol. 2012;120(3):718-734.

Qaseem A, Forciea MA, McLean RM, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(11):818-839.

A crucial component for good bone health maintenance and osteoporotic fracture prevention is understanding the current guidelines for therapy. The most recent practice bulletin of the American College of Obstetricians and Gynecologists (ACOG) on osteoporosis was published in 2012. ACOG states that treatment be recommended for women who have a bone mineral density (BMD) T-score of -2.5 or lower.

For women in the low bone mass category (T-score between -1 and -2.5), use of the Fracture Risk Assessment Tool (FRAX) calculator can assist in making an informed treatment decision.² Based on the FRAX calculator, women who have a 10-year risk of major osteoporotic fracture of 20% or greater, or a risk of hip fracture of 3% or greater, are candidates for pharmacologic therapy.

Women who have experienced a low-trauma fracture (especially of the vertebra or hip) also are candidates for treatment, even in the absence of osteoporosis on a dual-energy x-ray absorptiometry (DXA) report.

Related article:
Women’s Preventive Services Initiative Guidelines provide consensus for practicing ObGyns

Updated recommendations from the ACP

The 2017 guideline published by the American College of Physicians (ACP), whose target audience is "all clinicians," recommends that, for women who have known osteoporosis, clinicians offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk for hip and vertebral fractures.

In addition, the ACP recommends that clinicians make the decision whether or not to treat osteopenic women 65 years of age or older who are at a high risk for fracture based on a discussion of patient preferences, fracture risk profile, and benefits, harms, and costs of medications. This may seem somewhat contradictory to ACOG's guidance vis-a-vis women younger than 65 years of age.

The ACP further states that given the limited evidence supporting the benefit of treatment, the balance of benefits and harms in treating osteopenic women is most favorable when the risk for fracture is high. Women younger than 65 years with osteopenia and women older than 65 years with mild osteopenia (T-score between -1.0 and -1.5) will benefit less than women who are 65 years of age or older with severe osteopenia (T-score <-2.0).

Risk factors and risk assessment tools

Clinicians can use their own judgment based on risk factors for fracture (lower body weight, smoking, weight loss, family history of fractures, decreased physical activity, alcohol or caffeine use, low calcium and vitamin D intake, corticosteroid use), or they can use a risk assessment tool. Several risk assessment tools, such as the FRAX calculator mentioned earlier, are available to predict fracture risk among untreated people with low bone density. Although the FRAX calculator is widely used, there is no evidence from randomized controlled trials demonstrating a benefit of fracture reduction when FRAX scores are used in treatment decision making.

Duration of therapy. The ACP recommends that clinicians treat osteoporotic women with pharmacologic therapy for 5 years. Bone density monitoring is not recommended during the 5-year treatment period for osteoporosis in women; current evidence does not show any benefit for bone density monitoring during treatment.

Moderate-quality evidence demonstrated that women treated with antiresorptive therapies (including bisphosphonates, raloxifene, and teriparatide) benefited from reduced fractures, even if no increase in BMD occurred or if BMD decreased.

Read about fracture risk after stopping HT

Another WHI update: No increase in fractures after stopping HT

Watts NB, Cauley JA, Jackson RD, et al; Women's Health Initiative Investigators. No increase in fractures after stopping hormone therapy: results from the Women's Health Initiative. J Clin Endocrinol Metab. 2017;102(1):302-308.

The analysis and reanalysis of the Women's Health Initiative (WHI) trial data seems never-ending, yet the article by Watts and colleagues is important. Although the WHI hormone therapy (HT) trials showed that treatment protects against hip and total fractures, a later observational report suggested loss of benefit and rebound increased risk after HT was discontinued.3 The purpose of the Watts' study was to examine fractures after stopping HT.

Related article:
Did long-term follow-up of WHI participants reveal any mortality increase among women who received HT?

Details of the study

Two placebo-controlled randomized trials served as the study setting. The study included WHI participants (n = 15,187) who continued to take active HT or placebo through the intervention period and who did not take HT in the postintervention period. The trial interventions included conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) for women with natural menopause and CEE alone for women with prior hysterectomy. The investigators recorded total fractures and hip fractures through 5 years after HT discontinuation.

Findings on fractures. Hip fractures occurred infrequently, with approximately 2.5 per 1,000 person-years. This finding was similar between trials and in former HT users and placebo groups.

No difference was found in total fractures in the CEE plus MPA trial for former HT users compared with former placebo users (28.9 per 1,000 person-years and 29.9 per 1,000 person-years, respectively; hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.87-1.09; P = .63). In the CEE-alone trial, however, total fractures were higher in former placebo users (36.9 per 1,000 person-years) compared with the former active-treatment group (31.1 per 1,000 person-years). This finding suggests a residual benefit of CEE in reducing total fractures (HR, 0.85; 95% CI, 0.73-0.98; P = .03).

Investigators' takeaway. The authors concluded that, after discontinuing HT, there was no evidence of increased fracture risk (sustained or transient) in former HT users compared with former placebo users. In the CEE-alone trial, there was a residual benefit for total fracture reduction in former HT users compared with placebo users.

Read about reassessing FRAX scores

A new look at fracture risk assessment scores

Gourlay ML, Overman RA, Fine JP, et al; Women's Health Initiative Investigators. Time to clinically relevant fracture risk scores in postmenopausal women. Am J Med. 2017;130:862.e15-e23.

Jiang X, Gruner M, Trémollieres F, et al. Diagnostic accuracy of FRAX in predicting the 10-year risk of osteoporotic fractures using the USA treatment thresholds: a systematic review and meta-analysis. Bone. 2017;99:20-25.

The FRAX score has become a popular form of triage for women who do not yet meet the bone mass criteria of osteoporosis. Current practice guidelines recommend use of fracture risk scores for screening and pharmacologic therapeutic decision making. Some newer data, however, may give rise to questions about its utility, especially in younger women.

Fracture risk analysis in a large postmenopausal population

Gourlay and colleagues conducted a retrospective competing risk analysis of new occurrence of treatment-level and screening-level fracture risk scores. Study participants were postmenopausal women aged 50 years and older who had not previously received pharmacologic treatment and had not had a first hip or clinical vertebral facture.

Details of the study

In 54,280 postmenopausal women aged 50 to 64 years who did not have a bone mineral density test, the time for 10% to develop a treatment-level FRAX score could not be estimated accurately because the incidence of treatment-level scores was rare.

A total of 6,096 women had FRAX scores calculated with bone mineral density testing. In this group, the estimated unadjusted time to treatment-level FRAX scores was 7.6 years (95% CI, 6.6-8.7) for those aged 65 to 69, and 5.1 years (95% CI, 3.5-7.5) for women aged 75 to 79 at baseline.

Of 17,967 women aged 50 to 64 who had a screening-level FRAX at baseline, 100 (0.6%) experienced a hip or clinical vertebral fracture by age 65 years.

Age is key factor. Gourlay and colleagues concluded that postmenopausal women who had subthreshold fracture risk scores at baseline would be unlikely to develop a treatment-level FRAX score between ages 50 and 64. The increased incidence of treatment-level fracture risk scores, osteoporosis, and major osteoporotic fracture after age 65, however, supports more frequent consideration of FRAX assessment and bone mineral density testing.

Related article:
2015 Update on osteoporosis

Meta-analysis of FRAX tool accuracy

In another study, Jiang and colleagues conducted a systematic review and meta-analysis to determine how the FRAX score performed in predicting the 10-year risk of major osteoporotic fractures and hip fractures. The investigators used the US treatment thresholds.

Details of the study

Seven studies (n = 57,027) were analyzed to assess the diagnostic accuracy of FRAX in predicting major osteoporotic fractures; 20% was used as the 10-year fracture risk threshold for intervention. The mean sensitivity and specificity, along with their 95% CIs, were 10.25% (3.76%-25.06%) and 97.02% (91.17%-99.03%), respectively.

For hip fracture prediction, 6 studies (n = 50,944) were analyzed, and 3% was used as the 10-year fracture risk threshold. The mean sensitivity and specificity, along with their 95% CIs, were 45.70% (24.88%-68.13%) and 84.70% (76.41%-90.44%), respectively.

Predictive value of FRAX. The authors concluded that, using the 10-year intervention thresholds of 20% for major osteoporotic fracture and 3% for hip fracture, FRAX performed better in identifying individuals who will not have a major osteoporotic fracture or hip fracture within 10 years than in identifying those who will experience a fracture. A substantial number of those who developed fractures, especially major osteoporotic fracture within 10 years of follow up, were missed by the baseline FRAX assessment.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Bone health remains one of the most important health care concerns in the United States today. In 2004, the Surgeon General released a report on bone health and osteoporosis. According to the report’s introduction:

This first-ever Surgeon General’s Report on bone health and osteoporosis illustrates the large burden that bone disease places on our Nation and its citizens. Like other chronic diseases that disproportionately affect the elderly, the prevalence of bone disease and fractures is projected to increase markedly as the population ages. If these predictions come true, bone disease and fractures will have a tremendous negative impact on the future well-being of Americans. But as this report makes clear, they need not come true: by working together we can change the picture of aging in America. Osteoporosis and fractures…no longer should be thought of as an inevitable part of growing old. By focusing on prevention and lifestyle changes, including physical activity and nutrition, as well as early diagnosis and appropriate treatment, Americans can avoid much of the damaging impact of bone disease.¹

Related article:
2016 Update on bone health

Although men also experience osteoporosis as they age, in women the rapid loss of bone at menopause makes their disease burden much greater. As women’s health care providers, we stand at the front line for preventing, diagnosing, and treating osteoporosis to reduce the impact of this disease. In this Update I focus on important information that has emerged in the past year.

Read about new ACP guidelines to assess fracture risk

Guidelines for therapy: How to assess fracture risk and when to treat

American College of Obstetricians and Gynecologists Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin No. 129: Osteoporosis. Obstet Gynecol. 2012;120(3):718-734.

Qaseem A, Forciea MA, McLean RM, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(11):818-839.

A crucial component for good bone health maintenance and osteoporotic fracture prevention is understanding the current guidelines for therapy. The most recent practice bulletin of the American College of Obstetricians and Gynecologists (ACOG) on osteoporosis was published in 2012. ACOG states that treatment be recommended for women who have a bone mineral density (BMD) T-score of -2.5 or lower.

For women in the low bone mass category (T-score between -1 and -2.5), use of the Fracture Risk Assessment Tool (FRAX) calculator can assist in making an informed treatment decision.² Based on the FRAX calculator, women who have a 10-year risk of major osteoporotic fracture of 20% or greater, or a risk of hip fracture of 3% or greater, are candidates for pharmacologic therapy.

Women who have experienced a low-trauma fracture (especially of the vertebra or hip) also are candidates for treatment, even in the absence of osteoporosis on a dual-energy x-ray absorptiometry (DXA) report.

Related article:
Women’s Preventive Services Initiative Guidelines provide consensus for practicing ObGyns

Updated recommendations from the ACP

The 2017 guideline published by the American College of Physicians (ACP), whose target audience is "all clinicians," recommends that, for women who have known osteoporosis, clinicians offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk for hip and vertebral fractures.

In addition, the ACP recommends that clinicians make the decision whether or not to treat osteopenic women 65 years of age or older who are at a high risk for fracture based on a discussion of patient preferences, fracture risk profile, and benefits, harms, and costs of medications. This may seem somewhat contradictory to ACOG's guidance vis-a-vis women younger than 65 years of age.

The ACP further states that given the limited evidence supporting the benefit of treatment, the balance of benefits and harms in treating osteopenic women is most favorable when the risk for fracture is high. Women younger than 65 years with osteopenia and women older than 65 years with mild osteopenia (T-score between -1.0 and -1.5) will benefit less than women who are 65 years of age or older with severe osteopenia (T-score <-2.0).

Risk factors and risk assessment tools

Clinicians can use their own judgment based on risk factors for fracture (lower body weight, smoking, weight loss, family history of fractures, decreased physical activity, alcohol or caffeine use, low calcium and vitamin D intake, corticosteroid use), or they can use a risk assessment tool. Several risk assessment tools, such as the FRAX calculator mentioned earlier, are available to predict fracture risk among untreated people with low bone density. Although the FRAX calculator is widely used, there is no evidence from randomized controlled trials demonstrating a benefit of fracture reduction when FRAX scores are used in treatment decision making.

