Clinical Review

The older adult population in the VA is growing. Adults aged > 85 years are the fastest growing segment of the older veteran population and many are afflicted with multiple medical problems and functional impairments.^1,2 The majority of older veterans (94.6%, or about 1.9 million veterans) who seek care at the VA obtain care through primary care providers (PCPs) who are often not formally trained in geriatrics.^1,3 With the increasing number of older patients, new models of care are needed to provide coordinated, comprehensive, efficient, and patient-centered care.^4,5

Common themes found in successful models of care for older patients include a team approach, care management (comprehensive and coordinated), and patients who are active partners.⁴ These themes are reflected in the VA Patient Aligned Care Team (PACT) primary care program. PACT, a model of care that was initiated in 2010 and is built on a foundation of patient-centered care, encompasses a team approach to provide comprehensive, coordinated, and personalized care.^6-8 The challenge for the VA is to integrate gerontologic principles and tools into the daily practice of all PACTs in order to improve care provided for older veterans.⁹

This article discusses current challenges in caring for older veterans in the VA system and recommends tools that can be used to infuse geriatric care principles into VA primary care by the PACT, to improve the quality of care provided to older veterans. In addition, the article also describes VA geriatric programs that PACT clinicians can access to supplement older veterans’ care.

Challenges of Caring for Older Veterans

One concern when caring for older veterans arises when the veteran accesses both VA and non-VA health care services to offset medication costs and obtain services not covered by Medicare or other insurance companies.^2,3 This “dual care” can exacerbate polypharmacy issues and increase confusion regarding plans of care. Problems may arise when multiple providers from different systems of care prescribe medications available only within their own formulary and/or order diagnostic and laboratory tests with results available only within their own health care system.

The VA is also challenged by health care delivery for rural veterans. Thirty-six percent of all veterans live in rural areas, and they often depend on non-VA services to meet their health care needs due to difficulty traveling to the nearest VA facility.¹⁰ Seasonal residency also presents challenges. An increasing number of older veterans are seen at different VA facilities when they “winter” in a different section of the country.

Fortunately, a VA provider in one facility can access a patient’s electronic medical records in another facility, using the VA Computerized Patient Record System (CPRS). However, it is unclear to what extent busy VA PCPs use this function when seeing patients. Although individual pilot programs have shown promise, integrated electronic health records between VA and non-VA health care have not advanced to the point of sharing data or reconciling care plans (R. Rupper, personal communication, March 1, 2013).

Many PCPs and other PACT staff are not formally trained in geriatrics and may have had limited exposure to geriatric principles.³ Clinic time pressures, multiple clinical reminders (eg, vaccinations), and panel management of specific diseases make it challenging to find time to focus on complex geriatric syndromes. Current PACT performance measures also do not routinely include geriatric-specific quality of care criteria or focus on patient function (K. Shay, personal communication, February 12, 2013), a hallmark of geriatric care.⁸ Furthermore, with increasing complexity of the health care system and limited availability of resources, it is often time consuming to identify and collaborate with non-VA resources to ensure patients’ needs are met in their communities.

Opportunities for Improvement in Care

The VA transformation to PACTs has led to process changes in clinic workflow that may aid in addressing the aforementioned challenges in caring for older veterans. Each patient is assigned to a PCP-led team that includes a registered nurse care manager, a clinical associate, and an administrative associate. The PACT model of care has increased access to care by redesigning face-to-face visits, increasingly moving toward open access, and through the increased use of virtual access via secured e-mail, telephone visits, and telehealth.⁸

In addition to process changes, the VA has created new tools to assist teams in patient management. One of these is the Care Assessment Need (CAN) score, a risk stratification tool available for use by PACTs to identify patients at highest risk for hospital admission and/or death for focused care management.¹¹ It is based on statistical prediction models of veterans enrolled in primary care, using patient characteristics and health care use information.¹¹ Although the CAN score looks promising, more research is needed to evaluate its effectiveness  in improving care for older veterans and its association with better patient functioning—an important focus in quality geriatric care.

A tool that takes into account daily function is the Vulnerable Elders Survey-13 (VES-13). As measured by the VES-13, functional ability has been shown to be a strong predictor of decline and death in older adults independent of gender or comorbidities.¹² Integration of the VES-13 into the evaluation of older veterans could assist PACTs in considering patients’ current function and life expectancy in their care plans along with patient and family goals.

Another potentially useful tool for the PACT team is the SPICES mnemonic (Sleeping, Problems with feeding/eating, Incontinence or urinary problems, Confusion, Evidence of falls, and Skin breakdown).¹³ Although SPICES is not comprehensive, this mnemonic highlights potential problems facing older patients that may not be brought up routinely. It provides a concise, formalized format that can be used by clerks or patient support assistants  as part of the check-in process.

This tool has been used successfully by the Geriatric Evaluation and Management Clinic of the South Texas Veterans Health Care System (STVHCS) to improve communication between the PCP and nurse so that pertinent patient information is relayed concisely. SPICES was helpful in identifying patients needing interventions for fall risk. In a retrospective chart review of 100 randomly selected patients aged 75 to 90 years enrolled in the clinic, a 75% reduction in falls was noted during the first year of implementation (STVHCS unpublished data, 2012).

Additional tools that focus on identifying specific geriatric syndromes are available online from the Hartford Institute for Geriatric Nursing, which provides evidence-based information and training on how to assess, evaluate, and manage common geriatric syndromes such as depression, dementia, and delirium.¹⁴ The site also includes videos on how to use common brief geriatric assessment tools that can be performed by nurses and health care associates while the patient is in the waiting room. Though promising, further research is needed to study the effects of these tools on patient, provider, and system outcomes.

Infusing quality of care indicators (QI) can play an integral role in achieving PACT goals while improving the older veterans’ quality of life. For example, polypharmacy and medication-related injuries in older adults continue to pose both a safety and economic challenge to patients and the health care system.^15-17 The 2012 Beers criteria for Potentially Inappropriate Medications in Older Adults lists 53 medication classes that have been identified as potentially inappropriate medications for use in older adults.¹⁷ Use of this tool by PACTs in the development of patient care plans has the potential to reduce medication-related adverse reactions and improper prescribing.^18,19

Assessing Care of Vulnerable Elders (ACOVE ) also provides QIs that are specific to vulnerable older persons.^20-24 The most recent version, ACOVE-3, includes 392 QIs for 26 conditions and 14 types of care processes and covers all domains of care.²⁰ Findings from a study applying QIs involving vulnerable elderly patients in 2 managed care programs revealed that recipients of better-quality care had a 10% higher survival rate over 3 years.²⁵

The VA currently monitors 6 frail elderly QIs based on ACOVE criteria via reviews of medical records in veterans aged > 75 years. These QIs cover falls, incontinence, functional assessment, and the presence of a surrogate decision maker. PACT staff, unfortunately, do not receive feedback on these, because they are still QIs and not part of the performance measures (K. Shay, personal communication, February 12, 2013). Though some VA sites have adopted these QIs to some extent, until these frail elderly QIs become performance measures throughout VA, other competing priorities may be more at the forefront of quality improvement projects done by PACT teams.⁵

The American Geriatrics Society recently published recommendations on the care of older adults with multiple chronic conditions, to aid PCPs in practicing a more individualized, patient-centered care in complex cases.²⁶ In addition to focusing on a patient’s primary concern during a clinic visit and eliciting preferences, considering prognosis in deciding on treatment options allows patients to better weigh the potential benefits and burdens in their daily living.²⁶ A discussion on how aggressive potential treatments are and what the patient is willing to undertake is an important component of patient-centered care and should be incorporated during routine PACT clinic visits.

VA Geriatric Programs

It is important for PACT clinicians to be familiar with the geriatric programs and resources available within the VA medical home “neighborhood,” which can supplement care. One such resource is the Geriatric Research Education and Clinical Centers (GRECCs). There are currently 19 GRECCs throughout the nation that serve as Centers of Excellence in the care of older veterans.²⁷ The GRECCs provide training for clinicians, test innovative ways to care for older veterans, and collaborate with other staff to improve the care provided. Some have also developed Geriatric Primary Care Clinics (or Geri PACTs) to provide team care to very frail and high-risk older veterans. Since not all VA facilities have access to Geri PACTs, the GRECCs play an important role in making geriatric expertise and training available to the PACTs.³

To address this limitation in access, VA programs have begun using telehealth technology to increase competencies of PCPs in caring for older veterans. For example, the VA Geriatric Scholars Program is a national educational program with different avenues to “geriatricize” VA primary care services and improve knowledge and care provided to older veterans.²⁸ It consists of several subprograms: Geriatric Scholars Program for Rural Community Based Outpatient Clinics; Geriatric Scholars Program for Primary Care Providers; Rural Interdisciplinary Team Training; and the Geriatric Assessment Pocket Guide.²⁹ These components may include didactics both face-to-face and online, clinical experience with performing common geriatric screening tools, and a quality improvement project.

Some local VAMCs have also developed programs to address this need to improve care provided to older veterans in PACT. The VA Greater Los Angeles Healthcare System (GLA) GRECC, for example, has started several programs to infuse geriatrics into PACTs, including the Geri Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN-ECHO). VA SCAN-ECHO was developed to increase access to specialty care in rural/underserved areas. The PCP presents a case and a specialty provider gives guidance in the assessment and/or management of a specific clinical problem.³⁰ Unlike many other SCAN-ECHO programs, the GLA Geri SCAN-ECHO program encourages not only PCPs, but also nurses and social workers to submit consults for discussion and encourages team management (a hallmark of quality geriatric care). Another important GLA GRECC project is the Veterans Cognitive Assessment and Management Program (V-CAMP), which uses videoconferencing to assess and manage veterans with cognitive impairment/dementia who reside in underserved areas in the GLA region. The program provides dementia care management and access to neuropsychological examinations—services that are often not available in rural areas.³¹

Various VA program offices have also published useful resources to help PACT clinicians infuse gerontologic principles into their practice. The VA Office of Nursing Services has a Geriatrics and Extended Care Field Advisory Committee, which recently produced on-demand lectures in the virtual VA eHealth University (also known as myVeHU campus) on improving the PACT’s management of progressive chronic diseases and dementia recognition and initial evaluation. They also produced a resource guide for VA clinicians (nursing and non-nursing), based on a team consensus of what the workgroup thinks a clinician would find helpful in clinical practice to improve care of older veterans. The VA Office of Geriatrics and Extended Care Service also identified a list of clinical and educational resources to help PACT clinicians. These include the Geriatrics Evaluation and management (GEM) Tools Booklet (http://geriatricscareonline.org) and a SharePoint site to improve dementia care in all settings.

The VA Office of Geriatrics and Extended Care provides additional geriatric-specific programs (http://va.gov/geriatrics). These programs may be useful for consultation and collaboration for patients whom the PACT teams have found to be more challenging and require more assistance to meet performance measures and patient needs. A recent evidence synthesis notes that direct involvement of geriatricians (as opposed to indirect care with limited contact) is more likely to result in positive patient outcomes and should be considered for those patients who are the most frail and/or high utilizers of services.³²

Conclusion

The PACT initiative in the VA health care system may prove to be an important vehicle for improving and standardizing the care provided to older veterans. Use of reliable and valid tools in the identification and assessment of geriatric syndromes, provision of quality standards, and use of innovative telehealth practices are promising enhancements for the primary care of older veterans.

Acknowledgements
We would like to thank the following contributors for their thoughtful review of the initial drafts of this article: Dr. Balmatee Bidassie; Dr. Kathryn Corrigan; Dr. Gail McNut; Dr. Linda Kinsinger, chief consultant for preventive medicine in the Office of Patient Care Services; Dr. Theodore Hahn, GRECC deputy director from VA Greater Los Angeles Healthcare System; Dr. James Hallenbeck, associate chief of staff, Extended Care at VA Palo Alto Health Care System; Ms. Storm Morgan, VA Office of Nursing Services PACT program manager; and Dr. Kenneth Shay, director of Geriatric Programs for the VA Office of Geriatrics and Extended Care.

The authors also would like to express their gratitude to the VA Office of Nursing Services, Clinical Practice Program, Geriatrics and Extended Care Field Advisory Committee for the opportunity to work on this manuscript.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

The older adult population in the VA is growing. Adults aged > 85 years are the fastest growing segment of the older veteran population and many are afflicted with multiple medical problems and functional impairments.^1,2 The majority of older veterans (94.6%, or about 1.9 million veterans) who seek care at the VA obtain care through primary care providers (PCPs) who are often not formally trained in geriatrics.^1,3 With the increasing number of older patients, new models of care are needed to provide coordinated, comprehensive, efficient, and patient-centered care.^4,5

Common themes found in successful models of care for older patients include a team approach, care management (comprehensive and coordinated), and patients who are active partners.⁴ These themes are reflected in the VA Patient Aligned Care Team (PACT) primary care program. PACT, a model of care that was initiated in 2010 and is built on a foundation of patient-centered care, encompasses a team approach to provide comprehensive, coordinated, and personalized care.^6-8 The challenge for the VA is to integrate gerontologic principles and tools into the daily practice of all PACTs in order to improve care provided for older veterans.⁹

This article discusses current challenges in caring for older veterans in the VA system and recommends tools that can be used to infuse geriatric care principles into VA primary care by the PACT, to improve the quality of care provided to older veterans. In addition, the article also describes VA geriatric programs that PACT clinicians can access to supplement older veterans’ care.

Challenges of Caring for Older Veterans

One concern when caring for older veterans arises when the veteran accesses both VA and non-VA health care services to offset medication costs and obtain services not covered by Medicare or other insurance companies.^2,3 This “dual care” can exacerbate polypharmacy issues and increase confusion regarding plans of care. Problems may arise when multiple providers from different systems of care prescribe medications available only within their own formulary and/or order diagnostic and laboratory tests with results available only within their own health care system.

The VA is also challenged by health care delivery for rural veterans. Thirty-six percent of all veterans live in rural areas, and they often depend on non-VA services to meet their health care needs due to difficulty traveling to the nearest VA facility.¹⁰ Seasonal residency also presents challenges. An increasing number of older veterans are seen at different VA facilities when they “winter” in a different section of the country.

Fortunately, a VA provider in one facility can access a patient’s electronic medical records in another facility, using the VA Computerized Patient Record System (CPRS). However, it is unclear to what extent busy VA PCPs use this function when seeing patients. Although individual pilot programs have shown promise, integrated electronic health records between VA and non-VA health care have not advanced to the point of sharing data or reconciling care plans (R. Rupper, personal communication, March 1, 2013).

Many PCPs and other PACT staff are not formally trained in geriatrics and may have had limited exposure to geriatric principles.³ Clinic time pressures, multiple clinical reminders (eg, vaccinations), and panel management of specific diseases make it challenging to find time to focus on complex geriatric syndromes. Current PACT performance measures also do not routinely include geriatric-specific quality of care criteria or focus on patient function (K. Shay, personal communication, February 12, 2013), a hallmark of geriatric care.⁸ Furthermore, with increasing complexity of the health care system and limited availability of resources, it is often time consuming to identify and collaborate with non-VA resources to ensure patients’ needs are met in their communities.

Opportunities for Improvement in Care

The VA transformation to PACTs has led to process changes in clinic workflow that may aid in addressing the aforementioned challenges in caring for older veterans. Each patient is assigned to a PCP-led team that includes a registered nurse care manager, a clinical associate, and an administrative associate. The PACT model of care has increased access to care by redesigning face-to-face visits, increasingly moving toward open access, and through the increased use of virtual access via secured e-mail, telephone visits, and telehealth.⁸

In addition to process changes, the VA has created new tools to assist teams in patient management. One of these is the Care Assessment Need (CAN) score, a risk stratification tool available for use by PACTs to identify patients at highest risk for hospital admission and/or death for focused care management.¹¹ It is based on statistical prediction models of veterans enrolled in primary care, using patient characteristics and health care use information.¹¹ Although the CAN score looks promising, more research is needed to evaluate its effectiveness  in improving care for older veterans and its association with better patient functioning—an important focus in quality geriatric care.

A tool that takes into account daily function is the Vulnerable Elders Survey-13 (VES-13). As measured by the VES-13, functional ability has been shown to be a strong predictor of decline and death in older adults independent of gender or comorbidities.¹² Integration of the VES-13 into the evaluation of older veterans could assist PACTs in considering patients’ current function and life expectancy in their care plans along with patient and family goals.

Another potentially useful tool for the PACT team is the SPICES mnemonic (Sleeping, Problems with feeding/eating, Incontinence or urinary problems, Confusion, Evidence of falls, and Skin breakdown).¹³ Although SPICES is not comprehensive, this mnemonic highlights potential problems facing older patients that may not be brought up routinely. It provides a concise, formalized format that can be used by clerks or patient support assistants  as part of the check-in process.

This tool has been used successfully by the Geriatric Evaluation and Management Clinic of the South Texas Veterans Health Care System (STVHCS) to improve communication between the PCP and nurse so that pertinent patient information is relayed concisely. SPICES was helpful in identifying patients needing interventions for fall risk. In a retrospective chart review of 100 randomly selected patients aged 75 to 90 years enrolled in the clinic, a 75% reduction in falls was noted during the first year of implementation (STVHCS unpublished data, 2012).

Additional tools that focus on identifying specific geriatric syndromes are available online from the Hartford Institute for Geriatric Nursing, which provides evidence-based information and training on how to assess, evaluate, and manage common geriatric syndromes such as depression, dementia, and delirium.¹⁴ The site also includes videos on how to use common brief geriatric assessment tools that can be performed by nurses and health care associates while the patient is in the waiting room. Though promising, further research is needed to study the effects of these tools on patient, provider, and system outcomes.

Infusing quality of care indicators (QI) can play an integral role in achieving PACT goals while improving the older veterans’ quality of life. For example, polypharmacy and medication-related injuries in older adults continue to pose both a safety and economic challenge to patients and the health care system.^15-17 The 2012 Beers criteria for Potentially Inappropriate Medications in Older Adults lists 53 medication classes that have been identified as potentially inappropriate medications for use in older adults.¹⁷ Use of this tool by PACTs in the development of patient care plans has the potential to reduce medication-related adverse reactions and improper prescribing.^18,19

Assessing Care of Vulnerable Elders (ACOVE ) also provides QIs that are specific to vulnerable older persons.^20-24 The most recent version, ACOVE-3, includes 392 QIs for 26 conditions and 14 types of care processes and covers all domains of care.²⁰ Findings from a study applying QIs involving vulnerable elderly patients in 2 managed care programs revealed that recipients of better-quality care had a 10% higher survival rate over 3 years.²⁵

The VA currently monitors 6 frail elderly QIs based on ACOVE criteria via reviews of medical records in veterans aged > 75 years. These QIs cover falls, incontinence, functional assessment, and the presence of a surrogate decision maker. PACT staff, unfortunately, do not receive feedback on these, because they are still QIs and not part of the performance measures (K. Shay, personal communication, February 12, 2013). Though some VA sites have adopted these QIs to some extent, until these frail elderly QIs become performance measures throughout VA, other competing priorities may be more at the forefront of quality improvement projects done by PACT teams.⁵

The American Geriatrics Society recently published recommendations on the care of older adults with multiple chronic conditions, to aid PCPs in practicing a more individualized, patient-centered care in complex cases.²⁶ In addition to focusing on a patient’s primary concern during a clinic visit and eliciting preferences, considering prognosis in deciding on treatment options allows patients to better weigh the potential benefits and burdens in their daily living.²⁶ A discussion on how aggressive potential treatments are and what the patient is willing to undertake is an important component of patient-centered care and should be incorporated during routine PACT clinic visits.

VA Geriatric Programs

It is important for PACT clinicians to be familiar with the geriatric programs and resources available within the VA medical home “neighborhood,” which can supplement care. One such resource is the Geriatric Research Education and Clinical Centers (GRECCs). There are currently 19 GRECCs throughout the nation that serve as Centers of Excellence in the care of older veterans.²⁷ The GRECCs provide training for clinicians, test innovative ways to care for older veterans, and collaborate with other staff to improve the care provided. Some have also developed Geriatric Primary Care Clinics (or Geri PACTs) to provide team care to very frail and high-risk older veterans. Since not all VA facilities have access to Geri PACTs, the GRECCs play an important role in making geriatric expertise and training available to the PACTs.³

To address this limitation in access, VA programs have begun using telehealth technology to increase competencies of PCPs in caring for older veterans. For example, the VA Geriatric Scholars Program is a national educational program with different avenues to “geriatricize” VA primary care services and improve knowledge and care provided to older veterans.²⁸ It consists of several subprograms: Geriatric Scholars Program for Rural Community Based Outpatient Clinics; Geriatric Scholars Program for Primary Care Providers; Rural Interdisciplinary Team Training; and the Geriatric Assessment Pocket Guide.²⁹ These components may include didactics both face-to-face and online, clinical experience with performing common geriatric screening tools, and a quality improvement project.

Some local VAMCs have also developed programs to address this need to improve care provided to older veterans in PACT. The VA Greater Los Angeles Healthcare System (GLA) GRECC, for example, has started several programs to infuse geriatrics into PACTs, including the Geri Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN-ECHO). VA SCAN-ECHO was developed to increase access to specialty care in rural/underserved areas. The PCP presents a case and a specialty provider gives guidance in the assessment and/or management of a specific clinical problem.³⁰ Unlike many other SCAN-ECHO programs, the GLA Geri SCAN-ECHO program encourages not only PCPs, but also nurses and social workers to submit consults for discussion and encourages team management (a hallmark of quality geriatric care). Another important GLA GRECC project is the Veterans Cognitive Assessment and Management Program (V-CAMP), which uses videoconferencing to assess and manage veterans with cognitive impairment/dementia who reside in underserved areas in the GLA region. The program provides dementia care management and access to neuropsychological examinations—services that are often not available in rural areas.³¹

Various VA program offices have also published useful resources to help PACT clinicians infuse gerontologic principles into their practice. The VA Office of Nursing Services has a Geriatrics and Extended Care Field Advisory Committee, which recently produced on-demand lectures in the virtual VA eHealth University (also known as myVeHU campus) on improving the PACT’s management of progressive chronic diseases and dementia recognition and initial evaluation. They also produced a resource guide for VA clinicians (nursing and non-nursing), based on a team consensus of what the workgroup thinks a clinician would find helpful in clinical practice to improve care of older veterans. The VA Office of Geriatrics and Extended Care Service also identified a list of clinical and educational resources to help PACT clinicians. These include the Geriatrics Evaluation and management (GEM) Tools Booklet (http://geriatricscareonline.org) and a SharePoint site to improve dementia care in all settings.

The VA Office of Geriatrics and Extended Care provides additional geriatric-specific programs (http://va.gov/geriatrics). These programs may be useful for consultation and collaboration for patients whom the PACT teams have found to be more challenging and require more assistance to meet performance measures and patient needs. A recent evidence synthesis notes that direct involvement of geriatricians (as opposed to indirect care with limited contact) is more likely to result in positive patient outcomes and should be considered for those patients who are the most frail and/or high utilizers of services.³²

Conclusion

The PACT initiative in the VA health care system may prove to be an important vehicle for improving and standardizing the care provided to older veterans. Use of reliable and valid tools in the identification and assessment of geriatric syndromes, provision of quality standards, and use of innovative telehealth practices are promising enhancements for the primary care of older veterans.

