As the population of patients with limited English proficiency increases throughout English-speaking countries, health care providers often need translator services. Medical translator smartphone applications (apps) are useful tools that can provide ad hoc translator services.

According to the US Census Bureau in 2015, more than 60 million individuals — about 19% of Americans — reported speaking a language other than English at home, and more than 25 million said that they speak English “less than very well.”^1,2 The top 5 non-English languages spoken at home were Spanish, French, Chinese, Tagalog, and Vietnamese, encompassing 72% of non-English speakers.

In the health care sector, translator services are essential for providing accurate and culturally competent care. Current options for translator services include face-to-face interpreters, phone-based translator services, and translator apps on mobile devices. In settings where face-to-face interpreters or phone-based translator services are not available, translator apps may provide reasonable alternatives. My colleagues, Dr. Amrin Khander and Dr. Sara Farag, and I identified and evaluated medical translator apps that are available from the Apple iTunes and Google Play stores to aid clinicians in using such apps during clinical encounters.³

Three types of translator apps

Preset medical phrase translator apps require the user to search for or find a question or statement in order to facilitate a conversation. With these types of apps, a health care provider can choose fully conjugated sentences, which then can be played or read back to the patient in the chosen translated language. Within this group of apps, Canopy Speak and Universal Doctor Speaker are highly accessible, since both apps are available from the Apple iTunes and Google Play stores and both are free.

Medical dictionary apps require the user to search for a medical term in one language to receive a translation in another language. These apps are less useful, but they can help providers find and define specific terms in a given language.

General language translator apps require the user to enter a term, statement, or question in one language and then provide a translation in another language. Google Translate and Vocre Translate are examples.

The top recommended translator apps are listed in the TABLE alphabetically and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).⁴ I hope the apps described here will help you enhance communication with your patients who have limited English proficiency.

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.

As the population of patients with limited English proficiency increases throughout English-speaking countries, health care providers often need translator services. Medical translator smartphone applications (apps) are useful tools that can provide ad hoc translator services.

According to the US Census Bureau in 2015, more than 60 million individuals — about 19% of Americans — reported speaking a language other than English at home, and more than 25 million said that they speak English “less than very well.”^1,2 The top 5 non-English languages spoken at home were Spanish, French, Chinese, Tagalog, and Vietnamese, encompassing 72% of non-English speakers.

In the health care sector, translator services are essential for providing accurate and culturally competent care. Current options for translator services include face-to-face interpreters, phone-based translator services, and translator apps on mobile devices. In settings where face-to-face interpreters or phone-based translator services are not available, translator apps may provide reasonable alternatives. My colleagues, Dr. Amrin Khander and Dr. Sara Farag, and I identified and evaluated medical translator apps that are available from the Apple iTunes and Google Play stores to aid clinicians in using such apps during clinical encounters.³

Three types of translator apps

Preset medical phrase translator apps require the user to search for or find a question or statement in order to facilitate a conversation. With these types of apps, a health care provider can choose fully conjugated sentences, which then can be played or read back to the patient in the chosen translated language. Within this group of apps, Canopy Speak and Universal Doctor Speaker are highly accessible, since both apps are available from the Apple iTunes and Google Play stores and both are free.

Medical dictionary apps require the user to search for a medical term in one language to receive a translation in another language. These apps are less useful, but they can help providers find and define specific terms in a given language.

General language translator apps require the user to enter a term, statement, or question in one language and then provide a translation in another language. Google Translate and Vocre Translate are examples.

The top recommended translator apps are listed in the TABLE alphabetically and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).⁴ I hope the apps described here will help you enhance communication with your patients who have limited English proficiency.

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.

As the population of patients with limited English proficiency increases throughout English-speaking countries, health care providers often need translator services. Medical translator smartphone applications (apps) are useful tools that can provide ad hoc translator services.

According to the US Census Bureau in 2015, more than 60 million individuals — about 19% of Americans — reported speaking a language other than English at home, and more than 25 million said that they speak English “less than very well.”^1,2 The top 5 non-English languages spoken at home were Spanish, French, Chinese, Tagalog, and Vietnamese, encompassing 72% of non-English speakers.

In the health care sector, translator services are essential for providing accurate and culturally competent care. Current options for translator services include face-to-face interpreters, phone-based translator services, and translator apps on mobile devices. In settings where face-to-face interpreters or phone-based translator services are not available, translator apps may provide reasonable alternatives. My colleagues, Dr. Amrin Khander and Dr. Sara Farag, and I identified and evaluated medical translator apps that are available from the Apple iTunes and Google Play stores to aid clinicians in using such apps during clinical encounters.³

Three types of translator apps

Preset medical phrase translator apps require the user to search for or find a question or statement in order to facilitate a conversation. With these types of apps, a health care provider can choose fully conjugated sentences, which then can be played or read back to the patient in the chosen translated language. Within this group of apps, Canopy Speak and Universal Doctor Speaker are highly accessible, since both apps are available from the Apple iTunes and Google Play stores and both are free.

Medical dictionary apps require the user to search for a medical term in one language to receive a translation in another language. These apps are less useful, but they can help providers find and define specific terms in a given language.

General language translator apps require the user to enter a term, statement, or question in one language and then provide a translation in another language. Google Translate and Vocre Translate are examples.

The top recommended translator apps are listed in the TABLE alphabetically and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).⁴ I hope the apps described here will help you enhance communication with your patients who have limited English proficiency.

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.

Routine use of low-dose oxygen supplementation in the first days after stroke doesn’t improve overall survival or reduce disability, according to a large new study.

The poststroke death and disability odds ratio was 0.97 for those receiving one of two continuous low-dose oxygen protocols, compared with the control group (95% confidence interval, 0.89-1.05; P = .47).

Photodisc/ThinkStock

[email protected]

On Twitter @karioakes

Routine use of low-dose oxygen supplementation in the first days after stroke doesn’t improve overall survival or reduce disability, according to a large new study.

The poststroke death and disability odds ratio was 0.97 for those receiving one of two continuous low-dose oxygen protocols, compared with the control group (95% confidence interval, 0.89-1.05; P = .47).

Photodisc/ThinkStock

[email protected]

On Twitter @karioakes

Routine use of low-dose oxygen supplementation in the first days after stroke doesn’t improve overall survival or reduce disability, according to a large new study.

The poststroke death and disability odds ratio was 0.97 for those receiving one of two continuous low-dose oxygen protocols, compared with the control group (95% confidence interval, 0.89-1.05; P = .47).

Photodisc/ThinkStock

[email protected]

On Twitter @karioakes

Sen. Susan Collins (R-Maine) became the third GOP senator to confirm a no vote on the latest Republican attempt to repeal and replace the Affordable Care Act (ACA), a move that likely seals the bill’s fate.

The bill has the support of President Trump and many GOP leaders but has been roundly criticized by medical groups for insuring fewer Americans, failing to provide adequate protections for people with preexisting conditions, and barring Planned Parenthood from Medicaid participation.

designer491/Thinkstock

[email protected]

Sen. Susan Collins (R-Maine) became the third GOP senator to confirm a no vote on the latest Republican attempt to repeal and replace the Affordable Care Act (ACA), a move that likely seals the bill’s fate.

The bill has the support of President Trump and many GOP leaders but has been roundly criticized by medical groups for insuring fewer Americans, failing to provide adequate protections for people with preexisting conditions, and barring Planned Parenthood from Medicaid participation.

designer491/Thinkstock

[email protected]

Sen. Susan Collins (R-Maine) became the third GOP senator to confirm a no vote on the latest Republican attempt to repeal and replace the Affordable Care Act (ACA), a move that likely seals the bill’s fate.

The bill has the support of President Trump and many GOP leaders but has been roundly criticized by medical groups for insuring fewer Americans, failing to provide adequate protections for people with preexisting conditions, and barring Planned Parenthood from Medicaid participation.

designer491/Thinkstock

[email protected]

MY STORY: Prologue

My aunt received a breast cancer diagnosis at age 40, and she died at age 60, in 1970. Then, in 1975, my mother’s breast cancer was found at age 55, but only after she was examined for nipple retraction; on mammography, the cancer had been obscured by dense breast tissue. Mom had 2 metastatic nodes but participated in the earliest clinical trials of chemotherapy and lived free of breast cancer for another 41 years. Naturally I thought that, were I to develop this disease, I would want it found earlier. Ironically, it was, but only because I had spent my career trying to understand the optimal screening approaches for women with dense breasts—women like me.

Cancers are masked on mammography in dense breasts

For women, screening mammography is an important step in reducing the risk of dying from breast cancer. The greatest benefits are realized by those who start annual screening at age 40, or 45 at the latest.¹ As it takes 9 to 10 years to see a benefit from breast cancer screening at the population level, it is not logical to continue this testing when life expectancy is less than 10 years, as is the case with women age 85 or older, even those in the healthiest quartile.^2–4 However, despite recent advances, the development of 3D mammography (tomosynthesis) (FIGURE 1) in particular, cancers can still be masked by dense breast tissue. Both 2D and 3D mammograms are x-rays; both dense tissue and cancers absorb x-rays and appear white.

Breast density is determined on mammography and is categorized as fatty, scattered fibroglandular, heterogeneously dense, or extremely dense (FIGURE 2).⁵ Tissue in the heterogeneous and extreme categories is considered dense. More than half of women in their 40s have dense breasts; with some fatty involution occurring around menopause, the proportion drops to 25% for women in their 60s.⁶ About half of breast cancers have calcifications, which on mammography are usually easily visible even in dense breasts. The problem is with noncalcified invasive cancers that can be hidden by dense tissue (FIGURE 3).

3D mammography improves cancer detection but is of minimal benefit in extremely dense breasts

Although 3D mammography improves cancer detection in most women, any benefit is minimal in women with extremely dense breasts, as there is no inherent soft-tissue contrast.⁷ Masked cancers are often only discovered because of a lump after a normal screening mammogram, as so-called “interval cancers.” Compared with screen-detected cancers, interval cancers tend to be more biologically aggressive, to have spread to lymph nodes, and to have worse prognoses. However, even some small screen-detected cancers are biologically aggressive and can spread to lymph nodes quickly, and no screening test or combination of screening tests can prevent this occurrence completely, regardless of breast density.

Related article:
Get smart about dense breasts

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT/COURTESY OF WENDIE A. BERG, MD, PHD

MRI provides early detection across all breast densities

In all tissue densities, contrast-enhanced magnetic resonance imaging (MRI) is far better than mammography in detecting breast cancer.⁸ Women at high risk for breast cancer caused by mutations in BRCA1, BRCA2, p53, and other genes have poor outcomes with screening mammography alone—up to 50% of cancers are interval cancers. Annual screening MRI reduces this percentage significantly, to 11% in women with pathogenic BRCA1 mutations and to 4% in women with BRCA2 mutations.⁹ Warner and colleagues found a decrease in late-stage cancers in high-risk women who underwent annual MRI screenings compared to high-risk women unable to have MRI.¹⁰

The use of MRI for screening is limited by availability, patient tolerance,¹¹ and high cost. Research is being conducted to further validate approaches using shortened screening MRI times (so-called “abbreviated” or “fast” MRI) and, thereby, improve access, tolerance, and reduce associated costs; several investigators already have reported promising results, and a few centers offer this modality directly to patients willing to pay $300 to $350 out of pocket.^12,13 Even in normal-risk women, MRI significantly increases detection of early breast cancer after a normal mammogram and ultrasound, and the cancer detection benefit of MRI is seen across all breast densities.¹⁴

Most health insurance plans cover screening MRI only for women who meet defined risk criteria, including women who have a known disease-causing mutation—or are suspected of having one, given a family history of breast cancer with higher than 20% to 25% lifetime risk by a model that predicts mutation carrier status—as well as women who had chest radiation therapy before age 30, typically for Hodgkin lymphoma, and at least 8 years earlier.¹⁵ In addition, MRI can be considered in women with atypical breast biopsy results or a personal history of lobular carcinoma in situ (LCIS).¹⁶

Screening MRI should start by age 25 in women with disease-causing mutations, or at the time of atypical or LCIS biopsy results, and should be performed annually unless the woman is pregnant or has a metallic implant, renal insufficiency, or another contraindication to MRI. MRI can be beneficial in women with a personal history of cancer, although annual mammography remains the standard of care.^17–19

MRI and mammography can be performed at the same time or on an alternating 6-month basis, with mammography usually starting only after age 30 because of the small risk that radiation poses for younger women. There are a few other impediments to having breast MRI: The woman must lie on her stomach within a confined space (tunnel), the contrast that is injected may not be well tolerated, and insurance does not cover the test for women who do not meet the defined risk criteria.¹¹

Read why mammography supplemented by US is best for women with dense breasts.

Ultrasonography supplements mammography

Mammography supplemented with ultrasonography (US) has been studied as a “Goldilocks” or best-fit solution for the screening of women with dense breasts, as detection of invasive cancers is improved with the 2 modalities over mammography alone, and US is less invasive, better tolerated, and lower in cost than the more sensitive MRI.

In women with dense breasts, US has been found to improve cancer detection over mammography alone, and early results suggest a larger cancer detection benefit from US than from 3D mammography, although research is ongoing.²⁰ Adding US reduces the interval cancer rate in women with dense breasts to less than 10% of all cancers found—similar to results for women with fatty breasts.^17,21,22

US can be performed by a trained technologist or a physician using a small transducer, which usually provides diagnostic images (so that most callbacks would be for a true finding), or a larger transducer and an automated system can be used to create more than a thousand images for radiologist review.^23,24 Use of a hybrid system, a small transducer with an automated arm, has been validated as well.²⁵ Screening US is not available universally, and with all these approaches optimal performance requires trained personnel. Supplemental screening US usually is covered by insurance but is nearly always subject to a deductible/copay.

Related article:
Educate patients about dense breasts and cancer risk

Reducing false-positives, callbacks, and additional testing

Mammography carries a risk of false-positives. On average, 11% to 12% of women are called back for additional testing after a screening mammogram, and in more than 95% of women brought back for extra testing, no cancer is found.²⁶ Women with dense breasts are more likely than those with less dense breasts to be called back.²⁷ US and MRI improve cancer detection and therefore yield additional positive, but also false-positive, findings. Notably, callbacks decrease after the first round of screening with any modality or combination of tests, as long as prior examinations are available for comparison.

One advantage of 3D over 2D mammography is a decrease in extra testing for areas of asymmetry, which are often recognizable on 3D mammography as representing normal superimposed tissue.^28–30 Architectural distortion, which is better seen on 3D mammography and usually represents either cancer or a benign radial scar, can lead to false-positive biopsies, although the average biopsy rate is no higher for 3D than for 2D alone.³¹ Typically, the 3D and 2D examinations are performed together (slightly more than doubling the radiation dose), or synthetic 2D images can be created from the 3D slices (resulting in a total radiation dose almost the same as standard 2D alone).

Most additional cancers seen on 3D mammography or US are lower-grade invasive cancers with good prognoses. Some aggressive high-grade breast cancers go undetected even when mammography is supplemented with US, either because they are too small to be seen or because they resemble common benign masses and may not be recognized. MRI is particularly effective in depicting high-grade cancers, even small ones.

The TABLE summarizes the relative rates of cancer detection and additional testing by various breast screening tests or combinations of tests. Neither clinical breast examination by a physician or other health care professional nor routine breast self-examination reduces the number of deaths caused by breast cancer. Nevertheless, women should monitor any changes in their breasts and report these changes to their clinician. A new lump, skin or nipple retraction, or a spontaneous clear or bloody nipple discharge merits diagnostic breast imaging even if a recent screening mammogram was normal.

Read how to take advantage of today’s technology for breast density screening

MY STORY: Epilogue

My annual 3D mammograms were normal, even the year my cancer was present. In 2014, I entered my family history into the IBIS Breast Cancer Risk Evaluation Tool (Tyrer-Cuzick model of breast cancer risk) (http://www.ems-trials.org/riskevaluator/) and calculated my lifetime risk at 19.7%. That is when I decided to have a screening MRI. My invasive breast cancer was easily seen on MRI and then on US. The cancer was node-negative, easily confirmed with needle biopsy, and treated with lumpectomy and radiation. There was no need for chemotherapy.

My personal experience prompted me to join JoAnn Pushkin and Cindy Henke-Sarmento, RT(R)(M), BA, in developing a website, www.DenseBreast-info.org, to give women and their physicians easy access to information on making decisions about screening in dense breasts.

My colleagues and I are often asked what is the best way to order supplemental imaging for a patient who may have dense breasts. Even in cases in which a mammogram does not exist or is unavailable, the following prescription can be implemented easily at centers that offer US: “2D plus 3D mammogram if available; if dense, perform ultrasound as needed.”

Related article:
DenseBreast-info.org: What this resource can offer you, and your patients

Breast density screening: Take advantage of today’s technology

Breast screening and diagnostic imaging have improved significantly since the 1970s, when many of the randomized trials of mammography were conducted. Breast density is one of the most common and important risk factors for development of breast cancer and is now incorporated into the Breast Cancer Surveillance Consortium model (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm) and the Tyrer-Cuzick model (see also http://densebreast-info.org/explanation-of-dense-breast-risk-models.aspx).³² Although we continue to validate newer approaches, women should take advantage of the improved methods of early cancer detection, particularly if they have dense breasts or are at high risk for breast cancer.

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.

MY STORY: Prologue

My aunt received a breast cancer diagnosis at age 40, and she died at age 60, in 1970. Then, in 1975, my mother’s breast cancer was found at age 55, but only after she was examined for nipple retraction; on mammography, the cancer had been obscured by dense breast tissue. Mom had 2 metastatic nodes but participated in the earliest clinical trials of chemotherapy and lived free of breast cancer for another 41 years. Naturally I thought that, were I to develop this disease, I would want it found earlier. Ironically, it was, but only because I had spent my career trying to understand the optimal screening approaches for women with dense breasts—women like me.

Cancers are masked on mammography in dense breasts

For women, screening mammography is an important step in reducing the risk of dying from breast cancer. The greatest benefits are realized by those who start annual screening at age 40, or 45 at the latest.¹ As it takes 9 to 10 years to see a benefit from breast cancer screening at the population level, it is not logical to continue this testing when life expectancy is less than 10 years, as is the case with women age 85 or older, even those in the healthiest quartile.^2–4 However, despite recent advances, the development of 3D mammography (tomosynthesis) (FIGURE 1) in particular, cancers can still be masked by dense breast tissue. Both 2D and 3D mammograms are x-rays; both dense tissue and cancers absorb x-rays and appear white.

Breast density is determined on mammography and is categorized as fatty, scattered fibroglandular, heterogeneously dense, or extremely dense (FIGURE 2).⁵ Tissue in the heterogeneous and extreme categories is considered dense. More than half of women in their 40s have dense breasts; with some fatty involution occurring around menopause, the proportion drops to 25% for women in their 60s.⁶ About half of breast cancers have calcifications, which on mammography are usually easily visible even in dense breasts. The problem is with noncalcified invasive cancers that can be hidden by dense tissue (FIGURE 3).

3D mammography improves cancer detection but is of minimal benefit in extremely dense breasts

Although 3D mammography improves cancer detection in most women, any benefit is minimal in women with extremely dense breasts, as there is no inherent soft-tissue contrast.⁷ Masked cancers are often only discovered because of a lump after a normal screening mammogram, as so-called “interval cancers.” Compared with screen-detected cancers, interval cancers tend to be more biologically aggressive, to have spread to lymph nodes, and to have worse prognoses. However, even some small screen-detected cancers are biologically aggressive and can spread to lymph nodes quickly, and no screening test or combination of screening tests can prevent this occurrence completely, regardless of breast density.