Duration of therapy. The ACP recommends that clinicians treat osteoporotic women with pharmacologic therapy for 5 years. Bone density monitoring is not recommended during the 5-year treatment period for osteoporosis in women; current evidence does not show any benefit for bone density monitoring during treatment.

Moderate-quality evidence demonstrated that women treated with antiresorptive therapies (including bisphosphonates, raloxifene, and teriparatide) benefited from reduced fractures, even if no increase in BMD occurred or if BMD decreased.

Read about fracture risk after stopping HT

Another WHI update: No increase in fractures after stopping HT

Watts NB, Cauley JA, Jackson RD, et al; Women's Health Initiative Investigators. No increase in fractures after stopping hormone therapy: results from the Women's Health Initiative. J Clin Endocrinol Metab. 2017;102(1):302-308.

The analysis and reanalysis of the Women's Health Initiative (WHI) trial data seems never-ending, yet the article by Watts and colleagues is important. Although the WHI hormone therapy (HT) trials showed that treatment protects against hip and total fractures, a later observational report suggested loss of benefit and rebound increased risk after HT was discontinued.3 The purpose of the Watts' study was to examine fractures after stopping HT.

Related article:
Did long-term follow-up of WHI participants reveal any mortality increase among women who received HT?

Details of the study

Two placebo-controlled randomized trials served as the study setting. The study included WHI participants (n = 15,187) who continued to take active HT or placebo through the intervention period and who did not take HT in the postintervention period. The trial interventions included conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) for women with natural menopause and CEE alone for women with prior hysterectomy. The investigators recorded total fractures and hip fractures through 5 years after HT discontinuation.

Findings on fractures. Hip fractures occurred infrequently, with approximately 2.5 per 1,000 person-years. This finding was similar between trials and in former HT users and placebo groups.

No difference was found in total fractures in the CEE plus MPA trial for former HT users compared with former placebo users (28.9 per 1,000 person-years and 29.9 per 1,000 person-years, respectively; hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.87-1.09; P = .63). In the CEE-alone trial, however, total fractures were higher in former placebo users (36.9 per 1,000 person-years) compared with the former active-treatment group (31.1 per 1,000 person-years). This finding suggests a residual benefit of CEE in reducing total fractures (HR, 0.85; 95% CI, 0.73-0.98; P = .03).

Investigators' takeaway. The authors concluded that, after discontinuing HT, there was no evidence of increased fracture risk (sustained or transient) in former HT users compared with former placebo users. In the CEE-alone trial, there was a residual benefit for total fracture reduction in former HT users compared with placebo users.

Read about reassessing FRAX scores

A new look at fracture risk assessment scores

Gourlay ML, Overman RA, Fine JP, et al; Women's Health Initiative Investigators. Time to clinically relevant fracture risk scores in postmenopausal women. Am J Med. 2017;130:862.e15-e23.

Jiang X, Gruner M, Trémollieres F, et al. Diagnostic accuracy of FRAX in predicting the 10-year risk of osteoporotic fractures using the USA treatment thresholds: a systematic review and meta-analysis. Bone. 2017;99:20-25.

The FRAX score has become a popular form of triage for women who do not yet meet the bone mass criteria of osteoporosis. Current practice guidelines recommend use of fracture risk scores for screening and pharmacologic therapeutic decision making. Some newer data, however, may give rise to questions about its utility, especially in younger women.

Fracture risk analysis in a large postmenopausal population

Gourlay and colleagues conducted a retrospective competing risk analysis of new occurrence of treatment-level and screening-level fracture risk scores. Study participants were postmenopausal women aged 50 years and older who had not previously received pharmacologic treatment and had not had a first hip or clinical vertebral facture.

Details of the study

In 54,280 postmenopausal women aged 50 to 64 years who did not have a bone mineral density test, the time for 10% to develop a treatment-level FRAX score could not be estimated accurately because the incidence of treatment-level scores was rare.

A total of 6,096 women had FRAX scores calculated with bone mineral density testing. In this group, the estimated unadjusted time to treatment-level FRAX scores was 7.6 years (95% CI, 6.6-8.7) for those aged 65 to 69, and 5.1 years (95% CI, 3.5-7.5) for women aged 75 to 79 at baseline.

Of 17,967 women aged 50 to 64 who had a screening-level FRAX at baseline, 100 (0.6%) experienced a hip or clinical vertebral fracture by age 65 years.

Age is key factor. Gourlay and colleagues concluded that postmenopausal women who had subthreshold fracture risk scores at baseline would be unlikely to develop a treatment-level FRAX score between ages 50 and 64. The increased incidence of treatment-level fracture risk scores, osteoporosis, and major osteoporotic fracture after age 65, however, supports more frequent consideration of FRAX assessment and bone mineral density testing.

Related article:
2015 Update on osteoporosis

Meta-analysis of FRAX tool accuracy

In another study, Jiang and colleagues conducted a systematic review and meta-analysis to determine how the FRAX score performed in predicting the 10-year risk of major osteoporotic fractures and hip fractures. The investigators used the US treatment thresholds.

Details of the study

Seven studies (n = 57,027) were analyzed to assess the diagnostic accuracy of FRAX in predicting major osteoporotic fractures; 20% was used as the 10-year fracture risk threshold for intervention. The mean sensitivity and specificity, along with their 95% CIs, were 10.25% (3.76%-25.06%) and 97.02% (91.17%-99.03%), respectively.

For hip fracture prediction, 6 studies (n = 50,944) were analyzed, and 3% was used as the 10-year fracture risk threshold. The mean sensitivity and specificity, along with their 95% CIs, were 45.70% (24.88%-68.13%) and 84.70% (76.41%-90.44%), respectively.

Predictive value of FRAX. The authors concluded that, using the 10-year intervention thresholds of 20% for major osteoporotic fracture and 3% for hip fracture, FRAX performed better in identifying individuals who will not have a major osteoporotic fracture or hip fracture within 10 years than in identifying those who will experience a fracture. A substantial number of those who developed fractures, especially major osteoporotic fracture within 10 years of follow up, were missed by the baseline FRAX assessment.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Bone health remains one of the most important health care concerns in the United States today. In 2004, the Surgeon General released a report on bone health and osteoporosis. According to the report’s introduction:

This first-ever Surgeon General’s Report on bone health and osteoporosis illustrates the large burden that bone disease places on our Nation and its citizens. Like other chronic diseases that disproportionately affect the elderly, the prevalence of bone disease and fractures is projected to increase markedly as the population ages. If these predictions come true, bone disease and fractures will have a tremendous negative impact on the future well-being of Americans. But as this report makes clear, they need not come true: by working together we can change the picture of aging in America. Osteoporosis and fractures…no longer should be thought of as an inevitable part of growing old. By focusing on prevention and lifestyle changes, including physical activity and nutrition, as well as early diagnosis and appropriate treatment, Americans can avoid much of the damaging impact of bone disease.¹

Related article:
2016 Update on bone health

Although men also experience osteoporosis as they age, in women the rapid loss of bone at menopause makes their disease burden much greater. As women’s health care providers, we stand at the front line for preventing, diagnosing, and treating osteoporosis to reduce the impact of this disease. In this Update I focus on important information that has emerged in the past year.

Read about new ACP guidelines to assess fracture risk

Guidelines for therapy: How to assess fracture risk and when to treat

American College of Obstetricians and Gynecologists Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin No. 129: Osteoporosis. Obstet Gynecol. 2012;120(3):718-734.

Qaseem A, Forciea MA, McLean RM, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(11):818-839.

A crucial component for good bone health maintenance and osteoporotic fracture prevention is understanding the current guidelines for therapy. The most recent practice bulletin of the American College of Obstetricians and Gynecologists (ACOG) on osteoporosis was published in 2012. ACOG states that treatment be recommended for women who have a bone mineral density (BMD) T-score of -2.5 or lower.

For women in the low bone mass category (T-score between -1 and -2.5), use of the Fracture Risk Assessment Tool (FRAX) calculator can assist in making an informed treatment decision.² Based on the FRAX calculator, women who have a 10-year risk of major osteoporotic fracture of 20% or greater, or a risk of hip fracture of 3% or greater, are candidates for pharmacologic therapy.

Women who have experienced a low-trauma fracture (especially of the vertebra or hip) also are candidates for treatment, even in the absence of osteoporosis on a dual-energy x-ray absorptiometry (DXA) report.

Related article:
Women’s Preventive Services Initiative Guidelines provide consensus for practicing ObGyns

Updated recommendations from the ACP

The 2017 guideline published by the American College of Physicians (ACP), whose target audience is "all clinicians," recommends that, for women who have known osteoporosis, clinicians offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk for hip and vertebral fractures.

In addition, the ACP recommends that clinicians make the decision whether or not to treat osteopenic women 65 years of age or older who are at a high risk for fracture based on a discussion of patient preferences, fracture risk profile, and benefits, harms, and costs of medications. This may seem somewhat contradictory to ACOG's guidance vis-a-vis women younger than 65 years of age.

The ACP further states that given the limited evidence supporting the benefit of treatment, the balance of benefits and harms in treating osteopenic women is most favorable when the risk for fracture is high. Women younger than 65 years with osteopenia and women older than 65 years with mild osteopenia (T-score between -1.0 and -1.5) will benefit less than women who are 65 years of age or older with severe osteopenia (T-score <-2.0).

Risk factors and risk assessment tools

Clinicians can use their own judgment based on risk factors for fracture (lower body weight, smoking, weight loss, family history of fractures, decreased physical activity, alcohol or caffeine use, low calcium and vitamin D intake, corticosteroid use), or they can use a risk assessment tool. Several risk assessment tools, such as the FRAX calculator mentioned earlier, are available to predict fracture risk among untreated people with low bone density. Although the FRAX calculator is widely used, there is no evidence from randomized controlled trials demonstrating a benefit of fracture reduction when FRAX scores are used in treatment decision making.

Duration of therapy. The ACP recommends that clinicians treat osteoporotic women with pharmacologic therapy for 5 years. Bone density monitoring is not recommended during the 5-year treatment period for osteoporosis in women; current evidence does not show any benefit for bone density monitoring during treatment.

Moderate-quality evidence demonstrated that women treated with antiresorptive therapies (including bisphosphonates, raloxifene, and teriparatide) benefited from reduced fractures, even if no increase in BMD occurred or if BMD decreased.

Read about fracture risk after stopping HT

Another WHI update: No increase in fractures after stopping HT

Watts NB, Cauley JA, Jackson RD, et al; Women's Health Initiative Investigators. No increase in fractures after stopping hormone therapy: results from the Women's Health Initiative. J Clin Endocrinol Metab. 2017;102(1):302-308.

The analysis and reanalysis of the Women's Health Initiative (WHI) trial data seems never-ending, yet the article by Watts and colleagues is important. Although the WHI hormone therapy (HT) trials showed that treatment protects against hip and total fractures, a later observational report suggested loss of benefit and rebound increased risk after HT was discontinued.3 The purpose of the Watts' study was to examine fractures after stopping HT.

Related article:
Did long-term follow-up of WHI participants reveal any mortality increase among women who received HT?

Details of the study

Two placebo-controlled randomized trials served as the study setting. The study included WHI participants (n = 15,187) who continued to take active HT or placebo through the intervention period and who did not take HT in the postintervention period. The trial interventions included conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) for women with natural menopause and CEE alone for women with prior hysterectomy. The investigators recorded total fractures and hip fractures through 5 years after HT discontinuation.

Findings on fractures. Hip fractures occurred infrequently, with approximately 2.5 per 1,000 person-years. This finding was similar between trials and in former HT users and placebo groups.

No difference was found in total fractures in the CEE plus MPA trial for former HT users compared with former placebo users (28.9 per 1,000 person-years and 29.9 per 1,000 person-years, respectively; hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.87-1.09; P = .63). In the CEE-alone trial, however, total fractures were higher in former placebo users (36.9 per 1,000 person-years) compared with the former active-treatment group (31.1 per 1,000 person-years). This finding suggests a residual benefit of CEE in reducing total fractures (HR, 0.85; 95% CI, 0.73-0.98; P = .03).