Acknowledgements
We would like to thank the following contributors for their thoughtful review of the initial drafts of this article: Dr. Balmatee Bidassie; Dr. Kathryn Corrigan; Dr. Gail McNut; Dr. Linda Kinsinger, chief consultant for preventive medicine in the Office of Patient Care Services; Dr. Theodore Hahn, GRECC deputy director from VA Greater Los Angeles Healthcare System; Dr. James Hallenbeck, associate chief of staff, Extended Care at VA Palo Alto Health Care System; Ms. Storm Morgan, VA Office of Nursing Services PACT program manager; and Dr. Kenneth Shay, director of Geriatric Programs for the VA Office of Geriatrics and Extended Care.

The authors also would like to express their gratitude to the VA Office of Nursing Services, Clinical Practice Program, Geriatrics and Extended Care Field Advisory Committee for the opportunity to work on this manuscript.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

The older adult population in the VA is growing. Adults aged > 85 years are the fastest growing segment of the older veteran population and many are afflicted with multiple medical problems and functional impairments.^1,2 The majority of older veterans (94.6%, or about 1.9 million veterans) who seek care at the VA obtain care through primary care providers (PCPs) who are often not formally trained in geriatrics.^1,3 With the increasing number of older patients, new models of care are needed to provide coordinated, comprehensive, efficient, and patient-centered care.^4,5

Common themes found in successful models of care for older patients include a team approach, care management (comprehensive and coordinated), and patients who are active partners.⁴ These themes are reflected in the VA Patient Aligned Care Team (PACT) primary care program. PACT, a model of care that was initiated in 2010 and is built on a foundation of patient-centered care, encompasses a team approach to provide comprehensive, coordinated, and personalized care.^6-8 The challenge for the VA is to integrate gerontologic principles and tools into the daily practice of all PACTs in order to improve care provided for older veterans.⁹

This article discusses current challenges in caring for older veterans in the VA system and recommends tools that can be used to infuse geriatric care principles into VA primary care by the PACT, to improve the quality of care provided to older veterans. In addition, the article also describes VA geriatric programs that PACT clinicians can access to supplement older veterans’ care.

Challenges of Caring for Older Veterans

One concern when caring for older veterans arises when the veteran accesses both VA and non-VA health care services to offset medication costs and obtain services not covered by Medicare or other insurance companies.^2,3 This “dual care” can exacerbate polypharmacy issues and increase confusion regarding plans of care. Problems may arise when multiple providers from different systems of care prescribe medications available only within their own formulary and/or order diagnostic and laboratory tests with results available only within their own health care system.

The VA is also challenged by health care delivery for rural veterans. Thirty-six percent of all veterans live in rural areas, and they often depend on non-VA services to meet their health care needs due to difficulty traveling to the nearest VA facility.¹⁰ Seasonal residency also presents challenges. An increasing number of older veterans are seen at different VA facilities when they “winter” in a different section of the country.

Fortunately, a VA provider in one facility can access a patient’s electronic medical records in another facility, using the VA Computerized Patient Record System (CPRS). However, it is unclear to what extent busy VA PCPs use this function when seeing patients. Although individual pilot programs have shown promise, integrated electronic health records between VA and non-VA health care have not advanced to the point of sharing data or reconciling care plans (R. Rupper, personal communication, March 1, 2013).

Many PCPs and other PACT staff are not formally trained in geriatrics and may have had limited exposure to geriatric principles.³ Clinic time pressures, multiple clinical reminders (eg, vaccinations), and panel management of specific diseases make it challenging to find time to focus on complex geriatric syndromes. Current PACT performance measures also do not routinely include geriatric-specific quality of care criteria or focus on patient function (K. Shay, personal communication, February 12, 2013), a hallmark of geriatric care.⁸ Furthermore, with increasing complexity of the health care system and limited availability of resources, it is often time consuming to identify and collaborate with non-VA resources to ensure patients’ needs are met in their communities.

Opportunities for Improvement in Care

The VA transformation to PACTs has led to process changes in clinic workflow that may aid in addressing the aforementioned challenges in caring for older veterans. Each patient is assigned to a PCP-led team that includes a registered nurse care manager, a clinical associate, and an administrative associate. The PACT model of care has increased access to care by redesigning face-to-face visits, increasingly moving toward open access, and through the increased use of virtual access via secured e-mail, telephone visits, and telehealth.⁸

In addition to process changes, the VA has created new tools to assist teams in patient management. One of these is the Care Assessment Need (CAN) score, a risk stratification tool available for use by PACTs to identify patients at highest risk for hospital admission and/or death for focused care management.¹¹ It is based on statistical prediction models of veterans enrolled in primary care, using patient characteristics and health care use information.¹¹ Although the CAN score looks promising, more research is needed to evaluate its effectiveness  in improving care for older veterans and its association with better patient functioning—an important focus in quality geriatric care.

A tool that takes into account daily function is the Vulnerable Elders Survey-13 (VES-13). As measured by the VES-13, functional ability has been shown to be a strong predictor of decline and death in older adults independent of gender or comorbidities.¹² Integration of the VES-13 into the evaluation of older veterans could assist PACTs in considering patients’ current function and life expectancy in their care plans along with patient and family goals.

Another potentially useful tool for the PACT team is the SPICES mnemonic (Sleeping, Problems with feeding/eating, Incontinence or urinary problems, Confusion, Evidence of falls, and Skin breakdown).¹³ Although SPICES is not comprehensive, this mnemonic highlights potential problems facing older patients that may not be brought up routinely. It provides a concise, formalized format that can be used by clerks or patient support assistants  as part of the check-in process.

This tool has been used successfully by the Geriatric Evaluation and Management Clinic of the South Texas Veterans Health Care System (STVHCS) to improve communication between the PCP and nurse so that pertinent patient information is relayed concisely. SPICES was helpful in identifying patients needing interventions for fall risk. In a retrospective chart review of 100 randomly selected patients aged 75 to 90 years enrolled in the clinic, a 75% reduction in falls was noted during the first year of implementation (STVHCS unpublished data, 2012).

Additional tools that focus on identifying specific geriatric syndromes are available online from the Hartford Institute for Geriatric Nursing, which provides evidence-based information and training on how to assess, evaluate, and manage common geriatric syndromes such as depression, dementia, and delirium.¹⁴ The site also includes videos on how to use common brief geriatric assessment tools that can be performed by nurses and health care associates while the patient is in the waiting room. Though promising, further research is needed to study the effects of these tools on patient, provider, and system outcomes.

Infusing quality of care indicators (QI) can play an integral role in achieving PACT goals while improving the older veterans’ quality of life. For example, polypharmacy and medication-related injuries in older adults continue to pose both a safety and economic challenge to patients and the health care system.^15-17 The 2012 Beers criteria for Potentially Inappropriate Medications in Older Adults lists 53 medication classes that have been identified as potentially inappropriate medications for use in older adults.¹⁷ Use of this tool by PACTs in the development of patient care plans has the potential to reduce medication-related adverse reactions and improper prescribing.^18,19

Assessing Care of Vulnerable Elders (ACOVE ) also provides QIs that are specific to vulnerable older persons.^20-24 The most recent version, ACOVE-3, includes 392 QIs for 26 conditions and 14 types of care processes and covers all domains of care.²⁰ Findings from a study applying QIs involving vulnerable elderly patients in 2 managed care programs revealed that recipients of better-quality care had a 10% higher survival rate over 3 years.²⁵

The VA currently monitors 6 frail elderly QIs based on ACOVE criteria via reviews of medical records in veterans aged > 75 years. These QIs cover falls, incontinence, functional assessment, and the presence of a surrogate decision maker. PACT staff, unfortunately, do not receive feedback on these, because they are still QIs and not part of the performance measures (K. Shay, personal communication, February 12, 2013). Though some VA sites have adopted these QIs to some extent, until these frail elderly QIs become performance measures throughout VA, other competing priorities may be more at the forefront of quality improvement projects done by PACT teams.⁵

The American Geriatrics Society recently published recommendations on the care of older adults with multiple chronic conditions, to aid PCPs in practicing a more individualized, patient-centered care in complex cases.²⁶ In addition to focusing on a patient’s primary concern during a clinic visit and eliciting preferences, considering prognosis in deciding on treatment options allows patients to better weigh the potential benefits and burdens in their daily living.²⁶ A discussion on how aggressive potential treatments are and what the patient is willing to undertake is an important component of patient-centered care and should be incorporated during routine PACT clinic visits.

VA Geriatric Programs

It is important for PACT clinicians to be familiar with the geriatric programs and resources available within the VA medical home “neighborhood,” which can supplement care. One such resource is the Geriatric Research Education and Clinical Centers (GRECCs). There are currently 19 GRECCs throughout the nation that serve as Centers of Excellence in the care of older veterans.²⁷ The GRECCs provide training for clinicians, test innovative ways to care for older veterans, and collaborate with other staff to improve the care provided. Some have also developed Geriatric Primary Care Clinics (or Geri PACTs) to provide team care to very frail and high-risk older veterans. Since not all VA facilities have access to Geri PACTs, the GRECCs play an important role in making geriatric expertise and training available to the PACTs.³

To address this limitation in access, VA programs have begun using telehealth technology to increase competencies of PCPs in caring for older veterans. For example, the VA Geriatric Scholars Program is a national educational program with different avenues to “geriatricize” VA primary care services and improve knowledge and care provided to older veterans.²⁸ It consists of several subprograms: Geriatric Scholars Program for Rural Community Based Outpatient Clinics; Geriatric Scholars Program for Primary Care Providers; Rural Interdisciplinary Team Training; and the Geriatric Assessment Pocket Guide.²⁹ These components may include didactics both face-to-face and online, clinical experience with performing common geriatric screening tools, and a quality improvement project.

Some local VAMCs have also developed programs to address this need to improve care provided to older veterans in PACT. The VA Greater Los Angeles Healthcare System (GLA) GRECC, for example, has started several programs to infuse geriatrics into PACTs, including the Geri Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN-ECHO). VA SCAN-ECHO was developed to increase access to specialty care in rural/underserved areas. The PCP presents a case and a specialty provider gives guidance in the assessment and/or management of a specific clinical problem.³⁰ Unlike many other SCAN-ECHO programs, the GLA Geri SCAN-ECHO program encourages not only PCPs, but also nurses and social workers to submit consults for discussion and encourages team management (a hallmark of quality geriatric care). Another important GLA GRECC project is the Veterans Cognitive Assessment and Management Program (V-CAMP), which uses videoconferencing to assess and manage veterans with cognitive impairment/dementia who reside in underserved areas in the GLA region. The program provides dementia care management and access to neuropsychological examinations—services that are often not available in rural areas.³¹

Various VA program offices have also published useful resources to help PACT clinicians infuse gerontologic principles into their practice. The VA Office of Nursing Services has a Geriatrics and Extended Care Field Advisory Committee, which recently produced on-demand lectures in the virtual VA eHealth University (also known as myVeHU campus) on improving the PACT’s management of progressive chronic diseases and dementia recognition and initial evaluation. They also produced a resource guide for VA clinicians (nursing and non-nursing), based on a team consensus of what the workgroup thinks a clinician would find helpful in clinical practice to improve care of older veterans. The VA Office of Geriatrics and Extended Care Service also identified a list of clinical and educational resources to help PACT clinicians. These include the Geriatrics Evaluation and management (GEM) Tools Booklet (http://geriatricscareonline.org) and a SharePoint site to improve dementia care in all settings.

The VA Office of Geriatrics and Extended Care provides additional geriatric-specific programs (http://va.gov/geriatrics). These programs may be useful for consultation and collaboration for patients whom the PACT teams have found to be more challenging and require more assistance to meet performance measures and patient needs. A recent evidence synthesis notes that direct involvement of geriatricians (as opposed to indirect care with limited contact) is more likely to result in positive patient outcomes and should be considered for those patients who are the most frail and/or high utilizers of services.³²

Conclusion

The PACT initiative in the VA health care system may prove to be an important vehicle for improving and standardizing the care provided to older veterans. Use of reliable and valid tools in the identification and assessment of geriatric syndromes, provision of quality standards, and use of innovative telehealth practices are promising enhancements for the primary care of older veterans.

Acknowledgements
We would like to thank the following contributors for their thoughtful review of the initial drafts of this article: Dr. Balmatee Bidassie; Dr. Kathryn Corrigan; Dr. Gail McNut; Dr. Linda Kinsinger, chief consultant for preventive medicine in the Office of Patient Care Services; Dr. Theodore Hahn, GRECC deputy director from VA Greater Los Angeles Healthcare System; Dr. James Hallenbeck, associate chief of staff, Extended Care at VA Palo Alto Health Care System; Ms. Storm Morgan, VA Office of Nursing Services PACT program manager; and Dr. Kenneth Shay, director of Geriatric Programs for the VA Office of Geriatrics and Extended Care.

The authors also would like to express their gratitude to the VA Office of Nursing Services, Clinical Practice Program, Geriatrics and Extended Care Field Advisory Committee for the opportunity to work on this manuscript.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Although the VA has the largest health care system in the U.S., not every VA facility offers medical subspecialty care. As a result, patients are often separated by long distances from services they need.

At the VA Pittsburgh Healthcare System (VAPHS) in Pennsylvania, about 15,700 veterans received care in 2011. The Gastroenterology Department (GD) served many of these patients: 5,800 patients were seen in clinic appointments, 2,500 underwent colonoscopy, and 1,700 underwent esophagogastroduodenoscopy (EGD). Patients traveled up to 150 miles from 3 states for appointments and procedures. Prior to each procedure, a face-to-face appointment was standard practice for most patients to plan procedures and ensure medical stability. Patients expressed dissatisfaction with transportation, cost, time, and inconvenience, particularly when they were required to attend both the preprocedure and procedure appointments.

Patient satisfaction, timely care, and appropriate use of resources are important VA goals of care, so the VAPHS developed an electronic consultation (e-consult) program as a component of its long-term strategic plan. The goal was to increase access to care through the use of an e-consult in lieu of a face-to-face appointment for select patients. The e-consult program established guidelines and benchmark goals (Table). The program also established a database to track the benchmarks.

The purpose of this quality improvement (QI) project was to evaluate e-consults in the GD over a 6-month period from January 2012, when e-consults were implemented in the GD, to July 2012. Based on the outcomes, recommendations for program continuation, change, and sustainability were made.

Background

Telemedicine using information technologies has been reported as a viable solution to support health care delivery when distance limits patients’ access to care.^1,2 Telemedicine has also been shown to improve efficacy in clinical decision making and reduce costs. It also can increase patient satisfaction by reducing travel and time, minimize duplication of diagnostic testing, and integrate services effectively across multiple sites when an electronic medical record (EMR) is in place.^1-5

A randomized controlled trial in 2004 compared a standard outpatient referral appointment with a joint teleconsultation between provider, specialist, and patient.³ In the teleconsultation arm, there was higher patient satisfaction, fewer diagnostic tests (particularly in gastroenterology), and lower patient costs.

A study published in 2009 examined the impact of cardiac, dermatologic, and diabetes teleconsultations on organization and patient outcomes in 950 patients in 30 rural communities.² Rapid access to care was provided for 85% of the patients. Organizational benefits included resource savings and efficacy improvement measured by a provider opinion Likert scale. Patient benefits included reductions in wait times, transportation savings, avoidance of unnecessary office visits, and ease of use.

A large systematic review of telemedicine services across all medical specialties in 2006 included 106 published studies.⁴ Clinical outcomes (decision making, diagnosis, and management) were similar between conventional care and telemedicine in specialty care, particularly in neurology and psychiatry. Virtual consults provided equal care to traditional specialty visits.⁶

Communication and coordination of care via an e-consult instead of a face-to-face clinic visit was evaluated by Horner and colleagues.⁵ The authors identified e-consult benefits for patients and specialists and that e-consults can reduce unnecessary referrals and appointments by 30%. They concluded that reserved time to complete e-consults must be built into workflow systems and that an advanced EMR was necessary for successful use of e-consults.

Two studies have evaluated satisfaction with e-consults. A preliminary analysis of satisfaction with e-consults was conducted in 2009 by K. L. Rodriguez, PhD, and colleagues (unpublished data). Patients, primary care providers (PCPs), and medical specialists reported overall satisfaction in 8 satisfaction domains. A pilot study of 34 patients in 2011 with inflammatory bowel disease compared a standard patient-GD physician encounter with a video encounter.⁷ The authors reported patient satisfaction, appointment time, wait times, and quality of care were similar for the 2 groups.

Methods

The GD where this QI project was completed consisted of a clinic staffed by nurse practitioners (NPs) and a procedure lab staffed by gastroenterology physicians. Before e-consult implementation, a NP reviewed and triaged new referrals daily. During the project period, an average of 25 to 35 new referrals were received daily via the EMR. Referrals came mostly from PCPs requesting an evaluation of their patients’ gastroenterology problem. Patients were triaged either to an appointment for evaluation or directly to the GD procedure lab for EGD or colonoscopy.

When e-consults were implemented, several changes occurred. Two providers were assigned to new referral triage, and they were expected to process 20% as e-consults. In the EMR, e-consult note titles, templates, and an e-consult encounter form were created, and staff was given access to the e-consult tracking database. The EMR referral template was amended so the entering provider could say whether a face-to-face appointment was desired or whether an e-consult was acceptable. The patient was to be included in decision making about this choice. Department staff had permission to triage according to judgment and expertise; thus, appointment requests could be triaged to e-consults, and e-consult requests could be triaged to appointments.

To complete an e-consult, the EMR was reviewed for medical diagnoses, medications, diagnostics, and recent physical exam. A summary note outlining an impression, treatment recommendations, and follow-up was entered in the EMR and communicated to the PCP. In most cases, no discussion with the patient occurred. The encounter form was completed, and information was entered into the tracking database. The database was installed on each provider’s computer who processed e-consults. If EGD or colonoscopy was indicated, the scheduler was notified to call the patient. Once a procedure date was established, procedure orders were completed in the EMR, and instructions were mailed to the patient.

Project Description and Evaluation 

The project was reviewed by the Institutional Review Board and determined to be a QI project. VA organizational policies were followed for data collection and security. Benchmarks were identified from the e-consult program and from the GD, where available. Process variables were determined to measure benchmark outcomes. (Table)

To identify participants, a retrospective chart review was performed. A total of 203 potential patients were identified from the e-consult program database for the 6-month period between January and July 2012. For comparison, 50 patients who attended an appointment during the same time frame were systematically identified in the EMR. Although this comparison group was eligible for e-consults, they were triaged to in-person appointments and subsequently had colonoscopies completed.

Outcome data were extracted from the e-consult program database and the EMR. The data analysis was descriptive. Summary aggregate data were compared with the benchmarks and comparison patient outcomes. The Table summarizes the process variables, how they were measured, where they came from, and what the comparisons were.

Discussion 

Figure 1 illustrates the volume of completed e-consults from January to July 2012. A gastroenterology procedure was not indicated in 43 patients. A procedure was indicated for 160 patients and completed in 116 patients (72%). One hundred procedures were colonoscopies, and 16 were EGDs. Figure 2 provides reasons why procedures were not completed in 44 patients (27%). Group comparisons of colon prep quality and preprocedure reminder calls are displayed in Figures 3 and 4, respectively.

This project sought to evaluate VAPHS GD e-consults beginning in January 2012. Process variables were established to measure benchmarks in the e-consult program and in the GD. Some benchmarks were met with outcomes that were comparable between the groups, while others were not. To our knowledge, this project is the first to evaluate e-consults in the subspecialty of gastroenterology.

Volume of Completed E-Consults

The benchmark for 20% e-consults was not met (Figure 1). For weeks 1 through 8, the volume was between 10% and 20%. Lower volume in weeks 9 through 15 (late March and April) may have been due to staff vacations. Not only do the outcomes show a downward trend in e-consult volume, they also show a precipitous fall in volume at week 15 to almost no e-consults for the remainder of the project. To explore reasons for this outcome, the workflow process of new referral triage and e-consults was reviewed.

Two providers (1 NP, 1 physician) were assigned to new referral triage and e-consults from weeks 1 through 14. At week 15, the physician was reassigned to perform procedures. From this point, only 1 NP worked on e-consults and referral triage. Competing time demands included an e-consult encounter form, tracking database entry, procedure orders, patient instructions, appointment changes, phone calls, and resolution of medications issues for procedures. The triage NP was also required to see patients in the clinic. Each day, only a half-day was allotted to complete e-consults, new referral triage (25-35/day), and the aforementioned tasks.

Therefore, it became clear that a half-day was not sufficient to meet the 20% benchmark for e-consults. Horner and colleagues also found that dedicated time in workflow processes was necessary to allow for e-consult completion.⁵

E-Consults vs Appointment Groups 

All patients in both groups were offered the choice of e-consult or appointment; this benchmark was met. Of the 203 e-consult patients, 70% requested an appointment, but their evaluation was completed as an e-consult. By design, the appointment group patients chose e-consult but were triaged to appointment due to time constraints and the high volume of new referrals.

Evaluations via e-consult were completed within 2 to 3 days, whereas the mean for appointments was 19 days, with the longest time frame of 44 days. Thus, e-consult evaluations were completed sooner. Rapid access to care was also found by Zanaboni and colleagues.²

When appointments are delayed, patient complaints or status may change, which in turn may affect treatment plans. In addition, the reason for referral may have already resolved by the actual appointment, rendering the appointment unnecessary. This can be viewed as a missed opportunity for another patient to be seen. Ideally, it is best for a patient to be evaluated soon after a new referral is made.

The VA encounter form for an e-consult had only one 5-digit code, which allotted only 15 minutes of work credit. Encounter form codes were established by the Center for Medicare and Medicaid Services (CMS) for billing purposes in the private sector, with coding levels based on information documented in a chart note: review of systems, physical exam, and diagnoses decision making. Because all criteria could not be met in an e-consult, only 1 code was assigned for VAPHS e-consults. The CMS has specific telemedicine codes; it was unknown why they were not used for e-consults.

E-consults took an average of 19 minutes to complete, with 91 completed in ≤ 15 minutes and over half (112) having taken > 15 minutes. Therefore, the actual workload was not captured, and more work was done than was credited. To speculate, e-consults were in their infancy; a learning curve may have existed as staff became accustomed to this new process.

The EMRs were reviewed for the 7 e-consults that took > 30 minutes to complete. Two were in the early stage of e-consult implementation, but the remainder were scattered throughout. Patients in these e-consults had complicated medical histories and perhaps should not have been triaged to e-consult. Theoretically, only uncomplicated patients with simple reasons for gastroenterology referral should be triaged to e-consult, allowing for a shorter time frame and higher volume.

The wait times to procedure were 58 days for the e-consult group and 39 days in the appointment group. Although wait time was originally identified as an outcome, its relevance is questionable after looking at the outcome data. The procedure appointment date was a subjective decision by the patient; many factors affected what date the patient established, including weekday preference, time off from work, caretaker availability, season, and staffing. Many patients rescheduled their initial procedure dates, often several times. These factors are reflected in the variable ranges of wait times.