Related article:
Get smart about dense breasts

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT/COURTESY OF WENDIE A. BERG, MD, PHD

MRI provides early detection across all breast densities

In all tissue densities, contrast-enhanced magnetic resonance imaging (MRI) is far better than mammography in detecting breast cancer.⁸ Women at high risk for breast cancer caused by mutations in BRCA1, BRCA2, p53, and other genes have poor outcomes with screening mammography alone—up to 50% of cancers are interval cancers. Annual screening MRI reduces this percentage significantly, to 11% in women with pathogenic BRCA1 mutations and to 4% in women with BRCA2 mutations.⁹ Warner and colleagues found a decrease in late-stage cancers in high-risk women who underwent annual MRI screenings compared to high-risk women unable to have MRI.¹⁰

The use of MRI for screening is limited by availability, patient tolerance,¹¹ and high cost. Research is being conducted to further validate approaches using shortened screening MRI times (so-called “abbreviated” or “fast” MRI) and, thereby, improve access, tolerance, and reduce associated costs; several investigators already have reported promising results, and a few centers offer this modality directly to patients willing to pay $300 to $350 out of pocket.^12,13 Even in normal-risk women, MRI significantly increases detection of early breast cancer after a normal mammogram and ultrasound, and the cancer detection benefit of MRI is seen across all breast densities.¹⁴

Most health insurance plans cover screening MRI only for women who meet defined risk criteria, including women who have a known disease-causing mutation—or are suspected of having one, given a family history of breast cancer with higher than 20% to 25% lifetime risk by a model that predicts mutation carrier status—as well as women who had chest radiation therapy before age 30, typically for Hodgkin lymphoma, and at least 8 years earlier.¹⁵ In addition, MRI can be considered in women with atypical breast biopsy results or a personal history of lobular carcinoma in situ (LCIS).¹⁶

Screening MRI should start by age 25 in women with disease-causing mutations, or at the time of atypical or LCIS biopsy results, and should be performed annually unless the woman is pregnant or has a metallic implant, renal insufficiency, or another contraindication to MRI. MRI can be beneficial in women with a personal history of cancer, although annual mammography remains the standard of care.^17–19

MRI and mammography can be performed at the same time or on an alternating 6-month basis, with mammography usually starting only after age 30 because of the small risk that radiation poses for younger women. There are a few other impediments to having breast MRI: The woman must lie on her stomach within a confined space (tunnel), the contrast that is injected may not be well tolerated, and insurance does not cover the test for women who do not meet the defined risk criteria.¹¹

Read why mammography supplemented by US is best for women with dense breasts.

Ultrasonography supplements mammography

Mammography supplemented with ultrasonography (US) has been studied as a “Goldilocks” or best-fit solution for the screening of women with dense breasts, as detection of invasive cancers is improved with the 2 modalities over mammography alone, and US is less invasive, better tolerated, and lower in cost than the more sensitive MRI.

In women with dense breasts, US has been found to improve cancer detection over mammography alone, and early results suggest a larger cancer detection benefit from US than from 3D mammography, although research is ongoing.²⁰ Adding US reduces the interval cancer rate in women with dense breasts to less than 10% of all cancers found—similar to results for women with fatty breasts.^17,21,22

US can be performed by a trained technologist or a physician using a small transducer, which usually provides diagnostic images (so that most callbacks would be for a true finding), or a larger transducer and an automated system can be used to create more than a thousand images for radiologist review.^23,24 Use of a hybrid system, a small transducer with an automated arm, has been validated as well.²⁵ Screening US is not available universally, and with all these approaches optimal performance requires trained personnel. Supplemental screening US usually is covered by insurance but is nearly always subject to a deductible/copay.

Related article:
Educate patients about dense breasts and cancer risk

Reducing false-positives, callbacks, and additional testing

Mammography carries a risk of false-positives. On average, 11% to 12% of women are called back for additional testing after a screening mammogram, and in more than 95% of women brought back for extra testing, no cancer is found.²⁶ Women with dense breasts are more likely than those with less dense breasts to be called back.²⁷ US and MRI improve cancer detection and therefore yield additional positive, but also false-positive, findings. Notably, callbacks decrease after the first round of screening with any modality or combination of tests, as long as prior examinations are available for comparison.

One advantage of 3D over 2D mammography is a decrease in extra testing for areas of asymmetry, which are often recognizable on 3D mammography as representing normal superimposed tissue.^28–30 Architectural distortion, which is better seen on 3D mammography and usually represents either cancer or a benign radial scar, can lead to false-positive biopsies, although the average biopsy rate is no higher for 3D than for 2D alone.³¹ Typically, the 3D and 2D examinations are performed together (slightly more than doubling the radiation dose), or synthetic 2D images can be created from the 3D slices (resulting in a total radiation dose almost the same as standard 2D alone).

Most additional cancers seen on 3D mammography or US are lower-grade invasive cancers with good prognoses. Some aggressive high-grade breast cancers go undetected even when mammography is supplemented with US, either because they are too small to be seen or because they resemble common benign masses and may not be recognized. MRI is particularly effective in depicting high-grade cancers, even small ones.

The TABLE summarizes the relative rates of cancer detection and additional testing by various breast screening tests or combinations of tests. Neither clinical breast examination by a physician or other health care professional nor routine breast self-examination reduces the number of deaths caused by breast cancer. Nevertheless, women should monitor any changes in their breasts and report these changes to their clinician. A new lump, skin or nipple retraction, or a spontaneous clear or bloody nipple discharge merits diagnostic breast imaging even if a recent screening mammogram was normal.

Read how to take advantage of today’s technology for breast density screening

MY STORY: Epilogue

My annual 3D mammograms were normal, even the year my cancer was present. In 2014, I entered my family history into the IBIS Breast Cancer Risk Evaluation Tool (Tyrer-Cuzick model of breast cancer risk) (http://www.ems-trials.org/riskevaluator/) and calculated my lifetime risk at 19.7%. That is when I decided to have a screening MRI. My invasive breast cancer was easily seen on MRI and then on US. The cancer was node-negative, easily confirmed with needle biopsy, and treated with lumpectomy and radiation. There was no need for chemotherapy.

My personal experience prompted me to join JoAnn Pushkin and Cindy Henke-Sarmento, RT(R)(M), BA, in developing a website, www.DenseBreast-info.org, to give women and their physicians easy access to information on making decisions about screening in dense breasts.

My colleagues and I are often asked what is the best way to order supplemental imaging for a patient who may have dense breasts. Even in cases in which a mammogram does not exist or is unavailable, the following prescription can be implemented easily at centers that offer US: “2D plus 3D mammogram if available; if dense, perform ultrasound as needed.”

Related article:
DenseBreast-info.org: What this resource can offer you, and your patients

Breast density screening: Take advantage of today’s technology

Breast screening and diagnostic imaging have improved significantly since the 1970s, when many of the randomized trials of mammography were conducted. Breast density is one of the most common and important risk factors for development of breast cancer and is now incorporated into the Breast Cancer Surveillance Consortium model (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm) and the Tyrer-Cuzick model (see also http://densebreast-info.org/explanation-of-dense-breast-risk-models.aspx).³² Although we continue to validate newer approaches, women should take advantage of the improved methods of early cancer detection, particularly if they have dense breasts or are at high risk for breast cancer.

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.

MY STORY: Prologue

My aunt received a breast cancer diagnosis at age 40, and she died at age 60, in 1970. Then, in 1975, my mother’s breast cancer was found at age 55, but only after she was examined for nipple retraction; on mammography, the cancer had been obscured by dense breast tissue. Mom had 2 metastatic nodes but participated in the earliest clinical trials of chemotherapy and lived free of breast cancer for another 41 years. Naturally I thought that, were I to develop this disease, I would want it found earlier. Ironically, it was, but only because I had spent my career trying to understand the optimal screening approaches for women with dense breasts—women like me.

Cancers are masked on mammography in dense breasts

For women, screening mammography is an important step in reducing the risk of dying from breast cancer. The greatest benefits are realized by those who start annual screening at age 40, or 45 at the latest.¹ As it takes 9 to 10 years to see a benefit from breast cancer screening at the population level, it is not logical to continue this testing when life expectancy is less than 10 years, as is the case with women age 85 or older, even those in the healthiest quartile.^2–4 However, despite recent advances, the development of 3D mammography (tomosynthesis) (FIGURE 1) in particular, cancers can still be masked by dense breast tissue. Both 2D and 3D mammograms are x-rays; both dense tissue and cancers absorb x-rays and appear white.

Breast density is determined on mammography and is categorized as fatty, scattered fibroglandular, heterogeneously dense, or extremely dense (FIGURE 2).⁵ Tissue in the heterogeneous and extreme categories is considered dense. More than half of women in their 40s have dense breasts; with some fatty involution occurring around menopause, the proportion drops to 25% for women in their 60s.⁶ About half of breast cancers have calcifications, which on mammography are usually easily visible even in dense breasts. The problem is with noncalcified invasive cancers that can be hidden by dense tissue (FIGURE 3).

3D mammography improves cancer detection but is of minimal benefit in extremely dense breasts

Although 3D mammography improves cancer detection in most women, any benefit is minimal in women with extremely dense breasts, as there is no inherent soft-tissue contrast.⁷ Masked cancers are often only discovered because of a lump after a normal screening mammogram, as so-called “interval cancers.” Compared with screen-detected cancers, interval cancers tend to be more biologically aggressive, to have spread to lymph nodes, and to have worse prognoses. However, even some small screen-detected cancers are biologically aggressive and can spread to lymph nodes quickly, and no screening test or combination of screening tests can prevent this occurrence completely, regardless of breast density.

Related article:
Get smart about dense breasts

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT/COURTESY OF WENDIE A. BERG, MD, PHD

MRI provides early detection across all breast densities

In all tissue densities, contrast-enhanced magnetic resonance imaging (MRI) is far better than mammography in detecting breast cancer.⁸ Women at high risk for breast cancer caused by mutations in BRCA1, BRCA2, p53, and other genes have poor outcomes with screening mammography alone—up to 50% of cancers are interval cancers. Annual screening MRI reduces this percentage significantly, to 11% in women with pathogenic BRCA1 mutations and to 4% in women with BRCA2 mutations.⁹ Warner and colleagues found a decrease in late-stage cancers in high-risk women who underwent annual MRI screenings compared to high-risk women unable to have MRI.¹⁰

The use of MRI for screening is limited by availability, patient tolerance,¹¹ and high cost. Research is being conducted to further validate approaches using shortened screening MRI times (so-called “abbreviated” or “fast” MRI) and, thereby, improve access, tolerance, and reduce associated costs; several investigators already have reported promising results, and a few centers offer this modality directly to patients willing to pay $300 to $350 out of pocket.^12,13 Even in normal-risk women, MRI significantly increases detection of early breast cancer after a normal mammogram and ultrasound, and the cancer detection benefit of MRI is seen across all breast densities.¹⁴

Most health insurance plans cover screening MRI only for women who meet defined risk criteria, including women who have a known disease-causing mutation—or are suspected of having one, given a family history of breast cancer with higher than 20% to 25% lifetime risk by a model that predicts mutation carrier status—as well as women who had chest radiation therapy before age 30, typically for Hodgkin lymphoma, and at least 8 years earlier.¹⁵ In addition, MRI can be considered in women with atypical breast biopsy results or a personal history of lobular carcinoma in situ (LCIS).¹⁶

Screening MRI should start by age 25 in women with disease-causing mutations, or at the time of atypical or LCIS biopsy results, and should be performed annually unless the woman is pregnant or has a metallic implant, renal insufficiency, or another contraindication to MRI. MRI can be beneficial in women with a personal history of cancer, although annual mammography remains the standard of care.^17–19

MRI and mammography can be performed at the same time or on an alternating 6-month basis, with mammography usually starting only after age 30 because of the small risk that radiation poses for younger women. There are a few other impediments to having breast MRI: The woman must lie on her stomach within a confined space (tunnel), the contrast that is injected may not be well tolerated, and insurance does not cover the test for women who do not meet the defined risk criteria.¹¹

Read why mammography supplemented by US is best for women with dense breasts.

Ultrasonography supplements mammography

Mammography supplemented with ultrasonography (US) has been studied as a “Goldilocks” or best-fit solution for the screening of women with dense breasts, as detection of invasive cancers is improved with the 2 modalities over mammography alone, and US is less invasive, better tolerated, and lower in cost than the more sensitive MRI.

In women with dense breasts, US has been found to improve cancer detection over mammography alone, and early results suggest a larger cancer detection benefit from US than from 3D mammography, although research is ongoing.²⁰ Adding US reduces the interval cancer rate in women with dense breasts to less than 10% of all cancers found—similar to results for women with fatty breasts.^17,21,22

US can be performed by a trained technologist or a physician using a small transducer, which usually provides diagnostic images (so that most callbacks would be for a true finding), or a larger transducer and an automated system can be used to create more than a thousand images for radiologist review.^23,24 Use of a hybrid system, a small transducer with an automated arm, has been validated as well.²⁵ Screening US is not available universally, and with all these approaches optimal performance requires trained personnel. Supplemental screening US usually is covered by insurance but is nearly always subject to a deductible/copay.

Related article:
Educate patients about dense breasts and cancer risk

Reducing false-positives, callbacks, and additional testing

Mammography carries a risk of false-positives. On average, 11% to 12% of women are called back for additional testing after a screening mammogram, and in more than 95% of women brought back for extra testing, no cancer is found.²⁶ Women with dense breasts are more likely than those with less dense breasts to be called back.²⁷ US and MRI improve cancer detection and therefore yield additional positive, but also false-positive, findings. Notably, callbacks decrease after the first round of screening with any modality or combination of tests, as long as prior examinations are available for comparison.

One advantage of 3D over 2D mammography is a decrease in extra testing for areas of asymmetry, which are often recognizable on 3D mammography as representing normal superimposed tissue.^28–30 Architectural distortion, which is better seen on 3D mammography and usually represents either cancer or a benign radial scar, can lead to false-positive biopsies, although the average biopsy rate is no higher for 3D than for 2D alone.³¹ Typically, the 3D and 2D examinations are performed together (slightly more than doubling the radiation dose), or synthetic 2D images can be created from the 3D slices (resulting in a total radiation dose almost the same as standard 2D alone).

Most additional cancers seen on 3D mammography or US are lower-grade invasive cancers with good prognoses. Some aggressive high-grade breast cancers go undetected even when mammography is supplemented with US, either because they are too small to be seen or because they resemble common benign masses and may not be recognized. MRI is particularly effective in depicting high-grade cancers, even small ones.

The TABLE summarizes the relative rates of cancer detection and additional testing by various breast screening tests or combinations of tests. Neither clinical breast examination by a physician or other health care professional nor routine breast self-examination reduces the number of deaths caused by breast cancer. Nevertheless, women should monitor any changes in their breasts and report these changes to their clinician. A new lump, skin or nipple retraction, or a spontaneous clear or bloody nipple discharge merits diagnostic breast imaging even if a recent screening mammogram was normal.

Read how to take advantage of today’s technology for breast density screening

MY STORY: Epilogue

My annual 3D mammograms were normal, even the year my cancer was present. In 2014, I entered my family history into the IBIS Breast Cancer Risk Evaluation Tool (Tyrer-Cuzick model of breast cancer risk) (http://www.ems-trials.org/riskevaluator/) and calculated my lifetime risk at 19.7%. That is when I decided to have a screening MRI. My invasive breast cancer was easily seen on MRI and then on US. The cancer was node-negative, easily confirmed with needle biopsy, and treated with lumpectomy and radiation. There was no need for chemotherapy.

My personal experience prompted me to join JoAnn Pushkin and Cindy Henke-Sarmento, RT(R)(M), BA, in developing a website, www.DenseBreast-info.org, to give women and their physicians easy access to information on making decisions about screening in dense breasts.

My colleagues and I are often asked what is the best way to order supplemental imaging for a patient who may have dense breasts. Even in cases in which a mammogram does not exist or is unavailable, the following prescription can be implemented easily at centers that offer US: “2D plus 3D mammogram if available; if dense, perform ultrasound as needed.”

Related article:
DenseBreast-info.org: What this resource can offer you, and your patients

Breast density screening: Take advantage of today’s technology

Breast screening and diagnostic imaging have improved significantly since the 1970s, when many of the randomized trials of mammography were conducted. Breast density is one of the most common and important risk factors for development of breast cancer and is now incorporated into the Breast Cancer Surveillance Consortium model (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm) and the Tyrer-Cuzick model (see also http://densebreast-info.org/explanation-of-dense-breast-risk-models.aspx).³² Although we continue to validate newer approaches, women should take advantage of the improved methods of early cancer detection, particularly if they have dense breasts or are at high risk for breast cancer.

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.

LONDON—An investigational drug did not effectively treat symptoms of mild to moderate Alzheimer’s disease in phase III trials, according to results presented at the 2017 Alzheimer’s Association International Conference.

Investigators evaluated the efficacy and safety of idalopirdine, a selective 5-HT₆ receptor antagonist, as adjunctive therapy in patients taking acetylcholinesterase inhibitors. Researchers conducted three 24-week, double-blind, placebo-controlled trials that included more than 2,500 patients. Patients received 10, 30, or 60 mg/day of idalopirdine or placebo.

The drug had a good safety and tolerability profile, but did not effectively alleviate clinical symptoms, said Alireza Atri, MD, PhD, Ray Dolby Endowed Chair in Brain Health Research at California Pacific Medical Center in San Francisco and Lecturer in Neurology at Harvard Medical School in Boston.

Serotonin 5-HT₆ receptor antagonists nevertheless may prove effective in other trials with different compounds and doses, he said. “We have to wait for the other clinical trials to see whether they are positive,” Dr. Atri said.

Proof-of-Concept Findings

In a phase II study in patients with moderate Alzheimer’s disease (defined as a Mini-Mental State Examination [MMSE] score from 12 to 19), idalopirdine (90 mg/day [30 mg tid]) added to stable donepezil treatment significantly improved cognitive performance, compared with donepezil monotherapy.

The phase III trials included patients age 50 or older with mild to moderate Alzheimer’s disease (defined as MMSE score from 12 to 22). The main primary end point was change from baseline to Week 24 in Alzheimer’s Disease Assessment Scale–Cognitive subscale (ADAS-cog) total score. Other co-primary end points were change from baseline to Week 24 in Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL23) and Clinical Global Impression of Change (ADCS-CGIC) scores. Significant benefit over placebo for the main primary end point and at least one co-primary end point were needed to establish efficacy.

The phase III trials had similar designs. STARSHINE enrolled patients taking donepezil who received placebo, idalopirdine (30 mg/day), or idalopirdine (60 mg/day). STARBEAM enrolled patients taking donepezil who received placebo, idalopirdine (10 mg/day), or idalopirdine (30 mg/day). STARBRIGHT enrolled patients taking any acetylcholinesterase inhibitor who received placebo or idalopirdine (60 mg/day).

About 4,000 patients were screened, and 2,525 patients were randomized across the three studies. Patients had a mean age of 74, baseline ADAS-cog score of 26, and baseline MMSE score of 17. Patients on average had been diagnosed with Alzheimer’s disease for 2.2 years and had been on cholinesterase therapy for 1.7 years. About 55% to 60% of patients were APOE positive, and 62% to 65% were female.

None of the doses of idalopirdine met the prespecified efficacy criteria. An analysis suggested some indication of potential efficacy for the 60-mg/day dose in patients with moderate Alzheimer’s disease (ie, an MMSE score between 12 and 18), but there was no consistent replication across all end points, Dr. Atri said.

High Rate of Study Completion

Serious adverse events occurred in about 5% of patients who received placebo and idalopirdine (10 mg/day), and in about 6% to 7% of patients who received idalopirdine (30 mg/day) or idalopirdine (60 mg/day).