Investigators' takeaway. The authors concluded that, after discontinuing HT, there was no evidence of increased fracture risk (sustained or transient) in former HT users compared with former placebo users. In the CEE-alone trial, there was a residual benefit for total fracture reduction in former HT users compared with placebo users.

Read about reassessing FRAX scores

A new look at fracture risk assessment scores

Gourlay ML, Overman RA, Fine JP, et al; Women's Health Initiative Investigators. Time to clinically relevant fracture risk scores in postmenopausal women. Am J Med. 2017;130:862.e15-e23.

Jiang X, Gruner M, Trémollieres F, et al. Diagnostic accuracy of FRAX in predicting the 10-year risk of osteoporotic fractures using the USA treatment thresholds: a systematic review and meta-analysis. Bone. 2017;99:20-25.

The FRAX score has become a popular form of triage for women who do not yet meet the bone mass criteria of osteoporosis. Current practice guidelines recommend use of fracture risk scores for screening and pharmacologic therapeutic decision making. Some newer data, however, may give rise to questions about its utility, especially in younger women.

Fracture risk analysis in a large postmenopausal population

Gourlay and colleagues conducted a retrospective competing risk analysis of new occurrence of treatment-level and screening-level fracture risk scores. Study participants were postmenopausal women aged 50 years and older who had not previously received pharmacologic treatment and had not had a first hip or clinical vertebral facture.

Details of the study

In 54,280 postmenopausal women aged 50 to 64 years who did not have a bone mineral density test, the time for 10% to develop a treatment-level FRAX score could not be estimated accurately because the incidence of treatment-level scores was rare.

A total of 6,096 women had FRAX scores calculated with bone mineral density testing. In this group, the estimated unadjusted time to treatment-level FRAX scores was 7.6 years (95% CI, 6.6-8.7) for those aged 65 to 69, and 5.1 years (95% CI, 3.5-7.5) for women aged 75 to 79 at baseline.

Of 17,967 women aged 50 to 64 who had a screening-level FRAX at baseline, 100 (0.6%) experienced a hip or clinical vertebral fracture by age 65 years.

Age is key factor. Gourlay and colleagues concluded that postmenopausal women who had subthreshold fracture risk scores at baseline would be unlikely to develop a treatment-level FRAX score between ages 50 and 64. The increased incidence of treatment-level fracture risk scores, osteoporosis, and major osteoporotic fracture after age 65, however, supports more frequent consideration of FRAX assessment and bone mineral density testing.

Related article:
2015 Update on osteoporosis

Meta-analysis of FRAX tool accuracy

In another study, Jiang and colleagues conducted a systematic review and meta-analysis to determine how the FRAX score performed in predicting the 10-year risk of major osteoporotic fractures and hip fractures. The investigators used the US treatment thresholds.

Details of the study

Seven studies (n = 57,027) were analyzed to assess the diagnostic accuracy of FRAX in predicting major osteoporotic fractures; 20% was used as the 10-year fracture risk threshold for intervention. The mean sensitivity and specificity, along with their 95% CIs, were 10.25% (3.76%-25.06%) and 97.02% (91.17%-99.03%), respectively.

For hip fracture prediction, 6 studies (n = 50,944) were analyzed, and 3% was used as the 10-year fracture risk threshold. The mean sensitivity and specificity, along with their 95% CIs, were 45.70% (24.88%-68.13%) and 84.70% (76.41%-90.44%), respectively.

Predictive value of FRAX. The authors concluded that, using the 10-year intervention thresholds of 20% for major osteoporotic fracture and 3% for hip fracture, FRAX performed better in identifying individuals who will not have a major osteoporotic fracture or hip fracture within 10 years than in identifying those who will experience a fracture. A substantial number of those who developed fractures, especially major osteoporotic fracture within 10 years of follow up, were missed by the baseline FRAX assessment.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Postmenopausal bleeding is a symptom that can announce the presence of a gynecologic malignancy. In this column, we will discuss the important considerations to make in the work-up of this symptom.

Roughly 10% of women will present for evaluation of postmenopausal bleeding.¹ More than a third of these women will have benign pathology, with the incidence of endometrial cancer in this group at only about 5%.² Other gynecologic malignancies should be considered as well, including cervical, vaginal, vulvar, and more rarely, those of the fallopian tubes or ovaries.

Use of ultrasound

Ultrasound is a commonly performed initial approach to work-up because of its noninvasive nature. Transvaginal ultrasound has a high negative predictive value of 99.4%-100% in ruling out malignancy.³ Among women with postmenopausal bleeding, the risk of cancer is 7.3% if their endometrial lining is 5 mm or greater and less than 0.07% risk if their lining is 4 mm or less. Therefore, this cutoff dimension is typically used to triage patients to additional sampling.

If ultrasound is performed on postmenopausal women who are asymptomatic (no bleeding), then an endometrial stripe of greater than 11 mm is considered justification for further work-up and is associated with a 6.7% risk of endometrial cancer.⁴ If the ultrasound reveals intracavitary lesions, a sonohysterogram would be preferred to characterize intrauterine pathology. In fact, sonohysterography is superior to transvaginal ultrasound (with a sensitivity of 80% vs. 49%, respectively) in detecting endometrial polypoid lesions.⁵ Preoperative identification of an intracavitary lesion may assist in selecting the best sampling technique (blind vs. hysteroscopy-guided approach).
 

Endometrial sampling

If an ultrasound reveals a thickened or unevaluable endometrial stripe or if the clinician chooses to proceed directly with diagnostic confirmation, several options for endometrial sampling exist, including office-based or operative procedures, as well as blind or visually guided ones. Endometrial pipelle biopsy, D&C without hysteroscopy, endometrial lavage, and endometrial brush biopsy all constitute “blind” sampling techniques. Targeted biopsy techniques include hysteroscopy D&C and saline infusion sonohysterography–guided biopsy.

Blind D&C

Although D&C may be considered the gold standard of diagnostic sampling techniques, it should be noted that 60% of these procedures sample less than half of the endometrium.⁶ When used in conjunction with hysteroscopy, the sensitivity in detecting cancer is high at 97% with a specificity of 93%-100%.⁷

While some patients are candidates for office-based procedures, D&C often requires regional or general anesthesia and is frequently performed in a hospital-based environment or surgical center. This may be most appropriate for patients who have had failed office attempts at sampling, have multiple medical comorbidities that limit the feasibility of office-based procedures (such as morbid obesity), or have severe cervical stenosis. D&C is associated with an increased risk for uterine perforation, compared with outpatient sampling procedures.

The need to go to the operating room rather than to an ambulatory setting also may increase the costs borne by the patient. The advantages of D&C include the potential for large-volume sampling and the potentially therapeutic nature of the procedure in cases of benign pathology.
 

Office-based procedures

Office-based sampling techniques include those using a pipelle, those employing an endometrial brush, and those guided by saline infusion sonohysterography. If performed in the office, they require minimal or no cervical dilation, are associated with a lower risk of perforation or adverse reaction to anesthesia, and usually have lower costs for patients.

Endometrial pipelle biopsies are a very effective diagnostic tool when there is global, endometrial pathology; they have a sensitivity of 83% in confirming cancer.⁸ It is an inexpensive and technically straightforward technique that can be easily performed in an office setting.

However, when the endometrial lining is atrophied, alternative tools may provide superior results. Endometrial brushes have been shown to be 33% more successful in collecting adequate samples,compared with pipelles, because they sample a larger endometrial surface area.⁹

There is ongoing development of sampling techniques, such as endometrial lavage or the combination of saline infusion sonohysterography and endometrial biopsy.¹⁰ However, future studies regarding accuracy, cost, and patient acceptability are needed before these techniques are translated to the clinical setting.
 

Targeted endometrial sampling

Targeted or visually guided sampling, such as hysteroscopy, has been shown to be very accurate in identifying benign pathology, although the sensitivity of hysteroscopic diagnosis of cancer is significantly lower at approximately 50%.¹¹ Therefore, the benefit of hysteroscopy is in complementing the blind nature of D&C by guiding sampling of intracavitary lesions, should they exist.

Hysteroscopy is safe in endometrial cancer and is not associated with upstaging the cancer from transtubal extirpation of malignant cells.¹²

The addition of hysteroscopy contributes some cost and equipment to the blind D&C procedure; therefore, it might be best applied in cases where there is known intracavitary pathology or inadequate prior sampling. In well-selected patients, hysteroscopy often can be used in an office setting, which improves the practicality of the procedure. Smaller and, in some cases, disposable equipment aids in the feasibility of adding visual guidance to office sampling.
 

Optimizing sampling

Postmenopausal women have a higher risk for sampling failure, compared with younger women. Obesity also is a risk for failed sampling.¹³ Cervical ripening with misoprostol may increase access to the endometrial cavity, and ultrasound guidance may decrease the risk of uterine perforation in a stenotic cervix.

Clinicians should ensure that histology results are concordant with clinical data. Discordant results should be reevaluated. For example, if an ultrasound demonstrates a thickened endometrial stripe, but the sampling reveals “scant atrophic tissue,” then there is unexplained pathology to address. Further work-up, such as more comprehensive sampling with hysteroscopy, should be considered in such cases. Additionally, persistent postmenopausal bleeding, despite a benign endometrial biopsy, should be reevaluated over time to rule out occult disease missed during prior sampling.

Appropriate strategies for the work-up of postmenopausal bleeding should be tailored to each patient and their risk factors. Clinicians are now equipped with multiple ways of obtaining clinical data, and patients have options that may decrease barriers to their care. Hysteroscopy does not improve upon D&C in the diagnosis of endometrial cancer, although it may be helpful in distinguishing and treating nonmalignant lesions.
 

Dr. Cotangco is a resident in the department of obstetrics and gynecology at the University of Illinois, Chicago. Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina, Chapel Hill. They reported having no relevant financial disclosures.

References

1. Acta Obstet Gynecol Scand. 2004 Feb;83(2):203-7.

2. Menopause Int. 2010 Mar;16(1):5-8.

3. Obstet Gynecol. 2009 Aug;114(2 Pt 1):409-11.

4. Ultrasound Obstet Gynecol. 2004 Oct;24(5):558-65.

5. Ultrasound Obstet Gynecol. 2001 Aug;18(2):157-62.

6. Am J Obstet Gynecol. 2009 Jul;201(1):5-11.

7. Obstet Gynecol Clin North Am. 2000 Jun;27(2):235-44.

8. J Reprod Med. 1995 Aug;40(8):553-5.

9. BJOG. 2008 Jul;115(8):1028-36.

10. PLoS Med. 2016 Dec. doi: 10.1371/journal.pmed.1002206.

11. Arch Gynecol Obstet. 2012 Mar;285(3):839-43.

12. Am J Obstet Gynecol. 2012 Jul;207(1):71.e1-5.

13. Gynecol Oncol. 2017 Feb;144(2):324-8.

Postmenopausal bleeding is a symptom that can announce the presence of a gynecologic malignancy. In this column, we will discuss the important considerations to make in the work-up of this symptom.

Roughly 10% of women will present for evaluation of postmenopausal bleeding.¹ More than a third of these women will have benign pathology, with the incidence of endometrial cancer in this group at only about 5%.² Other gynecologic malignancies should be considered as well, including cervical, vaginal, vulvar, and more rarely, those of the fallopian tubes or ovaries.

Use of ultrasound

Ultrasound is a commonly performed initial approach to work-up because of its noninvasive nature. Transvaginal ultrasound has a high negative predictive value of 99.4%-100% in ruling out malignancy.³ Among women with postmenopausal bleeding, the risk of cancer is 7.3% if their endometrial lining is 5 mm or greater and less than 0.07% risk if their lining is 4 mm or less. Therefore, this cutoff dimension is typically used to triage patients to additional sampling.

If ultrasound is performed on postmenopausal women who are asymptomatic (no bleeding), then an endometrial stripe of greater than 11 mm is considered justification for further work-up and is associated with a 6.7% risk of endometrial cancer.⁴ If the ultrasound reveals intracavitary lesions, a sonohysterogram would be preferred to characterize intrauterine pathology. In fact, sonohysterography is superior to transvaginal ultrasound (with a sensitivity of 80% vs. 49%, respectively) in detecting endometrial polypoid lesions.⁵ Preoperative identification of an intracavitary lesion may assist in selecting the best sampling technique (blind vs. hysteroscopy-guided approach).
 