Colon Prep Quality

Colon prep refers to patient instructions on the day before the procedure and includes a clear liquid diet, drinking a liquid solution to empty bowel contents, and no food or liquid after midnight. Prep quality is stated in the colonoscopy report. During the procedure, the physician makes a visual decision based on presence or absence of stool inside the colon. Prep quality is important, because retained stool can preclude thorough visualization of the colon wall for polyps or abnormalities. In the event of fair and poor preps, the colonoscopy might be aborted and rescheduled or completed, but with the recommendation for another colonoscopy in a short time frame, such as 1 to 3 years.

Forty-four percent of the e-consult group and 62% of the appointment group had good or adequate preps. Thus, more patients in the appointment group achieved good and adequate preps, and far fewer achieved fair or poor preps. One important point was that almost half (47%) of the e-consult group had only a fair prep (Figure 3).

A number of reasons have been identified in the literature, which might help us understand these findings. First, patients may not fully understand or adhere to prep instructions.^8-10 Furthermore, certain medical diagnoses are known to affect prep quality (ie, diabetes, thyroid disease, constipation).^11,12 Another potential factor is the manner in which prep quality is determined.^13,14 However, due to the focus of this QI study, the influential drivers of prep quality can only be inferred from the literature; thus, a future research or QI study is warranted to ascertain the underlying mechanism of colon prep quality in our specific veteran population.

Preprocedure Reminder Calls

Outcomes were essentially reversed between the 2 groups (Figure 4). Between 50% and 60% of the e-consult group received a call, while the same percentage of appointment patients did not. All patients did attend their procedure appointment. A GD goal was to call every patient before their procedure, but the ability to make the calls was staffing-dependent, which may explain these findings.

Most Relevant Findings

Although this project provides a thorough analysis of various benchmarks within this recently implemented e-consult gastroenterology program, 3 findings emerged that were identified as most relevant. First, the benchmark of 20% volume of completed e-consults was not met. A review of the workflow processes revealed that a daily allotment of only a half-day was not sufficient to complete e-consults, referral triage, and related tasks.

Second, outcomes for colon prep quality and preprocedure reminder calls were also relevant. Although beyond the scope of this project, the question arose of a relationship between prep quality and the reminder call: Does the reminder call affect prep quality? The goal of colon prep is to achieve a good or adequate prep. The purpose of the reminder call was to confirm the appointment and to review the colon prep. Among patients in both groups who achieved only a fair prep, 62% in the e-consult group did receive the reminder call; thus, the call seemed to have failed in helping these patients achieve an adequate or good prep. The actual content of colon prep review during the call was unknown, but certainly bears improvement.

Another speculation concerned the prep instruction sheet. Although all patients received the same sheet, e-consult patients received it in the mail and read it themselves, while it was directly reviewed face-to-face with the appointment patients. Questions remain whether a face-to-face review increases the likelihood for a better prep and how to help e-consult patients achieve optimal prep, since they are not seen face-to-face. 

Practice Implications and Sustaining Measures

Theoretically, e-consults are a viable alternative to face-to-face appointments. Potential advantages include efficient use of an EMR, avoidance of unnecessary appointments, and improved access to care for patients who require an appointment. Although patient satisfaction was not measured in this project, the literature review revealed that satisfaction was increased through use of various virtual health care modalities, including a preliminary analysis in this facility by the aforementioned 2009 study by K. L. Rodriguez (unpublished data). Based on findings in this project, the following 4 recommendations were made to improve benchmark outcomes and quality of care.

1. Provide dedicated time to complete e-consults and related tasks. In this setting, a full day was recommended. An alternative was to hire a NP whose sole responsibility was e-consults.
2. Develop a selection process to determine which new referrals are best suited for e-consult. This process will increase e-consult efficiency and decrease the time to complete an e-consult. Recommended selection criteria were (A) gastroenterology referrals only for simple symptoms or issues; (B) referrals only for a procedure; and (C) stable patients with uncomplicated medical histories.
3. Sustain the preprocedure reminder phone call. The reminder call helps patients keep appointments and thus reduces a missed opportunity for care.
4. Plan a future QI project or research study on patient colon prep quality for colonoscopy. Such a project might evaluate types of colon prep, how prep quality is measured, patient instructions, and the timing/content of pre-procedure reminder phone calls, particularly for e-consult patients.

Conclusion

This QI project provided outcomes for e-consults in the subspecialty of gastroenterology at the VAPHS. Although some benchmark outcomes were met and favorable, others were less favorable. By conducting this benchmark analysis, the areas of needed improvement are now clear. This analysis provides information so recommendations for process improvements can be made.

Quality of care improvement is an ongoing process at VAPHS. Since completion of this project, several processes have been adjusted so that outcomes will be improved. For example, corrective actions were taken for patients who did not complete their gastroenterology procedure. The process for scheduling gastroenterology procedures was adjusted for appointments and cancellations. Ongoing efforts to sustain the reminder phone call were put in place. Changes in NP staffing and time assigned for both clinical and nonclinical work were proposed and are currently under review.

It is the mission of the VA to provide access to care, patient satisfaction, timely care, and appropriate use of resources. Having the ability to highlight our strengths, as well as the willingness to recognize weaknesses, allows us to create new improved processes to provide the best care possible for our veterans.

Acknowledgments
This project was Elena Swann’s capstone for the Doctor of Nursing Practice Program, University of Pittsburgh School of Nursing in Pennsylvania. Rich Laufer, Larry Priscella, and Janie Fleming assisted with the VA Gastroenterology Clinic and procedure metrics. Dr. Melissa Taylor, VA associate chief nurse for research provided project guidance and manuscript revisions. Dr. Sandra Engberg, University of Pittsburgh School of Nursing faculty, assisted with project and manuscript development.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Although the VA has the largest health care system in the U.S., not every VA facility offers medical subspecialty care. As a result, patients are often separated by long distances from services they need.

At the VA Pittsburgh Healthcare System (VAPHS) in Pennsylvania, about 15,700 veterans received care in 2011. The Gastroenterology Department (GD) served many of these patients: 5,800 patients were seen in clinic appointments, 2,500 underwent colonoscopy, and 1,700 underwent esophagogastroduodenoscopy (EGD). Patients traveled up to 150 miles from 3 states for appointments and procedures. Prior to each procedure, a face-to-face appointment was standard practice for most patients to plan procedures and ensure medical stability. Patients expressed dissatisfaction with transportation, cost, time, and inconvenience, particularly when they were required to attend both the preprocedure and procedure appointments.

Patient satisfaction, timely care, and appropriate use of resources are important VA goals of care, so the VAPHS developed an electronic consultation (e-consult) program as a component of its long-term strategic plan. The goal was to increase access to care through the use of an e-consult in lieu of a face-to-face appointment for select patients. The e-consult program established guidelines and benchmark goals (Table). The program also established a database to track the benchmarks.

The purpose of this quality improvement (QI) project was to evaluate e-consults in the GD over a 6-month period from January 2012, when e-consults were implemented in the GD, to July 2012. Based on the outcomes, recommendations for program continuation, change, and sustainability were made.

Background

Telemedicine using information technologies has been reported as a viable solution to support health care delivery when distance limits patients’ access to care.^1,2 Telemedicine has also been shown to improve efficacy in clinical decision making and reduce costs. It also can increase patient satisfaction by reducing travel and time, minimize duplication of diagnostic testing, and integrate services effectively across multiple sites when an electronic medical record (EMR) is in place.^1-5

A randomized controlled trial in 2004 compared a standard outpatient referral appointment with a joint teleconsultation between provider, specialist, and patient.³ In the teleconsultation arm, there was higher patient satisfaction, fewer diagnostic tests (particularly in gastroenterology), and lower patient costs.

A study published in 2009 examined the impact of cardiac, dermatologic, and diabetes teleconsultations on organization and patient outcomes in 950 patients in 30 rural communities.² Rapid access to care was provided for 85% of the patients. Organizational benefits included resource savings and efficacy improvement measured by a provider opinion Likert scale. Patient benefits included reductions in wait times, transportation savings, avoidance of unnecessary office visits, and ease of use.

A large systematic review of telemedicine services across all medical specialties in 2006 included 106 published studies.⁴ Clinical outcomes (decision making, diagnosis, and management) were similar between conventional care and telemedicine in specialty care, particularly in neurology and psychiatry. Virtual consults provided equal care to traditional specialty visits.⁶

Communication and coordination of care via an e-consult instead of a face-to-face clinic visit was evaluated by Horner and colleagues.⁵ The authors identified e-consult benefits for patients and specialists and that e-consults can reduce unnecessary referrals and appointments by 30%. They concluded that reserved time to complete e-consults must be built into workflow systems and that an advanced EMR was necessary for successful use of e-consults.

Two studies have evaluated satisfaction with e-consults. A preliminary analysis of satisfaction with e-consults was conducted in 2009 by K. L. Rodriguez, PhD, and colleagues (unpublished data). Patients, primary care providers (PCPs), and medical specialists reported overall satisfaction in 8 satisfaction domains. A pilot study of 34 patients in 2011 with inflammatory bowel disease compared a standard patient-GD physician encounter with a video encounter.⁷ The authors reported patient satisfaction, appointment time, wait times, and quality of care were similar for the 2 groups.

Methods

The GD where this QI project was completed consisted of a clinic staffed by nurse practitioners (NPs) and a procedure lab staffed by gastroenterology physicians. Before e-consult implementation, a NP reviewed and triaged new referrals daily. During the project period, an average of 25 to 35 new referrals were received daily via the EMR. Referrals came mostly from PCPs requesting an evaluation of their patients’ gastroenterology problem. Patients were triaged either to an appointment for evaluation or directly to the GD procedure lab for EGD or colonoscopy.

When e-consults were implemented, several changes occurred. Two providers were assigned to new referral triage, and they were expected to process 20% as e-consults. In the EMR, e-consult note titles, templates, and an e-consult encounter form were created, and staff was given access to the e-consult tracking database. The EMR referral template was amended so the entering provider could say whether a face-to-face appointment was desired or whether an e-consult was acceptable. The patient was to be included in decision making about this choice. Department staff had permission to triage according to judgment and expertise; thus, appointment requests could be triaged to e-consults, and e-consult requests could be triaged to appointments.

To complete an e-consult, the EMR was reviewed for medical diagnoses, medications, diagnostics, and recent physical exam. A summary note outlining an impression, treatment recommendations, and follow-up was entered in the EMR and communicated to the PCP. In most cases, no discussion with the patient occurred. The encounter form was completed, and information was entered into the tracking database. The database was installed on each provider’s computer who processed e-consults. If EGD or colonoscopy was indicated, the scheduler was notified to call the patient. Once a procedure date was established, procedure orders were completed in the EMR, and instructions were mailed to the patient.

Project Description and Evaluation 

The project was reviewed by the Institutional Review Board and determined to be a QI project. VA organizational policies were followed for data collection and security. Benchmarks were identified from the e-consult program and from the GD, where available. Process variables were determined to measure benchmark outcomes. (Table)

To identify participants, a retrospective chart review was performed. A total of 203 potential patients were identified from the e-consult program database for the 6-month period between January and July 2012. For comparison, 50 patients who attended an appointment during the same time frame were systematically identified in the EMR. Although this comparison group was eligible for e-consults, they were triaged to in-person appointments and subsequently had colonoscopies completed.

Outcome data were extracted from the e-consult program database and the EMR. The data analysis was descriptive. Summary aggregate data were compared with the benchmarks and comparison patient outcomes. The Table summarizes the process variables, how they were measured, where they came from, and what the comparisons were.

Discussion 

Figure 1 illustrates the volume of completed e-consults from January to July 2012. A gastroenterology procedure was not indicated in 43 patients. A procedure was indicated for 160 patients and completed in 116 patients (72%). One hundred procedures were colonoscopies, and 16 were EGDs. Figure 2 provides reasons why procedures were not completed in 44 patients (27%). Group comparisons of colon prep quality and preprocedure reminder calls are displayed in Figures 3 and 4, respectively.

This project sought to evaluate VAPHS GD e-consults beginning in January 2012. Process variables were established to measure benchmarks in the e-consult program and in the GD. Some benchmarks were met with outcomes that were comparable between the groups, while others were not. To our knowledge, this project is the first to evaluate e-consults in the subspecialty of gastroenterology.

Volume of Completed E-Consults

The benchmark for 20% e-consults was not met (Figure 1). For weeks 1 through 8, the volume was between 10% and 20%. Lower volume in weeks 9 through 15 (late March and April) may have been due to staff vacations. Not only do the outcomes show a downward trend in e-consult volume, they also show a precipitous fall in volume at week 15 to almost no e-consults for the remainder of the project. To explore reasons for this outcome, the workflow process of new referral triage and e-consults was reviewed.

Two providers (1 NP, 1 physician) were assigned to new referral triage and e-consults from weeks 1 through 14. At week 15, the physician was reassigned to perform procedures. From this point, only 1 NP worked on e-consults and referral triage. Competing time demands included an e-consult encounter form, tracking database entry, procedure orders, patient instructions, appointment changes, phone calls, and resolution of medications issues for procedures. The triage NP was also required to see patients in the clinic. Each day, only a half-day was allotted to complete e-consults, new referral triage (25-35/day), and the aforementioned tasks.

Therefore, it became clear that a half-day was not sufficient to meet the 20% benchmark for e-consults. Horner and colleagues also found that dedicated time in workflow processes was necessary to allow for e-consult completion.⁵

E-Consults vs Appointment Groups 

All patients in both groups were offered the choice of e-consult or appointment; this benchmark was met. Of the 203 e-consult patients, 70% requested an appointment, but their evaluation was completed as an e-consult. By design, the appointment group patients chose e-consult but were triaged to appointment due to time constraints and the high volume of new referrals.

Evaluations via e-consult were completed within 2 to 3 days, whereas the mean for appointments was 19 days, with the longest time frame of 44 days. Thus, e-consult evaluations were completed sooner. Rapid access to care was also found by Zanaboni and colleagues.²

When appointments are delayed, patient complaints or status may change, which in turn may affect treatment plans. In addition, the reason for referral may have already resolved by the actual appointment, rendering the appointment unnecessary. This can be viewed as a missed opportunity for another patient to be seen. Ideally, it is best for a patient to be evaluated soon after a new referral is made.

The VA encounter form for an e-consult had only one 5-digit code, which allotted only 15 minutes of work credit. Encounter form codes were established by the Center for Medicare and Medicaid Services (CMS) for billing purposes in the private sector, with coding levels based on information documented in a chart note: review of systems, physical exam, and diagnoses decision making. Because all criteria could not be met in an e-consult, only 1 code was assigned for VAPHS e-consults. The CMS has specific telemedicine codes; it was unknown why they were not used for e-consults.

E-consults took an average of 19 minutes to complete, with 91 completed in ≤ 15 minutes and over half (112) having taken > 15 minutes. Therefore, the actual workload was not captured, and more work was done than was credited. To speculate, e-consults were in their infancy; a learning curve may have existed as staff became accustomed to this new process.

The EMRs were reviewed for the 7 e-consults that took > 30 minutes to complete. Two were in the early stage of e-consult implementation, but the remainder were scattered throughout. Patients in these e-consults had complicated medical histories and perhaps should not have been triaged to e-consult. Theoretically, only uncomplicated patients with simple reasons for gastroenterology referral should be triaged to e-consult, allowing for a shorter time frame and higher volume.

The wait times to procedure were 58 days for the e-consult group and 39 days in the appointment group. Although wait time was originally identified as an outcome, its relevance is questionable after looking at the outcome data. The procedure appointment date was a subjective decision by the patient; many factors affected what date the patient established, including weekday preference, time off from work, caretaker availability, season, and staffing. Many patients rescheduled their initial procedure dates, often several times. These factors are reflected in the variable ranges of wait times.

Colon Prep Quality

Colon prep refers to patient instructions on the day before the procedure and includes a clear liquid diet, drinking a liquid solution to empty bowel contents, and no food or liquid after midnight. Prep quality is stated in the colonoscopy report. During the procedure, the physician makes a visual decision based on presence or absence of stool inside the colon. Prep quality is important, because retained stool can preclude thorough visualization of the colon wall for polyps or abnormalities. In the event of fair and poor preps, the colonoscopy might be aborted and rescheduled or completed, but with the recommendation for another colonoscopy in a short time frame, such as 1 to 3 years.

Forty-four percent of the e-consult group and 62% of the appointment group had good or adequate preps. Thus, more patients in the appointment group achieved good and adequate preps, and far fewer achieved fair or poor preps. One important point was that almost half (47%) of the e-consult group had only a fair prep (Figure 3).

A number of reasons have been identified in the literature, which might help us understand these findings. First, patients may not fully understand or adhere to prep instructions.^8-10 Furthermore, certain medical diagnoses are known to affect prep quality (ie, diabetes, thyroid disease, constipation).^11,12 Another potential factor is the manner in which prep quality is determined.^13,14 However, due to the focus of this QI study, the influential drivers of prep quality can only be inferred from the literature; thus, a future research or QI study is warranted to ascertain the underlying mechanism of colon prep quality in our specific veteran population.

Preprocedure Reminder Calls

Outcomes were essentially reversed between the 2 groups (Figure 4). Between 50% and 60% of the e-consult group received a call, while the same percentage of appointment patients did not. All patients did attend their procedure appointment. A GD goal was to call every patient before their procedure, but the ability to make the calls was staffing-dependent, which may explain these findings.

Most Relevant Findings

Although this project provides a thorough analysis of various benchmarks within this recently implemented e-consult gastroenterology program, 3 findings emerged that were identified as most relevant. First, the benchmark of 20% volume of completed e-consults was not met. A review of the workflow processes revealed that a daily allotment of only a half-day was not sufficient to complete e-consults, referral triage, and related tasks.

Second, outcomes for colon prep quality and preprocedure reminder calls were also relevant. Although beyond the scope of this project, the question arose of a relationship between prep quality and the reminder call: Does the reminder call affect prep quality? The goal of colon prep is to achieve a good or adequate prep. The purpose of the reminder call was to confirm the appointment and to review the colon prep. Among patients in both groups who achieved only a fair prep, 62% in the e-consult group did receive the reminder call; thus, the call seemed to have failed in helping these patients achieve an adequate or good prep. The actual content of colon prep review during the call was unknown, but certainly bears improvement.

Another speculation concerned the prep instruction sheet. Although all patients received the same sheet, e-consult patients received it in the mail and read it themselves, while it was directly reviewed face-to-face with the appointment patients. Questions remain whether a face-to-face review increases the likelihood for a better prep and how to help e-consult patients achieve optimal prep, since they are not seen face-to-face. 

Practice Implications and Sustaining Measures

Theoretically, e-consults are a viable alternative to face-to-face appointments. Potential advantages include efficient use of an EMR, avoidance of unnecessary appointments, and improved access to care for patients who require an appointment. Although patient satisfaction was not measured in this project, the literature review revealed that satisfaction was increased through use of various virtual health care modalities, including a preliminary analysis in this facility by the aforementioned 2009 study by K. L. Rodriguez (unpublished data). Based on findings in this project, the following 4 recommendations were made to improve benchmark outcomes and quality of care.

1. Provide dedicated time to complete e-consults and related tasks. In this setting, a full day was recommended. An alternative was to hire a NP whose sole responsibility was e-consults.
2. Develop a selection process to determine which new referrals are best suited for e-consult. This process will increase e-consult efficiency and decrease the time to complete an e-consult. Recommended selection criteria were (A) gastroenterology referrals only for simple symptoms or issues; (B) referrals only for a procedure; and (C) stable patients with uncomplicated medical histories.
3. Sustain the preprocedure reminder phone call. The reminder call helps patients keep appointments and thus reduces a missed opportunity for care.
4. Plan a future QI project or research study on patient colon prep quality for colonoscopy. Such a project might evaluate types of colon prep, how prep quality is measured, patient instructions, and the timing/content of pre-procedure reminder phone calls, particularly for e-consult patients.

Conclusion

This QI project provided outcomes for e-consults in the subspecialty of gastroenterology at the VAPHS. Although some benchmark outcomes were met and favorable, others were less favorable. By conducting this benchmark analysis, the areas of needed improvement are now clear. This analysis provides information so recommendations for process improvements can be made.

Quality of care improvement is an ongoing process at VAPHS. Since completion of this project, several processes have been adjusted so that outcomes will be improved. For example, corrective actions were taken for patients who did not complete their gastroenterology procedure. The process for scheduling gastroenterology procedures was adjusted for appointments and cancellations. Ongoing efforts to sustain the reminder phone call were put in place. Changes in NP staffing and time assigned for both clinical and nonclinical work were proposed and are currently under review.

It is the mission of the VA to provide access to care, patient satisfaction, timely care, and appropriate use of resources. Having the ability to highlight our strengths, as well as the willingness to recognize weaknesses, allows us to create new improved processes to provide the best care possible for our veterans.

Acknowledgments
This project was Elena Swann’s capstone for the Doctor of Nursing Practice Program, University of Pittsburgh School of Nursing in Pennsylvania. Rich Laufer, Larry Priscella, and Janie Fleming assisted with the VA Gastroenterology Clinic and procedure metrics. Dr. Melissa Taylor, VA associate chief nurse for research provided project guidance and manuscript revisions. Dr. Sandra Engberg, University of Pittsburgh School of Nursing faculty, assisted with project and manuscript development.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Although the VA has the largest health care system in the U.S., not every VA facility offers medical subspecialty care. As a result, patients are often separated by long distances from services they need.

At the VA Pittsburgh Healthcare System (VAPHS) in Pennsylvania, about 15,700 veterans received care in 2011. The Gastroenterology Department (GD) served many of these patients: 5,800 patients were seen in clinic appointments, 2,500 underwent colonoscopy, and 1,700 underwent esophagogastroduodenoscopy (EGD). Patients traveled up to 150 miles from 3 states for appointments and procedures. Prior to each procedure, a face-to-face appointment was standard practice for most patients to plan procedures and ensure medical stability. Patients expressed dissatisfaction with transportation, cost, time, and inconvenience, particularly when they were required to attend both the preprocedure and procedure appointments.

Patient satisfaction, timely care, and appropriate use of resources are important VA goals of care, so the VAPHS developed an electronic consultation (e-consult) program as a component of its long-term strategic plan. The goal was to increase access to care through the use of an e-consult in lieu of a face-to-face appointment for select patients. The e-consult program established guidelines and benchmark goals (Table). The program also established a database to track the benchmarks.

The purpose of this quality improvement (QI) project was to evaluate e-consults in the GD over a 6-month period from January 2012, when e-consults were implemented in the GD, to July 2012. Based on the outcomes, recommendations for program continuation, change, and sustainability were made.

Background

Telemedicine using information technologies has been reported as a viable solution to support health care delivery when distance limits patients’ access to care.^1,2 Telemedicine has also been shown to improve efficacy in clinical decision making and reduce costs. It also can increase patient satisfaction by reducing travel and time, minimize duplication of diagnostic testing, and integrate services effectively across multiple sites when an electronic medical record (EMR) is in place.^1-5

A randomized controlled trial in 2004 compared a standard outpatient referral appointment with a joint teleconsultation between provider, specialist, and patient.³ In the teleconsultation arm, there was higher patient satisfaction, fewer diagnostic tests (particularly in gastroenterology), and lower patient costs.