The percentage of patients with treatment-emergent adverse events was similar between the idalopirdine and placebo groups. Transient, dose-dependent increases in liver enzymes and vomiting were infrequently observed (< 5%).

The high rate of study completion and enrollment in the extension study (about 90%) suggests unmet need for therapies to treat patients with mild to moderate Alzheimer’s disease, Dr. Atri said.

One limitation of the trials was that patients did not need to have evidence of Alzheimer’s disease biomarkers to participate. In addition, investigators excluded patients who were taking memantine.

Researchers plan to further analyze the data from the phase III trials, Dr. Atri said. Lundbeck, based in Valby, Denmark, developed idalopirdine. The company announced in February that the phase III results did not support seeking regulatory approval for the drug.

—Jake Remaly

Suggested Reading

Ferrero H, Solas M, Francis PT, Ramirez MJ. Serotonin 5-HT6 receptor antagonists in Alzheimer’s disease: Therapeutic rationale and current development status. CNS Drugs. 2017;31(1):19-32.

Wilkinson D, Windfeld K, Colding-Jørgensen E. Safety and efficacy of idalopirdine, a 5-HT6 receptor antagonist, in patients with moderate Alzheimer’s disease (LADDER): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2014;13(11):1092-1099.

LONDON—An investigational drug did not effectively treat symptoms of mild to moderate Alzheimer’s disease in phase III trials, according to results presented at the 2017 Alzheimer’s Association International Conference.

Investigators evaluated the efficacy and safety of idalopirdine, a selective 5-HT₆ receptor antagonist, as adjunctive therapy in patients taking acetylcholinesterase inhibitors. Researchers conducted three 24-week, double-blind, placebo-controlled trials that included more than 2,500 patients. Patients received 10, 30, or 60 mg/day of idalopirdine or placebo.

The drug had a good safety and tolerability profile, but did not effectively alleviate clinical symptoms, said Alireza Atri, MD, PhD, Ray Dolby Endowed Chair in Brain Health Research at California Pacific Medical Center in San Francisco and Lecturer in Neurology at Harvard Medical School in Boston.

Serotonin 5-HT₆ receptor antagonists nevertheless may prove effective in other trials with different compounds and doses, he said. “We have to wait for the other clinical trials to see whether they are positive,” Dr. Atri said.

Proof-of-Concept Findings

In a phase II study in patients with moderate Alzheimer’s disease (defined as a Mini-Mental State Examination [MMSE] score from 12 to 19), idalopirdine (90 mg/day [30 mg tid]) added to stable donepezil treatment significantly improved cognitive performance, compared with donepezil monotherapy.

The phase III trials included patients age 50 or older with mild to moderate Alzheimer’s disease (defined as MMSE score from 12 to 22). The main primary end point was change from baseline to Week 24 in Alzheimer’s Disease Assessment Scale–Cognitive subscale (ADAS-cog) total score. Other co-primary end points were change from baseline to Week 24 in Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL23) and Clinical Global Impression of Change (ADCS-CGIC) scores. Significant benefit over placebo for the main primary end point and at least one co-primary end point were needed to establish efficacy.

The phase III trials had similar designs. STARSHINE enrolled patients taking donepezil who received placebo, idalopirdine (30 mg/day), or idalopirdine (60 mg/day). STARBEAM enrolled patients taking donepezil who received placebo, idalopirdine (10 mg/day), or idalopirdine (30 mg/day). STARBRIGHT enrolled patients taking any acetylcholinesterase inhibitor who received placebo or idalopirdine (60 mg/day).

About 4,000 patients were screened, and 2,525 patients were randomized across the three studies. Patients had a mean age of 74, baseline ADAS-cog score of 26, and baseline MMSE score of 17. Patients on average had been diagnosed with Alzheimer’s disease for 2.2 years and had been on cholinesterase therapy for 1.7 years. About 55% to 60% of patients were APOE positive, and 62% to 65% were female.

None of the doses of idalopirdine met the prespecified efficacy criteria. An analysis suggested some indication of potential efficacy for the 60-mg/day dose in patients with moderate Alzheimer’s disease (ie, an MMSE score between 12 and 18), but there was no consistent replication across all end points, Dr. Atri said.

High Rate of Study Completion

Serious adverse events occurred in about 5% of patients who received placebo and idalopirdine (10 mg/day), and in about 6% to 7% of patients who received idalopirdine (30 mg/day) or idalopirdine (60 mg/day).

The percentage of patients with treatment-emergent adverse events was similar between the idalopirdine and placebo groups. Transient, dose-dependent increases in liver enzymes and vomiting were infrequently observed (< 5%).

The high rate of study completion and enrollment in the extension study (about 90%) suggests unmet need for therapies to treat patients with mild to moderate Alzheimer’s disease, Dr. Atri said.

One limitation of the trials was that patients did not need to have evidence of Alzheimer’s disease biomarkers to participate. In addition, investigators excluded patients who were taking memantine.

Researchers plan to further analyze the data from the phase III trials, Dr. Atri said. Lundbeck, based in Valby, Denmark, developed idalopirdine. The company announced in February that the phase III results did not support seeking regulatory approval for the drug.

—Jake Remaly

Suggested Reading

Ferrero H, Solas M, Francis PT, Ramirez MJ. Serotonin 5-HT6 receptor antagonists in Alzheimer’s disease: Therapeutic rationale and current development status. CNS Drugs. 2017;31(1):19-32.

Wilkinson D, Windfeld K, Colding-Jørgensen E. Safety and efficacy of idalopirdine, a 5-HT6 receptor antagonist, in patients with moderate Alzheimer’s disease (LADDER): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2014;13(11):1092-1099.

LONDON—An investigational drug did not effectively treat symptoms of mild to moderate Alzheimer’s disease in phase III trials, according to results presented at the 2017 Alzheimer’s Association International Conference.

Investigators evaluated the efficacy and safety of idalopirdine, a selective 5-HT₆ receptor antagonist, as adjunctive therapy in patients taking acetylcholinesterase inhibitors. Researchers conducted three 24-week, double-blind, placebo-controlled trials that included more than 2,500 patients. Patients received 10, 30, or 60 mg/day of idalopirdine or placebo.

The drug had a good safety and tolerability profile, but did not effectively alleviate clinical symptoms, said Alireza Atri, MD, PhD, Ray Dolby Endowed Chair in Brain Health Research at California Pacific Medical Center in San Francisco and Lecturer in Neurology at Harvard Medical School in Boston.

Serotonin 5-HT₆ receptor antagonists nevertheless may prove effective in other trials with different compounds and doses, he said. “We have to wait for the other clinical trials to see whether they are positive,” Dr. Atri said.

Proof-of-Concept Findings

In a phase II study in patients with moderate Alzheimer’s disease (defined as a Mini-Mental State Examination [MMSE] score from 12 to 19), idalopirdine (90 mg/day [30 mg tid]) added to stable donepezil treatment significantly improved cognitive performance, compared with donepezil monotherapy.

The phase III trials included patients age 50 or older with mild to moderate Alzheimer’s disease (defined as MMSE score from 12 to 22). The main primary end point was change from baseline to Week 24 in Alzheimer’s Disease Assessment Scale–Cognitive subscale (ADAS-cog) total score. Other co-primary end points were change from baseline to Week 24 in Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL23) and Clinical Global Impression of Change (ADCS-CGIC) scores. Significant benefit over placebo for the main primary end point and at least one co-primary end point were needed to establish efficacy.

The phase III trials had similar designs. STARSHINE enrolled patients taking donepezil who received placebo, idalopirdine (30 mg/day), or idalopirdine (60 mg/day). STARBEAM enrolled patients taking donepezil who received placebo, idalopirdine (10 mg/day), or idalopirdine (30 mg/day). STARBRIGHT enrolled patients taking any acetylcholinesterase inhibitor who received placebo or idalopirdine (60 mg/day).

About 4,000 patients were screened, and 2,525 patients were randomized across the three studies. Patients had a mean age of 74, baseline ADAS-cog score of 26, and baseline MMSE score of 17. Patients on average had been diagnosed with Alzheimer’s disease for 2.2 years and had been on cholinesterase therapy for 1.7 years. About 55% to 60% of patients were APOE positive, and 62% to 65% were female.

None of the doses of idalopirdine met the prespecified efficacy criteria. An analysis suggested some indication of potential efficacy for the 60-mg/day dose in patients with moderate Alzheimer’s disease (ie, an MMSE score between 12 and 18), but there was no consistent replication across all end points, Dr. Atri said.

High Rate of Study Completion

Serious adverse events occurred in about 5% of patients who received placebo and idalopirdine (10 mg/day), and in about 6% to 7% of patients who received idalopirdine (30 mg/day) or idalopirdine (60 mg/day).

The percentage of patients with treatment-emergent adverse events was similar between the idalopirdine and placebo groups. Transient, dose-dependent increases in liver enzymes and vomiting were infrequently observed (< 5%).

The high rate of study completion and enrollment in the extension study (about 90%) suggests unmet need for therapies to treat patients with mild to moderate Alzheimer’s disease, Dr. Atri said.

One limitation of the trials was that patients did not need to have evidence of Alzheimer’s disease biomarkers to participate. In addition, investigators excluded patients who were taking memantine.

Researchers plan to further analyze the data from the phase III trials, Dr. Atri said. Lundbeck, based in Valby, Denmark, developed idalopirdine. The company announced in February that the phase III results did not support seeking regulatory approval for the drug.

—Jake Remaly

Suggested Reading

Ferrero H, Solas M, Francis PT, Ramirez MJ. Serotonin 5-HT6 receptor antagonists in Alzheimer’s disease: Therapeutic rationale and current development status. CNS Drugs. 2017;31(1):19-32.

Wilkinson D, Windfeld K, Colding-Jørgensen E. Safety and efficacy of idalopirdine, a 5-HT6 receptor antagonist, in patients with moderate Alzheimer’s disease (LADDER): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2014;13(11):1092-1099.

A customized educational intervention significantly increases the use of oral anticoagulants among patients with atrial fibrillation at risk for stroke, according to data published online ahead of print August 28 in Lancet. The intervention also appears to reduce the risk of stroke.

“If this intervention could be broadly applied, which we believe is possible, the public health implications would be substantial,” said Christopher B. Granger, MD, Professor of Medicine at Duke University School of Medicine in Durham, North Carolina. “More than 33 million people worldwide have atrial fibrillation, which is a leading cause of stoke. Improving adherence to anticoagulation therapy would be a lifesaver.”

Intervention Included Education and Monitoring

Dr. Granger and colleagues conducted IMPACT-AF—a prospective, cluster-randomized, controlled trial—to evaluate the effect of a multifaceted educational intervention on the use of oral anticoagulation in patients with atrial fibrillation, compared with usual care. The study was conducted in Argentina, Brazil, China, India, and Romania. Eligible patients were 18 or older, had atrial fibrillation not resulting from reversible causes, and had an indication for oral anticoagulation. Patients with an absolute contraindication to oral anticoagulation, those with a mechanical prosthetic valve, and those who were not able to have one year of follow-up were excluded.

Clusters (ie, sites) in each country were paired and randomized 1:1 to receive an educational intervention or usual care. The intervention’s two components were education and regular monitoring. Education was provided through various media (eg, web-based materials, videos, and guideline recommendations) to patients, their families, and healthcare providers. It was customized for each country and described the benefits, risks, and costs of anticoagulant therapies. The monitoring component, which included feedback, was designed to promote anticoagulant initiation among appropriate candidates who were not being treated, prevent discontinuation among treated patients, and improve adherence. The investigators collected data at baseline, six months, and 12 months at all sites. The intervention sites had additional telephone calls or patient visits at one month, three months, and nine months.

The primary end point was the change in the proportion of patients treated with oral anticoagulants from baseline to one year. Key secondary end points included the proportion of patients who were on oral anticoagulation at baseline, six months, and 12 months; and the proportion of patients who were not on oral anticoagulation at baseline, but were on this therapy at six months and 12 months. Other secondary clinical outcomes included all-cause death, stroke, transient ischemic attack, and major bleeding.

Anticoagulant Use Increased

In all, researchers enrolled 2,281 participants at 48 clusters. Mean age was approximately 70, and about 47% of participants were women. Five patients (three in the intervention group) were lost to follow-up after baseline. The median follow-up duration was 12 months. Age, sex, educational level, and socioeconomic factors were well balanced between the two groups. The intervention group, however, had a higher proportion of patients with permanent atrial fibrillation, history of major bleeding, systemic embolism, and uncontrolled hypertension, and a lower proportion of patients with rheumatic valvular heart disease, heart failure or left ventricular dysfunction, vascular disease, and previous myocardial infarction, than the control group.

The proportion of patients on oral anticoagulation increased from 68% at baseline to 80% at one year in the intervention group and from 64% to 67% in the control group. The absolute difference between groups in the change of oral anticoagulation use was 9.1%. This result yielded an odds ratio of 3.28, representing the proportional increase in anticoagulation use from baseline to one year in the intervention group, compared with the control group. The effect size in favor of the intervention was consistent across prespecified subgroups. The primary outcome result was consistent in all five countries.

Furthermore, 95% of patients who were on oral anticoagulants at baseline in the intervention group and 94% of patients in the control group continued taking oral anticoagulants at one year. For patients who were not on oral anticoagulants at baseline, 48% in the intervention group and 18% in the control group were on oral anticoagulants at one year. This result yielded an odds ratio of 4.60, representing the proportional increase in anticoagulation use from baseline to one year in the intervention group, compared with the control group.

“Our study also found a reduction in strokes in the intervention group, compared with the control group,” said Renato D. Lopes, MD, PhD, Professor of Medicine at Duke University School of Medicine and principal investigator for Brazil. The hazard ratio of stroke was 0.48 for the intervention group, compared with the control group. “While this was a secondary outcome, it highlights the potential benefit of improved anticoagulation care,” he added.

The number needed to treat was 100 patients exposed to intervention to prevent one stroke event over one year. The rates of all-cause death and the composite of stroke, systemic embolism, or major bleeding did not differ between the intervention and control groups.

Intervention Might Help Patients Worldwide

The majority of participants were using vitamin K antagonists at baseline, and data suggest that non-vitamin K antagonists have advantages (eg, reduced intracerebral bleeds) over this class of oral anticoagulants. Approximately 8% of participants in the intervention group had switched from vitamin K antagonists to non-vitamin K antagonists at one year, while participants in the control group did not change their medication. “A similar educational approach could be used for all anticoagulant classes with even greater benefit to patients,” said Michael D. Ezekowitz, MD, a cardiologist at Lankenau Medical Center in Wynnewood, Pennsylvania, and Anthony P. Kent, MD, a resident at Bridgeport Hospital in Bridgeport, Connecticut, in an accompanying editorial.

The study was limited to five countries and relied on a technological intervention, which might hinder the generalization of the results to broader clinical practice, said Drs. Ezekowitz and Kent. Nevertheless, “we are confident that the impact of IMPACT-AF will benefit patients with atrial fibrillation worldwide,” they concluded.

—Erik Greb

Suggested Reading

Ezekowitz MD, Kent AP. The impact of IMPACT-AF. Lancet. 2017 Aug 28 [Epub ahead of print].

Vinereanu D, Lopes RD, Bahit MC, et al. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Aug 28 [Epub ahead of print].

A customized educational intervention significantly increases the use of oral anticoagulants among patients with atrial fibrillation at risk for stroke, according to data published online ahead of print August 28 in Lancet. The intervention also appears to reduce the risk of stroke.

“If this intervention could be broadly applied, which we believe is possible, the public health implications would be substantial,” said Christopher B. Granger, MD, Professor of Medicine at Duke University School of Medicine in Durham, North Carolina. “More than 33 million people worldwide have atrial fibrillation, which is a leading cause of stoke. Improving adherence to anticoagulation therapy would be a lifesaver.”

Intervention Included Education and Monitoring

Dr. Granger and colleagues conducted IMPACT-AF—a prospective, cluster-randomized, controlled trial—to evaluate the effect of a multifaceted educational intervention on the use of oral anticoagulation in patients with atrial fibrillation, compared with usual care. The study was conducted in Argentina, Brazil, China, India, and Romania. Eligible patients were 18 or older, had atrial fibrillation not resulting from reversible causes, and had an indication for oral anticoagulation. Patients with an absolute contraindication to oral anticoagulation, those with a mechanical prosthetic valve, and those who were not able to have one year of follow-up were excluded.

Clusters (ie, sites) in each country were paired and randomized 1:1 to receive an educational intervention or usual care. The intervention’s two components were education and regular monitoring. Education was provided through various media (eg, web-based materials, videos, and guideline recommendations) to patients, their families, and healthcare providers. It was customized for each country and described the benefits, risks, and costs of anticoagulant therapies. The monitoring component, which included feedback, was designed to promote anticoagulant initiation among appropriate candidates who were not being treated, prevent discontinuation among treated patients, and improve adherence. The investigators collected data at baseline, six months, and 12 months at all sites. The intervention sites had additional telephone calls or patient visits at one month, three months, and nine months.

The primary end point was the change in the proportion of patients treated with oral anticoagulants from baseline to one year. Key secondary end points included the proportion of patients who were on oral anticoagulation at baseline, six months, and 12 months; and the proportion of patients who were not on oral anticoagulation at baseline, but were on this therapy at six months and 12 months. Other secondary clinical outcomes included all-cause death, stroke, transient ischemic attack, and major bleeding.

Anticoagulant Use Increased

In all, researchers enrolled 2,281 participants at 48 clusters. Mean age was approximately 70, and about 47% of participants were women. Five patients (three in the intervention group) were lost to follow-up after baseline. The median follow-up duration was 12 months. Age, sex, educational level, and socioeconomic factors were well balanced between the two groups. The intervention group, however, had a higher proportion of patients with permanent atrial fibrillation, history of major bleeding, systemic embolism, and uncontrolled hypertension, and a lower proportion of patients with rheumatic valvular heart disease, heart failure or left ventricular dysfunction, vascular disease, and previous myocardial infarction, than the control group.

The proportion of patients on oral anticoagulation increased from 68% at baseline to 80% at one year in the intervention group and from 64% to 67% in the control group. The absolute difference between groups in the change of oral anticoagulation use was 9.1%. This result yielded an odds ratio of 3.28, representing the proportional increase in anticoagulation use from baseline to one year in the intervention group, compared with the control group. The effect size in favor of the intervention was consistent across prespecified subgroups. The primary outcome result was consistent in all five countries.

Furthermore, 95% of patients who were on oral anticoagulants at baseline in the intervention group and 94% of patients in the control group continued taking oral anticoagulants at one year. For patients who were not on oral anticoagulants at baseline, 48% in the intervention group and 18% in the control group were on oral anticoagulants at one year. This result yielded an odds ratio of 4.60, representing the proportional increase in anticoagulation use from baseline to one year in the intervention group, compared with the control group.

“Our study also found a reduction in strokes in the intervention group, compared with the control group,” said Renato D. Lopes, MD, PhD, Professor of Medicine at Duke University School of Medicine and principal investigator for Brazil. The hazard ratio of stroke was 0.48 for the intervention group, compared with the control group. “While this was a secondary outcome, it highlights the potential benefit of improved anticoagulation care,” he added.

The number needed to treat was 100 patients exposed to intervention to prevent one stroke event over one year. The rates of all-cause death and the composite of stroke, systemic embolism, or major bleeding did not differ between the intervention and control groups.