Endometrial sampling

If an ultrasound reveals a thickened or unevaluable endometrial stripe or if the clinician chooses to proceed directly with diagnostic confirmation, several options for endometrial sampling exist, including office-based or operative procedures, as well as blind or visually guided ones. Endometrial pipelle biopsy, D&C without hysteroscopy, endometrial lavage, and endometrial brush biopsy all constitute “blind” sampling techniques. Targeted biopsy techniques include hysteroscopy D&C and saline infusion sonohysterography–guided biopsy.

Blind D&C

Although D&C may be considered the gold standard of diagnostic sampling techniques, it should be noted that 60% of these procedures sample less than half of the endometrium.⁶ When used in conjunction with hysteroscopy, the sensitivity in detecting cancer is high at 97% with a specificity of 93%-100%.⁷

While some patients are candidates for office-based procedures, D&C often requires regional or general anesthesia and is frequently performed in a hospital-based environment or surgical center. This may be most appropriate for patients who have had failed office attempts at sampling, have multiple medical comorbidities that limit the feasibility of office-based procedures (such as morbid obesity), or have severe cervical stenosis. D&C is associated with an increased risk for uterine perforation, compared with outpatient sampling procedures.

The need to go to the operating room rather than to an ambulatory setting also may increase the costs borne by the patient. The advantages of D&C include the potential for large-volume sampling and the potentially therapeutic nature of the procedure in cases of benign pathology.
 

Office-based procedures

Office-based sampling techniques include those using a pipelle, those employing an endometrial brush, and those guided by saline infusion sonohysterography. If performed in the office, they require minimal or no cervical dilation, are associated with a lower risk of perforation or adverse reaction to anesthesia, and usually have lower costs for patients.

Endometrial pipelle biopsies are a very effective diagnostic tool when there is global, endometrial pathology; they have a sensitivity of 83% in confirming cancer.⁸ It is an inexpensive and technically straightforward technique that can be easily performed in an office setting.

However, when the endometrial lining is atrophied, alternative tools may provide superior results. Endometrial brushes have been shown to be 33% more successful in collecting adequate samples,compared with pipelles, because they sample a larger endometrial surface area.⁹

There is ongoing development of sampling techniques, such as endometrial lavage or the combination of saline infusion sonohysterography and endometrial biopsy.¹⁰ However, future studies regarding accuracy, cost, and patient acceptability are needed before these techniques are translated to the clinical setting.
 

Targeted endometrial sampling

Targeted or visually guided sampling, such as hysteroscopy, has been shown to be very accurate in identifying benign pathology, although the sensitivity of hysteroscopic diagnosis of cancer is significantly lower at approximately 50%.¹¹ Therefore, the benefit of hysteroscopy is in complementing the blind nature of D&C by guiding sampling of intracavitary lesions, should they exist.

Hysteroscopy is safe in endometrial cancer and is not associated with upstaging the cancer from transtubal extirpation of malignant cells.¹²

The addition of hysteroscopy contributes some cost and equipment to the blind D&C procedure; therefore, it might be best applied in cases where there is known intracavitary pathology or inadequate prior sampling. In well-selected patients, hysteroscopy often can be used in an office setting, which improves the practicality of the procedure. Smaller and, in some cases, disposable equipment aids in the feasibility of adding visual guidance to office sampling.
 

Optimizing sampling

Postmenopausal women have a higher risk for sampling failure, compared with younger women. Obesity also is a risk for failed sampling.¹³ Cervical ripening with misoprostol may increase access to the endometrial cavity, and ultrasound guidance may decrease the risk of uterine perforation in a stenotic cervix.

Clinicians should ensure that histology results are concordant with clinical data. Discordant results should be reevaluated. For example, if an ultrasound demonstrates a thickened endometrial stripe, but the sampling reveals “scant atrophic tissue,” then there is unexplained pathology to address. Further work-up, such as more comprehensive sampling with hysteroscopy, should be considered in such cases. Additionally, persistent postmenopausal bleeding, despite a benign endometrial biopsy, should be reevaluated over time to rule out occult disease missed during prior sampling.

Appropriate strategies for the work-up of postmenopausal bleeding should be tailored to each patient and their risk factors. Clinicians are now equipped with multiple ways of obtaining clinical data, and patients have options that may decrease barriers to their care. Hysteroscopy does not improve upon D&C in the diagnosis of endometrial cancer, although it may be helpful in distinguishing and treating nonmalignant lesions.
 

Dr. Cotangco is a resident in the department of obstetrics and gynecology at the University of Illinois, Chicago. Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina, Chapel Hill. They reported having no relevant financial disclosures.

References

1. Acta Obstet Gynecol Scand. 2004 Feb;83(2):203-7.

2. Menopause Int. 2010 Mar;16(1):5-8.

3. Obstet Gynecol. 2009 Aug;114(2 Pt 1):409-11.

4. Ultrasound Obstet Gynecol. 2004 Oct;24(5):558-65.

5. Ultrasound Obstet Gynecol. 2001 Aug;18(2):157-62.

6. Am J Obstet Gynecol. 2009 Jul;201(1):5-11.

7. Obstet Gynecol Clin North Am. 2000 Jun;27(2):235-44.

8. J Reprod Med. 1995 Aug;40(8):553-5.

9. BJOG. 2008 Jul;115(8):1028-36.

10. PLoS Med. 2016 Dec. doi: 10.1371/journal.pmed.1002206.

11. Arch Gynecol Obstet. 2012 Mar;285(3):839-43.

12. Am J Obstet Gynecol. 2012 Jul;207(1):71.e1-5.

13. Gynecol Oncol. 2017 Feb;144(2):324-8.

Postmenopausal bleeding is a symptom that can announce the presence of a gynecologic malignancy. In this column, we will discuss the important considerations to make in the work-up of this symptom.

Roughly 10% of women will present for evaluation of postmenopausal bleeding.¹ More than a third of these women will have benign pathology, with the incidence of endometrial cancer in this group at only about 5%.² Other gynecologic malignancies should be considered as well, including cervical, vaginal, vulvar, and more rarely, those of the fallopian tubes or ovaries.

Use of ultrasound

Ultrasound is a commonly performed initial approach to work-up because of its noninvasive nature. Transvaginal ultrasound has a high negative predictive value of 99.4%-100% in ruling out malignancy.³ Among women with postmenopausal bleeding, the risk of cancer is 7.3% if their endometrial lining is 5 mm or greater and less than 0.07% risk if their lining is 4 mm or less. Therefore, this cutoff dimension is typically used to triage patients to additional sampling.

If ultrasound is performed on postmenopausal women who are asymptomatic (no bleeding), then an endometrial stripe of greater than 11 mm is considered justification for further work-up and is associated with a 6.7% risk of endometrial cancer.⁴ If the ultrasound reveals intracavitary lesions, a sonohysterogram would be preferred to characterize intrauterine pathology. In fact, sonohysterography is superior to transvaginal ultrasound (with a sensitivity of 80% vs. 49%, respectively) in detecting endometrial polypoid lesions.⁵ Preoperative identification of an intracavitary lesion may assist in selecting the best sampling technique (blind vs. hysteroscopy-guided approach).
 

Endometrial sampling

If an ultrasound reveals a thickened or unevaluable endometrial stripe or if the clinician chooses to proceed directly with diagnostic confirmation, several options for endometrial sampling exist, including office-based or operative procedures, as well as blind or visually guided ones. Endometrial pipelle biopsy, D&C without hysteroscopy, endometrial lavage, and endometrial brush biopsy all constitute “blind” sampling techniques. Targeted biopsy techniques include hysteroscopy D&C and saline infusion sonohysterography–guided biopsy.

Blind D&C

Although D&C may be considered the gold standard of diagnostic sampling techniques, it should be noted that 60% of these procedures sample less than half of the endometrium.⁶ When used in conjunction with hysteroscopy, the sensitivity in detecting cancer is high at 97% with a specificity of 93%-100%.⁷

While some patients are candidates for office-based procedures, D&C often requires regional or general anesthesia and is frequently performed in a hospital-based environment or surgical center. This may be most appropriate for patients who have had failed office attempts at sampling, have multiple medical comorbidities that limit the feasibility of office-based procedures (such as morbid obesity), or have severe cervical stenosis. D&C is associated with an increased risk for uterine perforation, compared with outpatient sampling procedures.

The need to go to the operating room rather than to an ambulatory setting also may increase the costs borne by the patient. The advantages of D&C include the potential for large-volume sampling and the potentially therapeutic nature of the procedure in cases of benign pathology.
 

Office-based procedures

Office-based sampling techniques include those using a pipelle, those employing an endometrial brush, and those guided by saline infusion sonohysterography. If performed in the office, they require minimal or no cervical dilation, are associated with a lower risk of perforation or adverse reaction to anesthesia, and usually have lower costs for patients.

Endometrial pipelle biopsies are a very effective diagnostic tool when there is global, endometrial pathology; they have a sensitivity of 83% in confirming cancer.⁸ It is an inexpensive and technically straightforward technique that can be easily performed in an office setting.

However, when the endometrial lining is atrophied, alternative tools may provide superior results. Endometrial brushes have been shown to be 33% more successful in collecting adequate samples,compared with pipelles, because they sample a larger endometrial surface area.⁹

There is ongoing development of sampling techniques, such as endometrial lavage or the combination of saline infusion sonohysterography and endometrial biopsy.¹⁰ However, future studies regarding accuracy, cost, and patient acceptability are needed before these techniques are translated to the clinical setting.
 

Targeted endometrial sampling

Targeted or visually guided sampling, such as hysteroscopy, has been shown to be very accurate in identifying benign pathology, although the sensitivity of hysteroscopic diagnosis of cancer is significantly lower at approximately 50%.¹¹ Therefore, the benefit of hysteroscopy is in complementing the blind nature of D&C by guiding sampling of intracavitary lesions, should they exist.

Hysteroscopy is safe in endometrial cancer and is not associated with upstaging the cancer from transtubal extirpation of malignant cells.¹²

The addition of hysteroscopy contributes some cost and equipment to the blind D&C procedure; therefore, it might be best applied in cases where there is known intracavitary pathology or inadequate prior sampling. In well-selected patients, hysteroscopy often can be used in an office setting, which improves the practicality of the procedure. Smaller and, in some cases, disposable equipment aids in the feasibility of adding visual guidance to office sampling.
 

Optimizing sampling

Postmenopausal women have a higher risk for sampling failure, compared with younger women. Obesity also is a risk for failed sampling.¹³ Cervical ripening with misoprostol may increase access to the endometrial cavity, and ultrasound guidance may decrease the risk of uterine perforation in a stenotic cervix.

Clinicians should ensure that histology results are concordant with clinical data. Discordant results should be reevaluated. For example, if an ultrasound demonstrates a thickened endometrial stripe, but the sampling reveals “scant atrophic tissue,” then there is unexplained pathology to address. Further work-up, such as more comprehensive sampling with hysteroscopy, should be considered in such cases. Additionally, persistent postmenopausal bleeding, despite a benign endometrial biopsy, should be reevaluated over time to rule out occult disease missed during prior sampling.

Appropriate strategies for the work-up of postmenopausal bleeding should be tailored to each patient and their risk factors. Clinicians are now equipped with multiple ways of obtaining clinical data, and patients have options that may decrease barriers to their care. Hysteroscopy does not improve upon D&C in the diagnosis of endometrial cancer, although it may be helpful in distinguishing and treating nonmalignant lesions.
 

Dr. Cotangco is a resident in the department of obstetrics and gynecology at the University of Illinois, Chicago. Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina, Chapel Hill. They reported having no relevant financial disclosures.