A study published in 2009 examined the impact of cardiac, dermatologic, and diabetes teleconsultations on organization and patient outcomes in 950 patients in 30 rural communities.² Rapid access to care was provided for 85% of the patients. Organizational benefits included resource savings and efficacy improvement measured by a provider opinion Likert scale. Patient benefits included reductions in wait times, transportation savings, avoidance of unnecessary office visits, and ease of use.

A large systematic review of telemedicine services across all medical specialties in 2006 included 106 published studies.⁴ Clinical outcomes (decision making, diagnosis, and management) were similar between conventional care and telemedicine in specialty care, particularly in neurology and psychiatry. Virtual consults provided equal care to traditional specialty visits.⁶

Communication and coordination of care via an e-consult instead of a face-to-face clinic visit was evaluated by Horner and colleagues.⁵ The authors identified e-consult benefits for patients and specialists and that e-consults can reduce unnecessary referrals and appointments by 30%. They concluded that reserved time to complete e-consults must be built into workflow systems and that an advanced EMR was necessary for successful use of e-consults.

Two studies have evaluated satisfaction with e-consults. A preliminary analysis of satisfaction with e-consults was conducted in 2009 by K. L. Rodriguez, PhD, and colleagues (unpublished data). Patients, primary care providers (PCPs), and medical specialists reported overall satisfaction in 8 satisfaction domains. A pilot study of 34 patients in 2011 with inflammatory bowel disease compared a standard patient-GD physician encounter with a video encounter.⁷ The authors reported patient satisfaction, appointment time, wait times, and quality of care were similar for the 2 groups.

Methods

The GD where this QI project was completed consisted of a clinic staffed by nurse practitioners (NPs) and a procedure lab staffed by gastroenterology physicians. Before e-consult implementation, a NP reviewed and triaged new referrals daily. During the project period, an average of 25 to 35 new referrals were received daily via the EMR. Referrals came mostly from PCPs requesting an evaluation of their patients’ gastroenterology problem. Patients were triaged either to an appointment for evaluation or directly to the GD procedure lab for EGD or colonoscopy.

When e-consults were implemented, several changes occurred. Two providers were assigned to new referral triage, and they were expected to process 20% as e-consults. In the EMR, e-consult note titles, templates, and an e-consult encounter form were created, and staff was given access to the e-consult tracking database. The EMR referral template was amended so the entering provider could say whether a face-to-face appointment was desired or whether an e-consult was acceptable. The patient was to be included in decision making about this choice. Department staff had permission to triage according to judgment and expertise; thus, appointment requests could be triaged to e-consults, and e-consult requests could be triaged to appointments.

To complete an e-consult, the EMR was reviewed for medical diagnoses, medications, diagnostics, and recent physical exam. A summary note outlining an impression, treatment recommendations, and follow-up was entered in the EMR and communicated to the PCP. In most cases, no discussion with the patient occurred. The encounter form was completed, and information was entered into the tracking database. The database was installed on each provider’s computer who processed e-consults. If EGD or colonoscopy was indicated, the scheduler was notified to call the patient. Once a procedure date was established, procedure orders were completed in the EMR, and instructions were mailed to the patient.

Project Description and Evaluation 

The project was reviewed by the Institutional Review Board and determined to be a QI project. VA organizational policies were followed for data collection and security. Benchmarks were identified from the e-consult program and from the GD, where available. Process variables were determined to measure benchmark outcomes. (Table)

To identify participants, a retrospective chart review was performed. A total of 203 potential patients were identified from the e-consult program database for the 6-month period between January and July 2012. For comparison, 50 patients who attended an appointment during the same time frame were systematically identified in the EMR. Although this comparison group was eligible for e-consults, they were triaged to in-person appointments and subsequently had colonoscopies completed.

Outcome data were extracted from the e-consult program database and the EMR. The data analysis was descriptive. Summary aggregate data were compared with the benchmarks and comparison patient outcomes. The Table summarizes the process variables, how they were measured, where they came from, and what the comparisons were.

Discussion 

Figure 1 illustrates the volume of completed e-consults from January to July 2012. A gastroenterology procedure was not indicated in 43 patients. A procedure was indicated for 160 patients and completed in 116 patients (72%). One hundred procedures were colonoscopies, and 16 were EGDs. Figure 2 provides reasons why procedures were not completed in 44 patients (27%). Group comparisons of colon prep quality and preprocedure reminder calls are displayed in Figures 3 and 4, respectively.

This project sought to evaluate VAPHS GD e-consults beginning in January 2012. Process variables were established to measure benchmarks in the e-consult program and in the GD. Some benchmarks were met with outcomes that were comparable between the groups, while others were not. To our knowledge, this project is the first to evaluate e-consults in the subspecialty of gastroenterology.

Volume of Completed E-Consults

The benchmark for 20% e-consults was not met (Figure 1). For weeks 1 through 8, the volume was between 10% and 20%. Lower volume in weeks 9 through 15 (late March and April) may have been due to staff vacations. Not only do the outcomes show a downward trend in e-consult volume, they also show a precipitous fall in volume at week 15 to almost no e-consults for the remainder of the project. To explore reasons for this outcome, the workflow process of new referral triage and e-consults was reviewed.

Two providers (1 NP, 1 physician) were assigned to new referral triage and e-consults from weeks 1 through 14. At week 15, the physician was reassigned to perform procedures. From this point, only 1 NP worked on e-consults and referral triage. Competing time demands included an e-consult encounter form, tracking database entry, procedure orders, patient instructions, appointment changes, phone calls, and resolution of medications issues for procedures. The triage NP was also required to see patients in the clinic. Each day, only a half-day was allotted to complete e-consults, new referral triage (25-35/day), and the aforementioned tasks.

Therefore, it became clear that a half-day was not sufficient to meet the 20% benchmark for e-consults. Horner and colleagues also found that dedicated time in workflow processes was necessary to allow for e-consult completion.⁵

E-Consults vs Appointment Groups 

All patients in both groups were offered the choice of e-consult or appointment; this benchmark was met. Of the 203 e-consult patients, 70% requested an appointment, but their evaluation was completed as an e-consult. By design, the appointment group patients chose e-consult but were triaged to appointment due to time constraints and the high volume of new referrals.

Evaluations via e-consult were completed within 2 to 3 days, whereas the mean for appointments was 19 days, with the longest time frame of 44 days. Thus, e-consult evaluations were completed sooner. Rapid access to care was also found by Zanaboni and colleagues.²

When appointments are delayed, patient complaints or status may change, which in turn may affect treatment plans. In addition, the reason for referral may have already resolved by the actual appointment, rendering the appointment unnecessary. This can be viewed as a missed opportunity for another patient to be seen. Ideally, it is best for a patient to be evaluated soon after a new referral is made.

The VA encounter form for an e-consult had only one 5-digit code, which allotted only 15 minutes of work credit. Encounter form codes were established by the Center for Medicare and Medicaid Services (CMS) for billing purposes in the private sector, with coding levels based on information documented in a chart note: review of systems, physical exam, and diagnoses decision making. Because all criteria could not be met in an e-consult, only 1 code was assigned for VAPHS e-consults. The CMS has specific telemedicine codes; it was unknown why they were not used for e-consults.

E-consults took an average of 19 minutes to complete, with 91 completed in ≤ 15 minutes and over half (112) having taken > 15 minutes. Therefore, the actual workload was not captured, and more work was done than was credited. To speculate, e-consults were in their infancy; a learning curve may have existed as staff became accustomed to this new process.

The EMRs were reviewed for the 7 e-consults that took > 30 minutes to complete. Two were in the early stage of e-consult implementation, but the remainder were scattered throughout. Patients in these e-consults had complicated medical histories and perhaps should not have been triaged to e-consult. Theoretically, only uncomplicated patients with simple reasons for gastroenterology referral should be triaged to e-consult, allowing for a shorter time frame and higher volume.

The wait times to procedure were 58 days for the e-consult group and 39 days in the appointment group. Although wait time was originally identified as an outcome, its relevance is questionable after looking at the outcome data. The procedure appointment date was a subjective decision by the patient; many factors affected what date the patient established, including weekday preference, time off from work, caretaker availability, season, and staffing. Many patients rescheduled their initial procedure dates, often several times. These factors are reflected in the variable ranges of wait times.

Colon Prep Quality

Colon prep refers to patient instructions on the day before the procedure and includes a clear liquid diet, drinking a liquid solution to empty bowel contents, and no food or liquid after midnight. Prep quality is stated in the colonoscopy report. During the procedure, the physician makes a visual decision based on presence or absence of stool inside the colon. Prep quality is important, because retained stool can preclude thorough visualization of the colon wall for polyps or abnormalities. In the event of fair and poor preps, the colonoscopy might be aborted and rescheduled or completed, but with the recommendation for another colonoscopy in a short time frame, such as 1 to 3 years.

Forty-four percent of the e-consult group and 62% of the appointment group had good or adequate preps. Thus, more patients in the appointment group achieved good and adequate preps, and far fewer achieved fair or poor preps. One important point was that almost half (47%) of the e-consult group had only a fair prep (Figure 3).

A number of reasons have been identified in the literature, which might help us understand these findings. First, patients may not fully understand or adhere to prep instructions.^8-10 Furthermore, certain medical diagnoses are known to affect prep quality (ie, diabetes, thyroid disease, constipation).^11,12 Another potential factor is the manner in which prep quality is determined.^13,14 However, due to the focus of this QI study, the influential drivers of prep quality can only be inferred from the literature; thus, a future research or QI study is warranted to ascertain the underlying mechanism of colon prep quality in our specific veteran population.

Preprocedure Reminder Calls

Outcomes were essentially reversed between the 2 groups (Figure 4). Between 50% and 60% of the e-consult group received a call, while the same percentage of appointment patients did not. All patients did attend their procedure appointment. A GD goal was to call every patient before their procedure, but the ability to make the calls was staffing-dependent, which may explain these findings.

Most Relevant Findings

Although this project provides a thorough analysis of various benchmarks within this recently implemented e-consult gastroenterology program, 3 findings emerged that were identified as most relevant. First, the benchmark of 20% volume of completed e-consults was not met. A review of the workflow processes revealed that a daily allotment of only a half-day was not sufficient to complete e-consults, referral triage, and related tasks.

Second, outcomes for colon prep quality and preprocedure reminder calls were also relevant. Although beyond the scope of this project, the question arose of a relationship between prep quality and the reminder call: Does the reminder call affect prep quality? The goal of colon prep is to achieve a good or adequate prep. The purpose of the reminder call was to confirm the appointment and to review the colon prep. Among patients in both groups who achieved only a fair prep, 62% in the e-consult group did receive the reminder call; thus, the call seemed to have failed in helping these patients achieve an adequate or good prep. The actual content of colon prep review during the call was unknown, but certainly bears improvement.

Another speculation concerned the prep instruction sheet. Although all patients received the same sheet, e-consult patients received it in the mail and read it themselves, while it was directly reviewed face-to-face with the appointment patients. Questions remain whether a face-to-face review increases the likelihood for a better prep and how to help e-consult patients achieve optimal prep, since they are not seen face-to-face. 

Practice Implications and Sustaining Measures

Theoretically, e-consults are a viable alternative to face-to-face appointments. Potential advantages include efficient use of an EMR, avoidance of unnecessary appointments, and improved access to care for patients who require an appointment. Although patient satisfaction was not measured in this project, the literature review revealed that satisfaction was increased through use of various virtual health care modalities, including a preliminary analysis in this facility by the aforementioned 2009 study by K. L. Rodriguez (unpublished data). Based on findings in this project, the following 4 recommendations were made to improve benchmark outcomes and quality of care.

1. Provide dedicated time to complete e-consults and related tasks. In this setting, a full day was recommended. An alternative was to hire a NP whose sole responsibility was e-consults.
2. Develop a selection process to determine which new referrals are best suited for e-consult. This process will increase e-consult efficiency and decrease the time to complete an e-consult. Recommended selection criteria were (A) gastroenterology referrals only for simple symptoms or issues; (B) referrals only for a procedure; and (C) stable patients with uncomplicated medical histories.
3. Sustain the preprocedure reminder phone call. The reminder call helps patients keep appointments and thus reduces a missed opportunity for care.
4. Plan a future QI project or research study on patient colon prep quality for colonoscopy. Such a project might evaluate types of colon prep, how prep quality is measured, patient instructions, and the timing/content of pre-procedure reminder phone calls, particularly for e-consult patients.

Conclusion

This QI project provided outcomes for e-consults in the subspecialty of gastroenterology at the VAPHS. Although some benchmark outcomes were met and favorable, others were less favorable. By conducting this benchmark analysis, the areas of needed improvement are now clear. This analysis provides information so recommendations for process improvements can be made.

Quality of care improvement is an ongoing process at VAPHS. Since completion of this project, several processes have been adjusted so that outcomes will be improved. For example, corrective actions were taken for patients who did not complete their gastroenterology procedure. The process for scheduling gastroenterology procedures was adjusted for appointments and cancellations. Ongoing efforts to sustain the reminder phone call were put in place. Changes in NP staffing and time assigned for both clinical and nonclinical work were proposed and are currently under review.

It is the mission of the VA to provide access to care, patient satisfaction, timely care, and appropriate use of resources. Having the ability to highlight our strengths, as well as the willingness to recognize weaknesses, allows us to create new improved processes to provide the best care possible for our veterans.

Acknowledgments
This project was Elena Swann’s capstone for the Doctor of Nursing Practice Program, University of Pittsburgh School of Nursing in Pennsylvania. Rich Laufer, Larry Priscella, and Janie Fleming assisted with the VA Gastroenterology Clinic and procedure metrics. Dr. Melissa Taylor, VA associate chief nurse for research provided project guidance and manuscript revisions. Dr. Sandra Engberg, University of Pittsburgh School of Nursing faculty, assisted with project and manuscript development.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Using age as the determining factor when screening for hepatitis is more useful than is measuring for elevated levels of alanine aminotransferase (ALT), an enzyme produced by the liver, say researchers from the CDC in Atlanta, Georgia.

Most people with hepatitis C virus (HCV) infection are aged in their late 40s to late 60s and were likely infected 25 to 45 years ago, the researchers say. Most were infected by tainted blood transfusions or IV drug use, kidney dialysis, or use of blood-clotting products.

Both the CDC and the American Association for the Study of Liver Disease recommend HCV testing for people with elevated ALT levels. The authors of the CDC study say that previous studies suggest that providers are more likely to test patients for HCV based on elevated ALT than on assessment of exposure risk factors. In fact, risk-based testing can identify most HCV infection, but only 58% to 63% of primary care providers ask about patients’ risk factors. And about 20% to 30% of HCV-infected people do not report risk factors, or they do not remember having been exposed to a risk.

However, only about 46% of patients are evaluated for liver function, and the ALT test has drawbacks, the researchers say. These include lack of a standard definition for the upper limit of normal and the need for multiple tests over time.

In 2012, the CDC recommended a onetime HCV test for people born between 1945 and 1965. According to the researchers, patients born during that time belong to a “high-prevalence cohort” of nearly 200 million people who could account for 67% to 76% of adult HCV infections.

Which approach is best able to diagnose the most HCV-infected individuals?

The researchers say targeting via the birth cohort has the potential to identify about 1 million more anti-HCV positive people, compared with the strategy based on an elevated ALT result. The prevalence of anti-HCV within the birth cohort was about 4 times that in the adult population born before 1945 or after 1965. Using the birth year cohort as the basis of anti-HCV testing would identify nearly 77% of anti-HCV cases in the U.S. adult population, compared with 50% identification using the ALT strategy.

In 2007, according to study researchers, HCV infection surpassed HIV as an underlying or contributing cause of mortality and accounted for > 15,000 deaths in the U.S. More than 1 million more are projected to die of complications of untreated HCV, they add. Without testing and treatment, the CDC estimates that 60% of people with HCV infection will develop cirrhosis, or the scarring of the liver found in advanced liver disease. Testing ALT would screen about 60 million fewer people than the birth cohort strategy and could fail to identify about 700,000 to 900,000 individual cases of current HCV infection, the researchers say. Implementing both strategies concurrently, however, would identify 87% of anti-HCV cases.

Source
Smith BD, Yartel AK. Am J Prev Med. 2014;47(3):233-241.
doi: 10.1016/j.amepre.2014.05.011.

Using age as the determining factor when screening for hepatitis is more useful than is measuring for elevated levels of alanine aminotransferase (ALT), an enzyme produced by the liver, say researchers from the CDC in Atlanta, Georgia.

Most people with hepatitis C virus (HCV) infection are aged in their late 40s to late 60s and were likely infected 25 to 45 years ago, the researchers say. Most were infected by tainted blood transfusions or IV drug use, kidney dialysis, or use of blood-clotting products.

Both the CDC and the American Association for the Study of Liver Disease recommend HCV testing for people with elevated ALT levels. The authors of the CDC study say that previous studies suggest that providers are more likely to test patients for HCV based on elevated ALT than on assessment of exposure risk factors. In fact, risk-based testing can identify most HCV infection, but only 58% to 63% of primary care providers ask about patients’ risk factors. And about 20% to 30% of HCV-infected people do not report risk factors, or they do not remember having been exposed to a risk.

However, only about 46% of patients are evaluated for liver function, and the ALT test has drawbacks, the researchers say. These include lack of a standard definition for the upper limit of normal and the need for multiple tests over time.

In 2012, the CDC recommended a onetime HCV test for people born between 1945 and 1965. According to the researchers, patients born during that time belong to a “high-prevalence cohort” of nearly 200 million people who could account for 67% to 76% of adult HCV infections.

Which approach is best able to diagnose the most HCV-infected individuals?

The researchers say targeting via the birth cohort has the potential to identify about 1 million more anti-HCV positive people, compared with the strategy based on an elevated ALT result. The prevalence of anti-HCV within the birth cohort was about 4 times that in the adult population born before 1945 or after 1965. Using the birth year cohort as the basis of anti-HCV testing would identify nearly 77% of anti-HCV cases in the U.S. adult population, compared with 50% identification using the ALT strategy.

In 2007, according to study researchers, HCV infection surpassed HIV as an underlying or contributing cause of mortality and accounted for > 15,000 deaths in the U.S. More than 1 million more are projected to die of complications of untreated HCV, they add. Without testing and treatment, the CDC estimates that 60% of people with HCV infection will develop cirrhosis, or the scarring of the liver found in advanced liver disease. Testing ALT would screen about 60 million fewer people than the birth cohort strategy and could fail to identify about 700,000 to 900,000 individual cases of current HCV infection, the researchers say. Implementing both strategies concurrently, however, would identify 87% of anti-HCV cases.

Source
Smith BD, Yartel AK. Am J Prev Med. 2014;47(3):233-241.
doi: 10.1016/j.amepre.2014.05.011.

Using age as the determining factor when screening for hepatitis is more useful than is measuring for elevated levels of alanine aminotransferase (ALT), an enzyme produced by the liver, say researchers from the CDC in Atlanta, Georgia.

Most people with hepatitis C virus (HCV) infection are aged in their late 40s to late 60s and were likely infected 25 to 45 years ago, the researchers say. Most were infected by tainted blood transfusions or IV drug use, kidney dialysis, or use of blood-clotting products.

Both the CDC and the American Association for the Study of Liver Disease recommend HCV testing for people with elevated ALT levels. The authors of the CDC study say that previous studies suggest that providers are more likely to test patients for HCV based on elevated ALT than on assessment of exposure risk factors. In fact, risk-based testing can identify most HCV infection, but only 58% to 63% of primary care providers ask about patients’ risk factors. And about 20% to 30% of HCV-infected people do not report risk factors, or they do not remember having been exposed to a risk.

However, only about 46% of patients are evaluated for liver function, and the ALT test has drawbacks, the researchers say. These include lack of a standard definition for the upper limit of normal and the need for multiple tests over time.

In 2012, the CDC recommended a onetime HCV test for people born between 1945 and 1965. According to the researchers, patients born during that time belong to a “high-prevalence cohort” of nearly 200 million people who could account for 67% to 76% of adult HCV infections.

Which approach is best able to diagnose the most HCV-infected individuals?

The researchers say targeting via the birth cohort has the potential to identify about 1 million more anti-HCV positive people, compared with the strategy based on an elevated ALT result. The prevalence of anti-HCV within the birth cohort was about 4 times that in the adult population born before 1945 or after 1965. Using the birth year cohort as the basis of anti-HCV testing would identify nearly 77% of anti-HCV cases in the U.S. adult population, compared with 50% identification using the ALT strategy.

In 2007, according to study researchers, HCV infection surpassed HIV as an underlying or contributing cause of mortality and accounted for > 15,000 deaths in the U.S. More than 1 million more are projected to die of complications of untreated HCV, they add. Without testing and treatment, the CDC estimates that 60% of people with HCV infection will develop cirrhosis, or the scarring of the liver found in advanced liver disease. Testing ALT would screen about 60 million fewer people than the birth cohort strategy and could fail to identify about 700,000 to 900,000 individual cases of current HCV infection, the researchers say. Implementing both strategies concurrently, however, would identify 87% of anti-HCV cases.

Source
Smith BD, Yartel AK. Am J Prev Med. 2014;47(3):233-241.
doi: 10.1016/j.amepre.2014.05.011.

Can a neighborhood be “obesogenic”? Yes, suggest researchers from the University of Washington in Seattle. According to their study, living in neighborhoods with lower property values may impact whether or not residents are likely to be overweight and obese.

For their study, the researchers used data from the Seattle Obesity Study of 2,001 adults in King County, Washington. The survey asked people 11 questions about their neighborhood, including whether they felt safe, whether the neighborhood was clean and well lit, whether traffic was a problem, and whether neighbors knew and trusted one another.

Having a fast-food restaurant within a 10-minute walk lowered property values by $50,000. Being within 10 minutes of a park boosted property values by an average $30,000. Neighborhoods with higher property values (P < .001) were perceived as safe, quiet, clean, and attractive, with parks, playing fields, and full-service restaurants within walking distance. Seven of the perceived environmental measures were significantly associated with body mass index (BMI), especially for women, the researchers found. These included feeling safe, trusting neighbors, and lower neighborhood diversity, but not traffic or perceiving the neighborhood as clean and attractive.

Neighborhoods with lower property values were also often obesogenic communities: Residents who reported living with crime, heavy traffic, bars, liquor stores, and fast food, had BMIs of about 27 on average, compared with 23.9 for women and 26.4 for men in the highest-valued neighborhoods.

But the amenities people value in their neighborhoods can vary. In New York, New York, and Seattle, Washington, for instance, having a park nearby was associated with higher property values. In Detroit, Michigan, having a supermarket nearby was more valued. Those kinds of independent variables can help explain inconsistent associations between environmental measures and BMI, the researchers say. Sometimes having fast food nearby is linked to obesity, sometimes not. Parks are not always linked to lower BMIs, either.

Establishing links between multiple measures of the environment, activity levels, and obesity rates is a “continuing challenge,” the researchers acknowledge. But they feel using property values as a marker is a new “wealth metric” that may offer a way to resolve the complexity. Because real estate stays put and people do not, the researchers suggest that property value is an effective way to sort the population by material resources and socioeconomic status.