Intervention Might Help Patients Worldwide

The majority of participants were using vitamin K antagonists at baseline, and data suggest that non-vitamin K antagonists have advantages (eg, reduced intracerebral bleeds) over this class of oral anticoagulants. Approximately 8% of participants in the intervention group had switched from vitamin K antagonists to non-vitamin K antagonists at one year, while participants in the control group did not change their medication. “A similar educational approach could be used for all anticoagulant classes with even greater benefit to patients,” said Michael D. Ezekowitz, MD, a cardiologist at Lankenau Medical Center in Wynnewood, Pennsylvania, and Anthony P. Kent, MD, a resident at Bridgeport Hospital in Bridgeport, Connecticut, in an accompanying editorial.

The study was limited to five countries and relied on a technological intervention, which might hinder the generalization of the results to broader clinical practice, said Drs. Ezekowitz and Kent. Nevertheless, “we are confident that the impact of IMPACT-AF will benefit patients with atrial fibrillation worldwide,” they concluded.

—Erik Greb

Suggested Reading

Ezekowitz MD, Kent AP. The impact of IMPACT-AF. Lancet. 2017 Aug 28 [Epub ahead of print].

Vinereanu D, Lopes RD, Bahit MC, et al. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Aug 28 [Epub ahead of print].

A customized educational intervention significantly increases the use of oral anticoagulants among patients with atrial fibrillation at risk for stroke, according to data published online ahead of print August 28 in Lancet. The intervention also appears to reduce the risk of stroke.

“If this intervention could be broadly applied, which we believe is possible, the public health implications would be substantial,” said Christopher B. Granger, MD, Professor of Medicine at Duke University School of Medicine in Durham, North Carolina. “More than 33 million people worldwide have atrial fibrillation, which is a leading cause of stoke. Improving adherence to anticoagulation therapy would be a lifesaver.”

Intervention Included Education and Monitoring

Dr. Granger and colleagues conducted IMPACT-AF—a prospective, cluster-randomized, controlled trial—to evaluate the effect of a multifaceted educational intervention on the use of oral anticoagulation in patients with atrial fibrillation, compared with usual care. The study was conducted in Argentina, Brazil, China, India, and Romania. Eligible patients were 18 or older, had atrial fibrillation not resulting from reversible causes, and had an indication for oral anticoagulation. Patients with an absolute contraindication to oral anticoagulation, those with a mechanical prosthetic valve, and those who were not able to have one year of follow-up were excluded.

Clusters (ie, sites) in each country were paired and randomized 1:1 to receive an educational intervention or usual care. The intervention’s two components were education and regular monitoring. Education was provided through various media (eg, web-based materials, videos, and guideline recommendations) to patients, their families, and healthcare providers. It was customized for each country and described the benefits, risks, and costs of anticoagulant therapies. The monitoring component, which included feedback, was designed to promote anticoagulant initiation among appropriate candidates who were not being treated, prevent discontinuation among treated patients, and improve adherence. The investigators collected data at baseline, six months, and 12 months at all sites. The intervention sites had additional telephone calls or patient visits at one month, three months, and nine months.

The primary end point was the change in the proportion of patients treated with oral anticoagulants from baseline to one year. Key secondary end points included the proportion of patients who were on oral anticoagulation at baseline, six months, and 12 months; and the proportion of patients who were not on oral anticoagulation at baseline, but were on this therapy at six months and 12 months. Other secondary clinical outcomes included all-cause death, stroke, transient ischemic attack, and major bleeding.

Anticoagulant Use Increased

In all, researchers enrolled 2,281 participants at 48 clusters. Mean age was approximately 70, and about 47% of participants were women. Five patients (three in the intervention group) were lost to follow-up after baseline. The median follow-up duration was 12 months. Age, sex, educational level, and socioeconomic factors were well balanced between the two groups. The intervention group, however, had a higher proportion of patients with permanent atrial fibrillation, history of major bleeding, systemic embolism, and uncontrolled hypertension, and a lower proportion of patients with rheumatic valvular heart disease, heart failure or left ventricular dysfunction, vascular disease, and previous myocardial infarction, than the control group.

The proportion of patients on oral anticoagulation increased from 68% at baseline to 80% at one year in the intervention group and from 64% to 67% in the control group. The absolute difference between groups in the change of oral anticoagulation use was 9.1%. This result yielded an odds ratio of 3.28, representing the proportional increase in anticoagulation use from baseline to one year in the intervention group, compared with the control group. The effect size in favor of the intervention was consistent across prespecified subgroups. The primary outcome result was consistent in all five countries.

Furthermore, 95% of patients who were on oral anticoagulants at baseline in the intervention group and 94% of patients in the control group continued taking oral anticoagulants at one year. For patients who were not on oral anticoagulants at baseline, 48% in the intervention group and 18% in the control group were on oral anticoagulants at one year. This result yielded an odds ratio of 4.60, representing the proportional increase in anticoagulation use from baseline to one year in the intervention group, compared with the control group.

“Our study also found a reduction in strokes in the intervention group, compared with the control group,” said Renato D. Lopes, MD, PhD, Professor of Medicine at Duke University School of Medicine and principal investigator for Brazil. The hazard ratio of stroke was 0.48 for the intervention group, compared with the control group. “While this was a secondary outcome, it highlights the potential benefit of improved anticoagulation care,” he added.

The number needed to treat was 100 patients exposed to intervention to prevent one stroke event over one year. The rates of all-cause death and the composite of stroke, systemic embolism, or major bleeding did not differ between the intervention and control groups.

Intervention Might Help Patients Worldwide

The majority of participants were using vitamin K antagonists at baseline, and data suggest that non-vitamin K antagonists have advantages (eg, reduced intracerebral bleeds) over this class of oral anticoagulants. Approximately 8% of participants in the intervention group had switched from vitamin K antagonists to non-vitamin K antagonists at one year, while participants in the control group did not change their medication. “A similar educational approach could be used for all anticoagulant classes with even greater benefit to patients,” said Michael D. Ezekowitz, MD, a cardiologist at Lankenau Medical Center in Wynnewood, Pennsylvania, and Anthony P. Kent, MD, a resident at Bridgeport Hospital in Bridgeport, Connecticut, in an accompanying editorial.

The study was limited to five countries and relied on a technological intervention, which might hinder the generalization of the results to broader clinical practice, said Drs. Ezekowitz and Kent. Nevertheless, “we are confident that the impact of IMPACT-AF will benefit patients with atrial fibrillation worldwide,” they concluded.

—Erik Greb

Suggested Reading

Ezekowitz MD, Kent AP. The impact of IMPACT-AF. Lancet. 2017 Aug 28 [Epub ahead of print].

Vinereanu D, Lopes RD, Bahit MC, et al. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Aug 28 [Epub ahead of print].

Independent of the Affordable Care Act or any upcoming changes in health care, the focus of an ObGyn practice remains paramount: the patient comes first.

The “recipe” for creating patient satisfaction and service excellence is predicated upon the mission of your practice and creating a shared vision with your employees. An action plan that is created and “visited/revisited”on a regular basis will serve to keep all abreast of the latest information to enhance the quality of patient care. It goes without saying, the ObGyn must first “lead by example” and always strive for satisfied patients who will tell their friends about your practice.

Start with the right tools

To organize a practice well, you need the right tools, which ideally include mission and vision statements and an action plan with goals and objectives.

Mission statement

A mission statement can be developed by the ObGyn(s) in your office or in concert with your staff. It should include:

• the “here and now” focus on the current approach to patient care
• why the practice exists (Develop a brief description of your practice, including the desired patient population.)
• the products and services offered and why and how those services are provided.

Here is an example of a mission statement for an ObGyn practice: “Our mission is to provide excellent, exceptional, personalized care for women of all ages in a warm and friendly environment. We incorporate leading-edge technology in our practice and continue to be a leader in obstetrics and gynecology.”

Vision statement

A vision statement should be developed in concert with your staff. It should include:

• the “then and there” focus on the historic perspective of your practice
• the ObGyn(s) and staff vision of the future
• what the ObGyn(s) and staff want to create.

The vision statement should energize and excite your personnel, create a shared and meaningful purpose, inspire passion and interest, and convey the values you want to share in your practice.

Here is an example of a vision statement for an ObGyn practice: “We aim to become the premier obstetrics and gynecology pro-vider to residents of (location) community.”

Action plan: Setting goals

To succeed, an ObGyn practice needs to:

• develop targets and challenges reflecting periodic (quarterly) meetings with staff and new entity development in the practice
• establish benchmarks and measurable parameters (How do you compare with other local practices? Set criteria/metrics to assess your progress.)
• ensure that the objectives support the goals (Develop goals and objectives over a defined period of time.)
• revisit the goals (Have they have been met? Do they need revision?)

Goals and objectives are essential for the continued health of your practice. This is all predicated upon developing a competitive advantage and then maintaining it.

Read about how to make a positive first impression on a new patient.

Is the environment welcoming?

When we examine a practice from the patient’s point of view, a good starting place is with the front desk. Have you looked at your front desk “from the outside in?” In one sense, this is the showcase of your practice.

Related article:
Four pillars of a successful practice: 2. Attract new patients

The first impression: Appointment scheduling

The first impression a patient receives about your practice occurs when she attempts to set up an appointment. Perhaps you might ask someone to call in to schedule an appointment. Is the caller immediately put on hold? Are your personnel courteous on the phone? Can she be seen quickly if she has a problem? How long is the wait for an annual exam? A test run can be very revealing.

Walk in the front door

When a patient walks in the door, does the physical office space radiate a friendly, relaxed atmosphere? Walk through the waiting room, then consultation and exam rooms as if you are a patient seeing it for the first time. Have you created an environment in which patients sense a well-organized office and the esprit de corps of the personnel? Does it look and smell fresh and clean? This all sends a loud and clear positive message about your practice.^1–3

Here are some suggestions for making a waiting room more inviting:

• Provide a seating arrangement that is “patient centered.” For example, semi- circular arrangements allow easy viewing of any monitors in the waiting room.
• WiFi is a great addition. Post several signs with the user name and password.
• Offer computers for patients to use to complete registration
• Set up a fish tank. If well-maintained, it can be soothing to many people.
• Display medical information pamphlets, even if they are rarely taken.
• Provide a big screen television that offers information about your practice, including personnel and procedures.

Streaming ads for physician offices are available. One platform, Outcome Health (https://www.outcomehealth.com), provides flat-screen TVs and tablets that show patient education videos.⁴ Another vendor, Patient Point (http://patientpoint.com), offers waiting room networks, editorials, and other communications designed to support “the goals of improving healthcare.”⁵ Other available media include channel news and music programming to relax patients.⁶

Wait times. A patient’s perceived wait time and the actual wait time are often quite different. How long she waits to see the ObGyn is “numero uno” with regard to patient satisfaction and can be a key source of annoyance, irritability, stress, and anger.

Does someone inform waiting patients that the ObGyn is running late? Does staff at the front desk or perhaps your medical assistant inquire, “Can I get you anything? The doctor is running late,” or “Dr. Jones has just finished delivering a baby. He’ll be here in 10 minutes. He’ll see you first.”

Consultation and exam rooms

Suggestions to develop a relaxing environment in your consultation and exam rooms are⁷:

• decorate the walls with soft, pastel colors
• use “spa aesthetics” to create a colorful atmosphere with appropriate lighting, artwork, and modern furnishings
• present a few magazines neatly and update them periodically
• stock and appropriately maintain the patients rooms with medical supplies
• remember, “Subjects perceive people more positively in beautiful rooms than in ugly rooms.”⁵

Read about how to keep your patients satisfied and your business stable.

Set the lead example

The need for open and supportive communication between you and your office staff cannot be overly emphasized. An ideal office staff member understands and shares in the vision, is aware of stated goals and objectives, is responsive to patient needs, and wants to create a win-win environment.

Frequently discuss your expectations with your staff. Expect them to be responsive, courteous, competent, have good communication skills, and be influenced by the appearance of the physical environ-ment. Provide support and educational tools to help them successfully perform their work.

Related article:
Four pillars of a successful practice: 1. Keep your current patients happy

Discover your patients’ vision of customer service

Formal measurement of patient satisfaction began with Professor Irwin Press at the University of Notre Dame. Rod Ganey, a sociologist and statistician, then developed the Press Ganey Patient Satisfaction Survey. These points earlier conveyed by Maslow and Mintz⁸ addressed the “effects of esthetic surroundings.” Color and art proved to be preferences in an esthetically pleasing environment. Additional historical information has been provided by Siegrist, who addressed “the patient experience.”⁹ He cites the myth that patients do not fill out satisfaction surveys. Indeed they do. Patient satisfaction is not a personality contest but rather a reflection of the health care provider’s investment of time and effort to offer patient-centered care. Siegrist also notes that the patient’s family plays a key role in how a patient perceives her experience with her health care professional.⁹

The federal government has been actively involved in assessing patient satisfaction in the hospital setting since 2002. This is reflected in the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys. The HCAHPS is a 27-question survey randomly administered to adult inpatients after discharge.^10–12

The following metrics are often included in patient satisfaction surveys^9,10:

• rating of hospital care from 0 (lowest) to 10 (highest)
• percentage of patients who would recommend a practice to family and friends
• number of patients who say their health care providers always communicate well
• the number of patients who report that the office is always clean and friendly.

Use of search engines focused on health care patient surveys can provide a number of options for clinicians to use in their practice.

Tips on patient satisfaction

Several interesting tips from the busi-ness world can be applied to an ObGyn’s practice¹⁴:

• You will only hear from 4% of unhappy customers.
• One dissatisfied customer tells 9.
• 95% of customers with resolved issues will do business with you again.
• If a problem is not addressed, that patient will tell 10 others.
• Resolve the problem and 5 people will know about it.
• It costs 5 times as much effort to gain 1 new customer.
• Loyal customers in 1 area of service are good prospects for other (new) services.

Related article:
Using the Internet in your practice. Part 2: Generating new patients using social media

Tell stories about good, satisfied patients

Sharing the stories of satisfied patients motivates others to consider coming to your practice. To develop these stories, offer a “suggestion box” where patients can leave compliments or comments about their experiences. Ask patients to record their positive reviews (be sure to obtain written consent before recording and publishing). Show the videos on the big-screen TVs in your waiting room and include patient reviews (written, audio, and video) on your website.¹⁵

Related article:
Four pillars of a successful practice: 4. Motivate your staff

Reevaluate periodically

Encouraging team spirit makes good business sense. Offer staff members bonuses for coming up with improved processes. Provide educational programs for staff on patient care, technology, etc. If a difficult experience occurs, discuss it openly with staff members without accusing, asking them for suggestions to improve the situation.¹⁶

Talking cents: Assessing your practice

---

To assess the monetary value of your practice, you need to know what contributes to your profit margin and overhead. What investments are the most profitable? Then monitor each segment of the office practice.

Should you proceed with a purchase? Should you take on a new hire? Let's look at one excellent model from the Boston Consulting Group (FIGURE) that provides insight into "low and high performance" aspects of business or practice.¹

In the matrix, Stars use large amounts of cash and are leaders in cash generation. Stars lead to development of a Cash Cow, which are entities that generate profits and cash with low investment prerequisites. Dogs are segments of product and service line(s) that should be carefully reevaluated. A decision must be made to liquidate if the problem cannot be corrected. Question Marks have the worst cash characteristics of all and are associated with high demands and low profit margin(s).¹

SWOT analysis
A SWOT analysis is most helpful when assessing a practice in real time. The basic tenets are²:  
Strengths:  

• prestigious reputation
• technological expertise

Weaknesses:  

• antiquated computer system
• lack of experience in specific areas

Opportunities:

• growing market demand for a specific product or procedure
• provision of unique services

Threats:

• changing demographics
• competitive practices
• changes in health care third-party payers.

The American College of Obstetricians and Gynecologists (ACOG) has developed an "ACOG Medical Home Toolkit" to allow ObGyns to assess how significant the changes regarding payers will be to their practice. Sections include the patient/practice partnership support; clinical care information; community resources; care delivery management; performance measurement and improvement; and payment and finance.³ The toolkit is available for download from the ACOG website.

References

1. Morrison A, Wensley R. Boxing up or boxed in? A short history of the Boston Consulting Group Share/Growth Matrix. J Market Manag. 1993;7(2):105-129. http://www.tandfonline.com/doi/abs/10.1080/0267257X.1991.9964145.
2. Klasko SK, Toub DB. It's not a plan without a business plan. In: Sanfilippo JS, Nolan TE, Whiteside BH, eds. MBA Handbook for Healthcare Professionals. New York, NY: Parthenon Publishing Group; 2002:36-37.
3. American Congress of Obstetricians and Gynecologists. ACOG Medical Home Toolkit. https://www.acog.org/About-ACOG/ACOG-Departments/Practice-Management-and-Managed-Care/ACOG-Medical-Home-Toolkit. Accessed August 14, 2017.

Bottom line

Ensuring that your patients have an outstanding experience is a smart business strategy. A unified approach that includes team members’ involvement to create a patient-centered environment will provide a quality experience and encourage patients to recommend your ObGyn practice to others.

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.

Independent of the Affordable Care Act or any upcoming changes in health care, the focus of an ObGyn practice remains paramount: the patient comes first.

The “recipe” for creating patient satisfaction and service excellence is predicated upon the mission of your practice and creating a shared vision with your employees. An action plan that is created and “visited/revisited”on a regular basis will serve to keep all abreast of the latest information to enhance the quality of patient care. It goes without saying, the ObGyn must first “lead by example” and always strive for satisfied patients who will tell their friends about your practice.

Start with the right tools

To organize a practice well, you need the right tools, which ideally include mission and vision statements and an action plan with goals and objectives.

Mission statement

A mission statement can be developed by the ObGyn(s) in your office or in concert with your staff. It should include:

• the “here and now” focus on the current approach to patient care
• why the practice exists (Develop a brief description of your practice, including the desired patient population.)
• the products and services offered and why and how those services are provided.

Here is an example of a mission statement for an ObGyn practice: “Our mission is to provide excellent, exceptional, personalized care for women of all ages in a warm and friendly environment. We incorporate leading-edge technology in our practice and continue to be a leader in obstetrics and gynecology.”

Vision statement

A vision statement should be developed in concert with your staff. It should include:

• the “then and there” focus on the historic perspective of your practice
• the ObGyn(s) and staff vision of the future
• what the ObGyn(s) and staff want to create.

The vision statement should energize and excite your personnel, create a shared and meaningful purpose, inspire passion and interest, and convey the values you want to share in your practice.

Here is an example of a vision statement for an ObGyn practice: “We aim to become the premier obstetrics and gynecology pro-vider to residents of (location) community.”

Action plan: Setting goals

To succeed, an ObGyn practice needs to:

• develop targets and challenges reflecting periodic (quarterly) meetings with staff and new entity development in the practice
• establish benchmarks and measurable parameters (How do you compare with other local practices? Set criteria/metrics to assess your progress.)
• ensure that the objectives support the goals (Develop goals and objectives over a defined period of time.)
• revisit the goals (Have they have been met? Do they need revision?)

Goals and objectives are essential for the continued health of your practice. This is all predicated upon developing a competitive advantage and then maintaining it.

Read about how to make a positive first impression on a new patient.

Is the environment welcoming?

When we examine a practice from the patient’s point of view, a good starting place is with the front desk. Have you looked at your front desk “from the outside in?” In one sense, this is the showcase of your practice.

Related article:
Four pillars of a successful practice: 2. Attract new patients

The first impression: Appointment scheduling

The first impression a patient receives about your practice occurs when she attempts to set up an appointment. Perhaps you might ask someone to call in to schedule an appointment. Is the caller immediately put on hold? Are your personnel courteous on the phone? Can she be seen quickly if she has a problem? How long is the wait for an annual exam? A test run can be very revealing.