References

1. Acta Obstet Gynecol Scand. 2004 Feb;83(2):203-7.

2. Menopause Int. 2010 Mar;16(1):5-8.

3. Obstet Gynecol. 2009 Aug;114(2 Pt 1):409-11.

4. Ultrasound Obstet Gynecol. 2004 Oct;24(5):558-65.

5. Ultrasound Obstet Gynecol. 2001 Aug;18(2):157-62.

6. Am J Obstet Gynecol. 2009 Jul;201(1):5-11.

7. Obstet Gynecol Clin North Am. 2000 Jun;27(2):235-44.

8. J Reprod Med. 1995 Aug;40(8):553-5.

9. BJOG. 2008 Jul;115(8):1028-36.

10. PLoS Med. 2016 Dec. doi: 10.1371/journal.pmed.1002206.

11. Arch Gynecol Obstet. 2012 Mar;285(3):839-43.

12. Am J Obstet Gynecol. 2012 Jul;207(1):71.e1-5.

13. Gynecol Oncol. 2017 Feb;144(2):324-8.

EXPERT COMMENTARY

 A 2013 report from the Women’s Health Initiative (WHI), the large National Institutes of Health–funded placebo-controlledrandomized trial of postmenopausal hormone therapy (HT) with oral estrogen (for women with hysterectomy) or estrogen-progestin (for women with an intact uterus), with 13 years of cumulative follow-up, documented the safety of systemic HT when initiated by women younger than 60 years of age or within 10 years of menopause onset.¹ Now, with 18 years of cumulative follow-up data available (intervention and extended postintervention phases), the WHI investigators present all-cause and cause-specific mortality outcomes from the 2 HT trials.

Related article:
2017 Update on menopause

Details of the study

A total of 27,347 WHI participants (baseline mean age, 63.4 years; 80.6% white) used oral estrogen-progestin therapy (EPT) or placebo for a median of 5.6 years (n = 16,608) or estrogen-only therapy (ET) or placebo for a median of 7.2 years (n = 10,739). Each hazard ratio (HR) reported below refers to 18-year cumulative follow-up.

All-cause mortality. In the overall pooled cohort (EPT and ET groups), all-cause mortality was similar, with a rate of 27.1% in the HT group and 27.6% in the placebo group (HR, 0.99; 95% confidence interval [CI], 0.94–1.03). The mortality end points included deaths from all causes; cardiovascular disease (coronary heart disease, stroke, and other cardiovascular diseases); cancer (breast, colorectal, and other cancers); and other (Alzheimer disease, other dementia, chronic obstructive pulmonary disease, injuries and accidents, and other).

Stratifying by baseline participant age (comparing women aged 50–59 years with those aged 70–79 years), the HR for all-cause mortality in the pooled cohort during the intervention phase was 0.61 (95% CI, 0.43–0.87), and during the cumulative 18-year follow-up, the HR was 0.87 (95% CI, 0.76–1.00).

Cause-specific mortality. Neither cardiovascular disease mortality nor total cancer mortality was significantly impacted by HT use. In the pooled cohort, cardiovascular disease mortality was 8.9% in the HT group and 9.0% in the placebo group (HR, 1.00; 95% CI, 0.92–1.08), with no differences between the EPT and the ET trials. Cancer mortality rates in the pooled cohort also were similar, with 8.2% in the HT group and 8.0% in the placebo group (HR, 1.03; 95% CI, 0.95–1.12).

With respect to breast cancer mortality, the impact of HT diverged for EPT and ET. For the EPT group, the HR for breast cancer mortality was 1.44 (95% CI, 0.97–2.15; P = .07), while for the ET group the HR was 0.55 (95% CI, 0.33–0.92; P = .02).

Related articles:
Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?

Study strengths and weaknesses

The WHI represents the largest randomized placebo-controlled trials of HT. The current WHI trials report provides new, cumulative 18-year follow-up data on all-cause and cause-specific mortality in women treated with HT or placebo.

The authors noted, however, that the use of only one HT dose, formulation, and route of administration in each trial may limit the generalizability of the study results to other HT preparations. For example, the WHI did not examine the transdermal route of estrogen administration. Likewise, the WHI did not examine use of progestational agents other than medroxyprogesterone acetate. In addition, while almost all cohort deaths were captured through the National Death Index for the data analyses, specificity of cause of death may vary across outcomes. Further, since multiple outcomes and subgroups were examined, clinicians should interpret cause-specific mortality rates with caution.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

 A 2013 report from the Women’s Health Initiative (WHI), the large National Institutes of Health–funded placebo-controlledrandomized trial of postmenopausal hormone therapy (HT) with oral estrogen (for women with hysterectomy) or estrogen-progestin (for women with an intact uterus), with 13 years of cumulative follow-up, documented the safety of systemic HT when initiated by women younger than 60 years of age or within 10 years of menopause onset.¹ Now, with 18 years of cumulative follow-up data available (intervention and extended postintervention phases), the WHI investigators present all-cause and cause-specific mortality outcomes from the 2 HT trials.

Related article:
2017 Update on menopause

Details of the study

A total of 27,347 WHI participants (baseline mean age, 63.4 years; 80.6% white) used oral estrogen-progestin therapy (EPT) or placebo for a median of 5.6 years (n = 16,608) or estrogen-only therapy (ET) or placebo for a median of 7.2 years (n = 10,739). Each hazard ratio (HR) reported below refers to 18-year cumulative follow-up.

All-cause mortality. In the overall pooled cohort (EPT and ET groups), all-cause mortality was similar, with a rate of 27.1% in the HT group and 27.6% in the placebo group (HR, 0.99; 95% confidence interval [CI], 0.94–1.03). The mortality end points included deaths from all causes; cardiovascular disease (coronary heart disease, stroke, and other cardiovascular diseases); cancer (breast, colorectal, and other cancers); and other (Alzheimer disease, other dementia, chronic obstructive pulmonary disease, injuries and accidents, and other).

Stratifying by baseline participant age (comparing women aged 50–59 years with those aged 70–79 years), the HR for all-cause mortality in the pooled cohort during the intervention phase was 0.61 (95% CI, 0.43–0.87), and during the cumulative 18-year follow-up, the HR was 0.87 (95% CI, 0.76–1.00).

Cause-specific mortality. Neither cardiovascular disease mortality nor total cancer mortality was significantly impacted by HT use. In the pooled cohort, cardiovascular disease mortality was 8.9% in the HT group and 9.0% in the placebo group (HR, 1.00; 95% CI, 0.92–1.08), with no differences between the EPT and the ET trials. Cancer mortality rates in the pooled cohort also were similar, with 8.2% in the HT group and 8.0% in the placebo group (HR, 1.03; 95% CI, 0.95–1.12).

With respect to breast cancer mortality, the impact of HT diverged for EPT and ET. For the EPT group, the HR for breast cancer mortality was 1.44 (95% CI, 0.97–2.15; P = .07), while for the ET group the HR was 0.55 (95% CI, 0.33–0.92; P = .02).

Related articles:
Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?

Study strengths and weaknesses

The WHI represents the largest randomized placebo-controlled trials of HT. The current WHI trials report provides new, cumulative 18-year follow-up data on all-cause and cause-specific mortality in women treated with HT or placebo.

The authors noted, however, that the use of only one HT dose, formulation, and route of administration in each trial may limit the generalizability of the study results to other HT preparations. For example, the WHI did not examine the transdermal route of estrogen administration. Likewise, the WHI did not examine use of progestational agents other than medroxyprogesterone acetate. In addition, while almost all cohort deaths were captured through the National Death Index for the data analyses, specificity of cause of death may vary across outcomes. Further, since multiple outcomes and subgroups were examined, clinicians should interpret cause-specific mortality rates with caution.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

 A 2013 report from the Women’s Health Initiative (WHI), the large National Institutes of Health–funded placebo-controlledrandomized trial of postmenopausal hormone therapy (HT) with oral estrogen (for women with hysterectomy) or estrogen-progestin (for women with an intact uterus), with 13 years of cumulative follow-up, documented the safety of systemic HT when initiated by women younger than 60 years of age or within 10 years of menopause onset.¹ Now, with 18 years of cumulative follow-up data available (intervention and extended postintervention phases), the WHI investigators present all-cause and cause-specific mortality outcomes from the 2 HT trials.

Related article:
2017 Update on menopause

Details of the study

A total of 27,347 WHI participants (baseline mean age, 63.4 years; 80.6% white) used oral estrogen-progestin therapy (EPT) or placebo for a median of 5.6 years (n = 16,608) or estrogen-only therapy (ET) or placebo for a median of 7.2 years (n = 10,739). Each hazard ratio (HR) reported below refers to 18-year cumulative follow-up.

All-cause mortality. In the overall pooled cohort (EPT and ET groups), all-cause mortality was similar, with a rate of 27.1% in the HT group and 27.6% in the placebo group (HR, 0.99; 95% confidence interval [CI], 0.94–1.03). The mortality end points included deaths from all causes; cardiovascular disease (coronary heart disease, stroke, and other cardiovascular diseases); cancer (breast, colorectal, and other cancers); and other (Alzheimer disease, other dementia, chronic obstructive pulmonary disease, injuries and accidents, and other).

Stratifying by baseline participant age (comparing women aged 50–59 years with those aged 70–79 years), the HR for all-cause mortality in the pooled cohort during the intervention phase was 0.61 (95% CI, 0.43–0.87), and during the cumulative 18-year follow-up, the HR was 0.87 (95% CI, 0.76–1.00).

Cause-specific mortality. Neither cardiovascular disease mortality nor total cancer mortality was significantly impacted by HT use. In the pooled cohort, cardiovascular disease mortality was 8.9% in the HT group and 9.0% in the placebo group (HR, 1.00; 95% CI, 0.92–1.08), with no differences between the EPT and the ET trials. Cancer mortality rates in the pooled cohort also were similar, with 8.2% in the HT group and 8.0% in the placebo group (HR, 1.03; 95% CI, 0.95–1.12).

With respect to breast cancer mortality, the impact of HT diverged for EPT and ET. For the EPT group, the HR for breast cancer mortality was 1.44 (95% CI, 0.97–2.15; P = .07), while for the ET group the HR was 0.55 (95% CI, 0.33–0.92; P = .02).

Related articles:
Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?

Study strengths and weaknesses

The WHI represents the largest randomized placebo-controlled trials of HT. The current WHI trials report provides new, cumulative 18-year follow-up data on all-cause and cause-specific mortality in women treated with HT or placebo.

The authors noted, however, that the use of only one HT dose, formulation, and route of administration in each trial may limit the generalizability of the study results to other HT preparations. For example, the WHI did not examine the transdermal route of estrogen administration. Likewise, the WHI did not examine use of progestational agents other than medroxyprogesterone acetate. In addition, while almost all cohort deaths were captured through the National Death Index for the data analyses, specificity of cause of death may vary across outcomes. Further, since multiple outcomes and subgroups were examined, clinicians should interpret cause-specific mortality rates with caution.

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PHILADELPHIA – When a woman is referred for pelvic floor physical therapy, what’s involved? Is there evidence behind the treatments, and what exactly does pelvic floor therapy look like?

Denise Hartzell Leggin, a physical therapist who specializes in pelvic floor dysfunction, reviewed how the female pelvic floor can change with age, and provided the rationale for pelvic floor physical therapy (PT) at the annual meeting of the North American Menopause Society.

“Physical therapists treat musculoskeletal and neuromuscular dysfunctions,” said Ms. Hartzell Leggin. So, when a physician suspects a musculoskeletal cause for pelvic floor dysfunction, a PT referral may be appropriate, she said.

Why refer for PT?

As part of the aging process, pelvic floor dysfunction can coexist with the genitourinary syndrome of menopause (GSM), said Ms. Hartzell. Though the pathophysiology is not always clear, aging does have some effect on the pelvic floor musculature and, together with GSM, can contribute to women’s urogenital symptoms in later life.

These symptoms, she said, can be the harbingers of “a host of clinical conditions,” including urinary incontinence and fecal incontinence, constipation, and bladder-emptying problems. Also, changes in the pelvic musculature from childbirth, surgeries, and hypotonicity or hypertonicity can contribute to sexual dysfunction in later life, said Ms. Hartzell Leggin, who is affiliated with Good Shepherd Penn Partners and in private practice in the Philadelphia area.

The musculature of the pelvic floor functions as more than a bowl for carrying the pelvic organs, Ms. Hartzell Leggin said. The collective muscles and fascia form a sling that fills in the pelvic ring and functions as an integrated system with constant resting tone. But the musculature is also active and interactive.

“The diaphragm and the pelvic floor move in symmetry during respiration,” and pelvic floor tone tightens in anticipation of increased intra-abdominal pressure from a cough, a sneeze, or even a laugh. “These are active structures – the brain can talk to the pelvic floor and make it do something,” she said.

Who’s a good candidate?