Source
Drewnowski A, Aggarwal A, Rehm CD, Cohen-Cline H, Hurvitz PM, Moudon AV. Am J Prev Med. 2014;47(3):260-274.
doi: 10.1016/j.amepre.2014.05.006.

Can a neighborhood be “obesogenic”? Yes, suggest researchers from the University of Washington in Seattle. According to their study, living in neighborhoods with lower property values may impact whether or not residents are likely to be overweight and obese.

For their study, the researchers used data from the Seattle Obesity Study of 2,001 adults in King County, Washington. The survey asked people 11 questions about their neighborhood, including whether they felt safe, whether the neighborhood was clean and well lit, whether traffic was a problem, and whether neighbors knew and trusted one another.

Having a fast-food restaurant within a 10-minute walk lowered property values by $50,000. Being within 10 minutes of a park boosted property values by an average $30,000. Neighborhoods with higher property values (P < .001) were perceived as safe, quiet, clean, and attractive, with parks, playing fields, and full-service restaurants within walking distance. Seven of the perceived environmental measures were significantly associated with body mass index (BMI), especially for women, the researchers found. These included feeling safe, trusting neighbors, and lower neighborhood diversity, but not traffic or perceiving the neighborhood as clean and attractive.

Neighborhoods with lower property values were also often obesogenic communities: Residents who reported living with crime, heavy traffic, bars, liquor stores, and fast food, had BMIs of about 27 on average, compared with 23.9 for women and 26.4 for men in the highest-valued neighborhoods.

But the amenities people value in their neighborhoods can vary. In New York, New York, and Seattle, Washington, for instance, having a park nearby was associated with higher property values. In Detroit, Michigan, having a supermarket nearby was more valued. Those kinds of independent variables can help explain inconsistent associations between environmental measures and BMI, the researchers say. Sometimes having fast food nearby is linked to obesity, sometimes not. Parks are not always linked to lower BMIs, either.

Establishing links between multiple measures of the environment, activity levels, and obesity rates is a “continuing challenge,” the researchers acknowledge. But they feel using property values as a marker is a new “wealth metric” that may offer a way to resolve the complexity. Because real estate stays put and people do not, the researchers suggest that property value is an effective way to sort the population by material resources and socioeconomic status.

Source
Drewnowski A, Aggarwal A, Rehm CD, Cohen-Cline H, Hurvitz PM, Moudon AV. Am J Prev Med. 2014;47(3):260-274.
doi: 10.1016/j.amepre.2014.05.006.

Can a neighborhood be “obesogenic”? Yes, suggest researchers from the University of Washington in Seattle. According to their study, living in neighborhoods with lower property values may impact whether or not residents are likely to be overweight and obese.

For their study, the researchers used data from the Seattle Obesity Study of 2,001 adults in King County, Washington. The survey asked people 11 questions about their neighborhood, including whether they felt safe, whether the neighborhood was clean and well lit, whether traffic was a problem, and whether neighbors knew and trusted one another.

Having a fast-food restaurant within a 10-minute walk lowered property values by $50,000. Being within 10 minutes of a park boosted property values by an average $30,000. Neighborhoods with higher property values (P < .001) were perceived as safe, quiet, clean, and attractive, with parks, playing fields, and full-service restaurants within walking distance. Seven of the perceived environmental measures were significantly associated with body mass index (BMI), especially for women, the researchers found. These included feeling safe, trusting neighbors, and lower neighborhood diversity, but not traffic or perceiving the neighborhood as clean and attractive.

Neighborhoods with lower property values were also often obesogenic communities: Residents who reported living with crime, heavy traffic, bars, liquor stores, and fast food, had BMIs of about 27 on average, compared with 23.9 for women and 26.4 for men in the highest-valued neighborhoods.

But the amenities people value in their neighborhoods can vary. In New York, New York, and Seattle, Washington, for instance, having a park nearby was associated with higher property values. In Detroit, Michigan, having a supermarket nearby was more valued. Those kinds of independent variables can help explain inconsistent associations between environmental measures and BMI, the researchers say. Sometimes having fast food nearby is linked to obesity, sometimes not. Parks are not always linked to lower BMIs, either.

Establishing links between multiple measures of the environment, activity levels, and obesity rates is a “continuing challenge,” the researchers acknowledge. But they feel using property values as a marker is a new “wealth metric” that may offer a way to resolve the complexity. Because real estate stays put and people do not, the researchers suggest that property value is an effective way to sort the population by material resources and socioeconomic status.

Source
Drewnowski A, Aggarwal A, Rehm CD, Cohen-Cline H, Hurvitz PM, Moudon AV. Am J Prev Med. 2014;47(3):260-274.
doi: 10.1016/j.amepre.2014.05.006.

THE CASE

A 23-year-old immunocompetent woman was referred to our spinal clinic with a 6-month history of low back pain that radiated to her right flank, buttock, and groin. She’d had intermittent urinary problems, including mild dysuria and frequency, and had been treated with antibiotics for a presumed urinary tract infection on 3 previous occasions, but her pain gradually increased and eventually became constant.

The patient had no history of fever, malaise, or weight loss. She denied consuming unpasteurized milk or undercooked poultry, and hadn’t recently experienced diarrhea or vomiting.

Eight years earlier, she had undergone anterior fusion of her spine for idiopathic scoliosis. At that time, she was at Risser grade 1, and her Cobb angle was 50°; metallic instrumentation was implanted at T10 to L3 to prevent progression of the scoliosis. Her recovery had been uneventful.

During examination, her temperature, pulse, respiratory rate, blood pressure, and nervous system were all normal. Her hips appeared normal, as well, and a straight leg raise was negative bilaterally. The patient had mild midline lumbar tenderness. Spinal range of movement revealed decreased flexion and mild pain.

X-rays (FIGURE 1) showed no changes in the previous metalwork in her spine. There was decreased disk height at the L3/4 level, but no significant bony erosion or soft-tissue shadows. Laboratory testing revealed a C-reactive protein (CRP) level of 240 mg/dL (normal, <1 mg/dL) and her erythrocyte sedimentation rate (ESR) was 102 mm/h—more than 5 times higher than it should have been.¹ The patient had a normal peripheral white cell count (WCC). Midstream urine cultures were negative.


The patient was admitted to the hospital for further work-up. Magnetic resonance imaging (MRI) of the lumbar spine showed gross abnormality at the L3-L4 disk level with erosion of the end plates, fluid in the disk space, marked enhancing edema, and mild surrounding soft-tissue edematous changes, but no evidence of any epidural abscess (FIGURE 2). The patient had a fluoroscopy-guided needle biopsy of the disk on the same day and received intravenous (IV) ceftriaxone 2 g twice a day. Blood and urine cultures were negative.

THE DIAGNOSIS

We suspected our patient had spondylodiscitis, an infection of the spine that includes spondylitis (inflammation of the vertebrae) and discitis (inflammation of the vertebral disk space). After 48 hours, the biopsy sample grew Salmonella typhimurium and confirmed the diagnosis. The organism was sensitive to ceftriaxone and ciprofloxacin; parenteral ceftriaxone was continued and the patient wore a thoracolumbar brace for immobilization. For 3 days, her inflammatory marker levels were checked daily, then every other day for the rest of that first week, and then 2 more times in the following week.

DISCUSSION

Thoracic and lumbar vertebrae are the most common sites of spondylodiscitis.² Spondylodiscitis accounts for 3% to 5% of pyogenic osteomyelitis in patients in developed countries.³ The incidence of pyogenic spondylodiscitis may be rising due to an increase in the number of elderly and immunocompromised patients, as well as a rise in invasive medical procedures.^4-6

If left untreated, spondylodiscitis can spread longitudinally (involving the adjacent levels), posteriorly (causing bacterial meningitis, abscess formation, and cord compromise), or anteriorly (causing paravertebral abscess). Untreated spondylodiscitis can also send distant infective emboli and cause endocarditis^7-9 or mycotic abdominal aneurysm.¹⁰

Historically, mortality in patients with vertebral osteomyelitis has been as high as 25%.¹¹ The combination of earlier diagnosis, antibiotics, and surgical debridement and stabilization has decreased mortality to less than 15%.^12-14

Risk factors for spondylodiscitis include male sex, IV drug abuse, diabetes, morbid obesity, having had a genitourinary or spinal procedure, and being immunocompromised (eg, from alcohol abuse, malignancy, organ transplantation, chemotherapy, or corticosteroid use).^12,15,16

Gram-positive organisms cause most spine infections in both adults and children, with 40% to 90% caused by Staphylococcus aureus.¹⁷ Gram-negative organisms (Escherichia coli, Pseudomonas, and Proteus), which can also cause spondylodiscitis, typically occur after genitourinary infections or procedures. IV drug abusers are prone to Pseudomonas infections.¹⁸ Anaerobic infections may be seen in patients with diabetes or after penetrating trauma.¹⁵ Salmonella species can cause spondylodiscitis, especially in patients with sickle cell disease from an intestinal source.¹⁹

Mycobacterium tuberculosis is the most common nonpyogenic infecting agent that also can cause spondylodiscitis. Infection caused by tuberculosis (TB) has had a recent resurgence with resistant strains, especially in patients with human immunodeficiency virus.¹⁵ Although less than 10% of patients with TB have skeletal involvement, 50% of the skeletal involvement occurs in the spine.¹⁵

The clinical presentation of spondylodiscitis depends on the location of the infection, the virulence of the organism, and the immune status of the patient. Discitis can present as pain in the back, hip, abdomen (especially in children²⁰) and, occasionally, with meningeal involvement.¹¹ Patients with discitis often have a normal temperature.^15,21 In patients with discitis, the patient’s WCC will be normal, but the ESR is almost always elevated.^15,22 Suspect spondylodiscitis in patients who present with persistent or increasing pain 3 to 4 weeks after back surgery. For such patients, measure inflammatory markers and order imaging of the spine.

Risk factors for spondylodiscitis include IV drug abuse, diabetes, morbid obesity, and having had a genitourinary or spinal procedure. X-ray findings for patients with spondylodiscitis will include osteolysis and end plate erosions (early) and narrowing and collapse of the disk space (late). (In TB, relative preservation of the disk spaces is seen, with significant vertebral destruction.)

MRI is the modality of choice for diagnosis and assessment of suspected spondylodiscitis because it can provide imaging of the soft tissue, neural elements, and bony changes with a high sensitivity and specificity.²³ Once infection is suspected, the diagnosis should be confirmed by fluoroscopic- or computed tomography-guided biopsy before starting antibiotic treatment.

Long-term antibiotics
 are required to prevent recurrence


IV antibiotics are the mainstay of treatment for spondylodiscitis;²⁴ the specific drug used will depend upon the organism identified. Patients typically receive 2 to 6 weeks of IV therapy. Then, once the patient improves and inflammatory markers return to normal levels, the patient receives a course of oral antibiotics for 2 to 6 more weeks. Grados et al¹⁹ found recurrence rates of 10% to 15% for patients who were treated 4 to 8 weeks compared to 3.9% in those treated for 12 weeks or longer; therefore, a total duration of 12 weeks is commonly chosen.^25-28

To minimize the risk of spondylolisthesis, kyphosis, and fractures of the infected bone, patients are advised to rest and the spine is often immobilized with a spinal brace. Surgery may be needed if antibiotics are not effective, or for patients who develop complications such as fluid collection, neurologic deficits, or deformity.

Our patient’s pain improved after 2 weeks and she became more comfortable wearing the thoracolumbar brace. Her CRP and ESR also improved and there was no radiologic evidence of fluid collection. The patient was discharged with a peripherally inserted central catheter in place and received IV ceftriaxone for 6 more weeks at home. This was followed by 4 weeks of oral ciprofloxacin 750 mg twice daily, thereby completing a 12-week course of antibiotics.

Our patient’s response to treatment was monitored clinically and the inflammatory markers were checked weekly after discharge until the end of treatment and at 6 and 12 months after start of treatment. At 12 months, our patient’s CRP was <1 mg/dL and ESR was 22 mm/h. One year later, our patient remained asymptomatic with normal inflammatory marker levels and no evidence of recurrence.

THE TAKEAWAY

Spondylodiscitis is an important differential diagnosis of lower back, flank, groin, and buttock pain. It’s important to be aware of this diagnosis, especially in patients who have risk factors such as IV drug abuse, diabetes, and morbid obesity. Although previous spinal surgery is a risk factor, spondylodiscitis should be considered in patients with persistent back pain even if they haven’t had spinal surgery. It can be present even when there is no tenderness over the spinous process or any fever.

Checking inflammatory markers is a reasonable next step if a patient’s pain does not resolve after at least 4 weeks. If levels of inflammatory markers such as CRP and ESR are elevated and symptoms continue, MRI can confirm or rule out the presence of spondylodiscitis. Treatments include orthotic support, antibiotics, and surgical intervention when complications arise.

REFERENCES

1. Miller A, Green M, Robinson D. Simple rule for calculating normal erythrocyte sedimentation rate. Br Med J. 1983;286:266.

2. Calhoun JH, Manring MM. Adult osteomyelitis. Infect Dis Clin North Am. 2005;19:765-786.

3. Sobottke R, Seifert H, Fätkenheuer G, et al. Current diagnosis and treatment of spondylodiscitis. Dtsch Arztebl Int. 2008;105:181-187.

4. Beronius M, Bergman B, Andersson R. Vertebral osteomyelitis in Göteborg, Sweden: a retrospective study of patients during 1990-95. Scand J Infect Dis. 2001;33:527-532.

5. Digby JM, Kersley JB. Pyogenic non-tuberculous spinal infection: an analysis of thirty cases. J Bone Joint Surg Br. 1979;61: 47-55.

6. Gouliouris T, Aliyu SH, Brown NM. Spondylodiscitis: update on diagnosis and management. J Antimicrob Chemother. 2010;65 suppl 3:iii11-iii24.

7. Aoki K, Watanabe M, Ohzeki H. Successful surgical treatment of tricuspid valve endocarditis associated with vertebral osteomyelitis. Ann Thorac Cardiovasc Surg. 2010;16:207-209.

8. Gonzalez-Juanatey C, Testa-Fernandez A, Gonzalez-Gay MA. Septic discitis as initial manifestation of streptococcus bovis endocarditis. Int J Cardiol. 2006;108:128-129.

9. Morelli S, Carmenini E, Caporossi AP, et al. Spondylodiscitis and infective endocarditis: case studies and review of the literature. Spine (Phila Pa 1976). 2001;26:499-500.

10. Learch TJ, Sakamoto B, Ling AC, et al. Salmonella spondylodiscitis associated with a mycotic abdominal aortic aneurysm and paravertebral abscess. Emerg Radiol. 2009;16:147-150.

11. Guri JP. Pyogenic osteomyelitis of the spine. J Bone Joint Surg Am. 1946;28:29-39.

12. Carragee EJ. Pyogenic vertebral osteomyelitis. J Bone Joint Surg Am. 1997;79:874-880.

13. Garcia A Jr, Grantham SA. Hematogenous pyogenic vertebral osteomyelitis. J Bone Joint Surg Am. 1960;42-A:429-436.

14. Eismont FJ, Bohlman HH, Soni PL, et al. Pyogenic and fungal vertebral osteomyelitis with paralysis. J Bone Joint Surg Am. 1983;65:19-29.

15. Tay BK, Deckey J, Hu SS. Spinal infections. J Am Acad Orthop Surg. 2002;10:188-197.

16. Krogsgaard MR, Wagn P, Bengtsson J. Epidemiology of acute vertebral osteomyelitis in Denmark: 137 cases in Denmark 1978-1982, compared to cases reported to the National Patient Register 1991-1993. Acta Orthop Scand. 1998;69:513-517.

17. Francis X. Infections of spine. In: Canale ST, Beaty JH, eds. Campbell’s Operative Orthopaedics. 11th ed. New York, NY: Mosby; 2007:2241.

18. Roca RP, Yoshikawa TT. Primary skeletal infections in heroin users: a clinical characterization, diagnosis and therapy. Clin Orthop Relat Res. 1979;(144):238-248.

19. Grados F, Lescure FX, Senneville E, et al. Suggestions for managing pyogenic (non-tuberculous) discitis in adults. Joint Bone Spine. 2007;74:133-139.

20. Cheyne G, Runau F, Lloyd DM. Right upper quadrant pain and raised alkaline phosphatase is not always a hepatobiliary problem. Ann R Coll Surg Engl. 2014;96:118E-120E.

21. Varma R, Lander P, Assaf A. Imaging of pyogenic infectious spondylodiskitis. Radiol Clin North Am. 2001;39: 203-213.

22. Lehovsky J. Pyogenic vertebral osteomyelitis/disc infection. Baillieres Best Pract Res Clin Rheumatol. 1999;13:59-75.

23. Modic MT, Feiglin DH, Piraino DW, et al. Vertebral osteomyelitis: assessment using MR. Radiology. 1985;157:157-166.

24. Amritanand R, Venkatesh K, Sundararaj GD. Salmonella spondylodiscitis in the immunocompetent: our experience with eleven patients. Spine (Phila Pa 1976). 2010;35:E1317-E1321.

25. Govender S. Spinal infections. J Bone Joint Surg Br. 2005;87:1454-1458.

26. Lam KS, Webb JK. Discitis. Hosp Med. 2004;65:280-286.

27. Gasbarrini AL, Bertoldi E, Mazzetti M, et al. Clinical features, diagnostic and therapeutic approaches to haematogenous vertebral osteomyelitis. Eur Rev Med Pharmacol Sci. 2005;9: 53-66.

28. Cottle L, Riordan T. Infectious spondylodiscitis. J Infect. 2008;56:401-412.

THE CASE

A 23-year-old immunocompetent woman was referred to our spinal clinic with a 6-month history of low back pain that radiated to her right flank, buttock, and groin. She’d had intermittent urinary problems, including mild dysuria and frequency, and had been treated with antibiotics for a presumed urinary tract infection on 3 previous occasions, but her pain gradually increased and eventually became constant.

The patient had no history of fever, malaise, or weight loss. She denied consuming unpasteurized milk or undercooked poultry, and hadn’t recently experienced diarrhea or vomiting.

Eight years earlier, she had undergone anterior fusion of her spine for idiopathic scoliosis. At that time, she was at Risser grade 1, and her Cobb angle was 50°; metallic instrumentation was implanted at T10 to L3 to prevent progression of the scoliosis. Her recovery had been uneventful.

During examination, her temperature, pulse, respiratory rate, blood pressure, and nervous system were all normal. Her hips appeared normal, as well, and a straight leg raise was negative bilaterally. The patient had mild midline lumbar tenderness. Spinal range of movement revealed decreased flexion and mild pain.

X-rays (FIGURE 1) showed no changes in the previous metalwork in her spine. There was decreased disk height at the L3/4 level, but no significant bony erosion or soft-tissue shadows. Laboratory testing revealed a C-reactive protein (CRP) level of 240 mg/dL (normal, <1 mg/dL) and her erythrocyte sedimentation rate (ESR) was 102 mm/h—more than 5 times higher than it should have been.¹ The patient had a normal peripheral white cell count (WCC). Midstream urine cultures were negative.


The patient was admitted to the hospital for further work-up. Magnetic resonance imaging (MRI) of the lumbar spine showed gross abnormality at the L3-L4 disk level with erosion of the end plates, fluid in the disk space, marked enhancing edema, and mild surrounding soft-tissue edematous changes, but no evidence of any epidural abscess (FIGURE 2). The patient had a fluoroscopy-guided needle biopsy of the disk on the same day and received intravenous (IV) ceftriaxone 2 g twice a day. Blood and urine cultures were negative.

THE DIAGNOSIS

We suspected our patient had spondylodiscitis, an infection of the spine that includes spondylitis (inflammation of the vertebrae) and discitis (inflammation of the vertebral disk space). After 48 hours, the biopsy sample grew Salmonella typhimurium and confirmed the diagnosis. The organism was sensitive to ceftriaxone and ciprofloxacin; parenteral ceftriaxone was continued and the patient wore a thoracolumbar brace for immobilization. For 3 days, her inflammatory marker levels were checked daily, then every other day for the rest of that first week, and then 2 more times in the following week.

DISCUSSION

Thoracic and lumbar vertebrae are the most common sites of spondylodiscitis.² Spondylodiscitis accounts for 3% to 5% of pyogenic osteomyelitis in patients in developed countries.³ The incidence of pyogenic spondylodiscitis may be rising due to an increase in the number of elderly and immunocompromised patients, as well as a rise in invasive medical procedures.^4-6

If left untreated, spondylodiscitis can spread longitudinally (involving the adjacent levels), posteriorly (causing bacterial meningitis, abscess formation, and cord compromise), or anteriorly (causing paravertebral abscess). Untreated spondylodiscitis can also send distant infective emboli and cause endocarditis^7-9 or mycotic abdominal aneurysm.¹⁰

Historically, mortality in patients with vertebral osteomyelitis has been as high as 25%.¹¹ The combination of earlier diagnosis, antibiotics, and surgical debridement and stabilization has decreased mortality to less than 15%.^12-14

Risk factors for spondylodiscitis include male sex, IV drug abuse, diabetes, morbid obesity, having had a genitourinary or spinal procedure, and being immunocompromised (eg, from alcohol abuse, malignancy, organ transplantation, chemotherapy, or corticosteroid use).^12,15,16

Gram-positive organisms cause most spine infections in both adults and children, with 40% to 90% caused by Staphylococcus aureus.¹⁷ Gram-negative organisms (Escherichia coli, Pseudomonas, and Proteus), which can also cause spondylodiscitis, typically occur after genitourinary infections or procedures. IV drug abusers are prone to Pseudomonas infections.¹⁸ Anaerobic infections may be seen in patients with diabetes or after penetrating trauma.¹⁵ Salmonella species can cause spondylodiscitis, especially in patients with sickle cell disease from an intestinal source.¹⁹

Mycobacterium tuberculosis is the most common nonpyogenic infecting agent that also can cause spondylodiscitis. Infection caused by tuberculosis (TB) has had a recent resurgence with resistant strains, especially in patients with human immunodeficiency virus.¹⁵ Although less than 10% of patients with TB have skeletal involvement, 50% of the skeletal involvement occurs in the spine.¹⁵

The clinical presentation of spondylodiscitis depends on the location of the infection, the virulence of the organism, and the immune status of the patient. Discitis can present as pain in the back, hip, abdomen (especially in children²⁰) and, occasionally, with meningeal involvement.¹¹ Patients with discitis often have a normal temperature.^15,21 In patients with discitis, the patient’s WCC will be normal, but the ESR is almost always elevated.^15,22 Suspect spondylodiscitis in patients who present with persistent or increasing pain 3 to 4 weeks after back surgery. For such patients, measure inflammatory markers and order imaging of the spine.

Risk factors for spondylodiscitis include IV drug abuse, diabetes, morbid obesity, and having had a genitourinary or spinal procedure. X-ray findings for patients with spondylodiscitis will include osteolysis and end plate erosions (early) and narrowing and collapse of the disk space (late). (In TB, relative preservation of the disk spaces is seen, with significant vertebral destruction.)