Walk in the front door

When a patient walks in the door, does the physical office space radiate a friendly, relaxed atmosphere? Walk through the waiting room, then consultation and exam rooms as if you are a patient seeing it for the first time. Have you created an environment in which patients sense a well-organized office and the esprit de corps of the personnel? Does it look and smell fresh and clean? This all sends a loud and clear positive message about your practice.^1–3

Here are some suggestions for making a waiting room more inviting:

• Provide a seating arrangement that is “patient centered.” For example, semi- circular arrangements allow easy viewing of any monitors in the waiting room.
• WiFi is a great addition. Post several signs with the user name and password.
• Offer computers for patients to use to complete registration
• Set up a fish tank. If well-maintained, it can be soothing to many people.
• Display medical information pamphlets, even if they are rarely taken.
• Provide a big screen television that offers information about your practice, including personnel and procedures.

Streaming ads for physician offices are available. One platform, Outcome Health (https://www.outcomehealth.com), provides flat-screen TVs and tablets that show patient education videos.⁴ Another vendor, Patient Point (http://patientpoint.com), offers waiting room networks, editorials, and other communications designed to support “the goals of improving healthcare.”⁵ Other available media include channel news and music programming to relax patients.⁶

Wait times. A patient’s perceived wait time and the actual wait time are often quite different. How long she waits to see the ObGyn is “numero uno” with regard to patient satisfaction and can be a key source of annoyance, irritability, stress, and anger.

Does someone inform waiting patients that the ObGyn is running late? Does staff at the front desk or perhaps your medical assistant inquire, “Can I get you anything? The doctor is running late,” or “Dr. Jones has just finished delivering a baby. He’ll be here in 10 minutes. He’ll see you first.”

Consultation and exam rooms

Suggestions to develop a relaxing environment in your consultation and exam rooms are⁷:

• decorate the walls with soft, pastel colors
• use “spa aesthetics” to create a colorful atmosphere with appropriate lighting, artwork, and modern furnishings
• present a few magazines neatly and update them periodically
• stock and appropriately maintain the patients rooms with medical supplies
• remember, “Subjects perceive people more positively in beautiful rooms than in ugly rooms.”⁵

Read about how to keep your patients satisfied and your business stable.

Set the lead example

The need for open and supportive communication between you and your office staff cannot be overly emphasized. An ideal office staff member understands and shares in the vision, is aware of stated goals and objectives, is responsive to patient needs, and wants to create a win-win environment.

Frequently discuss your expectations with your staff. Expect them to be responsive, courteous, competent, have good communication skills, and be influenced by the appearance of the physical environ-ment. Provide support and educational tools to help them successfully perform their work.

Related article:
Four pillars of a successful practice: 1. Keep your current patients happy

Discover your patients’ vision of customer service

Formal measurement of patient satisfaction began with Professor Irwin Press at the University of Notre Dame. Rod Ganey, a sociologist and statistician, then developed the Press Ganey Patient Satisfaction Survey. These points earlier conveyed by Maslow and Mintz⁸ addressed the “effects of esthetic surroundings.” Color and art proved to be preferences in an esthetically pleasing environment. Additional historical information has been provided by Siegrist, who addressed “the patient experience.”⁹ He cites the myth that patients do not fill out satisfaction surveys. Indeed they do. Patient satisfaction is not a personality contest but rather a reflection of the health care provider’s investment of time and effort to offer patient-centered care. Siegrist also notes that the patient’s family plays a key role in how a patient perceives her experience with her health care professional.⁹

The federal government has been actively involved in assessing patient satisfaction in the hospital setting since 2002. This is reflected in the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys. The HCAHPS is a 27-question survey randomly administered to adult inpatients after discharge.^10–12

The following metrics are often included in patient satisfaction surveys^9,10:

• rating of hospital care from 0 (lowest) to 10 (highest)
• percentage of patients who would recommend a practice to family and friends
• number of patients who say their health care providers always communicate well
• the number of patients who report that the office is always clean and friendly.

Use of search engines focused on health care patient surveys can provide a number of options for clinicians to use in their practice.

Tips on patient satisfaction

Several interesting tips from the busi-ness world can be applied to an ObGyn’s practice¹⁴:

• You will only hear from 4% of unhappy customers.
• One dissatisfied customer tells 9.
• 95% of customers with resolved issues will do business with you again.
• If a problem is not addressed, that patient will tell 10 others.
• Resolve the problem and 5 people will know about it.
• It costs 5 times as much effort to gain 1 new customer.
• Loyal customers in 1 area of service are good prospects for other (new) services.

Related article:
Using the Internet in your practice. Part 2: Generating new patients using social media

Tell stories about good, satisfied patients

Sharing the stories of satisfied patients motivates others to consider coming to your practice. To develop these stories, offer a “suggestion box” where patients can leave compliments or comments about their experiences. Ask patients to record their positive reviews (be sure to obtain written consent before recording and publishing). Show the videos on the big-screen TVs in your waiting room and include patient reviews (written, audio, and video) on your website.¹⁵

Related article:
Four pillars of a successful practice: 4. Motivate your staff

Reevaluate periodically

Encouraging team spirit makes good business sense. Offer staff members bonuses for coming up with improved processes. Provide educational programs for staff on patient care, technology, etc. If a difficult experience occurs, discuss it openly with staff members without accusing, asking them for suggestions to improve the situation.¹⁶

Talking cents: Assessing your practice

---

To assess the monetary value of your practice, you need to know what contributes to your profit margin and overhead. What investments are the most profitable? Then monitor each segment of the office practice.

Should you proceed with a purchase? Should you take on a new hire? Let's look at one excellent model from the Boston Consulting Group (FIGURE) that provides insight into "low and high performance" aspects of business or practice.¹

In the matrix, Stars use large amounts of cash and are leaders in cash generation. Stars lead to development of a Cash Cow, which are entities that generate profits and cash with low investment prerequisites. Dogs are segments of product and service line(s) that should be carefully reevaluated. A decision must be made to liquidate if the problem cannot be corrected. Question Marks have the worst cash characteristics of all and are associated with high demands and low profit margin(s).¹

SWOT analysis
A SWOT analysis is most helpful when assessing a practice in real time. The basic tenets are²:  
Strengths:  

• prestigious reputation
• technological expertise

Weaknesses:  

• antiquated computer system
• lack of experience in specific areas

Opportunities:

• growing market demand for a specific product or procedure
• provision of unique services

Threats:

• changing demographics
• competitive practices
• changes in health care third-party payers.

The American College of Obstetricians and Gynecologists (ACOG) has developed an "ACOG Medical Home Toolkit" to allow ObGyns to assess how significant the changes regarding payers will be to their practice. Sections include the patient/practice partnership support; clinical care information; community resources; care delivery management; performance measurement and improvement; and payment and finance.³ The toolkit is available for download from the ACOG website.

References

1. Morrison A, Wensley R. Boxing up or boxed in? A short history of the Boston Consulting Group Share/Growth Matrix. J Market Manag. 1993;7(2):105-129. http://www.tandfonline.com/doi/abs/10.1080/0267257X.1991.9964145.
2. Klasko SK, Toub DB. It's not a plan without a business plan. In: Sanfilippo JS, Nolan TE, Whiteside BH, eds. MBA Handbook for Healthcare Professionals. New York, NY: Parthenon Publishing Group; 2002:36-37.
3. American Congress of Obstetricians and Gynecologists. ACOG Medical Home Toolkit. https://www.acog.org/About-ACOG/ACOG-Departments/Practice-Management-and-Managed-Care/ACOG-Medical-Home-Toolkit. Accessed August 14, 2017.

Bottom line

Ensuring that your patients have an outstanding experience is a smart business strategy. A unified approach that includes team members’ involvement to create a patient-centered environment will provide a quality experience and encourage patients to recommend your ObGyn practice to others.

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.

Independent of the Affordable Care Act or any upcoming changes in health care, the focus of an ObGyn practice remains paramount: the patient comes first.

The “recipe” for creating patient satisfaction and service excellence is predicated upon the mission of your practice and creating a shared vision with your employees. An action plan that is created and “visited/revisited”on a regular basis will serve to keep all abreast of the latest information to enhance the quality of patient care. It goes without saying, the ObGyn must first “lead by example” and always strive for satisfied patients who will tell their friends about your practice.

Start with the right tools

To organize a practice well, you need the right tools, which ideally include mission and vision statements and an action plan with goals and objectives.

Mission statement

A mission statement can be developed by the ObGyn(s) in your office or in concert with your staff. It should include:

• the “here and now” focus on the current approach to patient care
• why the practice exists (Develop a brief description of your practice, including the desired patient population.)
• the products and services offered and why and how those services are provided.

Here is an example of a mission statement for an ObGyn practice: “Our mission is to provide excellent, exceptional, personalized care for women of all ages in a warm and friendly environment. We incorporate leading-edge technology in our practice and continue to be a leader in obstetrics and gynecology.”

Vision statement

A vision statement should be developed in concert with your staff. It should include:

• the “then and there” focus on the historic perspective of your practice
• the ObGyn(s) and staff vision of the future
• what the ObGyn(s) and staff want to create.

The vision statement should energize and excite your personnel, create a shared and meaningful purpose, inspire passion and interest, and convey the values you want to share in your practice.

Here is an example of a vision statement for an ObGyn practice: “We aim to become the premier obstetrics and gynecology pro-vider to residents of (location) community.”

Action plan: Setting goals

To succeed, an ObGyn practice needs to:

• develop targets and challenges reflecting periodic (quarterly) meetings with staff and new entity development in the practice
• establish benchmarks and measurable parameters (How do you compare with other local practices? Set criteria/metrics to assess your progress.)
• ensure that the objectives support the goals (Develop goals and objectives over a defined period of time.)
• revisit the goals (Have they have been met? Do they need revision?)

Goals and objectives are essential for the continued health of your practice. This is all predicated upon developing a competitive advantage and then maintaining it.

Read about how to make a positive first impression on a new patient.

Is the environment welcoming?

When we examine a practice from the patient’s point of view, a good starting place is with the front desk. Have you looked at your front desk “from the outside in?” In one sense, this is the showcase of your practice.

Related article:
Four pillars of a successful practice: 2. Attract new patients

The first impression: Appointment scheduling

The first impression a patient receives about your practice occurs when she attempts to set up an appointment. Perhaps you might ask someone to call in to schedule an appointment. Is the caller immediately put on hold? Are your personnel courteous on the phone? Can she be seen quickly if she has a problem? How long is the wait for an annual exam? A test run can be very revealing.

Walk in the front door

When a patient walks in the door, does the physical office space radiate a friendly, relaxed atmosphere? Walk through the waiting room, then consultation and exam rooms as if you are a patient seeing it for the first time. Have you created an environment in which patients sense a well-organized office and the esprit de corps of the personnel? Does it look and smell fresh and clean? This all sends a loud and clear positive message about your practice.^1–3

Here are some suggestions for making a waiting room more inviting:

• Provide a seating arrangement that is “patient centered.” For example, semi- circular arrangements allow easy viewing of any monitors in the waiting room.
• WiFi is a great addition. Post several signs with the user name and password.
• Offer computers for patients to use to complete registration
• Set up a fish tank. If well-maintained, it can be soothing to many people.
• Display medical information pamphlets, even if they are rarely taken.
• Provide a big screen television that offers information about your practice, including personnel and procedures.

Streaming ads for physician offices are available. One platform, Outcome Health (https://www.outcomehealth.com), provides flat-screen TVs and tablets that show patient education videos.⁴ Another vendor, Patient Point (http://patientpoint.com), offers waiting room networks, editorials, and other communications designed to support “the goals of improving healthcare.”⁵ Other available media include channel news and music programming to relax patients.⁶

Wait times. A patient’s perceived wait time and the actual wait time are often quite different. How long she waits to see the ObGyn is “numero uno” with regard to patient satisfaction and can be a key source of annoyance, irritability, stress, and anger.

Does someone inform waiting patients that the ObGyn is running late? Does staff at the front desk or perhaps your medical assistant inquire, “Can I get you anything? The doctor is running late,” or “Dr. Jones has just finished delivering a baby. He’ll be here in 10 minutes. He’ll see you first.”

Consultation and exam rooms

Suggestions to develop a relaxing environment in your consultation and exam rooms are⁷:

• decorate the walls with soft, pastel colors
• use “spa aesthetics” to create a colorful atmosphere with appropriate lighting, artwork, and modern furnishings
• present a few magazines neatly and update them periodically
• stock and appropriately maintain the patients rooms with medical supplies
• remember, “Subjects perceive people more positively in beautiful rooms than in ugly rooms.”⁵

Read about how to keep your patients satisfied and your business stable.

Set the lead example

The need for open and supportive communication between you and your office staff cannot be overly emphasized. An ideal office staff member understands and shares in the vision, is aware of stated goals and objectives, is responsive to patient needs, and wants to create a win-win environment.

Frequently discuss your expectations with your staff. Expect them to be responsive, courteous, competent, have good communication skills, and be influenced by the appearance of the physical environ-ment. Provide support and educational tools to help them successfully perform their work.

Related article:
Four pillars of a successful practice: 1. Keep your current patients happy

Discover your patients’ vision of customer service

Formal measurement of patient satisfaction began with Professor Irwin Press at the University of Notre Dame. Rod Ganey, a sociologist and statistician, then developed the Press Ganey Patient Satisfaction Survey. These points earlier conveyed by Maslow and Mintz⁸ addressed the “effects of esthetic surroundings.” Color and art proved to be preferences in an esthetically pleasing environment. Additional historical information has been provided by Siegrist, who addressed “the patient experience.”⁹ He cites the myth that patients do not fill out satisfaction surveys. Indeed they do. Patient satisfaction is not a personality contest but rather a reflection of the health care provider’s investment of time and effort to offer patient-centered care. Siegrist also notes that the patient’s family plays a key role in how a patient perceives her experience with her health care professional.⁹

The federal government has been actively involved in assessing patient satisfaction in the hospital setting since 2002. This is reflected in the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys. The HCAHPS is a 27-question survey randomly administered to adult inpatients after discharge.^10–12

The following metrics are often included in patient satisfaction surveys^9,10:

• rating of hospital care from 0 (lowest) to 10 (highest)
• percentage of patients who would recommend a practice to family and friends
• number of patients who say their health care providers always communicate well
• the number of patients who report that the office is always clean and friendly.

Use of search engines focused on health care patient surveys can provide a number of options for clinicians to use in their practice.

Tips on patient satisfaction

Several interesting tips from the busi-ness world can be applied to an ObGyn’s practice¹⁴:

• You will only hear from 4% of unhappy customers.
• One dissatisfied customer tells 9.
• 95% of customers with resolved issues will do business with you again.
• If a problem is not addressed, that patient will tell 10 others.
• Resolve the problem and 5 people will know about it.
• It costs 5 times as much effort to gain 1 new customer.
• Loyal customers in 1 area of service are good prospects for other (new) services.

Related article:
Using the Internet in your practice. Part 2: Generating new patients using social media

Tell stories about good, satisfied patients

Sharing the stories of satisfied patients motivates others to consider coming to your practice. To develop these stories, offer a “suggestion box” where patients can leave compliments or comments about their experiences. Ask patients to record their positive reviews (be sure to obtain written consent before recording and publishing). Show the videos on the big-screen TVs in your waiting room and include patient reviews (written, audio, and video) on your website.¹⁵

Related article:
Four pillars of a successful practice: 4. Motivate your staff

Reevaluate periodically

Encouraging team spirit makes good business sense. Offer staff members bonuses for coming up with improved processes. Provide educational programs for staff on patient care, technology, etc. If a difficult experience occurs, discuss it openly with staff members without accusing, asking them for suggestions to improve the situation.¹⁶

Talking cents: Assessing your practice

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To assess the monetary value of your practice, you need to know what contributes to your profit margin and overhead. What investments are the most profitable? Then monitor each segment of the office practice.

Should you proceed with a purchase? Should you take on a new hire? Let's look at one excellent model from the Boston Consulting Group (FIGURE) that provides insight into "low and high performance" aspects of business or practice.¹

In the matrix, Stars use large amounts of cash and are leaders in cash generation. Stars lead to development of a Cash Cow, which are entities that generate profits and cash with low investment prerequisites. Dogs are segments of product and service line(s) that should be carefully reevaluated. A decision must be made to liquidate if the problem cannot be corrected. Question Marks have the worst cash characteristics of all and are associated with high demands and low profit margin(s).¹

SWOT analysis
A SWOT analysis is most helpful when assessing a practice in real time. The basic tenets are²:  
Strengths:  

• prestigious reputation
• technological expertise

Weaknesses:  

• antiquated computer system
• lack of experience in specific areas

Opportunities:

• growing market demand for a specific product or procedure
• provision of unique services

Threats:

• changing demographics
• competitive practices
• changes in health care third-party payers.

The American College of Obstetricians and Gynecologists (ACOG) has developed an "ACOG Medical Home Toolkit" to allow ObGyns to assess how significant the changes regarding payers will be to their practice. Sections include the patient/practice partnership support; clinical care information; community resources; care delivery management; performance measurement and improvement; and payment and finance.³ The toolkit is available for download from the ACOG website.

References

1. Morrison A, Wensley R. Boxing up or boxed in? A short history of the Boston Consulting Group Share/Growth Matrix. J Market Manag. 1993;7(2):105-129. http://www.tandfonline.com/doi/abs/10.1080/0267257X.1991.9964145.
2. Klasko SK, Toub DB. It's not a plan without a business plan. In: Sanfilippo JS, Nolan TE, Whiteside BH, eds. MBA Handbook for Healthcare Professionals. New York, NY: Parthenon Publishing Group; 2002:36-37.
3. American Congress of Obstetricians and Gynecologists. ACOG Medical Home Toolkit. https://www.acog.org/About-ACOG/ACOG-Departments/Practice-Management-and-Managed-Care/ACOG-Medical-Home-Toolkit. Accessed August 14, 2017.

Bottom line

Ensuring that your patients have an outstanding experience is a smart business strategy. A unified approach that includes team members’ involvement to create a patient-centered environment will provide a quality experience and encourage patients to recommend your ObGyn practice to others.

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.

Wrongful Life

There have been recent discussions in the lay media about a growing trend of litigation cases focused not on the “right to live,” but rather on the “right to die.” These cases have involved patients who received aggressive treatment, despite having documentation of their wishes not to receive such aggressive treatment. Although unsettling, it is not surprising that this issue has arisen, given the national conversations about the exorbitant cost of care at the end of life in the United States, and the frequency with which patients do not receive end-of-life care that is concordant with their wishes.

These conversations have spurred providers and patients to discuss and document their wishes, via advanced care directives and/or POLST orders (Physicians Orders for Life Sustaining Treatment). There is now even a national day devoted to advanced care decision making (National Healthcare Decisions Day).

Also on The Hospital Leader…

Follow You, Follow Me by Tracy Cardin, ACNP-BC, SFHM

SHM Movers & Shakers, Hospital Silos & JHM Research in HM News by Felicia Steele
 

Wrongful Life

There have been recent discussions in the lay media about a growing trend of litigation cases focused not on the “right to live,” but rather on the “right to die.” These cases have involved patients who received aggressive treatment, despite having documentation of their wishes not to receive such aggressive treatment. Although unsettling, it is not surprising that this issue has arisen, given the national conversations about the exorbitant cost of care at the end of life in the United States, and the frequency with which patients do not receive end-of-life care that is concordant with their wishes.

These conversations have spurred providers and patients to discuss and document their wishes, via advanced care directives and/or POLST orders (Physicians Orders for Life Sustaining Treatment). There is now even a national day devoted to advanced care decision making (National Healthcare Decisions Day).