Looking at risk factors for pelvic organ prolapse alone, Ms. Hartzell Leggin said these can include age, body mass index, a history of occupational or recreational heavy lifting, chronic cough, and even genetics.

However, one of the most significant risk factors for prolapse of pelvic organs is simply having had a vaginal delivery. Up to 50% of women who have delivered a child vaginally may eventually have some degree of pelvic organ prolapse, though not all women will be symptomatic, Ms. Hartzell Leggin said.

Since postsurgical pelvic organ prolapse rates may top 30% within 2 years, an initial referral for pelvic floor PT is a rational conservative approach, she said. And even if a patient progresses to surgery, PT may be a useful adjunct.

Pelvic floor dysfunction may also be considered if a diastasis recti is discovered on physical exam, or if the patient reports a linear abdominal bulge. Patients with diastasis recti are more likely to have pelvic floor dysfunction than the general population, she said, so it’s worth asking about any related symptoms.

For voiding issues, “conservative treatment is first-line,” said Ms. Hartzell Leggin, so a PT referral for pelvic floor therapy and, in some cases, some behavioral retraining can help with issues of urinary frequency and urgency. These are options that may be considered before prescribing anticholinergic medication, she said.

How does pelvic floor PT work?

When a physician refers a patient for pelvic floor PT, what’s the process? The physical therapy evaluation will begin with history taking, including the chief complaint, past medical and surgical history, and an obstetric/gynecologic/sexual history, said Ms. Hartzell Leggin. Medications are also reviewed.

The physical therapist’s examination should encompass a thorough orthopedic examination, with attention to the lumbar spine and hips, and posture and gait. An external and internal examination of the pelvic floor will look for muscle tone at rest and with strain, and for any defects or prolapse.

Pelvic floor strength is assessed according to ability to contract, with some assessment of strength available through palpation. More quantitative means may include manometry, dynamometry, or the use of progressive weighted vaginal cones.

There’s no single standardized measurement tool to assess pelvic floor strength. Palpation is a valuable tool for an experienced clinician, and it also can provide real-time feedback to the patient as she becomes more aware of her pelvic floor. The discipline is moving toward more standardized terminology, with several reporting scales now available to report pelvic floor strength, said Ms. Hartzell Leggin.

The Pelvic Floor Distress Inventory is a validated tool that captures information about the impact of pelvic floor dysfunction on a patient’s daily functioning. “I think I capture a lot when my patient comes in and completes that form,” said Ms. Hartzell Leggin. The Genitourinary Pain Index is another validated tool that measures urinary symptoms, pain, and associated quality of life impacts. Patients may be asked to keep a home therapy and symptom or voiding diary for additional information.

The pelvic floor PT treatment algorithm will vary, depending on whether there’s underlying hypertonicity or hypotonicity, but will involve pelvic floor exercises, soft tissue mobilization, and consideration of a variety of modalities including electrical stimulation and ultrasound. For hypertonicity, vaginal dilators may be used, while weighted vaginal cones may be used for hypotonicity.

Physical therapists should know when to refer a patient back to a physician and should always work as part of an interdisciplinary team, she said.

Ms. Hartzell Leggin reported that she is the president of Elite Rehabilitation Services in Audubon, Pa.

[email protected]
On Twitter @karioakes

PHILADELPHIA – When a woman is referred for pelvic floor physical therapy, what’s involved? Is there evidence behind the treatments, and what exactly does pelvic floor therapy look like?

Denise Hartzell Leggin, a physical therapist who specializes in pelvic floor dysfunction, reviewed how the female pelvic floor can change with age, and provided the rationale for pelvic floor physical therapy (PT) at the annual meeting of the North American Menopause Society.

“Physical therapists treat musculoskeletal and neuromuscular dysfunctions,” said Ms. Hartzell Leggin. So, when a physician suspects a musculoskeletal cause for pelvic floor dysfunction, a PT referral may be appropriate, she said.

Why refer for PT?

As part of the aging process, pelvic floor dysfunction can coexist with the genitourinary syndrome of menopause (GSM), said Ms. Hartzell. Though the pathophysiology is not always clear, aging does have some effect on the pelvic floor musculature and, together with GSM, can contribute to women’s urogenital symptoms in later life.

These symptoms, she said, can be the harbingers of “a host of clinical conditions,” including urinary incontinence and fecal incontinence, constipation, and bladder-emptying problems. Also, changes in the pelvic musculature from childbirth, surgeries, and hypotonicity or hypertonicity can contribute to sexual dysfunction in later life, said Ms. Hartzell Leggin, who is affiliated with Good Shepherd Penn Partners and in private practice in the Philadelphia area.

The musculature of the pelvic floor functions as more than a bowl for carrying the pelvic organs, Ms. Hartzell Leggin said. The collective muscles and fascia form a sling that fills in the pelvic ring and functions as an integrated system with constant resting tone. But the musculature is also active and interactive.

“The diaphragm and the pelvic floor move in symmetry during respiration,” and pelvic floor tone tightens in anticipation of increased intra-abdominal pressure from a cough, a sneeze, or even a laugh. “These are active structures – the brain can talk to the pelvic floor and make it do something,” she said.

Who’s a good candidate?

Looking at risk factors for pelvic organ prolapse alone, Ms. Hartzell Leggin said these can include age, body mass index, a history of occupational or recreational heavy lifting, chronic cough, and even genetics.

However, one of the most significant risk factors for prolapse of pelvic organs is simply having had a vaginal delivery. Up to 50% of women who have delivered a child vaginally may eventually have some degree of pelvic organ prolapse, though not all women will be symptomatic, Ms. Hartzell Leggin said.

Since postsurgical pelvic organ prolapse rates may top 30% within 2 years, an initial referral for pelvic floor PT is a rational conservative approach, she said. And even if a patient progresses to surgery, PT may be a useful adjunct.

Pelvic floor dysfunction may also be considered if a diastasis recti is discovered on physical exam, or if the patient reports a linear abdominal bulge. Patients with diastasis recti are more likely to have pelvic floor dysfunction than the general population, she said, so it’s worth asking about any related symptoms.

For voiding issues, “conservative treatment is first-line,” said Ms. Hartzell Leggin, so a PT referral for pelvic floor therapy and, in some cases, some behavioral retraining can help with issues of urinary frequency and urgency. These are options that may be considered before prescribing anticholinergic medication, she said.

How does pelvic floor PT work?

When a physician refers a patient for pelvic floor PT, what’s the process? The physical therapy evaluation will begin with history taking, including the chief complaint, past medical and surgical history, and an obstetric/gynecologic/sexual history, said Ms. Hartzell Leggin. Medications are also reviewed.

The physical therapist’s examination should encompass a thorough orthopedic examination, with attention to the lumbar spine and hips, and posture and gait. An external and internal examination of the pelvic floor will look for muscle tone at rest and with strain, and for any defects or prolapse.

Pelvic floor strength is assessed according to ability to contract, with some assessment of strength available through palpation. More quantitative means may include manometry, dynamometry, or the use of progressive weighted vaginal cones.

There’s no single standardized measurement tool to assess pelvic floor strength. Palpation is a valuable tool for an experienced clinician, and it also can provide real-time feedback to the patient as she becomes more aware of her pelvic floor. The discipline is moving toward more standardized terminology, with several reporting scales now available to report pelvic floor strength, said Ms. Hartzell Leggin.

The Pelvic Floor Distress Inventory is a validated tool that captures information about the impact of pelvic floor dysfunction on a patient’s daily functioning. “I think I capture a lot when my patient comes in and completes that form,” said Ms. Hartzell Leggin. The Genitourinary Pain Index is another validated tool that measures urinary symptoms, pain, and associated quality of life impacts. Patients may be asked to keep a home therapy and symptom or voiding diary for additional information.

The pelvic floor PT treatment algorithm will vary, depending on whether there’s underlying hypertonicity or hypotonicity, but will involve pelvic floor exercises, soft tissue mobilization, and consideration of a variety of modalities including electrical stimulation and ultrasound. For hypertonicity, vaginal dilators may be used, while weighted vaginal cones may be used for hypotonicity.

Physical therapists should know when to refer a patient back to a physician and should always work as part of an interdisciplinary team, she said.

Ms. Hartzell Leggin reported that she is the president of Elite Rehabilitation Services in Audubon, Pa.

[email protected]
On Twitter @karioakes

PHILADELPHIA – When a woman is referred for pelvic floor physical therapy, what’s involved? Is there evidence behind the treatments, and what exactly does pelvic floor therapy look like?

Denise Hartzell Leggin, a physical therapist who specializes in pelvic floor dysfunction, reviewed how the female pelvic floor can change with age, and provided the rationale for pelvic floor physical therapy (PT) at the annual meeting of the North American Menopause Society.

“Physical therapists treat musculoskeletal and neuromuscular dysfunctions,” said Ms. Hartzell Leggin. So, when a physician suspects a musculoskeletal cause for pelvic floor dysfunction, a PT referral may be appropriate, she said.

Why refer for PT?

As part of the aging process, pelvic floor dysfunction can coexist with the genitourinary syndrome of menopause (GSM), said Ms. Hartzell. Though the pathophysiology is not always clear, aging does have some effect on the pelvic floor musculature and, together with GSM, can contribute to women’s urogenital symptoms in later life.

These symptoms, she said, can be the harbingers of “a host of clinical conditions,” including urinary incontinence and fecal incontinence, constipation, and bladder-emptying problems. Also, changes in the pelvic musculature from childbirth, surgeries, and hypotonicity or hypertonicity can contribute to sexual dysfunction in later life, said Ms. Hartzell Leggin, who is affiliated with Good Shepherd Penn Partners and in private practice in the Philadelphia area.

The musculature of the pelvic floor functions as more than a bowl for carrying the pelvic organs, Ms. Hartzell Leggin said. The collective muscles and fascia form a sling that fills in the pelvic ring and functions as an integrated system with constant resting tone. But the musculature is also active and interactive.

“The diaphragm and the pelvic floor move in symmetry during respiration,” and pelvic floor tone tightens in anticipation of increased intra-abdominal pressure from a cough, a sneeze, or even a laugh. “These are active structures – the brain can talk to the pelvic floor and make it do something,” she said.

Who’s a good candidate?

Looking at risk factors for pelvic organ prolapse alone, Ms. Hartzell Leggin said these can include age, body mass index, a history of occupational or recreational heavy lifting, chronic cough, and even genetics.

However, one of the most significant risk factors for prolapse of pelvic organs is simply having had a vaginal delivery. Up to 50% of women who have delivered a child vaginally may eventually have some degree of pelvic organ prolapse, though not all women will be symptomatic, Ms. Hartzell Leggin said.

Since postsurgical pelvic organ prolapse rates may top 30% within 2 years, an initial referral for pelvic floor PT is a rational conservative approach, she said. And even if a patient progresses to surgery, PT may be a useful adjunct.

Pelvic floor dysfunction may also be considered if a diastasis recti is discovered on physical exam, or if the patient reports a linear abdominal bulge. Patients with diastasis recti are more likely to have pelvic floor dysfunction than the general population, she said, so it’s worth asking about any related symptoms.

For voiding issues, “conservative treatment is first-line,” said Ms. Hartzell Leggin, so a PT referral for pelvic floor therapy and, in some cases, some behavioral retraining can help with issues of urinary frequency and urgency. These are options that may be considered before prescribing anticholinergic medication, she said.

How does pelvic floor PT work?

When a physician refers a patient for pelvic floor PT, what’s the process? The physical therapy evaluation will begin with history taking, including the chief complaint, past medical and surgical history, and an obstetric/gynecologic/sexual history, said Ms. Hartzell Leggin. Medications are also reviewed.

The physical therapist’s examination should encompass a thorough orthopedic examination, with attention to the lumbar spine and hips, and posture and gait. An external and internal examination of the pelvic floor will look for muscle tone at rest and with strain, and for any defects or prolapse.

Pelvic floor strength is assessed according to ability to contract, with some assessment of strength available through palpation. More quantitative means may include manometry, dynamometry, or the use of progressive weighted vaginal cones.

There’s no single standardized measurement tool to assess pelvic floor strength. Palpation is a valuable tool for an experienced clinician, and it also can provide real-time feedback to the patient as she becomes more aware of her pelvic floor. The discipline is moving toward more standardized terminology, with several reporting scales now available to report pelvic floor strength, said Ms. Hartzell Leggin.