MRI is the modality of choice for diagnosis and assessment of suspected spondylodiscitis because it can provide imaging of the soft tissue, neural elements, and bony changes with a high sensitivity and specificity.²³ Once infection is suspected, the diagnosis should be confirmed by fluoroscopic- or computed tomography-guided biopsy before starting antibiotic treatment.

Long-term antibiotics
 are required to prevent recurrence


IV antibiotics are the mainstay of treatment for spondylodiscitis;²⁴ the specific drug used will depend upon the organism identified. Patients typically receive 2 to 6 weeks of IV therapy. Then, once the patient improves and inflammatory markers return to normal levels, the patient receives a course of oral antibiotics for 2 to 6 more weeks. Grados et al¹⁹ found recurrence rates of 10% to 15% for patients who were treated 4 to 8 weeks compared to 3.9% in those treated for 12 weeks or longer; therefore, a total duration of 12 weeks is commonly chosen.^25-28

To minimize the risk of spondylolisthesis, kyphosis, and fractures of the infected bone, patients are advised to rest and the spine is often immobilized with a spinal brace. Surgery may be needed if antibiotics are not effective, or for patients who develop complications such as fluid collection, neurologic deficits, or deformity.

Our patient’s pain improved after 2 weeks and she became more comfortable wearing the thoracolumbar brace. Her CRP and ESR also improved and there was no radiologic evidence of fluid collection. The patient was discharged with a peripherally inserted central catheter in place and received IV ceftriaxone for 6 more weeks at home. This was followed by 4 weeks of oral ciprofloxacin 750 mg twice daily, thereby completing a 12-week course of antibiotics.

Our patient’s response to treatment was monitored clinically and the inflammatory markers were checked weekly after discharge until the end of treatment and at 6 and 12 months after start of treatment. At 12 months, our patient’s CRP was <1 mg/dL and ESR was 22 mm/h. One year later, our patient remained asymptomatic with normal inflammatory marker levels and no evidence of recurrence.

THE TAKEAWAY

Spondylodiscitis is an important differential diagnosis of lower back, flank, groin, and buttock pain. It’s important to be aware of this diagnosis, especially in patients who have risk factors such as IV drug abuse, diabetes, and morbid obesity. Although previous spinal surgery is a risk factor, spondylodiscitis should be considered in patients with persistent back pain even if they haven’t had spinal surgery. It can be present even when there is no tenderness over the spinous process or any fever.

Checking inflammatory markers is a reasonable next step if a patient’s pain does not resolve after at least 4 weeks. If levels of inflammatory markers such as CRP and ESR are elevated and symptoms continue, MRI can confirm or rule out the presence of spondylodiscitis. Treatments include orthotic support, antibiotics, and surgical intervention when complications arise.

REFERENCES

1. Miller A, Green M, Robinson D. Simple rule for calculating normal erythrocyte sedimentation rate. Br Med J. 1983;286:266.

2. Calhoun JH, Manring MM. Adult osteomyelitis. Infect Dis Clin North Am. 2005;19:765-786.

3. Sobottke R, Seifert H, Fätkenheuer G, et al. Current diagnosis and treatment of spondylodiscitis. Dtsch Arztebl Int. 2008;105:181-187.

4. Beronius M, Bergman B, Andersson R. Vertebral osteomyelitis in Göteborg, Sweden: a retrospective study of patients during 1990-95. Scand J Infect Dis. 2001;33:527-532.

5. Digby JM, Kersley JB. Pyogenic non-tuberculous spinal infection: an analysis of thirty cases. J Bone Joint Surg Br. 1979;61: 47-55.

6. Gouliouris T, Aliyu SH, Brown NM. Spondylodiscitis: update on diagnosis and management. J Antimicrob Chemother. 2010;65 suppl 3:iii11-iii24.

7. Aoki K, Watanabe M, Ohzeki H. Successful surgical treatment of tricuspid valve endocarditis associated with vertebral osteomyelitis. Ann Thorac Cardiovasc Surg. 2010;16:207-209.

8. Gonzalez-Juanatey C, Testa-Fernandez A, Gonzalez-Gay MA. Septic discitis as initial manifestation of streptococcus bovis endocarditis. Int J Cardiol. 2006;108:128-129.

9. Morelli S, Carmenini E, Caporossi AP, et al. Spondylodiscitis and infective endocarditis: case studies and review of the literature. Spine (Phila Pa 1976). 2001;26:499-500.

10. Learch TJ, Sakamoto B, Ling AC, et al. Salmonella spondylodiscitis associated with a mycotic abdominal aortic aneurysm and paravertebral abscess. Emerg Radiol. 2009;16:147-150.

11. Guri JP. Pyogenic osteomyelitis of the spine. J Bone Joint Surg Am. 1946;28:29-39.

12. Carragee EJ. Pyogenic vertebral osteomyelitis. J Bone Joint Surg Am. 1997;79:874-880.

13. Garcia A Jr, Grantham SA. Hematogenous pyogenic vertebral osteomyelitis. J Bone Joint Surg Am. 1960;42-A:429-436.

14. Eismont FJ, Bohlman HH, Soni PL, et al. Pyogenic and fungal vertebral osteomyelitis with paralysis. J Bone Joint Surg Am. 1983;65:19-29.

15. Tay BK, Deckey J, Hu SS. Spinal infections. J Am Acad Orthop Surg. 2002;10:188-197.

16. Krogsgaard MR, Wagn P, Bengtsson J. Epidemiology of acute vertebral osteomyelitis in Denmark: 137 cases in Denmark 1978-1982, compared to cases reported to the National Patient Register 1991-1993. Acta Orthop Scand. 1998;69:513-517.

17. Francis X. Infections of spine. In: Canale ST, Beaty JH, eds. Campbell’s Operative Orthopaedics. 11th ed. New York, NY: Mosby; 2007:2241.

18. Roca RP, Yoshikawa TT. Primary skeletal infections in heroin users: a clinical characterization, diagnosis and therapy. Clin Orthop Relat Res. 1979;(144):238-248.

19. Grados F, Lescure FX, Senneville E, et al. Suggestions for managing pyogenic (non-tuberculous) discitis in adults. Joint Bone Spine. 2007;74:133-139.

20. Cheyne G, Runau F, Lloyd DM. Right upper quadrant pain and raised alkaline phosphatase is not always a hepatobiliary problem. Ann R Coll Surg Engl. 2014;96:118E-120E.

21. Varma R, Lander P, Assaf A. Imaging of pyogenic infectious spondylodiskitis. Radiol Clin North Am. 2001;39: 203-213.

22. Lehovsky J. Pyogenic vertebral osteomyelitis/disc infection. Baillieres Best Pract Res Clin Rheumatol. 1999;13:59-75.

23. Modic MT, Feiglin DH, Piraino DW, et al. Vertebral osteomyelitis: assessment using MR. Radiology. 1985;157:157-166.

24. Amritanand R, Venkatesh K, Sundararaj GD. Salmonella spondylodiscitis in the immunocompetent: our experience with eleven patients. Spine (Phila Pa 1976). 2010;35:E1317-E1321.

25. Govender S. Spinal infections. J Bone Joint Surg Br. 2005;87:1454-1458.

26. Lam KS, Webb JK. Discitis. Hosp Med. 2004;65:280-286.

27. Gasbarrini AL, Bertoldi E, Mazzetti M, et al. Clinical features, diagnostic and therapeutic approaches to haematogenous vertebral osteomyelitis. Eur Rev Med Pharmacol Sci. 2005;9: 53-66.

28. Cottle L, Riordan T. Infectious spondylodiscitis. J Infect. 2008;56:401-412.

THE CASE

A 23-year-old immunocompetent woman was referred to our spinal clinic with a 6-month history of low back pain that radiated to her right flank, buttock, and groin. She’d had intermittent urinary problems, including mild dysuria and frequency, and had been treated with antibiotics for a presumed urinary tract infection on 3 previous occasions, but her pain gradually increased and eventually became constant.

The patient had no history of fever, malaise, or weight loss. She denied consuming unpasteurized milk or undercooked poultry, and hadn’t recently experienced diarrhea or vomiting.

Eight years earlier, she had undergone anterior fusion of her spine for idiopathic scoliosis. At that time, she was at Risser grade 1, and her Cobb angle was 50°; metallic instrumentation was implanted at T10 to L3 to prevent progression of the scoliosis. Her recovery had been uneventful.

During examination, her temperature, pulse, respiratory rate, blood pressure, and nervous system were all normal. Her hips appeared normal, as well, and a straight leg raise was negative bilaterally. The patient had mild midline lumbar tenderness. Spinal range of movement revealed decreased flexion and mild pain.

X-rays (FIGURE 1) showed no changes in the previous metalwork in her spine. There was decreased disk height at the L3/4 level, but no significant bony erosion or soft-tissue shadows. Laboratory testing revealed a C-reactive protein (CRP) level of 240 mg/dL (normal, <1 mg/dL) and her erythrocyte sedimentation rate (ESR) was 102 mm/h—more than 5 times higher than it should have been.¹ The patient had a normal peripheral white cell count (WCC). Midstream urine cultures were negative.


The patient was admitted to the hospital for further work-up. Magnetic resonance imaging (MRI) of the lumbar spine showed gross abnormality at the L3-L4 disk level with erosion of the end plates, fluid in the disk space, marked enhancing edema, and mild surrounding soft-tissue edematous changes, but no evidence of any epidural abscess (FIGURE 2). The patient had a fluoroscopy-guided needle biopsy of the disk on the same day and received intravenous (IV) ceftriaxone 2 g twice a day. Blood and urine cultures were negative.

THE DIAGNOSIS

We suspected our patient had spondylodiscitis, an infection of the spine that includes spondylitis (inflammation of the vertebrae) and discitis (inflammation of the vertebral disk space). After 48 hours, the biopsy sample grew Salmonella typhimurium and confirmed the diagnosis. The organism was sensitive to ceftriaxone and ciprofloxacin; parenteral ceftriaxone was continued and the patient wore a thoracolumbar brace for immobilization. For 3 days, her inflammatory marker levels were checked daily, then every other day for the rest of that first week, and then 2 more times in the following week.

DISCUSSION

Thoracic and lumbar vertebrae are the most common sites of spondylodiscitis.² Spondylodiscitis accounts for 3% to 5% of pyogenic osteomyelitis in patients in developed countries.³ The incidence of pyogenic spondylodiscitis may be rising due to an increase in the number of elderly and immunocompromised patients, as well as a rise in invasive medical procedures.^4-6

If left untreated, spondylodiscitis can spread longitudinally (involving the adjacent levels), posteriorly (causing bacterial meningitis, abscess formation, and cord compromise), or anteriorly (causing paravertebral abscess). Untreated spondylodiscitis can also send distant infective emboli and cause endocarditis^7-9 or mycotic abdominal aneurysm.¹⁰

Historically, mortality in patients with vertebral osteomyelitis has been as high as 25%.¹¹ The combination of earlier diagnosis, antibiotics, and surgical debridement and stabilization has decreased mortality to less than 15%.^12-14

Risk factors for spondylodiscitis include male sex, IV drug abuse, diabetes, morbid obesity, having had a genitourinary or spinal procedure, and being immunocompromised (eg, from alcohol abuse, malignancy, organ transplantation, chemotherapy, or corticosteroid use).^12,15,16

Gram-positive organisms cause most spine infections in both adults and children, with 40% to 90% caused by Staphylococcus aureus.¹⁷ Gram-negative organisms (Escherichia coli, Pseudomonas, and Proteus), which can also cause spondylodiscitis, typically occur after genitourinary infections or procedures. IV drug abusers are prone to Pseudomonas infections.¹⁸ Anaerobic infections may be seen in patients with diabetes or after penetrating trauma.¹⁵ Salmonella species can cause spondylodiscitis, especially in patients with sickle cell disease from an intestinal source.¹⁹

Mycobacterium tuberculosis is the most common nonpyogenic infecting agent that also can cause spondylodiscitis. Infection caused by tuberculosis (TB) has had a recent resurgence with resistant strains, especially in patients with human immunodeficiency virus.¹⁵ Although less than 10% of patients with TB have skeletal involvement, 50% of the skeletal involvement occurs in the spine.¹⁵

The clinical presentation of spondylodiscitis depends on the location of the infection, the virulence of the organism, and the immune status of the patient. Discitis can present as pain in the back, hip, abdomen (especially in children²⁰) and, occasionally, with meningeal involvement.¹¹ Patients with discitis often have a normal temperature.^15,21 In patients with discitis, the patient’s WCC will be normal, but the ESR is almost always elevated.^15,22 Suspect spondylodiscitis in patients who present with persistent or increasing pain 3 to 4 weeks after back surgery. For such patients, measure inflammatory markers and order imaging of the spine.

Risk factors for spondylodiscitis include IV drug abuse, diabetes, morbid obesity, and having had a genitourinary or spinal procedure. X-ray findings for patients with spondylodiscitis will include osteolysis and end plate erosions (early) and narrowing and collapse of the disk space (late). (In TB, relative preservation of the disk spaces is seen, with significant vertebral destruction.)

MRI is the modality of choice for diagnosis and assessment of suspected spondylodiscitis because it can provide imaging of the soft tissue, neural elements, and bony changes with a high sensitivity and specificity.²³ Once infection is suspected, the diagnosis should be confirmed by fluoroscopic- or computed tomography-guided biopsy before starting antibiotic treatment.

Long-term antibiotics
 are required to prevent recurrence


IV antibiotics are the mainstay of treatment for spondylodiscitis;²⁴ the specific drug used will depend upon the organism identified. Patients typically receive 2 to 6 weeks of IV therapy. Then, once the patient improves and inflammatory markers return to normal levels, the patient receives a course of oral antibiotics for 2 to 6 more weeks. Grados et al¹⁹ found recurrence rates of 10% to 15% for patients who were treated 4 to 8 weeks compared to 3.9% in those treated for 12 weeks or longer; therefore, a total duration of 12 weeks is commonly chosen.^25-28

To minimize the risk of spondylolisthesis, kyphosis, and fractures of the infected bone, patients are advised to rest and the spine is often immobilized with a spinal brace. Surgery may be needed if antibiotics are not effective, or for patients who develop complications such as fluid collection, neurologic deficits, or deformity.

Our patient’s pain improved after 2 weeks and she became more comfortable wearing the thoracolumbar brace. Her CRP and ESR also improved and there was no radiologic evidence of fluid collection. The patient was discharged with a peripherally inserted central catheter in place and received IV ceftriaxone for 6 more weeks at home. This was followed by 4 weeks of oral ciprofloxacin 750 mg twice daily, thereby completing a 12-week course of antibiotics.

Our patient’s response to treatment was monitored clinically and the inflammatory markers were checked weekly after discharge until the end of treatment and at 6 and 12 months after start of treatment. At 12 months, our patient’s CRP was <1 mg/dL and ESR was 22 mm/h. One year later, our patient remained asymptomatic with normal inflammatory marker levels and no evidence of recurrence.

THE TAKEAWAY

Spondylodiscitis is an important differential diagnosis of lower back, flank, groin, and buttock pain. It’s important to be aware of this diagnosis, especially in patients who have risk factors such as IV drug abuse, diabetes, and morbid obesity. Although previous spinal surgery is a risk factor, spondylodiscitis should be considered in patients with persistent back pain even if they haven’t had spinal surgery. It can be present even when there is no tenderness over the spinous process or any fever.

Checking inflammatory markers is a reasonable next step if a patient’s pain does not resolve after at least 4 weeks. If levels of inflammatory markers such as CRP and ESR are elevated and symptoms continue, MRI can confirm or rule out the presence of spondylodiscitis. Treatments include orthotic support, antibiotics, and surgical intervention when complications arise.

REFERENCES

1. Miller A, Green M, Robinson D. Simple rule for calculating normal erythrocyte sedimentation rate. Br Med J. 1983;286:266.

2. Calhoun JH, Manring MM. Adult osteomyelitis. Infect Dis Clin North Am. 2005;19:765-786.

3. Sobottke R, Seifert H, Fätkenheuer G, et al. Current diagnosis and treatment of spondylodiscitis. Dtsch Arztebl Int. 2008;105:181-187.

4. Beronius M, Bergman B, Andersson R. Vertebral osteomyelitis in Göteborg, Sweden: a retrospective study of patients during 1990-95. Scand J Infect Dis. 2001;33:527-532.

5. Digby JM, Kersley JB. Pyogenic non-tuberculous spinal infection: an analysis of thirty cases. J Bone Joint Surg Br. 1979;61: 47-55.

6. Gouliouris T, Aliyu SH, Brown NM. Spondylodiscitis: update on diagnosis and management. J Antimicrob Chemother. 2010;65 suppl 3:iii11-iii24.

7. Aoki K, Watanabe M, Ohzeki H. Successful surgical treatment of tricuspid valve endocarditis associated with vertebral osteomyelitis. Ann Thorac Cardiovasc Surg. 2010;16:207-209.

8. Gonzalez-Juanatey C, Testa-Fernandez A, Gonzalez-Gay MA. Septic discitis as initial manifestation of streptococcus bovis endocarditis. Int J Cardiol. 2006;108:128-129.

9. Morelli S, Carmenini E, Caporossi AP, et al. Spondylodiscitis and infective endocarditis: case studies and review of the literature. Spine (Phila Pa 1976). 2001;26:499-500.

10. Learch TJ, Sakamoto B, Ling AC, et al. Salmonella spondylodiscitis associated with a mycotic abdominal aortic aneurysm and paravertebral abscess. Emerg Radiol. 2009;16:147-150.

11. Guri JP. Pyogenic osteomyelitis of the spine. J Bone Joint Surg Am. 1946;28:29-39.

12. Carragee EJ. Pyogenic vertebral osteomyelitis. J Bone Joint Surg Am. 1997;79:874-880.

13. Garcia A Jr, Grantham SA. Hematogenous pyogenic vertebral osteomyelitis. J Bone Joint Surg Am. 1960;42-A:429-436.

14. Eismont FJ, Bohlman HH, Soni PL, et al. Pyogenic and fungal vertebral osteomyelitis with paralysis. J Bone Joint Surg Am. 1983;65:19-29.

15. Tay BK, Deckey J, Hu SS. Spinal infections. J Am Acad Orthop Surg. 2002;10:188-197.

16. Krogsgaard MR, Wagn P, Bengtsson J. Epidemiology of acute vertebral osteomyelitis in Denmark: 137 cases in Denmark 1978-1982, compared to cases reported to the National Patient Register 1991-1993. Acta Orthop Scand. 1998;69:513-517.

17. Francis X. Infections of spine. In: Canale ST, Beaty JH, eds. Campbell’s Operative Orthopaedics. 11th ed. New York, NY: Mosby; 2007:2241.

18. Roca RP, Yoshikawa TT. Primary skeletal infections in heroin users: a clinical characterization, diagnosis and therapy. Clin Orthop Relat Res. 1979;(144):238-248.

19. Grados F, Lescure FX, Senneville E, et al. Suggestions for managing pyogenic (non-tuberculous) discitis in adults. Joint Bone Spine. 2007;74:133-139.

20. Cheyne G, Runau F, Lloyd DM. Right upper quadrant pain and raised alkaline phosphatase is not always a hepatobiliary problem. Ann R Coll Surg Engl. 2014;96:118E-120E.

21. Varma R, Lander P, Assaf A. Imaging of pyogenic infectious spondylodiskitis. Radiol Clin North Am. 2001;39: 203-213.

22. Lehovsky J. Pyogenic vertebral osteomyelitis/disc infection. Baillieres Best Pract Res Clin Rheumatol. 1999;13:59-75.

23. Modic MT, Feiglin DH, Piraino DW, et al. Vertebral osteomyelitis: assessment using MR. Radiology. 1985;157:157-166.

24. Amritanand R, Venkatesh K, Sundararaj GD. Salmonella spondylodiscitis in the immunocompetent: our experience with eleven patients. Spine (Phila Pa 1976). 2010;35:E1317-E1321.

25. Govender S. Spinal infections. J Bone Joint Surg Br. 2005;87:1454-1458.

26. Lam KS, Webb JK. Discitis. Hosp Med. 2004;65:280-286.

27. Gasbarrini AL, Bertoldi E, Mazzetti M, et al. Clinical features, diagnostic and therapeutic approaches to haematogenous vertebral osteomyelitis. Eur Rev Med Pharmacol Sci. 2005;9: 53-66.

28. Cottle L, Riordan T. Infectious spondylodiscitis. J Infect. 2008;56:401-412.

A common cause for total hip arthroplasty (THA) revision is joint instability.^1,2 The reported incidence of dislocation in primary THA ranges from 0.4% to 5.8%,^3-5 but this rate increases after revision surgery.^1,3-8 Use of large-diameter femoral heads has been proposed to decrease the risks for instability and to improve impingement-free range of motion (ROM).

The biomechanical rationale for using large-diameter femoral heads is that they must travel farther before subluxation or dislocation occurs (jump distance). Despite these benefits, there were initial concerns that catastrophic failure and high levels of volumetric wear would occur if these heads were used with conventional polyethylene liners. These concerns led to the development of alternative bearing surfaces, particularly metal-on-metal bearings, which offered theoretical benefits of large-diameter articulations that improved stability while purportedly being highly wear-resistant.^9-11 However, concerns about adverse local soft-tissue reactions and high blood concentrations of metal ions tempered the initial enthusiasm for metal bearings.^12-16 Fortunately, highly cross-linked polyethylene and fourth-generation ceramic bearing surfaces, with improved toughness and better wear properties, may allow use of large-diameter heads without the need for metal-on-metal bearings.^17,18

In this article, we review the concepts and principles behind use of large-diameter ceramic or cobalt-chromium femoral heads on polyethylene-bearing surfaces in THA with particular attention to biomechanics, early concerns about polyethylene wear and rim fractures, recent improvements in material properties of polyethylene and ceramic bearings, dislocation rates, and clinical and functional outcomes.

Definitions

For this review, we define large-diameter femoral heads as having diameters of 36 mm or more and conventional or small-diameter femoral heads as having diameters between 22 and 32 mm.