Also on The Hospital Leader…

Follow You, Follow Me by Tracy Cardin, ACNP-BC, SFHM

SHM Movers & Shakers, Hospital Silos & JHM Research in HM News by Felicia Steele
 

Wrongful Life

There have been recent discussions in the lay media about a growing trend of litigation cases focused not on the “right to live,” but rather on the “right to die.” These cases have involved patients who received aggressive treatment, despite having documentation of their wishes not to receive such aggressive treatment. Although unsettling, it is not surprising that this issue has arisen, given the national conversations about the exorbitant cost of care at the end of life in the United States, and the frequency with which patients do not receive end-of-life care that is concordant with their wishes.

These conversations have spurred providers and patients to discuss and document their wishes, via advanced care directives and/or POLST orders (Physicians Orders for Life Sustaining Treatment). There is now even a national day devoted to advanced care decision making (National Healthcare Decisions Day).

Also on The Hospital Leader…

Follow You, Follow Me by Tracy Cardin, ACNP-BC, SFHM

SHM Movers & Shakers, Hospital Silos & JHM Research in HM News by Felicia Steele
 

The ability to perform activities of daily living (ADLs), commonly called functional status, is central to older adults’ quality of life (QOL) and independence.^1,2 Understanding functional status is key to improving outcomes for older adults. In community-dwelling older adults with difficulty performing basic ADLs, practical interventions, including physical and occupational therapy, can improve functioning and prevent functional decline.^3,4 Understanding function also is important for delivering patient-centered care, including individualizing cancer screening,⁵ evaluating how patients will tolerate interventions,^6-9 and helping patients and families determine the need for long-term services and supports.

For these reasons, assessing functional status is a cornerstone of geriatrics practice. However, most older adults are cared for in primary care settings where routine measurement of functional status is uncommon.^10,11 Although policy leaders have long noted this gap and the obstacle it poses to improving the quality and outcomes of care for older adults, many health care systems have been slow to incorporate measurement of functional status into routine patient care.^12-14

Over the past several years, the VA has been a leader in the efforts to address this barrier by implementing routine, standardized measurement of functional status in primary care clinics. Initially, the VA encouraged, but did not require, measurement of functional status among older adults, but the implementation barriers and facilitators were not formally assessed.¹⁵ In a postimplementation evaluation, the authors found that a relatively small number of medical centers implemented functional measures. Moreover, the level of implementation seemed to vary across sites. Some sites were collecting complete measures on all eligible older patients, while other sites were collecting measures less consistently.¹⁵

As part of a national VA initiative to learn how best to implement standardized functional status measurement, the authors are conducting a qualitative study, including a formal assessment of barriers and facilitators to implementing functional assessments in VA primary care clinics. In the current project, which serves as formative work for this larger ongoing study, the authors identified and described current processes for measuring functional status in VA primary care patient aligned care team (PACT) and Geriatric (GeriPACT) clinics.

Methods

A rapid qualitative analysis approach was used, which included semistructured interviews with primary care stakeholders and rapid data analysis to summarize each clinic’s approach to measuring functional status and develop process maps for each clinic (eFigures 1, 2, 3, and 4 ). Interviews and analyses were conducted by a team consisting of a geriatrician clinician-researcher, a medical anthropologist, and a research coordinator. The institutional review boards of the San Francisco VAMC and the University of California, San Francisco approved the study.

Sampling Strategy

In order to identify VAMCs with varying approaches to assessing functional status in older patients who attended primary care appointments, the study used a criterion sampling approach.^16,17 First, national “health factors” data were extracted from the VA Corporate Data Warehouse (CDW). Health factors are patient data collected through screening tools called clinical reminders, which prompt clinic staff and providers to enter data into checkbox-formatted templates. The study then identified medical centers that collected health factors data from patients aged ≥ 65 years (157 of 165 medical centers). A keyword search identified health factors related to the Katz ADL (bathing, dressing, transferring, toileting, and eating), and Lawton Instrumental ADL (IADL) Scale (using the telephone, shopping, preparing food, housekeeping, doing laundry, using transportation, managing medications, and managing finances).^18,19 Health factors that were not collected during a primary care appointment were excluded.

Of the original 157 medical centers, 139 met these initial inclusion criteria. Among these 139 medical centers, 66 centers did not collect complete data on these 5 ADLs and 8 IADLs (eg, only ADLs or only IADLs, or only certain ADLs or IADLs).

Two medical centers were selected in each of the following 3 categories: (1) routinely used clinical reminders to collect standardized data on the Katz ADL and the Lawton IADL Scale; (2) routinely used clinical reminders to collect functional status data but collected partial information; and (3) did not use a clinical reminder to collect functional status data. To ensure that these 6 medical centers were geographically representative, the sample included at least 1 site from each of the 5 VA regions: 1 North Atlantic, 1 Southeast, 1 Midwest, 2 Continental (1 from the northern Continental region and 1 from the southern), and 1 Pacific. Three sites that included GeriPACTs also were sampled.

Primary care PACT and GeriPACT members from these 6 medical centers were recruited to participate. These PACT members included individuals who can assess function or use functional status information to inform patient care, including front-line nursing staff (licensed practical nurses [LPNs], and registered nurses [RNs]), primary care providers (medical doctors [MDs] and nurse practitioners [NPs]), and social workers (SWs).

Local bargaining units, nurse managers, and clinic directors provided lists of all clinic staff. All members of each group then received recruitment e-mails. Phone interviews were scheduled with interested participants. In several cases, a snowball sampling approach was used to increase enrollment numbers by asking interview participants to recommend colleagues who might be interested in participating.¹⁷

Data Collection

Telephone interviews were conducted between March 2016 and October 2016 using semistructured guides developed from the project aims and from related literature in implementation science.^20,21 Interview domains included clinic structure, team member roles and responsibilities, current practices for collecting functional status data, and opinions on barriers and facilitators to assessing and recording functional status (Appendix:

Data Analysis

Rapid analysis, a team-based qualitative approach was used to engage efficiently and systematically with the data.^22,23 This approach allowed results to be analyzed more quickly than in traditional qualitative analysis in order to inform intervention design and develop implementation strategies.²³ Rapid analysis typically includes organization of interview data into summary templates, followed by a matrix analysis, which was used to create process maps.²⁴

Summary Templates

Summary templates were developed from the interview guides by shortening each question into a representative code. The project team then read the transcripts and summarized key points in the appropriate section of the template. This process, known as data reduction, is used to organize and highlight material so conclusions can be drawn from the data easily.²² In order to maintain rigor and trustworthiness, one team member conducted the interview, and a different team member created the interview summary. All team members reviewed each summary and met regularly to discuss results.

The summary templates were converted into matrix analyses, a method of displaying data to identify relationships, including commonalities and differences.²⁴ The matrixes were organized by stakeholder group and clinic in order to compare functional status assessment and documentation workflows across clinics.

Process Maps

Finally, the team used the matrix data to create process maps for each clinic of when, where, and by whom functional status information was assessed and documented. These maps were created using Microsoft Visio (Redmond, WA). The maps integrated perspectives from all participants to give an overview of the process for collecting functional status data in each clinic setting. To ensure accuracy, participants at each site received process maps to solicit feedback and validation.

Results

Forty-six participants at 6 medical centers (20 MDs and NPs, 19 RNs and LPNs, and 7 SWs) from 9 primary care clinics provided samples and interviews. The study team identified 3 general approaches to functional status assessment: (1) Routine collection of functional status data via a standardized clinical reminder; (2) Routine collection of functional status data via methods other than a clinical reminder (eg, a previsit telephone screen or electronic note template); and (3) Ad hoc approaches to measuring functional status (ie, no standard or routine approach to assessing or documenting functional status). The study team selected 4 clinics (2 PACTs and 2 GeriPACTs) clinics to serve as examples of the 3 identified approaches.

The processes for functional status assessment in each of 4 clinics are summarized in the following detailed descriptions (Table).

Clinic 1

Clinic 1 is a GeriPACT clinic that routinely assesses and documents functional status for all patients (efigure 1, available at feprac.com). The clinic’s current process includes 4 elements: (1) a patient questionnaire; (2) an annual clinical reminder administered by an RN; (3) a primary care provider (PCP) assessment; and (4) a postvisit SW assessment if referred by the PCP.

All newly referred patients are mailed a paper questionnaire that includes questions about their medical history and functional status. The patient is asked to bring the completed questionnaire to the first appointment. The clinic RN completes this form for returning patients at every visit during patient intake.

Second, the clinic uses an annual functional status clinical reminder for patients aged ≥ 75 years. The reminder includes questions about a patient’s ability to perform ADLs and IADLs with 3 to 4 response options for each question. If the clinical reminder is due at the time of a patient appointment, the RN fills out the reminder using information from the paper questionnaire. The RN also records this functional status in the nursing intake note. The RN may elect to designate the PCP as a cosigner for the nursing intake note especially if there are concerns about or changes in the patient’s functional status.

Third, the RN brings the paper form to the PCP, who often uses the questionnaire to guide the patient history. The PCP then uses the questionnaire and patient history to complete a functional status template within their visit note. The PCP also may use this information to inform patient care (eg, to make referrals to physical or occupational therapy).

Finally, the PCP might refer the patient to SW. The SW may be able to see the patient immediately after the PCP appointment, but if not, the SW follows up with a phone call to complete further functional status assessment and eligibility forms.

In addition to the above assessments by individual team members, the PACT has an interdisciplinary team huddle at the end of each clinic to discuss any issues or concerns about specific patients. The huddles often focus on issues related to functional status.

Clinic 2

Clinic 2 is a primary care PACT clinic that routinely assesses and documents functional status (eFigure 2, available at fedprac.com). The clinic process includes 3 steps: an annual clinical reminder for patients aged ≥ 75 years; a PCP assessment; and a postvisit SW assessment if referred by the PCP.

First, patients see an LPN for the intake process. During intake, the LPN records vitals and completes relevant clinical reminders. Similar to Clinic 1, Clinic 2 requires an annual functional status clinical reminder that includes ADLs and IADLs for patients aged ≥ 75 years. Patient information from the intake and clinical reminders are recorded by the LPN in a preventative medicine note in the electronic health record. This note is printed and handed to the PCP.

The PCP may review the preventative medicine note prior to completing the patient history and physical, including the functional status clinical reminder when applicable. If the PCP follows up on any functional issues identified by the LPN or completes further assessment of patient function, he or she may use this information to refer the patient to services or to place a SW consult; the PCP’s functional assessment is documented in a free-form visit note.

When the SW receives a consult, a chart review for social history, demographic information, and previous functional status assessments is conducted. The SW then calls the patient to administer functional and cognitive assessments over the phone and refers the patient to appropriate services based on eligibility.

Clinic 3

Clinic 3 is a GeriPACT clinic where functional status information is routinely collected for all new patients but may or may not be collected for returning patients (eFigure 3, available at fedprac.com). The process for new patients includes a previsit SW assessment; an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit SW assessment if referred by the provider. The process for returning patients is similar but omits the previsit social work assessment. New patients complete a comprehensive questionnaire with a SW before their first clinic visit. The questionnaire is completed by phone and involves an extensive social and medical history, including an assessment of ADLs and IADLs. This assessment is recorded in a free-form social work note.

Next, both new and returning patients see an LPN who completes the intake process, including vitals and clinical reminders. Clinic 3 does not have a clinical reminder for functional status. However, the LPN could elect to ask about ADLs or IADLs if the patient brings up a functional issue related to the chief symptom or if the LPN observes something that indicates possible functional impairment, such as difficulty walking or a disheveled appearance. If discussed, this information is recorded in the LPN intake note, and the LPN also could verbally inform the PCP of the patient’s functional status. The RN is not formally involved in intake or functional status assessment in this clinic.

Finally, the patient sees the PCP, who may or may not have reviewed the LPN note. The PCP may assess functional status at his or her discretion, but there was no required assessment. The PCP could complete an optional functional status assessment template included in the PCP visit note. The PCP can refer the patient to services or to SW for further evaluation.

Clinic 4

Clinic 4 is a primary care PACT clinic that does not routinely measure functional status (eFigure 4, available at fedprac.com). The approach includes an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit social worker assessment if referred by the provider. These steps are very similar to those of clinic 3, but they do not include a previsit SW assessment for new patients.

Although not represented within the 4 clinics described in this article, the content of functional status clinical reminders differed across the 9 clinics in the larger sample. Clinical reminders differed across several domains, including the type of question stems (scripted questions for each ADL vs categories for each activity); response options (eg, dichotomous vs ≥ 3 options), and the presence of free-text boxes to allow staff to enter any additional notes.

Discussion

Approaches to assessing and documenting functional status varied widely. Whereas some clinics primarily used informal approaches to assessing and documenting functional status (ie, neither routine nor standardized), others used a routine, standardized clinical reminder, and some combined several standardized approaches to measuring function. The study team identified variability across several domains of the functional status assessment process, including documentation, workflow, and clinical reminder content.

Approaches to functional assessment differed between GeriPACT and PACT clinics. Consistent with the central role that functional status assessment plays in geriatrics practice, GeriPACTs tended to employ a routine, multidisciplinary approach to measuring functional status. This approach included standardized functional assessments by multiple primary care team members, including LPNs, SWs, and PCPs. In contrast, when PACTs completed standardized functional status assessment, it was generally carried out by a single team member (typically an LPN). The PCPs in PACTs used a nonroutine approach to assess functional status in which they performed detailed functional assessments for certain high-risk patients and referred a subset for further SW evaluation.

These processes are consistent with research showing that standardized functional status data are seldom collected routinely in nongeriatric primary care settings.¹¹ Reports by PCPs that they did not always assess functional status also are consistent with previous research demonstrating that clinicians are not always aware of their patients’ functional ability.¹⁰

In addition to highlighting differences between GeriPACT and PACTs, the identified processes illustrate the variability in documentation, clinic workflow, and clinical reminder content across all clinics. Approaches to documentation included checkbox-formatted clinical reminders with and without associated nursing notes, patient questionnaires, and templated PCP and SW notes. Clinics employed varying approaches to collect functional status information and to ensure that those data were shared with the team. Clinic staff assessed functional status at different times during the clinical encounter. Clinics used several approaches to share this information with team members, including warm handoffs from LPNs to PCPs, interdisciplinary team huddles, and electronic signoffs. Finally, clinical reminder content varied between clinics, with differences in the wording of ADL and IADL questions as well as in the number and type of response options.

This variability highlights the challenges inherent in developing a routine, standardized approach to measuring functional status that can be adapted across primary care settings. Such an approach must be both flexible enough to accommodate variation in workflow and structured enough to capture accurate data that can be used to guide clinical decisions. Capturing accurate, standardized data in CDW also will inform efforts to improve population health by allowing VHA leaders to understand the scope of disability among older veterans and plan for service needs and interventions.

Whereas the larger qualitative study will identify the specific barriers and facilitators to developing and implementing such an approach, current clinic processes present here offer hints as to which features may be important. For example, several clinics collected functional status information before the visit by telephone or questionnaire. Therefore, it will be important to choose a functional status assessment instrument that is validated for both telephone and in-person use. Similarly, some clinics had structured clinical reminders with categoric response options, whereas others included free-text boxes. Incorporating both categoric responses (to ensure accurate data) as well as free-text (to allow for additional notes about a patient’s specific circumstances that may influence service needs) may be one approach.

Limitations

This study’s approach to identifying clinic processes had several limitations. First, the authors did not send process maps to clinic directors for verification. However, speaking with PACT members who carry out clinic processes is likely the most accurate way to identify practice. Second, the results may not be generalizable to all VA primary care settings. Due to resource limitations and project scope, community-based outpatient clinics (CBOCs) were not included. Compared with clinics based in medical centers, CBOCs may have different staffing levels, practice models, and needs regarding implementation of functional status assessment.

Although 46 participants from 9 clinics were interviewed, there are likely additional approaches to measuring functional status that are not represented within this sample. In addition, 3 of the 4 clinics included are affiliated with academic institutions, and all 4 are located in large cities. Efforts to include rural VAMCs were not successful. Finally, clinic-level characteristics were not reported, which may impact clinic processes. Although study participants were asked about clinic characteristics, they were often unsure or only able to provide rough estimates. In the ongoing qualitative study, the authors will attempt to collect more reliable data about these clinic-level characteristics and to examine the potential role these characteristics may play as barriers or facilitators to implementing routine assessment of functional status in primary care settings.

Conclusion

VA primary care clinics had widely varying approaches for assessing and documenting functional status. This work along with a larger ongoing qualitative study that includes interviews with veterans will directly inform the design and implementation of a standardized, patient-centered approach to functional assessment that can be adapted across varied primary care settings. Implementing standardized functional status measurement will allow the VA to serve veterans better by using functional status information to refer patients to appropriate services and to deliver patient-centered care with the potential to improve patient function and quality of life.

The ability to perform activities of daily living (ADLs), commonly called functional status, is central to older adults’ quality of life (QOL) and independence.^1,2 Understanding functional status is key to improving outcomes for older adults. In community-dwelling older adults with difficulty performing basic ADLs, practical interventions, including physical and occupational therapy, can improve functioning and prevent functional decline.^3,4 Understanding function also is important for delivering patient-centered care, including individualizing cancer screening,⁵ evaluating how patients will tolerate interventions,^6-9 and helping patients and families determine the need for long-term services and supports.

For these reasons, assessing functional status is a cornerstone of geriatrics practice. However, most older adults are cared for in primary care settings where routine measurement of functional status is uncommon.^10,11 Although policy leaders have long noted this gap and the obstacle it poses to improving the quality and outcomes of care for older adults, many health care systems have been slow to incorporate measurement of functional status into routine patient care.^12-14

Over the past several years, the VA has been a leader in the efforts to address this barrier by implementing routine, standardized measurement of functional status in primary care clinics. Initially, the VA encouraged, but did not require, measurement of functional status among older adults, but the implementation barriers and facilitators were not formally assessed.¹⁵ In a postimplementation evaluation, the authors found that a relatively small number of medical centers implemented functional measures. Moreover, the level of implementation seemed to vary across sites. Some sites were collecting complete measures on all eligible older patients, while other sites were collecting measures less consistently.¹⁵

As part of a national VA initiative to learn how best to implement standardized functional status measurement, the authors are conducting a qualitative study, including a formal assessment of barriers and facilitators to implementing functional assessments in VA primary care clinics. In the current project, which serves as formative work for this larger ongoing study, the authors identified and described current processes for measuring functional status in VA primary care patient aligned care team (PACT) and Geriatric (GeriPACT) clinics.

Methods

A rapid qualitative analysis approach was used, which included semistructured interviews with primary care stakeholders and rapid data analysis to summarize each clinic’s approach to measuring functional status and develop process maps for each clinic (eFigures 1, 2, 3, and 4 ). Interviews and analyses were conducted by a team consisting of a geriatrician clinician-researcher, a medical anthropologist, and a research coordinator. The institutional review boards of the San Francisco VAMC and the University of California, San Francisco approved the study.

Sampling Strategy

In order to identify VAMCs with varying approaches to assessing functional status in older patients who attended primary care appointments, the study used a criterion sampling approach.^16,17 First, national “health factors” data were extracted from the VA Corporate Data Warehouse (CDW). Health factors are patient data collected through screening tools called clinical reminders, which prompt clinic staff and providers to enter data into checkbox-formatted templates. The study then identified medical centers that collected health factors data from patients aged ≥ 65 years (157 of 165 medical centers). A keyword search identified health factors related to the Katz ADL (bathing, dressing, transferring, toileting, and eating), and Lawton Instrumental ADL (IADL) Scale (using the telephone, shopping, preparing food, housekeeping, doing laundry, using transportation, managing medications, and managing finances).^18,19 Health factors that were not collected during a primary care appointment were excluded.