The Pelvic Floor Distress Inventory is a validated tool that captures information about the impact of pelvic floor dysfunction on a patient’s daily functioning. “I think I capture a lot when my patient comes in and completes that form,” said Ms. Hartzell Leggin. The Genitourinary Pain Index is another validated tool that measures urinary symptoms, pain, and associated quality of life impacts. Patients may be asked to keep a home therapy and symptom or voiding diary for additional information.

The pelvic floor PT treatment algorithm will vary, depending on whether there’s underlying hypertonicity or hypotonicity, but will involve pelvic floor exercises, soft tissue mobilization, and consideration of a variety of modalities including electrical stimulation and ultrasound. For hypertonicity, vaginal dilators may be used, while weighted vaginal cones may be used for hypotonicity.

Physical therapists should know when to refer a patient back to a physician and should always work as part of an interdisciplinary team, she said.

Ms. Hartzell Leggin reported that she is the president of Elite Rehabilitation Services in Audubon, Pa.

[email protected]
On Twitter @karioakes

PHILADELPHIA – New clarity from an international consensus report may help guide evaluation of adnexal masses. The report provides guidelines for risk stratification and diagnostic evaluation when an ovarian mass is found.

Accurate and thorough evaluation of an adnexal mass in a menopausal woman must respect cancer prevalence data, Frederick Ueland, MD, one of the report’s coauthors, said at the annual meeting of the North American Menopause Society. In premenopausal women, there are “many tumors, but few cancers,” he said. Only about 15% of ovarian tumors are malignant when found before menopause.

But after menopause, there are “few tumors, but many cancers,” Dr. Ueland said. Up to 50% of tumors in postmenopausal women are malignant, with epithelial ovarian cancer, metastatic cancer, and granulosa cell tumors predominating.

Multiple clinical trials have taught physicians that “tumor morphology helps stratify cancer risk,” he noted.

Ultrasound is the best imaging modality to evaluate adnexal masses, he said. At his institution, the use of a morphology index to guide management of adnexal masses has reduced the number of surgeries performed to remove one cancer over the years, said Dr. Ueland, chief of the division of gynecologic oncology at the University of Kentucky, Lexington.

During the 1990s, when the Morphology Index was first used at the University of Kentucky, surgeons performed 12.5 surgeries per cancer. In the 2000s, that number fell to 5.2, and during the present decade, one cancer is detected in every 4 surgeries, he reported.

Limiting subjectivity is a key to accurate cancer detection when evaluating adnexal masses, so that the dual goals of accurate cancer detection and avoidance of unnecessary surgeries can be met, Dr. Ueland said. To address these dual needs, the first international consensus report on adnexal masses was issued in May 2017 (J Ultrasound Med. 2017 May;36[5]:849-863).

The report noted the sharp discrepancy between surgery rates in the United States and Europe. “In the United States, there are approximately 9.1 surgeries per malignancy, compared with the European International Ovarian Tumor Analysis center trials, with only 2.3 (oncology centers) and 5.9 (other centers) reported surgeries per malignancy, suggesting that there is room to improve our preoperative assessments,” the investigators wrote.

In reviewing management guidelines, Dr. Ueland said that, when the risk of malignancy is low, as with smooth-walled, unilocular or septate cysts, the mass can be monitored without surgery, with ultrasound reevaluation at the 6-month mark. If there are no concerning changes, the mass can then be imaged annually for 5 years. No further follow-up is needed at the 5-year mark, barring growth or other changes of the mass.

If the ultrasound evaluation of the mass shows intermediate risk, then secondary testing is needed. Masses that show as partly solid or that have small, irregular wall abnormalities, or atypical nonpapillary projections on ultrasound fall into this category. Secondary testing may be accomplished either by serial ultrasound or by using biomarker testing.

Commercially available triage biomarker tests such as OVA1, ROMA, and Overa may offer higher detection rates than cancer antigen 125 (CA 125) testing alone, Dr. Ueland said. For instance, OVA1, a multivariate index assay, detected 76% of malignancies missed by CA 125 (Am J Obstet Gynecol. 2016 Jul;215[1]:82.e1-11).

If the mass has high-risk characteristics, then a prompt surgical referral to a gynecologic oncologist is a must. Included in this category are mostly solid masses and those with papillary projections, as well as those associated with any ascites. No secondary testing or watchful waiting is recommended in these cases, said Dr. Ueland, since they carry a greater than 25% risk of malignancy.

Dr. Ueland is currently enrolling patients in a clinical trial to assess whether serial transvaginal ultrasonography with Morphology Index can reduce false-positive results by more accurately distinguishing benign from malignant ovarian tumors. He reported having no financial disclosures.

[email protected]
On Twitter @karioakes

PHILADELPHIA – New clarity from an international consensus report may help guide evaluation of adnexal masses. The report provides guidelines for risk stratification and diagnostic evaluation when an ovarian mass is found.

Accurate and thorough evaluation of an adnexal mass in a menopausal woman must respect cancer prevalence data, Frederick Ueland, MD, one of the report’s coauthors, said at the annual meeting of the North American Menopause Society. In premenopausal women, there are “many tumors, but few cancers,” he said. Only about 15% of ovarian tumors are malignant when found before menopause.

But after menopause, there are “few tumors, but many cancers,” Dr. Ueland said. Up to 50% of tumors in postmenopausal women are malignant, with epithelial ovarian cancer, metastatic cancer, and granulosa cell tumors predominating.

Multiple clinical trials have taught physicians that “tumor morphology helps stratify cancer risk,” he noted.

Ultrasound is the best imaging modality to evaluate adnexal masses, he said. At his institution, the use of a morphology index to guide management of adnexal masses has reduced the number of surgeries performed to remove one cancer over the years, said Dr. Ueland, chief of the division of gynecologic oncology at the University of Kentucky, Lexington.

During the 1990s, when the Morphology Index was first used at the University of Kentucky, surgeons performed 12.5 surgeries per cancer. In the 2000s, that number fell to 5.2, and during the present decade, one cancer is detected in every 4 surgeries, he reported.

Limiting subjectivity is a key to accurate cancer detection when evaluating adnexal masses, so that the dual goals of accurate cancer detection and avoidance of unnecessary surgeries can be met, Dr. Ueland said. To address these dual needs, the first international consensus report on adnexal masses was issued in May 2017 (J Ultrasound Med. 2017 May;36[5]:849-863).

The report noted the sharp discrepancy between surgery rates in the United States and Europe. “In the United States, there are approximately 9.1 surgeries per malignancy, compared with the European International Ovarian Tumor Analysis center trials, with only 2.3 (oncology centers) and 5.9 (other centers) reported surgeries per malignancy, suggesting that there is room to improve our preoperative assessments,” the investigators wrote.

In reviewing management guidelines, Dr. Ueland said that, when the risk of malignancy is low, as with smooth-walled, unilocular or septate cysts, the mass can be monitored without surgery, with ultrasound reevaluation at the 6-month mark. If there are no concerning changes, the mass can then be imaged annually for 5 years. No further follow-up is needed at the 5-year mark, barring growth or other changes of the mass.

If the ultrasound evaluation of the mass shows intermediate risk, then secondary testing is needed. Masses that show as partly solid or that have small, irregular wall abnormalities, or atypical nonpapillary projections on ultrasound fall into this category. Secondary testing may be accomplished either by serial ultrasound or by using biomarker testing.

Commercially available triage biomarker tests such as OVA1, ROMA, and Overa may offer higher detection rates than cancer antigen 125 (CA 125) testing alone, Dr. Ueland said. For instance, OVA1, a multivariate index assay, detected 76% of malignancies missed by CA 125 (Am J Obstet Gynecol. 2016 Jul;215[1]:82.e1-11).

If the mass has high-risk characteristics, then a prompt surgical referral to a gynecologic oncologist is a must. Included in this category are mostly solid masses and those with papillary projections, as well as those associated with any ascites. No secondary testing or watchful waiting is recommended in these cases, said Dr. Ueland, since they carry a greater than 25% risk of malignancy.

Dr. Ueland is currently enrolling patients in a clinical trial to assess whether serial transvaginal ultrasonography with Morphology Index can reduce false-positive results by more accurately distinguishing benign from malignant ovarian tumors. He reported having no financial disclosures.

[email protected]
On Twitter @karioakes

PHILADELPHIA – New clarity from an international consensus report may help guide evaluation of adnexal masses. The report provides guidelines for risk stratification and diagnostic evaluation when an ovarian mass is found.

Accurate and thorough evaluation of an adnexal mass in a menopausal woman must respect cancer prevalence data, Frederick Ueland, MD, one of the report’s coauthors, said at the annual meeting of the North American Menopause Society. In premenopausal women, there are “many tumors, but few cancers,” he said. Only about 15% of ovarian tumors are malignant when found before menopause.

But after menopause, there are “few tumors, but many cancers,” Dr. Ueland said. Up to 50% of tumors in postmenopausal women are malignant, with epithelial ovarian cancer, metastatic cancer, and granulosa cell tumors predominating.

Multiple clinical trials have taught physicians that “tumor morphology helps stratify cancer risk,” he noted.

Ultrasound is the best imaging modality to evaluate adnexal masses, he said. At his institution, the use of a morphology index to guide management of adnexal masses has reduced the number of surgeries performed to remove one cancer over the years, said Dr. Ueland, chief of the division of gynecologic oncology at the University of Kentucky, Lexington.

During the 1990s, when the Morphology Index was first used at the University of Kentucky, surgeons performed 12.5 surgeries per cancer. In the 2000s, that number fell to 5.2, and during the present decade, one cancer is detected in every 4 surgeries, he reported.

Limiting subjectivity is a key to accurate cancer detection when evaluating adnexal masses, so that the dual goals of accurate cancer detection and avoidance of unnecessary surgeries can be met, Dr. Ueland said. To address these dual needs, the first international consensus report on adnexal masses was issued in May 2017 (J Ultrasound Med. 2017 May;36[5]:849-863).

The report noted the sharp discrepancy between surgery rates in the United States and Europe. “In the United States, there are approximately 9.1 surgeries per malignancy, compared with the European International Ovarian Tumor Analysis center trials, with only 2.3 (oncology centers) and 5.9 (other centers) reported surgeries per malignancy, suggesting that there is room to improve our preoperative assessments,” the investigators wrote.

In reviewing management guidelines, Dr. Ueland said that, when the risk of malignancy is low, as with smooth-walled, unilocular or septate cysts, the mass can be monitored without surgery, with ultrasound reevaluation at the 6-month mark. If there are no concerning changes, the mass can then be imaged annually for 5 years. No further follow-up is needed at the 5-year mark, barring growth or other changes of the mass.

If the ultrasound evaluation of the mass shows intermediate risk, then secondary testing is needed. Masses that show as partly solid or that have small, irregular wall abnormalities, or atypical nonpapillary projections on ultrasound fall into this category. Secondary testing may be accomplished either by serial ultrasound or by using biomarker testing.

Commercially available triage biomarker tests such as OVA1, ROMA, and Overa may offer higher detection rates than cancer antigen 125 (CA 125) testing alone, Dr. Ueland said. For instance, OVA1, a multivariate index assay, detected 76% of malignancies missed by CA 125 (Am J Obstet Gynecol. 2016 Jul;215[1]:82.e1-11).

If the mass has high-risk characteristics, then a prompt surgical referral to a gynecologic oncologist is a must. Included in this category are mostly solid masses and those with papillary projections, as well as those associated with any ascites. No secondary testing or watchful waiting is recommended in these cases, said Dr. Ueland, since they carry a greater than 25% risk of malignancy.

Dr. Ueland is currently enrolling patients in a clinical trial to assess whether serial transvaginal ultrasonography with Morphology Index can reduce false-positive results by more accurately distinguishing benign from malignant ovarian tumors. He reported having no financial disclosures.

[email protected]
On Twitter @karioakes

Surgeons treated 95% of preoperatively diagnosed cases of papillary thyroid microcarcinoma with total thyroidectomy, compared with only 69% of postoperatively diagnosed cases, in to a single-center retrospective cohort study.