Biomechanics

Head–Neck Ratio, Impingement-Free ROM, and Jump Distance

Several implant design principles have been proposed to reduce the risks for impingement and dislocation. Of these, large femoral head diameters have been extensively studied.^19,20 It is well known that impingement of the femoral neck on the cup edge promotes edge loading and higher wear rates. In addition, impingement increases the tendency of the head to sublux from the acetabulum. One strategy for avoiding this component-to-component impingement is to increase the head–neck ratio (HNR), the ratio of the femoral head to the neck diameter. Biomechanically, increased HNRs lead to delayed contact between the femoral neck and the acetabular liner.^21,22 Therefore, with large femoral heads, which have large HNRs, impingement occurs later and at larger ROMs—compared with small-diameter femoral heads, which have lower HNRs and are more prone to early impingement and subluxation (Figure 1).^23-26

In a cadaveric study of 6 hips, Bartz and colleagues²³ reported a significantly higher preimpingement ROM when the prosthetic head size increased from 22 mm to 28 mm (P < .05). They found a change from prosthetic to osseous impingement when the head size increased from 22 mm to 32 mm. Similar results were observed in a computer simulation model by Cinotti and colleagues,²⁷ who demonstrated that increasing the femoral head size from 28 mm to 38 mm resulted in a 5° improvement in ROM. However, the largest gains were observed when the heads with the smallest diameters were upsized; ROM improved only marginally when femoral head size was further increased from 32 mm to 38 mm. The primary reason for the lack of expected improvement in ROM with head sizes of more than 32 mm is often bone-on-bone impingement. Burroughs and colleagues²⁸ demonstrated that the 38-mm and 44-mm heads virtually eliminated component-to-component impingement except in extremes of external rotation. However, there were no differences in ROM between 38-mm and 44-mm heads because of osseous impingement. In addition, large heads are less likely to sublux or dislocate, as they need to travel farther before reaching the edge of the acetabular cup before dislocation. This is known as the jump distance, and it corresponds to the depth of the acetabular shell, which in turn equates with the radius of the femoral head (Figures 2A, 2B).  For this reason, the larger the femoral head diameter, the farther the jump distance and, correspondingly, the lower the risk for dislocation.²⁹

Elevated liners historically were used to increase the jump distance for dislocation.³⁰ These liners, however, can increase impingement at the extremes of motion.³¹ Some of these problems can be avoided with use of larger heads, which have increased jump distances without additional risks for impingement. Moreover, large heads create a suction effect that provides passive resistance to dislocation.³² With head diameters beyond 38 mm, impingement-free ROM often plateaus. However, the jump distance required for dislocations to occur continues to increase as femoral head diameters increase in size. Thus, patients may experience fewer motion benefits but continue to benefit from overall stability with femoral head sizes increasing beyond 38 mm.

Current evidence suggests there may be substantial benefits toward improved stability from increasing head diameters from 22 mm to 38 mm because of the increase in jump distances and improvements in prosthetic impingement-free ROM. However, there may be little gain in ROM from increasing the head diameters beyond these dimensions because of the potential risks of bony impingement. Nevertheless, there may be some additional benefits toward stability from improvement in jump distances with incremental head sizes
beyond 38 mm.^29,33,34

Finite Element Analysis Studies

Finite element analysis of large-diameter heads in THA has shown that, at optimal cup inclination (45°), most stresses occur on the articular surface of the liner. However, these stresses remain well below the yield strength of the polyethylene liners.²⁹ With increasing abduction angles, the stress concentration increases substantially because of the decreased contact surface area. At these angles, the point of maximum contact moves toward the rim of the polyethylene liner, which can lead to rim fractures or failure of locking mechanisms.^29,35,36

Early Concerns With Large-Diameter Femoral Heads: Wear, Liner Failure, and Fracture of Ceramic Components

Use of small-diameter femoral heads started with the first report by Charnley³⁷ of “low frictional torque arthroplasty.” Charnley initially considered a 41.5-mm femoral head, but he thought it would increase risks for acetabular loosening from high frictional torque generated by the large head, and he switched to a small-diameter (22.5 mm) design. One of the tradeoffs with smaller diameter heads was decreased jump height in addition to increased linear wear.

Large femoral heads used with cemented polyethylene acetabular components historically have been associated with increased rates of volumetric wear but low rates of linear wear, which potentially may increase the risk for osteolysis.^38-40 However, newer highly cross-linked polyethylene liners have shown improved in vitro and in vivo volumetric wear characteristics and potentially lower linear wear rates compared with earlier designs (Table 1).^28,41-43

Another concern about earlier generations of large femoral heads was the risk for catastrophic liner failure on conventional polyethylene. This was originally reported by Berry and colleagues,⁴⁷ who described wear-through and failure in patients with thin (< 5 mm) acetabular cups. However, these concerns have been largely addressed by the development of highly cross-linked polyethylene, which has improved wear characteristics and fatigue resistance.⁴⁸

Recent Improvements in Material Properties of Polyethylene and Ceramic Bearings

The development of highly cross-linked polyethylene and fourth-generation ceramics has renewed interest in large-diameter bearings in THA. These bearing surfaces improve wear, enhance material properties, and have superior oxidation resistance.^42,48-53

We now briefly describe the methods used to improve the material properties of polyethylene and ceramics. Studies have shown that increasing the radiation dose (up to 200 kGy)  increases cross-linking and causes an inverse exponential decrease in polyethylene wear.^28,41,48-51 However, increasing radiation doses also increases production of free radicals, which diminish the material strength of these polyethylenes. The  current generation of highly cross-linked polyethylene liners is produced through a variety of manufacturing strategies to improve cross-linking and reduce wear. These strategies include differential radiation doses (50-100 kGy), techniques (electron beam, radiation), and thermal treatments (melting, annealing). Moreover, to enhance the material properties and reduce the incidence of rim cracking and delamination, authors have proposed using vitamin E supplementation to minimize the amount of subsurface oxidation that occurs as an inevitable consequence of free radical formation during fabrication.^54,55  A terminal sterilization process (eg, gas plasma, ethylene oxide, or gamma sterilization in nitrogen) is needed to make commercial, highly cross-linked polyethylene.^52,53

Fourth-generation ceramics manufactured with nano-sized yttria-stabilized tetragonal zirconia particles in a stable alumina matrix have more fracture toughness and improved wear characteristics.^54,55 In addition, oxide additives (eg, chromium oxide, strontium oxide) improve hardness and dissipate energy by deflecting cracks to prevent their propagation.⁵⁶ Moreover, the smaller grain sizes of fourth-generation ceramic bearings compared with third-generation designs (0.8 µm vs 1-5 µm) cause less disruption of the fluid film layer, which ultimately results in improved wear performance.⁵⁷

Multiple studies have found reduced wear rates with metal and ceramic large heads coupled with highly cross-linked polyethylene-bearings (Table 2).^17,41,50,58 Bragdon and colleagues,⁵⁸ using radiostereometric analysis in 25 patients, found no significant differences in mean head penetration rates between 36-mm and 28-mm cobalt-chromium (Co-Cr) heads articulating with highly cross-linked polyethylene cups at a mean follow-up of 3 years (0.035 mm/y vs 0.046 mm/y; P = .11). Geller and colleagues,⁶⁴ in their study of 42 patients with large-diameter (> 32 mm) Co-Cr femoral heads, found low mean (SD) linear wear rates of 0.06 (0.41) mm/y at a mean follow-up of 3 years. D’Antonio and colleagues,⁶⁵ in a multicenter study, reported low average linear wear (0.015 mm/y) and volumetric wear (12.1 mm³/y) over 5 years using sequentially annealed cross-linked polyethylene. In vitro reports suggest that large-diameter ceramic heads may have lower wear properties than Co-Cr heads do. Galvin and colleagues,⁶⁶ in an in vitro hip simulator study, found that large-diameter ceramic heads on highly cross-linked ultrahigh-molecular-weight polyethylene had 40% reductions in steady-state wear rates compared with Co-Cr heads on highly cross-linked bearings (4.7 vs 8.1 mm³/million cycles; P < 0.01).

Dislocation Rates

Several patient, surgeon, and implant factors affect the rate of dislocations after THA. Multiple implant options utilize the biomechanical advantage that large-diameter heads have in improving stability. Various alternatives include use of constrained tripolar heads, dual-mobility bearings, and conventional large-diameter heads with standard liners.^67-69

Large-Diameter Heads

Despite the biomechanical advantages of large-diameter metal-on-polyethylene bearings, prior studies have questioned use of these bearings because of risks for increased wear and rim failures. However, the improved wear properties of highly cross-linked polyethylene, elaborated earlier, have led to a reappraisal of this option (Table 2).^4,70 Howie and colleagues,⁷¹ in a randomized control trial of 644 patients, also found significantly lower rates of dislocation after primary THA with 36-mm heads compared with 28-mm heads (1.3% vs 5.4%; P = .012); in addition, fewer dislocations occurred with 36-mm heads than with 28-mm heads (4.9% vs 12.2%; P = .27) in a series of 44 patients in revision settings. Similarly, in a study conducted with 39,271 Medicare patients between 1998 and 2007, Malkani and colleagues⁷² found a decrease in the dislocation rate, from 4.21% to 2.14%, with use of large-diameter femoral heads. These results have been confirmed by several other authors.^34,66,73,74 Similar results were observed in 65,992 patients in the Australian National Joint Replacement Registry by Conroy and colleagues,⁷⁵ who reported a significant decrease in the risk for dislocation with large heads (≥ 30 mm) compared with 22-mm heads (relative risk, 1.0 vs 3.1; P ≤ .001).

Few studies have analyzed the role of large-diameter femoral heads in the presence of compromised soft tissues around the hip. Kung and Ries,⁷⁶ evaluating the influence of large-diameter heads in the presence and absence of a deficient abductor mechanism, demonstrated statistically significant reductions in rates of dislocation after 230 revision THAs when the abductor mechanism was intact with use of 36-mm heads compared with 28-mm heads (12.7% vs 0%; P = .015). With abductor deficiency, though, the positive effect of large heads in reducing dislocation rates was substantially reduced and was similar to that of small heads (P = .74).⁷⁶

Large heads considerably improve overall stability and lower dislocation rates in THA. With the development of newer ceramics and highly cross-linked polyethylenes, the wear rates reported in multiple studies appear to be less concerning.

Constrained Tripolar Heads

Tripolar heads have been proposed as treatment options for improving stability in patients with chronic and recurrent instability after THA. The tripolar implant consists of a metal head that snap-fits into a polyethylene liner with a polished Co-Cr backing. This bipolar head articulates with a polyethylene bearing that is press-fitted onto a metal acetabular shell and constrained by a metal ring snapped to the outer polyethylene bearing. The bipolar component behaves as a large-diameter femoral head, and the metal ring provides additional restraint, further improving stability.

Williams and colleagues⁷⁷ performed a systematic review and reported on the outcomes of constrained tripolar liners in 1199 hips at a mean follow-up of 4 years (range, 2-10 years). The mean dislocation rate was 10%, and the mean rate of revision surgery unrelated to instability was 4%. In a study of 43 hips at a mean follow-up of 4 years (range, 2-9 years), Zywiel and colleagues⁷⁸ reported on the clinical and radiographic outcomes of tripolar constrained liners. Their study group had a mean Harris Hip Score (HHS) of 82 points (range, 38-100 points) and overall survival of 91%, with no evidence of radiographic loosening during follow-up. Despite the improvements in stability with constrained tripolar liners, some authors have reported multiple mechanisms of failure with these devices.^79-81 In a study of 43 failed constrained tripolar liners with a mean time to failure of about 2 years, Guyen and colleagues⁷⁹ identified 5 different failure modes (types 1-5) involving all 4 interfaces in these components.

Encouraging outcomes have been reported at midterm follow-up with tripolar constrained liners. However, concerns about failure at the interfaces suggest that use of these components should be restricted to patients with deficient abductor mechanisms or neuromuscular compromise, low-demand elderly patients, and salvage cases of recurrent dislocations.⁷⁹

Dual-Mobility Bearings

For more than 20 years, different dual-mobility bearings have been used for difficult acetabular reconstructive scenarios and prevention of instability.^82,83 Dual-mobility cups provide constructs that snap-fit a small-diameter femoral head within a large polyethylene insert that articulates with a fixed metal shell. This effectively increases the functional head diameter.

Various authors have reported excellent survivorship rates (92%-99%) and low dislocation rates for these bearings at 5- to 10-year follow-up.^82,84-90 Philippot and colleagues,⁸⁶ in a recent study of 438 hips with dual-mobility cups, reported excellent survivorship (96%) and no early or late instability within a 15-year follow-up. Bouchet and colleagues⁶⁹ compared dual-mobility bearings (105 hips) with conventional metal-on-polythene bearings (108 hips) and found significantly (P < .05) lower dislocation rates for the dual-mobility implants at a minimum 1-year follow-up. The French Society of Orthopaedics and Traumatology performed a multicenter analysis of 3473 hips with dual-mobility cups implanted in France between January 1998 and December 2003.⁸⁷ During a mean follow-up of 7 years (range, 5-11 years), there were 15 dislocations (0.43%), 14 of which occurred early, within 3 months of implantation (0.4%). Aseptic implant survivorship was 95% at 10-year follow-up.

Use of these bearings has recently increased in the United States. Short-term and midterm follow-up data show low rates of dislocation and wear. Long-term data are to come.

Clinical and Functional Outcomes of Large-Diameter Femoral Heads

There is a paucity of long-term outcomes data on use of large-diameter heads with highly cross-linked polyethylene bearings. Short-term and midterm clinical results appear to be excellent, with low rates of wear, osteolysis, and aseptic loosening.^{28,41,73,89-92}

Plate and colleagues⁹¹ compared the effects of large-diameter (≥ 36 mm) and small-diameter (26 mm, 28 mm) metal heads on highly cross-linked polyethylene bearings. At a mean follow-up of 5 years (range, 4-8.4 years), the large-head cohort had a mean HHS of 90 points (range, 50-100 points) and no dislocations or radiographic evidence of stem or cup loosening. Similarly, Meftah and colleagues⁹³ reported 100% stem survivorship and excellent clinical outcomes—a mean Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of 30 points—for 72 hips with use of large ceramic heads (≥ 32 mm) on highly cross-linked polyethylene at a mean follow-up of 3 years. Gagala and colleagues⁹⁴ reported excellent clinical and radiographic outcomes in 50 hips (18 ceramic on ceramic, 32 ceramic on polyethylene; 36-mm heads) at a mean follow-up of 3.5 years. Mean HHS was 94 points, and there was no evidence of liner fractures, aseptic loosening, or osteolysis.

In summary, large-diameter femoral heads in THA have become increasingly popular because of improvements in the material properties and wear characteristics of highly cross-linked polyethylene and fourth-generation ceramics. Despite the potential advantages of large heads in preventing dislocations, the basic surgical tenets of placing the acetabular component in appropriate alignment remain firmly established. Implants with functionally large heads (eg, dual-mobility bearings, constrained tripolar liners) may play an important role in patients at high risk for dislocation—particularly elderly patients with poor neuromuscular muscle coordination or deficient abductors, trauma patients, and patients with prior dislocations. Short-term and midterm results are excellent; rates of wear, aseptic loosening, and osteolysis are low. However, long-term outcomes data are needed to support widespread use of large heads in younger and more active patients.

A common cause for total hip arthroplasty (THA) revision is joint instability.^1,2 The reported incidence of dislocation in primary THA ranges from 0.4% to 5.8%,^3-5 but this rate increases after revision surgery.^1,3-8 Use of large-diameter femoral heads has been proposed to decrease the risks for instability and to improve impingement-free range of motion (ROM).

The biomechanical rationale for using large-diameter femoral heads is that they must travel farther before subluxation or dislocation occurs (jump distance). Despite these benefits, there were initial concerns that catastrophic failure and high levels of volumetric wear would occur if these heads were used with conventional polyethylene liners. These concerns led to the development of alternative bearing surfaces, particularly metal-on-metal bearings, which offered theoretical benefits of large-diameter articulations that improved stability while purportedly being highly wear-resistant.^9-11 However, concerns about adverse local soft-tissue reactions and high blood concentrations of metal ions tempered the initial enthusiasm for metal bearings.^12-16 Fortunately, highly cross-linked polyethylene and fourth-generation ceramic bearing surfaces, with improved toughness and better wear properties, may allow use of large-diameter heads without the need for metal-on-metal bearings.^17,18

In this article, we review the concepts and principles behind use of large-diameter ceramic or cobalt-chromium femoral heads on polyethylene-bearing surfaces in THA with particular attention to biomechanics, early concerns about polyethylene wear and rim fractures, recent improvements in material properties of polyethylene and ceramic bearings, dislocation rates, and clinical and functional outcomes.

Definitions

For this review, we define large-diameter femoral heads as having diameters of 36 mm or more and conventional or small-diameter femoral heads as having diameters between 22 and 32 mm.

Biomechanics

Head–Neck Ratio, Impingement-Free ROM, and Jump Distance

Several implant design principles have been proposed to reduce the risks for impingement and dislocation. Of these, large femoral head diameters have been extensively studied.^19,20 It is well known that impingement of the femoral neck on the cup edge promotes edge loading and higher wear rates. In addition, impingement increases the tendency of the head to sublux from the acetabulum. One strategy for avoiding this component-to-component impingement is to increase the head–neck ratio (HNR), the ratio of the femoral head to the neck diameter. Biomechanically, increased HNRs lead to delayed contact between the femoral neck and the acetabular liner.^21,22 Therefore, with large femoral heads, which have large HNRs, impingement occurs later and at larger ROMs—compared with small-diameter femoral heads, which have lower HNRs and are more prone to early impingement and subluxation (Figure 1).^23-26

In a cadaveric study of 6 hips, Bartz and colleagues²³ reported a significantly higher preimpingement ROM when the prosthetic head size increased from 22 mm to 28 mm (P < .05). They found a change from prosthetic to osseous impingement when the head size increased from 22 mm to 32 mm. Similar results were observed in a computer simulation model by Cinotti and colleagues,²⁷ who demonstrated that increasing the femoral head size from 28 mm to 38 mm resulted in a 5° improvement in ROM. However, the largest gains were observed when the heads with the smallest diameters were upsized; ROM improved only marginally when femoral head size was further increased from 32 mm to 38 mm. The primary reason for the lack of expected improvement in ROM with head sizes of more than 32 mm is often bone-on-bone impingement. Burroughs and colleagues²⁸ demonstrated that the 38-mm and 44-mm heads virtually eliminated component-to-component impingement except in extremes of external rotation. However, there were no differences in ROM between 38-mm and 44-mm heads because of osseous impingement. In addition, large heads are less likely to sublux or dislocate, as they need to travel farther before reaching the edge of the acetabular cup before dislocation. This is known as the jump distance, and it corresponds to the depth of the acetabular shell, which in turn equates with the radius of the femoral head (Figures 2A, 2B).  For this reason, the larger the femoral head diameter, the farther the jump distance and, correspondingly, the lower the risk for dislocation.²⁹

Elevated liners historically were used to increase the jump distance for dislocation.³⁰ These liners, however, can increase impingement at the extremes of motion.³¹ Some of these problems can be avoided with use of larger heads, which have increased jump distances without additional risks for impingement. Moreover, large heads create a suction effect that provides passive resistance to dislocation.³² With head diameters beyond 38 mm, impingement-free ROM often plateaus. However, the jump distance required for dislocations to occur continues to increase as femoral head diameters increase in size. Thus, patients may experience fewer motion benefits but continue to benefit from overall stability with femoral head sizes increasing beyond 38 mm.

Current evidence suggests there may be substantial benefits toward improved stability from increasing head diameters from 22 mm to 38 mm because of the increase in jump distances and improvements in prosthetic impingement-free ROM. However, there may be little gain in ROM from increasing the head diameters beyond these dimensions because of the potential risks of bony impingement. Nevertheless, there may be some additional benefits toward stability from improvement in jump distances with incremental head sizes
beyond 38 mm.^29,33,34

Finite Element Analysis Studies

Finite element analysis of large-diameter heads in THA has shown that, at optimal cup inclination (45°), most stresses occur on the articular surface of the liner. However, these stresses remain well below the yield strength of the polyethylene liners.²⁹ With increasing abduction angles, the stress concentration increases substantially because of the decreased contact surface area. At these angles, the point of maximum contact moves toward the rim of the polyethylene liner, which can lead to rim fractures or failure of locking mechanisms.^29,35,36

Early Concerns With Large-Diameter Femoral Heads: Wear, Liner Failure, and Fracture of Ceramic Components

Use of small-diameter femoral heads started with the first report by Charnley³⁷ of “low frictional torque arthroplasty.” Charnley initially considered a 41.5-mm femoral head, but he thought it would increase risks for acetabular loosening from high frictional torque generated by the large head, and he switched to a small-diameter (22.5 mm) design. One of the tradeoffs with smaller diameter heads was decreased jump height in addition to increased linear wear.

Large femoral heads used with cemented polyethylene acetabular components historically have been associated with increased rates of volumetric wear but low rates of linear wear, which potentially may increase the risk for osteolysis.^38-40 However, newer highly cross-linked polyethylene liners have shown improved in vitro and in vivo volumetric wear characteristics and potentially lower linear wear rates compared with earlier designs (Table 1).^28,41-43

Another concern about earlier generations of large femoral heads was the risk for catastrophic liner failure on conventional polyethylene. This was originally reported by Berry and colleagues,⁴⁷ who described wear-through and failure in patients with thin (< 5 mm) acetabular cups. However, these concerns have been largely addressed by the development of highly cross-linked polyethylene, which has improved wear characteristics and fatigue resistance.⁴⁸

Recent Improvements in Material Properties of Polyethylene and Ceramic Bearings

The development of highly cross-linked polyethylene and fourth-generation ceramics has renewed interest in large-diameter bearings in THA. These bearing surfaces improve wear, enhance material properties, and have superior oxidation resistance.^42,48-53

We now briefly describe the methods used to improve the material properties of polyethylene and ceramics. Studies have shown that increasing the radiation dose (up to 200 kGy)  increases cross-linking and causes an inverse exponential decrease in polyethylene wear.^28,41,48-51 However, increasing radiation doses also increases production of free radicals, which diminish the material strength of these polyethylenes. The  current generation of highly cross-linked polyethylene liners is produced through a variety of manufacturing strategies to improve cross-linking and reduce wear. These strategies include differential radiation doses (50-100 kGy), techniques (electron beam, radiation), and thermal treatments (melting, annealing). Moreover, to enhance the material properties and reduce the incidence of rim cracking and delamination, authors have proposed using vitamin E supplementation to minimize the amount of subsurface oxidation that occurs as an inevitable consequence of free radical formation during fabrication.^54,55  A terminal sterilization process (eg, gas plasma, ethylene oxide, or gamma sterilization in nitrogen) is needed to make commercial, highly cross-linked polyethylene.^52,53

Fourth-generation ceramics manufactured with nano-sized yttria-stabilized tetragonal zirconia particles in a stable alumina matrix have more fracture toughness and improved wear characteristics.^54,55 In addition, oxide additives (eg, chromium oxide, strontium oxide) improve hardness and dissipate energy by deflecting cracks to prevent their propagation.⁵⁶ Moreover, the smaller grain sizes of fourth-generation ceramic bearings compared with third-generation designs (0.8 µm vs 1-5 µm) cause less disruption of the fluid film layer, which ultimately results in improved wear performance.⁵⁷

Multiple studies have found reduced wear rates with metal and ceramic large heads coupled with highly cross-linked polyethylene-bearings (Table 2).^17,41,50,58 Bragdon and colleagues,⁵⁸ using radiostereometric analysis in 25 patients, found no significant differences in mean head penetration rates between 36-mm and 28-mm cobalt-chromium (Co-Cr) heads articulating with highly cross-linked polyethylene cups at a mean follow-up of 3 years (0.035 mm/y vs 0.046 mm/y; P = .11). Geller and colleagues,⁶⁴ in their study of 42 patients with large-diameter (> 32 mm) Co-Cr femoral heads, found low mean (SD) linear wear rates of 0.06 (0.41) mm/y at a mean follow-up of 3 years. D’Antonio and colleagues,⁶⁵ in a multicenter study, reported low average linear wear (0.015 mm/y) and volumetric wear (12.1 mm³/y) over 5 years using sequentially annealed cross-linked polyethylene. In vitro reports suggest that large-diameter ceramic heads may have lower wear properties than Co-Cr heads do. Galvin and colleagues,⁶⁶ in an in vitro hip simulator study, found that large-diameter ceramic heads on highly cross-linked ultrahigh-molecular-weight polyethylene had 40% reductions in steady-state wear rates compared with Co-Cr heads on highly cross-linked bearings (4.7 vs 8.1 mm³/million cycles; P < 0.01).