Of the original 157 medical centers, 139 met these initial inclusion criteria. Among these 139 medical centers, 66 centers did not collect complete data on these 5 ADLs and 8 IADLs (eg, only ADLs or only IADLs, or only certain ADLs or IADLs).

Two medical centers were selected in each of the following 3 categories: (1) routinely used clinical reminders to collect standardized data on the Katz ADL and the Lawton IADL Scale; (2) routinely used clinical reminders to collect functional status data but collected partial information; and (3) did not use a clinical reminder to collect functional status data. To ensure that these 6 medical centers were geographically representative, the sample included at least 1 site from each of the 5 VA regions: 1 North Atlantic, 1 Southeast, 1 Midwest, 2 Continental (1 from the northern Continental region and 1 from the southern), and 1 Pacific. Three sites that included GeriPACTs also were sampled.

Primary care PACT and GeriPACT members from these 6 medical centers were recruited to participate. These PACT members included individuals who can assess function or use functional status information to inform patient care, including front-line nursing staff (licensed practical nurses [LPNs], and registered nurses [RNs]), primary care providers (medical doctors [MDs] and nurse practitioners [NPs]), and social workers (SWs).

Local bargaining units, nurse managers, and clinic directors provided lists of all clinic staff. All members of each group then received recruitment e-mails. Phone interviews were scheduled with interested participants. In several cases, a snowball sampling approach was used to increase enrollment numbers by asking interview participants to recommend colleagues who might be interested in participating.¹⁷

Data Collection

Telephone interviews were conducted between March 2016 and October 2016 using semistructured guides developed from the project aims and from related literature in implementation science.^20,21 Interview domains included clinic structure, team member roles and responsibilities, current practices for collecting functional status data, and opinions on barriers and facilitators to assessing and recording functional status (Appendix:

Data Analysis

Rapid analysis, a team-based qualitative approach was used to engage efficiently and systematically with the data.^22,23 This approach allowed results to be analyzed more quickly than in traditional qualitative analysis in order to inform intervention design and develop implementation strategies.²³ Rapid analysis typically includes organization of interview data into summary templates, followed by a matrix analysis, which was used to create process maps.²⁴

Summary Templates

Summary templates were developed from the interview guides by shortening each question into a representative code. The project team then read the transcripts and summarized key points in the appropriate section of the template. This process, known as data reduction, is used to organize and highlight material so conclusions can be drawn from the data easily.²² In order to maintain rigor and trustworthiness, one team member conducted the interview, and a different team member created the interview summary. All team members reviewed each summary and met regularly to discuss results.

The summary templates were converted into matrix analyses, a method of displaying data to identify relationships, including commonalities and differences.²⁴ The matrixes were organized by stakeholder group and clinic in order to compare functional status assessment and documentation workflows across clinics.

Process Maps

Finally, the team used the matrix data to create process maps for each clinic of when, where, and by whom functional status information was assessed and documented. These maps were created using Microsoft Visio (Redmond, WA). The maps integrated perspectives from all participants to give an overview of the process for collecting functional status data in each clinic setting. To ensure accuracy, participants at each site received process maps to solicit feedback and validation.

Results

Forty-six participants at 6 medical centers (20 MDs and NPs, 19 RNs and LPNs, and 7 SWs) from 9 primary care clinics provided samples and interviews. The study team identified 3 general approaches to functional status assessment: (1) Routine collection of functional status data via a standardized clinical reminder; (2) Routine collection of functional status data via methods other than a clinical reminder (eg, a previsit telephone screen or electronic note template); and (3) Ad hoc approaches to measuring functional status (ie, no standard or routine approach to assessing or documenting functional status). The study team selected 4 clinics (2 PACTs and 2 GeriPACTs) clinics to serve as examples of the 3 identified approaches.

The processes for functional status assessment in each of 4 clinics are summarized in the following detailed descriptions (Table).

Clinic 1

Clinic 1 is a GeriPACT clinic that routinely assesses and documents functional status for all patients (efigure 1, available at feprac.com). The clinic’s current process includes 4 elements: (1) a patient questionnaire; (2) an annual clinical reminder administered by an RN; (3) a primary care provider (PCP) assessment; and (4) a postvisit SW assessment if referred by the PCP.

All newly referred patients are mailed a paper questionnaire that includes questions about their medical history and functional status. The patient is asked to bring the completed questionnaire to the first appointment. The clinic RN completes this form for returning patients at every visit during patient intake.

Second, the clinic uses an annual functional status clinical reminder for patients aged ≥ 75 years. The reminder includes questions about a patient’s ability to perform ADLs and IADLs with 3 to 4 response options for each question. If the clinical reminder is due at the time of a patient appointment, the RN fills out the reminder using information from the paper questionnaire. The RN also records this functional status in the nursing intake note. The RN may elect to designate the PCP as a cosigner for the nursing intake note especially if there are concerns about or changes in the patient’s functional status.

Third, the RN brings the paper form to the PCP, who often uses the questionnaire to guide the patient history. The PCP then uses the questionnaire and patient history to complete a functional status template within their visit note. The PCP also may use this information to inform patient care (eg, to make referrals to physical or occupational therapy).

Finally, the PCP might refer the patient to SW. The SW may be able to see the patient immediately after the PCP appointment, but if not, the SW follows up with a phone call to complete further functional status assessment and eligibility forms.

In addition to the above assessments by individual team members, the PACT has an interdisciplinary team huddle at the end of each clinic to discuss any issues or concerns about specific patients. The huddles often focus on issues related to functional status.

Clinic 2

Clinic 2 is a primary care PACT clinic that routinely assesses and documents functional status (eFigure 2, available at fedprac.com). The clinic process includes 3 steps: an annual clinical reminder for patients aged ≥ 75 years; a PCP assessment; and a postvisit SW assessment if referred by the PCP.

First, patients see an LPN for the intake process. During intake, the LPN records vitals and completes relevant clinical reminders. Similar to Clinic 1, Clinic 2 requires an annual functional status clinical reminder that includes ADLs and IADLs for patients aged ≥ 75 years. Patient information from the intake and clinical reminders are recorded by the LPN in a preventative medicine note in the electronic health record. This note is printed and handed to the PCP.

The PCP may review the preventative medicine note prior to completing the patient history and physical, including the functional status clinical reminder when applicable. If the PCP follows up on any functional issues identified by the LPN or completes further assessment of patient function, he or she may use this information to refer the patient to services or to place a SW consult; the PCP’s functional assessment is documented in a free-form visit note.

When the SW receives a consult, a chart review for social history, demographic information, and previous functional status assessments is conducted. The SW then calls the patient to administer functional and cognitive assessments over the phone and refers the patient to appropriate services based on eligibility.

Clinic 3

Clinic 3 is a GeriPACT clinic where functional status information is routinely collected for all new patients but may or may not be collected for returning patients (eFigure 3, available at fedprac.com). The process for new patients includes a previsit SW assessment; an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit SW assessment if referred by the provider. The process for returning patients is similar but omits the previsit social work assessment. New patients complete a comprehensive questionnaire with a SW before their first clinic visit. The questionnaire is completed by phone and involves an extensive social and medical history, including an assessment of ADLs and IADLs. This assessment is recorded in a free-form social work note.

Next, both new and returning patients see an LPN who completes the intake process, including vitals and clinical reminders. Clinic 3 does not have a clinical reminder for functional status. However, the LPN could elect to ask about ADLs or IADLs if the patient brings up a functional issue related to the chief symptom or if the LPN observes something that indicates possible functional impairment, such as difficulty walking or a disheveled appearance. If discussed, this information is recorded in the LPN intake note, and the LPN also could verbally inform the PCP of the patient’s functional status. The RN is not formally involved in intake or functional status assessment in this clinic.

Finally, the patient sees the PCP, who may or may not have reviewed the LPN note. The PCP may assess functional status at his or her discretion, but there was no required assessment. The PCP could complete an optional functional status assessment template included in the PCP visit note. The PCP can refer the patient to services or to SW for further evaluation.

Clinic 4

Clinic 4 is a primary care PACT clinic that does not routinely measure functional status (eFigure 4, available at fedprac.com). The approach includes an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit social worker assessment if referred by the provider. These steps are very similar to those of clinic 3, but they do not include a previsit SW assessment for new patients.

Although not represented within the 4 clinics described in this article, the content of functional status clinical reminders differed across the 9 clinics in the larger sample. Clinical reminders differed across several domains, including the type of question stems (scripted questions for each ADL vs categories for each activity); response options (eg, dichotomous vs ≥ 3 options), and the presence of free-text boxes to allow staff to enter any additional notes.

Discussion

Approaches to assessing and documenting functional status varied widely. Whereas some clinics primarily used informal approaches to assessing and documenting functional status (ie, neither routine nor standardized), others used a routine, standardized clinical reminder, and some combined several standardized approaches to measuring function. The study team identified variability across several domains of the functional status assessment process, including documentation, workflow, and clinical reminder content.

Approaches to functional assessment differed between GeriPACT and PACT clinics. Consistent with the central role that functional status assessment plays in geriatrics practice, GeriPACTs tended to employ a routine, multidisciplinary approach to measuring functional status. This approach included standardized functional assessments by multiple primary care team members, including LPNs, SWs, and PCPs. In contrast, when PACTs completed standardized functional status assessment, it was generally carried out by a single team member (typically an LPN). The PCPs in PACTs used a nonroutine approach to assess functional status in which they performed detailed functional assessments for certain high-risk patients and referred a subset for further SW evaluation.

These processes are consistent with research showing that standardized functional status data are seldom collected routinely in nongeriatric primary care settings.¹¹ Reports by PCPs that they did not always assess functional status also are consistent with previous research demonstrating that clinicians are not always aware of their patients’ functional ability.¹⁰

In addition to highlighting differences between GeriPACT and PACTs, the identified processes illustrate the variability in documentation, clinic workflow, and clinical reminder content across all clinics. Approaches to documentation included checkbox-formatted clinical reminders with and without associated nursing notes, patient questionnaires, and templated PCP and SW notes. Clinics employed varying approaches to collect functional status information and to ensure that those data were shared with the team. Clinic staff assessed functional status at different times during the clinical encounter. Clinics used several approaches to share this information with team members, including warm handoffs from LPNs to PCPs, interdisciplinary team huddles, and electronic signoffs. Finally, clinical reminder content varied between clinics, with differences in the wording of ADL and IADL questions as well as in the number and type of response options.

This variability highlights the challenges inherent in developing a routine, standardized approach to measuring functional status that can be adapted across primary care settings. Such an approach must be both flexible enough to accommodate variation in workflow and structured enough to capture accurate data that can be used to guide clinical decisions. Capturing accurate, standardized data in CDW also will inform efforts to improve population health by allowing VHA leaders to understand the scope of disability among older veterans and plan for service needs and interventions.

Whereas the larger qualitative study will identify the specific barriers and facilitators to developing and implementing such an approach, current clinic processes present here offer hints as to which features may be important. For example, several clinics collected functional status information before the visit by telephone or questionnaire. Therefore, it will be important to choose a functional status assessment instrument that is validated for both telephone and in-person use. Similarly, some clinics had structured clinical reminders with categoric response options, whereas others included free-text boxes. Incorporating both categoric responses (to ensure accurate data) as well as free-text (to allow for additional notes about a patient’s specific circumstances that may influence service needs) may be one approach.

Limitations

This study’s approach to identifying clinic processes had several limitations. First, the authors did not send process maps to clinic directors for verification. However, speaking with PACT members who carry out clinic processes is likely the most accurate way to identify practice. Second, the results may not be generalizable to all VA primary care settings. Due to resource limitations and project scope, community-based outpatient clinics (CBOCs) were not included. Compared with clinics based in medical centers, CBOCs may have different staffing levels, practice models, and needs regarding implementation of functional status assessment.

Although 46 participants from 9 clinics were interviewed, there are likely additional approaches to measuring functional status that are not represented within this sample. In addition, 3 of the 4 clinics included are affiliated with academic institutions, and all 4 are located in large cities. Efforts to include rural VAMCs were not successful. Finally, clinic-level characteristics were not reported, which may impact clinic processes. Although study participants were asked about clinic characteristics, they were often unsure or only able to provide rough estimates. In the ongoing qualitative study, the authors will attempt to collect more reliable data about these clinic-level characteristics and to examine the potential role these characteristics may play as barriers or facilitators to implementing routine assessment of functional status in primary care settings.

Conclusion

VA primary care clinics had widely varying approaches for assessing and documenting functional status. This work along with a larger ongoing qualitative study that includes interviews with veterans will directly inform the design and implementation of a standardized, patient-centered approach to functional assessment that can be adapted across varied primary care settings. Implementing standardized functional status measurement will allow the VA to serve veterans better by using functional status information to refer patients to appropriate services and to deliver patient-centered care with the potential to improve patient function and quality of life.

The ability to perform activities of daily living (ADLs), commonly called functional status, is central to older adults’ quality of life (QOL) and independence.^1,2 Understanding functional status is key to improving outcomes for older adults. In community-dwelling older adults with difficulty performing basic ADLs, practical interventions, including physical and occupational therapy, can improve functioning and prevent functional decline.^3,4 Understanding function also is important for delivering patient-centered care, including individualizing cancer screening,⁵ evaluating how patients will tolerate interventions,^6-9 and helping patients and families determine the need for long-term services and supports.

For these reasons, assessing functional status is a cornerstone of geriatrics practice. However, most older adults are cared for in primary care settings where routine measurement of functional status is uncommon.^10,11 Although policy leaders have long noted this gap and the obstacle it poses to improving the quality and outcomes of care for older adults, many health care systems have been slow to incorporate measurement of functional status into routine patient care.^12-14

Over the past several years, the VA has been a leader in the efforts to address this barrier by implementing routine, standardized measurement of functional status in primary care clinics. Initially, the VA encouraged, but did not require, measurement of functional status among older adults, but the implementation barriers and facilitators were not formally assessed.¹⁵ In a postimplementation evaluation, the authors found that a relatively small number of medical centers implemented functional measures. Moreover, the level of implementation seemed to vary across sites. Some sites were collecting complete measures on all eligible older patients, while other sites were collecting measures less consistently.¹⁵

As part of a national VA initiative to learn how best to implement standardized functional status measurement, the authors are conducting a qualitative study, including a formal assessment of barriers and facilitators to implementing functional assessments in VA primary care clinics. In the current project, which serves as formative work for this larger ongoing study, the authors identified and described current processes for measuring functional status in VA primary care patient aligned care team (PACT) and Geriatric (GeriPACT) clinics.

Methods

A rapid qualitative analysis approach was used, which included semistructured interviews with primary care stakeholders and rapid data analysis to summarize each clinic’s approach to measuring functional status and develop process maps for each clinic (eFigures 1, 2, 3, and 4 ). Interviews and analyses were conducted by a team consisting of a geriatrician clinician-researcher, a medical anthropologist, and a research coordinator. The institutional review boards of the San Francisco VAMC and the University of California, San Francisco approved the study.

Sampling Strategy

In order to identify VAMCs with varying approaches to assessing functional status in older patients who attended primary care appointments, the study used a criterion sampling approach.^16,17 First, national “health factors” data were extracted from the VA Corporate Data Warehouse (CDW). Health factors are patient data collected through screening tools called clinical reminders, which prompt clinic staff and providers to enter data into checkbox-formatted templates. The study then identified medical centers that collected health factors data from patients aged ≥ 65 years (157 of 165 medical centers). A keyword search identified health factors related to the Katz ADL (bathing, dressing, transferring, toileting, and eating), and Lawton Instrumental ADL (IADL) Scale (using the telephone, shopping, preparing food, housekeeping, doing laundry, using transportation, managing medications, and managing finances).^18,19 Health factors that were not collected during a primary care appointment were excluded.

Of the original 157 medical centers, 139 met these initial inclusion criteria. Among these 139 medical centers, 66 centers did not collect complete data on these 5 ADLs and 8 IADLs (eg, only ADLs or only IADLs, or only certain ADLs or IADLs).

Two medical centers were selected in each of the following 3 categories: (1) routinely used clinical reminders to collect standardized data on the Katz ADL and the Lawton IADL Scale; (2) routinely used clinical reminders to collect functional status data but collected partial information; and (3) did not use a clinical reminder to collect functional status data. To ensure that these 6 medical centers were geographically representative, the sample included at least 1 site from each of the 5 VA regions: 1 North Atlantic, 1 Southeast, 1 Midwest, 2 Continental (1 from the northern Continental region and 1 from the southern), and 1 Pacific. Three sites that included GeriPACTs also were sampled.

Primary care PACT and GeriPACT members from these 6 medical centers were recruited to participate. These PACT members included individuals who can assess function or use functional status information to inform patient care, including front-line nursing staff (licensed practical nurses [LPNs], and registered nurses [RNs]), primary care providers (medical doctors [MDs] and nurse practitioners [NPs]), and social workers (SWs).

Local bargaining units, nurse managers, and clinic directors provided lists of all clinic staff. All members of each group then received recruitment e-mails. Phone interviews were scheduled with interested participants. In several cases, a snowball sampling approach was used to increase enrollment numbers by asking interview participants to recommend colleagues who might be interested in participating.¹⁷

Data Collection

Telephone interviews were conducted between March 2016 and October 2016 using semistructured guides developed from the project aims and from related literature in implementation science.^20,21 Interview domains included clinic structure, team member roles and responsibilities, current practices for collecting functional status data, and opinions on barriers and facilitators to assessing and recording functional status (Appendix:

Data Analysis

Rapid analysis, a team-based qualitative approach was used to engage efficiently and systematically with the data.^22,23 This approach allowed results to be analyzed more quickly than in traditional qualitative analysis in order to inform intervention design and develop implementation strategies.²³ Rapid analysis typically includes organization of interview data into summary templates, followed by a matrix analysis, which was used to create process maps.²⁴

Summary Templates

Summary templates were developed from the interview guides by shortening each question into a representative code. The project team then read the transcripts and summarized key points in the appropriate section of the template. This process, known as data reduction, is used to organize and highlight material so conclusions can be drawn from the data easily.²² In order to maintain rigor and trustworthiness, one team member conducted the interview, and a different team member created the interview summary. All team members reviewed each summary and met regularly to discuss results.

The summary templates were converted into matrix analyses, a method of displaying data to identify relationships, including commonalities and differences.²⁴ The matrixes were organized by stakeholder group and clinic in order to compare functional status assessment and documentation workflows across clinics.

Process Maps

Finally, the team used the matrix data to create process maps for each clinic of when, where, and by whom functional status information was assessed and documented. These maps were created using Microsoft Visio (Redmond, WA). The maps integrated perspectives from all participants to give an overview of the process for collecting functional status data in each clinic setting. To ensure accuracy, participants at each site received process maps to solicit feedback and validation.

Results

Forty-six participants at 6 medical centers (20 MDs and NPs, 19 RNs and LPNs, and 7 SWs) from 9 primary care clinics provided samples and interviews. The study team identified 3 general approaches to functional status assessment: (1) Routine collection of functional status data via a standardized clinical reminder; (2) Routine collection of functional status data via methods other than a clinical reminder (eg, a previsit telephone screen or electronic note template); and (3) Ad hoc approaches to measuring functional status (ie, no standard or routine approach to assessing or documenting functional status). The study team selected 4 clinics (2 PACTs and 2 GeriPACTs) clinics to serve as examples of the 3 identified approaches.

The processes for functional status assessment in each of 4 clinics are summarized in the following detailed descriptions (Table).