“During the study period, thyroid lobectomy was an acceptable alternative endorsed by the American Thyroid Association,” said Susan C. Pitt, MD, and her associates at the University of Wisconsin, Madison. “Nonetheless, documentation rarely stated that [thyroid lobectomy] was discussed as an option. Whether this finding indicates a true lack of discussion or a deficit in documentation is unclear, but emphasizes the need to improve the quality of the [electronic health record] and capture all elements of shared decision-making.”

Papillary thyroid microcarcinomas (PTMC) measure 1 cm or less, affect up to a third of adults, and explain about half of the recent rise in rates of papillary thyroid cancer, the investigators stated. Most cases are found incidentally and there is no evidence that they contribute to a rise in mortality, which stands at about 0.5 deaths per 100,000 diagnoses of thyroid carcinoma. Accordingly, in 2015, the American Thyroid Association (ATA) endorsed active surveillance and thyroid lobectomy as acceptable management strategies for most patients with PTMC (Thyroid. 2016 Jan 12;26[1]:1-133).

“The pendulum for the ATA guidelines has swung back and forth,” Dr. Pitt said in an interview. “I think the current 2015 ATA guidelines are still controversial – some surgeons and endocrinologists think we have swung too far [in the other direction]. Moving the field from total thyroidectomy to active surveillance is a big jump. Understanding the factors underlying current decisions will help us to implement less extensive management, like lobectomy and active surveillance.”

To do that, Dr. Pitt and her associates reviewed medical records from 125 patients with PTMC treated at the University of Wisconsin between 2008 and 2016. Most of the patients (90%) were white, 85% were female, average age was 50 years, and nearly all had classic or follicular-variant disease. Only 27% of patients underwent thyroid lobectomy; the rest underwent total thyroidectomy. Furthermore, among 19 patients diagnosed preoperatively, 95% underwent total thyroidectomy and 21% had a complication, including one (5%) case of permanent hypocalcemia that less extensive surgery might have avoided (J Surg Res. 2017;218:237-45).

“In all cases, documentation indicated that these preoperatively diagnosed patients followed the surgeon’s recommendation regarding the extent of surgery,” the researchers wrote. Surgeons cited various reasons for recommending total thyroidectomy, including – in about 20% of cases – a belief that it was the recommended treatment.

Only one of the 19 preoperatively diagnosed patients had a documented discussion of thyroid lobectomy, the researchers found.

While physicians might be concerned about recurrence or other “downstream” outcomes of a less-is-more approach to PTMC, Dr. Pitt noted that, in a recent large study, only 3.4% of these tumors metastasized over 10 years (World J Surg. 2010 Jan;34[1]:28-35).

“At the same time, I think that we have a better sense [that] patient-centered outcomes after thyroidectomy, such as health-related quality of life, swallowing, and voice outcomes, can be worse after a total thyroidectomy,” she added.

As surgical and medical therapies expand for PTMC and other nonmalignant diseases, it becomes increasingly vital that surgeons and patients undertake shared decision-making, she said. At the University of Wisconsin, physicians can enter free text in the EHR to document such discussions. She gave an example of how she does that: “‘Total thyroidectomy and lobectomy are both appropriate approaches for Ms. Smith. We discussed these options at length, including X, Y, and Z. Given Mrs. Smith’s (strong) preference to avoid X, we will proceed with a lobectomy.”

In her own practice, Dr. Pitt added, “when I look back at a note, I want to know what the decision was, and why it was made.”

Shared decision-making differs from informed consent by focusing on patient preferences, she noted. “I have used my notes in the operating room to help me decide what to do. I can look back and have a window into our conversation and what an individual patient values.” For PTMC, shared decisions should focus less on cancer risk and more on quality of life and outcomes a year later, she said.

“Patients don’t die from PTMC, and most live longer than the age-matched population. Given the risks of more extensive surgery and our current data on surgical and patient-centered outcomes, I think that thyroid lobectomy should be the initial treatment for most patients with PTMC, and surgeons should help their patients make informed decisions,” Dr. Pitt said.

The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.

Surgeons treated 95% of preoperatively diagnosed cases of papillary thyroid microcarcinoma with total thyroidectomy, compared with only 69% of postoperatively diagnosed cases, in to a single-center retrospective cohort study.

“During the study period, thyroid lobectomy was an acceptable alternative endorsed by the American Thyroid Association,” said Susan C. Pitt, MD, and her associates at the University of Wisconsin, Madison. “Nonetheless, documentation rarely stated that [thyroid lobectomy] was discussed as an option. Whether this finding indicates a true lack of discussion or a deficit in documentation is unclear, but emphasizes the need to improve the quality of the [electronic health record] and capture all elements of shared decision-making.”

Papillary thyroid microcarcinomas (PTMC) measure 1 cm or less, affect up to a third of adults, and explain about half of the recent rise in rates of papillary thyroid cancer, the investigators stated. Most cases are found incidentally and there is no evidence that they contribute to a rise in mortality, which stands at about 0.5 deaths per 100,000 diagnoses of thyroid carcinoma. Accordingly, in 2015, the American Thyroid Association (ATA) endorsed active surveillance and thyroid lobectomy as acceptable management strategies for most patients with PTMC (Thyroid. 2016 Jan 12;26[1]:1-133).

“The pendulum for the ATA guidelines has swung back and forth,” Dr. Pitt said in an interview. “I think the current 2015 ATA guidelines are still controversial – some surgeons and endocrinologists think we have swung too far [in the other direction]. Moving the field from total thyroidectomy to active surveillance is a big jump. Understanding the factors underlying current decisions will help us to implement less extensive management, like lobectomy and active surveillance.”

To do that, Dr. Pitt and her associates reviewed medical records from 125 patients with PTMC treated at the University of Wisconsin between 2008 and 2016. Most of the patients (90%) were white, 85% were female, average age was 50 years, and nearly all had classic or follicular-variant disease. Only 27% of patients underwent thyroid lobectomy; the rest underwent total thyroidectomy. Furthermore, among 19 patients diagnosed preoperatively, 95% underwent total thyroidectomy and 21% had a complication, including one (5%) case of permanent hypocalcemia that less extensive surgery might have avoided (J Surg Res. 2017;218:237-45).

“In all cases, documentation indicated that these preoperatively diagnosed patients followed the surgeon’s recommendation regarding the extent of surgery,” the researchers wrote. Surgeons cited various reasons for recommending total thyroidectomy, including – in about 20% of cases – a belief that it was the recommended treatment.

Only one of the 19 preoperatively diagnosed patients had a documented discussion of thyroid lobectomy, the researchers found.

While physicians might be concerned about recurrence or other “downstream” outcomes of a less-is-more approach to PTMC, Dr. Pitt noted that, in a recent large study, only 3.4% of these tumors metastasized over 10 years (World J Surg. 2010 Jan;34[1]:28-35).

“At the same time, I think that we have a better sense [that] patient-centered outcomes after thyroidectomy, such as health-related quality of life, swallowing, and voice outcomes, can be worse after a total thyroidectomy,” she added.

As surgical and medical therapies expand for PTMC and other nonmalignant diseases, it becomes increasingly vital that surgeons and patients undertake shared decision-making, she said. At the University of Wisconsin, physicians can enter free text in the EHR to document such discussions. She gave an example of how she does that: “‘Total thyroidectomy and lobectomy are both appropriate approaches for Ms. Smith. We discussed these options at length, including X, Y, and Z. Given Mrs. Smith’s (strong) preference to avoid X, we will proceed with a lobectomy.”

In her own practice, Dr. Pitt added, “when I look back at a note, I want to know what the decision was, and why it was made.”

Shared decision-making differs from informed consent by focusing on patient preferences, she noted. “I have used my notes in the operating room to help me decide what to do. I can look back and have a window into our conversation and what an individual patient values.” For PTMC, shared decisions should focus less on cancer risk and more on quality of life and outcomes a year later, she said.

“Patients don’t die from PTMC, and most live longer than the age-matched population. Given the risks of more extensive surgery and our current data on surgical and patient-centered outcomes, I think that thyroid lobectomy should be the initial treatment for most patients with PTMC, and surgeons should help their patients make informed decisions,” Dr. Pitt said.

The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.

Surgeons treated 95% of preoperatively diagnosed cases of papillary thyroid microcarcinoma with total thyroidectomy, compared with only 69% of postoperatively diagnosed cases, in to a single-center retrospective cohort study.

“During the study period, thyroid lobectomy was an acceptable alternative endorsed by the American Thyroid Association,” said Susan C. Pitt, MD, and her associates at the University of Wisconsin, Madison. “Nonetheless, documentation rarely stated that [thyroid lobectomy] was discussed as an option. Whether this finding indicates a true lack of discussion or a deficit in documentation is unclear, but emphasizes the need to improve the quality of the [electronic health record] and capture all elements of shared decision-making.”

Papillary thyroid microcarcinomas (PTMC) measure 1 cm or less, affect up to a third of adults, and explain about half of the recent rise in rates of papillary thyroid cancer, the investigators stated. Most cases are found incidentally and there is no evidence that they contribute to a rise in mortality, which stands at about 0.5 deaths per 100,000 diagnoses of thyroid carcinoma. Accordingly, in 2015, the American Thyroid Association (ATA) endorsed active surveillance and thyroid lobectomy as acceptable management strategies for most patients with PTMC (Thyroid. 2016 Jan 12;26[1]:1-133).

“The pendulum for the ATA guidelines has swung back and forth,” Dr. Pitt said in an interview. “I think the current 2015 ATA guidelines are still controversial – some surgeons and endocrinologists think we have swung too far [in the other direction]. Moving the field from total thyroidectomy to active surveillance is a big jump. Understanding the factors underlying current decisions will help us to implement less extensive management, like lobectomy and active surveillance.”

To do that, Dr. Pitt and her associates reviewed medical records from 125 patients with PTMC treated at the University of Wisconsin between 2008 and 2016. Most of the patients (90%) were white, 85% were female, average age was 50 years, and nearly all had classic or follicular-variant disease. Only 27% of patients underwent thyroid lobectomy; the rest underwent total thyroidectomy. Furthermore, among 19 patients diagnosed preoperatively, 95% underwent total thyroidectomy and 21% had a complication, including one (5%) case of permanent hypocalcemia that less extensive surgery might have avoided (J Surg Res. 2017;218:237-45).

“In all cases, documentation indicated that these preoperatively diagnosed patients followed the surgeon’s recommendation regarding the extent of surgery,” the researchers wrote. Surgeons cited various reasons for recommending total thyroidectomy, including – in about 20% of cases – a belief that it was the recommended treatment.

Only one of the 19 preoperatively diagnosed patients had a documented discussion of thyroid lobectomy, the researchers found.

While physicians might be concerned about recurrence or other “downstream” outcomes of a less-is-more approach to PTMC, Dr. Pitt noted that, in a recent large study, only 3.4% of these tumors metastasized over 10 years (World J Surg. 2010 Jan;34[1]:28-35).

“At the same time, I think that we have a better sense [that] patient-centered outcomes after thyroidectomy, such as health-related quality of life, swallowing, and voice outcomes, can be worse after a total thyroidectomy,” she added.

As surgical and medical therapies expand for PTMC and other nonmalignant diseases, it becomes increasingly vital that surgeons and patients undertake shared decision-making, she said. At the University of Wisconsin, physicians can enter free text in the EHR to document such discussions. She gave an example of how she does that: “‘Total thyroidectomy and lobectomy are both appropriate approaches for Ms. Smith. We discussed these options at length, including X, Y, and Z. Given Mrs. Smith’s (strong) preference to avoid X, we will proceed with a lobectomy.”

In her own practice, Dr. Pitt added, “when I look back at a note, I want to know what the decision was, and why it was made.”

Shared decision-making differs from informed consent by focusing on patient preferences, she noted. “I have used my notes in the operating room to help me decide what to do. I can look back and have a window into our conversation and what an individual patient values.” For PTMC, shared decisions should focus less on cancer risk and more on quality of life and outcomes a year later, she said.

“Patients don’t die from PTMC, and most live longer than the age-matched population. Given the risks of more extensive surgery and our current data on surgical and patient-centered outcomes, I think that thyroid lobectomy should be the initial treatment for most patients with PTMC, and surgeons should help their patients make informed decisions,” Dr. Pitt said.

The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.

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Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Visit the NAMS annual meetings website

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Visit the NAMS annual meetings website

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.