Clinic 1

Clinic 1 is a GeriPACT clinic that routinely assesses and documents functional status for all patients (efigure 1, available at feprac.com). The clinic’s current process includes 4 elements: (1) a patient questionnaire; (2) an annual clinical reminder administered by an RN; (3) a primary care provider (PCP) assessment; and (4) a postvisit SW assessment if referred by the PCP.

All newly referred patients are mailed a paper questionnaire that includes questions about their medical history and functional status. The patient is asked to bring the completed questionnaire to the first appointment. The clinic RN completes this form for returning patients at every visit during patient intake.

Second, the clinic uses an annual functional status clinical reminder for patients aged ≥ 75 years. The reminder includes questions about a patient’s ability to perform ADLs and IADLs with 3 to 4 response options for each question. If the clinical reminder is due at the time of a patient appointment, the RN fills out the reminder using information from the paper questionnaire. The RN also records this functional status in the nursing intake note. The RN may elect to designate the PCP as a cosigner for the nursing intake note especially if there are concerns about or changes in the patient’s functional status.

Third, the RN brings the paper form to the PCP, who often uses the questionnaire to guide the patient history. The PCP then uses the questionnaire and patient history to complete a functional status template within their visit note. The PCP also may use this information to inform patient care (eg, to make referrals to physical or occupational therapy).

Finally, the PCP might refer the patient to SW. The SW may be able to see the patient immediately after the PCP appointment, but if not, the SW follows up with a phone call to complete further functional status assessment and eligibility forms.

In addition to the above assessments by individual team members, the PACT has an interdisciplinary team huddle at the end of each clinic to discuss any issues or concerns about specific patients. The huddles often focus on issues related to functional status.

Clinic 2

Clinic 2 is a primary care PACT clinic that routinely assesses and documents functional status (eFigure 2, available at fedprac.com). The clinic process includes 3 steps: an annual clinical reminder for patients aged ≥ 75 years; a PCP assessment; and a postvisit SW assessment if referred by the PCP.

First, patients see an LPN for the intake process. During intake, the LPN records vitals and completes relevant clinical reminders. Similar to Clinic 1, Clinic 2 requires an annual functional status clinical reminder that includes ADLs and IADLs for patients aged ≥ 75 years. Patient information from the intake and clinical reminders are recorded by the LPN in a preventative medicine note in the electronic health record. This note is printed and handed to the PCP.

The PCP may review the preventative medicine note prior to completing the patient history and physical, including the functional status clinical reminder when applicable. If the PCP follows up on any functional issues identified by the LPN or completes further assessment of patient function, he or she may use this information to refer the patient to services or to place a SW consult; the PCP’s functional assessment is documented in a free-form visit note.

When the SW receives a consult, a chart review for social history, demographic information, and previous functional status assessments is conducted. The SW then calls the patient to administer functional and cognitive assessments over the phone and refers the patient to appropriate services based on eligibility.

Clinic 3

Clinic 3 is a GeriPACT clinic where functional status information is routinely collected for all new patients but may or may not be collected for returning patients (eFigure 3, available at fedprac.com). The process for new patients includes a previsit SW assessment; an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit SW assessment if referred by the provider. The process for returning patients is similar but omits the previsit social work assessment. New patients complete a comprehensive questionnaire with a SW before their first clinic visit. The questionnaire is completed by phone and involves an extensive social and medical history, including an assessment of ADLs and IADLs. This assessment is recorded in a free-form social work note.

Next, both new and returning patients see an LPN who completes the intake process, including vitals and clinical reminders. Clinic 3 does not have a clinical reminder for functional status. However, the LPN could elect to ask about ADLs or IADLs if the patient brings up a functional issue related to the chief symptom or if the LPN observes something that indicates possible functional impairment, such as difficulty walking or a disheveled appearance. If discussed, this information is recorded in the LPN intake note, and the LPN also could verbally inform the PCP of the patient’s functional status. The RN is not formally involved in intake or functional status assessment in this clinic.

Finally, the patient sees the PCP, who may or may not have reviewed the LPN note. The PCP may assess functional status at his or her discretion, but there was no required assessment. The PCP could complete an optional functional status assessment template included in the PCP visit note. The PCP can refer the patient to services or to SW for further evaluation.

Clinic 4

Clinic 4 is a primary care PACT clinic that does not routinely measure functional status (eFigure 4, available at fedprac.com). The approach includes an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit social worker assessment if referred by the provider. These steps are very similar to those of clinic 3, but they do not include a previsit SW assessment for new patients.

Although not represented within the 4 clinics described in this article, the content of functional status clinical reminders differed across the 9 clinics in the larger sample. Clinical reminders differed across several domains, including the type of question stems (scripted questions for each ADL vs categories for each activity); response options (eg, dichotomous vs ≥ 3 options), and the presence of free-text boxes to allow staff to enter any additional notes.

Discussion

Approaches to assessing and documenting functional status varied widely. Whereas some clinics primarily used informal approaches to assessing and documenting functional status (ie, neither routine nor standardized), others used a routine, standardized clinical reminder, and some combined several standardized approaches to measuring function. The study team identified variability across several domains of the functional status assessment process, including documentation, workflow, and clinical reminder content.

Approaches to functional assessment differed between GeriPACT and PACT clinics. Consistent with the central role that functional status assessment plays in geriatrics practice, GeriPACTs tended to employ a routine, multidisciplinary approach to measuring functional status. This approach included standardized functional assessments by multiple primary care team members, including LPNs, SWs, and PCPs. In contrast, when PACTs completed standardized functional status assessment, it was generally carried out by a single team member (typically an LPN). The PCPs in PACTs used a nonroutine approach to assess functional status in which they performed detailed functional assessments for certain high-risk patients and referred a subset for further SW evaluation.

These processes are consistent with research showing that standardized functional status data are seldom collected routinely in nongeriatric primary care settings.¹¹ Reports by PCPs that they did not always assess functional status also are consistent with previous research demonstrating that clinicians are not always aware of their patients’ functional ability.¹⁰

In addition to highlighting differences between GeriPACT and PACTs, the identified processes illustrate the variability in documentation, clinic workflow, and clinical reminder content across all clinics. Approaches to documentation included checkbox-formatted clinical reminders with and without associated nursing notes, patient questionnaires, and templated PCP and SW notes. Clinics employed varying approaches to collect functional status information and to ensure that those data were shared with the team. Clinic staff assessed functional status at different times during the clinical encounter. Clinics used several approaches to share this information with team members, including warm handoffs from LPNs to PCPs, interdisciplinary team huddles, and electronic signoffs. Finally, clinical reminder content varied between clinics, with differences in the wording of ADL and IADL questions as well as in the number and type of response options.

This variability highlights the challenges inherent in developing a routine, standardized approach to measuring functional status that can be adapted across primary care settings. Such an approach must be both flexible enough to accommodate variation in workflow and structured enough to capture accurate data that can be used to guide clinical decisions. Capturing accurate, standardized data in CDW also will inform efforts to improve population health by allowing VHA leaders to understand the scope of disability among older veterans and plan for service needs and interventions.

Whereas the larger qualitative study will identify the specific barriers and facilitators to developing and implementing such an approach, current clinic processes present here offer hints as to which features may be important. For example, several clinics collected functional status information before the visit by telephone or questionnaire. Therefore, it will be important to choose a functional status assessment instrument that is validated for both telephone and in-person use. Similarly, some clinics had structured clinical reminders with categoric response options, whereas others included free-text boxes. Incorporating both categoric responses (to ensure accurate data) as well as free-text (to allow for additional notes about a patient’s specific circumstances that may influence service needs) may be one approach.

Limitations

This study’s approach to identifying clinic processes had several limitations. First, the authors did not send process maps to clinic directors for verification. However, speaking with PACT members who carry out clinic processes is likely the most accurate way to identify practice. Second, the results may not be generalizable to all VA primary care settings. Due to resource limitations and project scope, community-based outpatient clinics (CBOCs) were not included. Compared with clinics based in medical centers, CBOCs may have different staffing levels, practice models, and needs regarding implementation of functional status assessment.

Although 46 participants from 9 clinics were interviewed, there are likely additional approaches to measuring functional status that are not represented within this sample. In addition, 3 of the 4 clinics included are affiliated with academic institutions, and all 4 are located in large cities. Efforts to include rural VAMCs were not successful. Finally, clinic-level characteristics were not reported, which may impact clinic processes. Although study participants were asked about clinic characteristics, they were often unsure or only able to provide rough estimates. In the ongoing qualitative study, the authors will attempt to collect more reliable data about these clinic-level characteristics and to examine the potential role these characteristics may play as barriers or facilitators to implementing routine assessment of functional status in primary care settings.

Conclusion

VA primary care clinics had widely varying approaches for assessing and documenting functional status. This work along with a larger ongoing qualitative study that includes interviews with veterans will directly inform the design and implementation of a standardized, patient-centered approach to functional assessment that can be adapted across varied primary care settings. Implementing standardized functional status measurement will allow the VA to serve veterans better by using functional status information to refer patients to appropriate services and to deliver patient-centered care with the potential to improve patient function and quality of life.

Woman dies following cervical cone biopsy: $4.25M award  

A 46-year-old woman underwent a cervical cone biopsy at a Veterans Administration (VA) hospital on July 18. Following the test, significant bleeding occurred. The gynecologic surgeon attempted to control the hemorrhage by injecting ferric subsulfate (Monsel’s) solution into the patient’s vagina. The bleeding abated, but the patient went into hypovolemic shock. During emergency laparotomy, a uterine perforation and injuries to both uterine arteries were detected. A hysterectomy was performed to stop the hemorrhage. The patient improved at first, but developed sepsis, small-bowel necrosis, and other complications. A bowel resection procedure was performed on July 26. She died on September 5.

ESTATE'S CLAIM:
The surgeon’s actions were negligent. She removed too much tissue during the biopsy, injured the vaginal and uterine walls, and failed to timely diagnose and appropriately treat the injuries. The ferric subsulfate solution entered the abdominal cavity via the perforation, causing peritonitis and bowel injuries. A pathology report from the bowel resection surgery informed the surgeon that the bowel was not properly reconnected after the damaged portion was removed, but this condition was neither detected intraoperatively nor treated postoperatively.

DEFENDANTS' DEFENSE:
The surgeon moved for summary judgment, countering that, as a federal employee, she was exempt from personal liability for the services performed as an employee of the VA. That motion was denied. She then argued that injury to the vaginal/uterine wall is a known complication of the biopsy procedure.

VERDICT:
A $4.25 million Illinois verdict was returned in federal court.

Related article:
Reducing maternal mortality in the United States—Let’s get organized!

Needle stick not reported to patient

A woman delivered a baby assisted by an on-call ObGyn. When the baby developed fetal tachycardia, the ObGyn recommended expediting delivery and discussed various options and the risks of each option. The mother chose a vaginal forceps delivery. During the procedure, the mother experienced a 3rd-degree perineal laceration and a few minor lacerations, which were repaired. The mother was in pain, so the ObGyn performed a revision repair. During the procedure, the ObGyn accidentally stuck himself with a clean needle. He replaced the needle and changed his glove. The mother reported instant pain relief following revision and was discharged. After the needle incident, the ObGyn’s thumb became red and swollen, so he took antibiotics.

Two days after discharge, the patient reported to the ObGyn’s office with fever, pain, and a foul odor emanating from the surgery site. She was given the diagnosis of pelvic incisional cellulitis and was taken to the operating room for exploration and debridement. The patient developed septic shock and necrotizing fasciitis. She was placed on a ventilator and underwent 13 surgeries.

PATIENTS' CLAIM:
The ObGyn was negligent. The patient claimed breach of duty: the ObGyn did not disclose that his thumb was swollen and that he took antibiotics.

PHYSICIANS' DEFENSE:
There was no breach of duty. He did not feel the need to concern the patient about an injury to himself that did not affect her.

VERDICT:
A Kansas defense verdict was returned.

Related article:
2017 Update on infectious disease

Catheter removal, air embolism: $3.5M settlement

A 44-year-old woman underwent gynecologic surgery on April 22. She developed a rectovaginal fistula and other complications. Intravenous antibiotics were required and parenteral nutrition was delivered through a central venous catheter. On May 22, after a hospital nurse removed the catheter, an air embolism developed, causing a brain injury. The patient has a mental disability and residual leg tremors.

PATIENTS' CLAIM:
Because of the surgeon’s negligence during surgery, a fistula developed. The nurse negligently removed the catheter, causing the embolism.

DEFENDANTS' DEFENSE:
The case settled during the trial.

VERDICT:
A $3.5 million Illinois settlement was reached, including payments of $1 million from the surgeon and $2.5 million from the hospital.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

Woman dies following cervical cone biopsy: $4.25M award  

A 46-year-old woman underwent a cervical cone biopsy at a Veterans Administration (VA) hospital on July 18. Following the test, significant bleeding occurred. The gynecologic surgeon attempted to control the hemorrhage by injecting ferric subsulfate (Monsel’s) solution into the patient’s vagina. The bleeding abated, but the patient went into hypovolemic shock. During emergency laparotomy, a uterine perforation and injuries to both uterine arteries were detected. A hysterectomy was performed to stop the hemorrhage. The patient improved at first, but developed sepsis, small-bowel necrosis, and other complications. A bowel resection procedure was performed on July 26. She died on September 5.

ESTATE'S CLAIM:
The surgeon’s actions were negligent. She removed too much tissue during the biopsy, injured the vaginal and uterine walls, and failed to timely diagnose and appropriately treat the injuries. The ferric subsulfate solution entered the abdominal cavity via the perforation, causing peritonitis and bowel injuries. A pathology report from the bowel resection surgery informed the surgeon that the bowel was not properly reconnected after the damaged portion was removed, but this condition was neither detected intraoperatively nor treated postoperatively.

DEFENDANTS' DEFENSE:
The surgeon moved for summary judgment, countering that, as a federal employee, she was exempt from personal liability for the services performed as an employee of the VA. That motion was denied. She then argued that injury to the vaginal/uterine wall is a known complication of the biopsy procedure.

VERDICT:
A $4.25 million Illinois verdict was returned in federal court.

Related article:
Reducing maternal mortality in the United States—Let’s get organized!

Needle stick not reported to patient

A woman delivered a baby assisted by an on-call ObGyn. When the baby developed fetal tachycardia, the ObGyn recommended expediting delivery and discussed various options and the risks of each option. The mother chose a vaginal forceps delivery. During the procedure, the mother experienced a 3rd-degree perineal laceration and a few minor lacerations, which were repaired. The mother was in pain, so the ObGyn performed a revision repair. During the procedure, the ObGyn accidentally stuck himself with a clean needle. He replaced the needle and changed his glove. The mother reported instant pain relief following revision and was discharged. After the needle incident, the ObGyn’s thumb became red and swollen, so he took antibiotics.

Two days after discharge, the patient reported to the ObGyn’s office with fever, pain, and a foul odor emanating from the surgery site. She was given the diagnosis of pelvic incisional cellulitis and was taken to the operating room for exploration and debridement. The patient developed septic shock and necrotizing fasciitis. She was placed on a ventilator and underwent 13 surgeries.

PATIENTS' CLAIM:
The ObGyn was negligent. The patient claimed breach of duty: the ObGyn did not disclose that his thumb was swollen and that he took antibiotics.

PHYSICIANS' DEFENSE:
There was no breach of duty. He did not feel the need to concern the patient about an injury to himself that did not affect her.

VERDICT:
A Kansas defense verdict was returned.

Related article:
2017 Update on infectious disease

Catheter removal, air embolism: $3.5M settlement

A 44-year-old woman underwent gynecologic surgery on April 22. She developed a rectovaginal fistula and other complications. Intravenous antibiotics were required and parenteral nutrition was delivered through a central venous catheter. On May 22, after a hospital nurse removed the catheter, an air embolism developed, causing a brain injury. The patient has a mental disability and residual leg tremors.

PATIENTS' CLAIM:
Because of the surgeon’s negligence during surgery, a fistula developed. The nurse negligently removed the catheter, causing the embolism.

DEFENDANTS' DEFENSE:
The case settled during the trial.

VERDICT:
A $3.5 million Illinois settlement was reached, including payments of $1 million from the surgeon and $2.5 million from the hospital.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.

Woman dies following cervical cone biopsy: $4.25M award  

A 46-year-old woman underwent a cervical cone biopsy at a Veterans Administration (VA) hospital on July 18. Following the test, significant bleeding occurred. The gynecologic surgeon attempted to control the hemorrhage by injecting ferric subsulfate (Monsel’s) solution into the patient’s vagina. The bleeding abated, but the patient went into hypovolemic shock. During emergency laparotomy, a uterine perforation and injuries to both uterine arteries were detected. A hysterectomy was performed to stop the hemorrhage. The patient improved at first, but developed sepsis, small-bowel necrosis, and other complications. A bowel resection procedure was performed on July 26. She died on September 5.

ESTATE'S CLAIM:
The surgeon’s actions were negligent. She removed too much tissue during the biopsy, injured the vaginal and uterine walls, and failed to timely diagnose and appropriately treat the injuries. The ferric subsulfate solution entered the abdominal cavity via the perforation, causing peritonitis and bowel injuries. A pathology report from the bowel resection surgery informed the surgeon that the bowel was not properly reconnected after the damaged portion was removed, but this condition was neither detected intraoperatively nor treated postoperatively.

DEFENDANTS' DEFENSE:
The surgeon moved for summary judgment, countering that, as a federal employee, she was exempt from personal liability for the services performed as an employee of the VA. That motion was denied. She then argued that injury to the vaginal/uterine wall is a known complication of the biopsy procedure.

VERDICT:
A $4.25 million Illinois verdict was returned in federal court.

Related article:
Reducing maternal mortality in the United States—Let’s get organized!

Needle stick not reported to patient

A woman delivered a baby assisted by an on-call ObGyn. When the baby developed fetal tachycardia, the ObGyn recommended expediting delivery and discussed various options and the risks of each option. The mother chose a vaginal forceps delivery. During the procedure, the mother experienced a 3rd-degree perineal laceration and a few minor lacerations, which were repaired. The mother was in pain, so the ObGyn performed a revision repair. During the procedure, the ObGyn accidentally stuck himself with a clean needle. He replaced the needle and changed his glove. The mother reported instant pain relief following revision and was discharged. After the needle incident, the ObGyn’s thumb became red and swollen, so he took antibiotics.

Two days after discharge, the patient reported to the ObGyn’s office with fever, pain, and a foul odor emanating from the surgery site. She was given the diagnosis of pelvic incisional cellulitis and was taken to the operating room for exploration and debridement. The patient developed septic shock and necrotizing fasciitis. She was placed on a ventilator and underwent 13 surgeries.

PATIENTS' CLAIM:
The ObGyn was negligent. The patient claimed breach of duty: the ObGyn did not disclose that his thumb was swollen and that he took antibiotics.

PHYSICIANS' DEFENSE:
There was no breach of duty. He did not feel the need to concern the patient about an injury to himself that did not affect her.

VERDICT:
A Kansas defense verdict was returned.

Related article:
2017 Update on infectious disease

Catheter removal, air embolism: $3.5M settlement

A 44-year-old woman underwent gynecologic surgery on April 22. She developed a rectovaginal fistula and other complications. Intravenous antibiotics were required and parenteral nutrition was delivered through a central venous catheter. On May 22, after a hospital nurse removed the catheter, an air embolism developed, causing a brain injury. The patient has a mental disability and residual leg tremors.

PATIENTS' CLAIM:
Because of the surgeon’s negligence during surgery, a fistula developed. The nurse negligently removed the catheter, causing the embolism.

DEFENDANTS' DEFENSE:
The case settled during the trial.

VERDICT:
A $3.5 million Illinois settlement was reached, including payments of $1 million from the surgeon and $2.5 million from the hospital.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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.