Dislocation Rates

Several patient, surgeon, and implant factors affect the rate of dislocations after THA. Multiple implant options utilize the biomechanical advantage that large-diameter heads have in improving stability. Various alternatives include use of constrained tripolar heads, dual-mobility bearings, and conventional large-diameter heads with standard liners.^67-69

Large-Diameter Heads

Despite the biomechanical advantages of large-diameter metal-on-polyethylene bearings, prior studies have questioned use of these bearings because of risks for increased wear and rim failures. However, the improved wear properties of highly cross-linked polyethylene, elaborated earlier, have led to a reappraisal of this option (Table 2).^4,70 Howie and colleagues,⁷¹ in a randomized control trial of 644 patients, also found significantly lower rates of dislocation after primary THA with 36-mm heads compared with 28-mm heads (1.3% vs 5.4%; P = .012); in addition, fewer dislocations occurred with 36-mm heads than with 28-mm heads (4.9% vs 12.2%; P = .27) in a series of 44 patients in revision settings. Similarly, in a study conducted with 39,271 Medicare patients between 1998 and 2007, Malkani and colleagues⁷² found a decrease in the dislocation rate, from 4.21% to 2.14%, with use of large-diameter femoral heads. These results have been confirmed by several other authors.^34,66,73,74 Similar results were observed in 65,992 patients in the Australian National Joint Replacement Registry by Conroy and colleagues,⁷⁵ who reported a significant decrease in the risk for dislocation with large heads (≥ 30 mm) compared with 22-mm heads (relative risk, 1.0 vs 3.1; P ≤ .001).

Few studies have analyzed the role of large-diameter femoral heads in the presence of compromised soft tissues around the hip. Kung and Ries,⁷⁶ evaluating the influence of large-diameter heads in the presence and absence of a deficient abductor mechanism, demonstrated statistically significant reductions in rates of dislocation after 230 revision THAs when the abductor mechanism was intact with use of 36-mm heads compared with 28-mm heads (12.7% vs 0%; P = .015). With abductor deficiency, though, the positive effect of large heads in reducing dislocation rates was substantially reduced and was similar to that of small heads (P = .74).⁷⁶

Large heads considerably improve overall stability and lower dislocation rates in THA. With the development of newer ceramics and highly cross-linked polyethylenes, the wear rates reported in multiple studies appear to be less concerning.

Constrained Tripolar Heads

Tripolar heads have been proposed as treatment options for improving stability in patients with chronic and recurrent instability after THA. The tripolar implant consists of a metal head that snap-fits into a polyethylene liner with a polished Co-Cr backing. This bipolar head articulates with a polyethylene bearing that is press-fitted onto a metal acetabular shell and constrained by a metal ring snapped to the outer polyethylene bearing. The bipolar component behaves as a large-diameter femoral head, and the metal ring provides additional restraint, further improving stability.

Williams and colleagues⁷⁷ performed a systematic review and reported on the outcomes of constrained tripolar liners in 1199 hips at a mean follow-up of 4 years (range, 2-10 years). The mean dislocation rate was 10%, and the mean rate of revision surgery unrelated to instability was 4%. In a study of 43 hips at a mean follow-up of 4 years (range, 2-9 years), Zywiel and colleagues⁷⁸ reported on the clinical and radiographic outcomes of tripolar constrained liners. Their study group had a mean Harris Hip Score (HHS) of 82 points (range, 38-100 points) and overall survival of 91%, with no evidence of radiographic loosening during follow-up. Despite the improvements in stability with constrained tripolar liners, some authors have reported multiple mechanisms of failure with these devices.^79-81 In a study of 43 failed constrained tripolar liners with a mean time to failure of about 2 years, Guyen and colleagues⁷⁹ identified 5 different failure modes (types 1-5) involving all 4 interfaces in these components.

Encouraging outcomes have been reported at midterm follow-up with tripolar constrained liners. However, concerns about failure at the interfaces suggest that use of these components should be restricted to patients with deficient abductor mechanisms or neuromuscular compromise, low-demand elderly patients, and salvage cases of recurrent dislocations.⁷⁹

Dual-Mobility Bearings

For more than 20 years, different dual-mobility bearings have been used for difficult acetabular reconstructive scenarios and prevention of instability.^82,83 Dual-mobility cups provide constructs that snap-fit a small-diameter femoral head within a large polyethylene insert that articulates with a fixed metal shell. This effectively increases the functional head diameter.

Various authors have reported excellent survivorship rates (92%-99%) and low dislocation rates for these bearings at 5- to 10-year follow-up.^82,84-90 Philippot and colleagues,⁸⁶ in a recent study of 438 hips with dual-mobility cups, reported excellent survivorship (96%) and no early or late instability within a 15-year follow-up. Bouchet and colleagues⁶⁹ compared dual-mobility bearings (105 hips) with conventional metal-on-polythene bearings (108 hips) and found significantly (P < .05) lower dislocation rates for the dual-mobility implants at a minimum 1-year follow-up. The French Society of Orthopaedics and Traumatology performed a multicenter analysis of 3473 hips with dual-mobility cups implanted in France between January 1998 and December 2003.⁸⁷ During a mean follow-up of 7 years (range, 5-11 years), there were 15 dislocations (0.43%), 14 of which occurred early, within 3 months of implantation (0.4%). Aseptic implant survivorship was 95% at 10-year follow-up.

Use of these bearings has recently increased in the United States. Short-term and midterm follow-up data show low rates of dislocation and wear. Long-term data are to come.

Clinical and Functional Outcomes of Large-Diameter Femoral Heads

There is a paucity of long-term outcomes data on use of large-diameter heads with highly cross-linked polyethylene bearings. Short-term and midterm clinical results appear to be excellent, with low rates of wear, osteolysis, and aseptic loosening.^{28,41,73,89-92}

Plate and colleagues⁹¹ compared the effects of large-diameter (≥ 36 mm) and small-diameter (26 mm, 28 mm) metal heads on highly cross-linked polyethylene bearings. At a mean follow-up of 5 years (range, 4-8.4 years), the large-head cohort had a mean HHS of 90 points (range, 50-100 points) and no dislocations or radiographic evidence of stem or cup loosening. Similarly, Meftah and colleagues⁹³ reported 100% stem survivorship and excellent clinical outcomes—a mean Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of 30 points—for 72 hips with use of large ceramic heads (≥ 32 mm) on highly cross-linked polyethylene at a mean follow-up of 3 years. Gagala and colleagues⁹⁴ reported excellent clinical and radiographic outcomes in 50 hips (18 ceramic on ceramic, 32 ceramic on polyethylene; 36-mm heads) at a mean follow-up of 3.5 years. Mean HHS was 94 points, and there was no evidence of liner fractures, aseptic loosening, or osteolysis.

In summary, large-diameter femoral heads in THA have become increasingly popular because of improvements in the material properties and wear characteristics of highly cross-linked polyethylene and fourth-generation ceramics. Despite the potential advantages of large heads in preventing dislocations, the basic surgical tenets of placing the acetabular component in appropriate alignment remain firmly established. Implants with functionally large heads (eg, dual-mobility bearings, constrained tripolar liners) may play an important role in patients at high risk for dislocation—particularly elderly patients with poor neuromuscular muscle coordination or deficient abductors, trauma patients, and patients with prior dislocations. Short-term and midterm results are excellent; rates of wear, aseptic loosening, and osteolysis are low. However, long-term outcomes data are needed to support widespread use of large heads in younger and more active patients.

A common cause for total hip arthroplasty (THA) revision is joint instability.^1,2 The reported incidence of dislocation in primary THA ranges from 0.4% to 5.8%,^3-5 but this rate increases after revision surgery.^1,3-8 Use of large-diameter femoral heads has been proposed to decrease the risks for instability and to improve impingement-free range of motion (ROM).

The biomechanical rationale for using large-diameter femoral heads is that they must travel farther before subluxation or dislocation occurs (jump distance). Despite these benefits, there were initial concerns that catastrophic failure and high levels of volumetric wear would occur if these heads were used with conventional polyethylene liners. These concerns led to the development of alternative bearing surfaces, particularly metal-on-metal bearings, which offered theoretical benefits of large-diameter articulations that improved stability while purportedly being highly wear-resistant.^9-11 However, concerns about adverse local soft-tissue reactions and high blood concentrations of metal ions tempered the initial enthusiasm for metal bearings.^12-16 Fortunately, highly cross-linked polyethylene and fourth-generation ceramic bearing surfaces, with improved toughness and better wear properties, may allow use of large-diameter heads without the need for metal-on-metal bearings.^17,18

In this article, we review the concepts and principles behind use of large-diameter ceramic or cobalt-chromium femoral heads on polyethylene-bearing surfaces in THA with particular attention to biomechanics, early concerns about polyethylene wear and rim fractures, recent improvements in material properties of polyethylene and ceramic bearings, dislocation rates, and clinical and functional outcomes.

Definitions

For this review, we define large-diameter femoral heads as having diameters of 36 mm or more and conventional or small-diameter femoral heads as having diameters between 22 and 32 mm.

Biomechanics

Head–Neck Ratio, Impingement-Free ROM, and Jump Distance

Several implant design principles have been proposed to reduce the risks for impingement and dislocation. Of these, large femoral head diameters have been extensively studied.^19,20 It is well known that impingement of the femoral neck on the cup edge promotes edge loading and higher wear rates. In addition, impingement increases the tendency of the head to sublux from the acetabulum. One strategy for avoiding this component-to-component impingement is to increase the head–neck ratio (HNR), the ratio of the femoral head to the neck diameter. Biomechanically, increased HNRs lead to delayed contact between the femoral neck and the acetabular liner.^21,22 Therefore, with large femoral heads, which have large HNRs, impingement occurs later and at larger ROMs—compared with small-diameter femoral heads, which have lower HNRs and are more prone to early impingement and subluxation (Figure 1).^23-26

In a cadaveric study of 6 hips, Bartz and colleagues²³ reported a significantly higher preimpingement ROM when the prosthetic head size increased from 22 mm to 28 mm (P < .05). They found a change from prosthetic to osseous impingement when the head size increased from 22 mm to 32 mm. Similar results were observed in a computer simulation model by Cinotti and colleagues,²⁷ who demonstrated that increasing the femoral head size from 28 mm to 38 mm resulted in a 5° improvement in ROM. However, the largest gains were observed when the heads with the smallest diameters were upsized; ROM improved only marginally when femoral head size was further increased from 32 mm to 38 mm. The primary reason for the lack of expected improvement in ROM with head sizes of more than 32 mm is often bone-on-bone impingement. Burroughs and colleagues²⁸ demonstrated that the 38-mm and 44-mm heads virtually eliminated component-to-component impingement except in extremes of external rotation. However, there were no differences in ROM between 38-mm and 44-mm heads because of osseous impingement. In addition, large heads are less likely to sublux or dislocate, as they need to travel farther before reaching the edge of the acetabular cup before dislocation. This is known as the jump distance, and it corresponds to the depth of the acetabular shell, which in turn equates with the radius of the femoral head (Figures 2A, 2B).  For this reason, the larger the femoral head diameter, the farther the jump distance and, correspondingly, the lower the risk for dislocation.²⁹

Elevated liners historically were used to increase the jump distance for dislocation.³⁰ These liners, however, can increase impingement at the extremes of motion.³¹ Some of these problems can be avoided with use of larger heads, which have increased jump distances without additional risks for impingement. Moreover, large heads create a suction effect that provides passive resistance to dislocation.³² With head diameters beyond 38 mm, impingement-free ROM often plateaus. However, the jump distance required for dislocations to occur continues to increase as femoral head diameters increase in size. Thus, patients may experience fewer motion benefits but continue to benefit from overall stability with femoral head sizes increasing beyond 38 mm.

Current evidence suggests there may be substantial benefits toward improved stability from increasing head diameters from 22 mm to 38 mm because of the increase in jump distances and improvements in prosthetic impingement-free ROM. However, there may be little gain in ROM from increasing the head diameters beyond these dimensions because of the potential risks of bony impingement. Nevertheless, there may be some additional benefits toward stability from improvement in jump distances with incremental head sizes
beyond 38 mm.^29,33,34

Finite Element Analysis Studies

Finite element analysis of large-diameter heads in THA has shown that, at optimal cup inclination (45°), most stresses occur on the articular surface of the liner. However, these stresses remain well below the yield strength of the polyethylene liners.²⁹ With increasing abduction angles, the stress concentration increases substantially because of the decreased contact surface area. At these angles, the point of maximum contact moves toward the rim of the polyethylene liner, which can lead to rim fractures or failure of locking mechanisms.^29,35,36

Early Concerns With Large-Diameter Femoral Heads: Wear, Liner Failure, and Fracture of Ceramic Components

Use of small-diameter femoral heads started with the first report by Charnley³⁷ of “low frictional torque arthroplasty.” Charnley initially considered a 41.5-mm femoral head, but he thought it would increase risks for acetabular loosening from high frictional torque generated by the large head, and he switched to a small-diameter (22.5 mm) design. One of the tradeoffs with smaller diameter heads was decreased jump height in addition to increased linear wear.

Large femoral heads used with cemented polyethylene acetabular components historically have been associated with increased rates of volumetric wear but low rates of linear wear, which potentially may increase the risk for osteolysis.^38-40 However, newer highly cross-linked polyethylene liners have shown improved in vitro and in vivo volumetric wear characteristics and potentially lower linear wear rates compared with earlier designs (Table 1).^28,41-43

Another concern about earlier generations of large femoral heads was the risk for catastrophic liner failure on conventional polyethylene. This was originally reported by Berry and colleagues,⁴⁷ who described wear-through and failure in patients with thin (< 5 mm) acetabular cups. However, these concerns have been largely addressed by the development of highly cross-linked polyethylene, which has improved wear characteristics and fatigue resistance.⁴⁸

Recent Improvements in Material Properties of Polyethylene and Ceramic Bearings

The development of highly cross-linked polyethylene and fourth-generation ceramics has renewed interest in large-diameter bearings in THA. These bearing surfaces improve wear, enhance material properties, and have superior oxidation resistance.^42,48-53

We now briefly describe the methods used to improve the material properties of polyethylene and ceramics. Studies have shown that increasing the radiation dose (up to 200 kGy)  increases cross-linking and causes an inverse exponential decrease in polyethylene wear.^28,41,48-51 However, increasing radiation doses also increases production of free radicals, which diminish the material strength of these polyethylenes. The  current generation of highly cross-linked polyethylene liners is produced through a variety of manufacturing strategies to improve cross-linking and reduce wear. These strategies include differential radiation doses (50-100 kGy), techniques (electron beam, radiation), and thermal treatments (melting, annealing). Moreover, to enhance the material properties and reduce the incidence of rim cracking and delamination, authors have proposed using vitamin E supplementation to minimize the amount of subsurface oxidation that occurs as an inevitable consequence of free radical formation during fabrication.^54,55  A terminal sterilization process (eg, gas plasma, ethylene oxide, or gamma sterilization in nitrogen) is needed to make commercial, highly cross-linked polyethylene.^52,53

Fourth-generation ceramics manufactured with nano-sized yttria-stabilized tetragonal zirconia particles in a stable alumina matrix have more fracture toughness and improved wear characteristics.^54,55 In addition, oxide additives (eg, chromium oxide, strontium oxide) improve hardness and dissipate energy by deflecting cracks to prevent their propagation.⁵⁶ Moreover, the smaller grain sizes of fourth-generation ceramic bearings compared with third-generation designs (0.8 µm vs 1-5 µm) cause less disruption of the fluid film layer, which ultimately results in improved wear performance.⁵⁷

Multiple studies have found reduced wear rates with metal and ceramic large heads coupled with highly cross-linked polyethylene-bearings (Table 2).^17,41,50,58 Bragdon and colleagues,⁵⁸ using radiostereometric analysis in 25 patients, found no significant differences in mean head penetration rates between 36-mm and 28-mm cobalt-chromium (Co-Cr) heads articulating with highly cross-linked polyethylene cups at a mean follow-up of 3 years (0.035 mm/y vs 0.046 mm/y; P = .11). Geller and colleagues,⁶⁴ in their study of 42 patients with large-diameter (> 32 mm) Co-Cr femoral heads, found low mean (SD) linear wear rates of 0.06 (0.41) mm/y at a mean follow-up of 3 years. D’Antonio and colleagues,⁶⁵ in a multicenter study, reported low average linear wear (0.015 mm/y) and volumetric wear (12.1 mm³/y) over 5 years using sequentially annealed cross-linked polyethylene. In vitro reports suggest that large-diameter ceramic heads may have lower wear properties than Co-Cr heads do. Galvin and colleagues,⁶⁶ in an in vitro hip simulator study, found that large-diameter ceramic heads on highly cross-linked ultrahigh-molecular-weight polyethylene had 40% reductions in steady-state wear rates compared with Co-Cr heads on highly cross-linked bearings (4.7 vs 8.1 mm³/million cycles; P < 0.01).

Dislocation Rates

Several patient, surgeon, and implant factors affect the rate of dislocations after THA. Multiple implant options utilize the biomechanical advantage that large-diameter heads have in improving stability. Various alternatives include use of constrained tripolar heads, dual-mobility bearings, and conventional large-diameter heads with standard liners.^67-69

Large-Diameter Heads

Despite the biomechanical advantages of large-diameter metal-on-polyethylene bearings, prior studies have questioned use of these bearings because of risks for increased wear and rim failures. However, the improved wear properties of highly cross-linked polyethylene, elaborated earlier, have led to a reappraisal of this option (Table 2).^4,70 Howie and colleagues,⁷¹ in a randomized control trial of 644 patients, also found significantly lower rates of dislocation after primary THA with 36-mm heads compared with 28-mm heads (1.3% vs 5.4%; P = .012); in addition, fewer dislocations occurred with 36-mm heads than with 28-mm heads (4.9% vs 12.2%; P = .27) in a series of 44 patients in revision settings. Similarly, in a study conducted with 39,271 Medicare patients between 1998 and 2007, Malkani and colleagues⁷² found a decrease in the dislocation rate, from 4.21% to 2.14%, with use of large-diameter femoral heads. These results have been confirmed by several other authors.^34,66,73,74 Similar results were observed in 65,992 patients in the Australian National Joint Replacement Registry by Conroy and colleagues,⁷⁵ who reported a significant decrease in the risk for dislocation with large heads (≥ 30 mm) compared with 22-mm heads (relative risk, 1.0 vs 3.1; P ≤ .001).

Few studies have analyzed the role of large-diameter femoral heads in the presence of compromised soft tissues around the hip. Kung and Ries,⁷⁶ evaluating the influence of large-diameter heads in the presence and absence of a deficient abductor mechanism, demonstrated statistically significant reductions in rates of dislocation after 230 revision THAs when the abductor mechanism was intact with use of 36-mm heads compared with 28-mm heads (12.7% vs 0%; P = .015). With abductor deficiency, though, the positive effect of large heads in reducing dislocation rates was substantially reduced and was similar to that of small heads (P = .74).⁷⁶

Large heads considerably improve overall stability and lower dislocation rates in THA. With the development of newer ceramics and highly cross-linked polyethylenes, the wear rates reported in multiple studies appear to be less concerning.

Constrained Tripolar Heads

Tripolar heads have been proposed as treatment options for improving stability in patients with chronic and recurrent instability after THA. The tripolar implant consists of a metal head that snap-fits into a polyethylene liner with a polished Co-Cr backing. This bipolar head articulates with a polyethylene bearing that is press-fitted onto a metal acetabular shell and constrained by a metal ring snapped to the outer polyethylene bearing. The bipolar component behaves as a large-diameter femoral head, and the metal ring provides additional restraint, further improving stability.

Williams and colleagues⁷⁷ performed a systematic review and reported on the outcomes of constrained tripolar liners in 1199 hips at a mean follow-up of 4 years (range, 2-10 years). The mean dislocation rate was 10%, and the mean rate of revision surgery unrelated to instability was 4%. In a study of 43 hips at a mean follow-up of 4 years (range, 2-9 years), Zywiel and colleagues⁷⁸ reported on the clinical and radiographic outcomes of tripolar constrained liners. Their study group had a mean Harris Hip Score (HHS) of 82 points (range, 38-100 points) and overall survival of 91%, with no evidence of radiographic loosening during follow-up. Despite the improvements in stability with constrained tripolar liners, some authors have reported multiple mechanisms of failure with these devices.^79-81 In a study of 43 failed constrained tripolar liners with a mean time to failure of about 2 years, Guyen and colleagues⁷⁹ identified 5 different failure modes (types 1-5) involving all 4 interfaces in these components.

Encouraging outcomes have been reported at midterm follow-up with tripolar constrained liners. However, concerns about failure at the interfaces suggest that use of these components should be restricted to patients with deficient abductor mechanisms or neuromuscular compromise, low-demand elderly patients, and salvage cases of recurrent dislocations.⁷⁹

Dual-Mobility Bearings

For more than 20 years, different dual-mobility bearings have been used for difficult acetabular reconstructive scenarios and prevention of instability.^82,83 Dual-mobility cups provide constructs that snap-fit a small-diameter femoral head within a large polyethylene insert that articulates with a fixed metal shell. This effectively increases the functional head diameter.

Various authors have reported excellent survivorship rates (92%-99%) and low dislocation rates for these bearings at 5- to 10-year follow-up.^82,84-90 Philippot and colleagues,⁸⁶ in a recent study of 438 hips with dual-mobility cups, reported excellent survivorship (96%) and no early or late instability within a 15-year follow-up. Bouchet and colleagues⁶⁹ compared dual-mobility bearings (105 hips) with conventional metal-on-polythene bearings (108 hips) and found significantly (P < .05) lower dislocation rates for the dual-mobility implants at a minimum 1-year follow-up. The French Society of Orthopaedics and Traumatology performed a multicenter analysis of 3473 hips with dual-mobility cups implanted in France between January 1998 and December 2003.⁸⁷ During a mean follow-up of 7 years (range, 5-11 years), there were 15 dislocations (0.43%), 14 of which occurred early, within 3 months of implantation (0.4%). Aseptic implant survivorship was 95% at 10-year follow-up.

Use of these bearings has recently increased in the United States. Short-term and midterm follow-up data show low rates of dislocation and wear. Long-term data are to come.

Clinical and Functional Outcomes of Large-Diameter Femoral Heads

There is a paucity of long-term outcomes data on use of large-diameter heads with highly cross-linked polyethylene bearings. Short-term and midterm clinical results appear to be excellent, with low rates of wear, osteolysis, and aseptic loosening.^{28,41,73,89-92}

Plate and colleagues⁹¹ compared the effects of large-diameter (≥ 36 mm) and small-diameter (26 mm, 28 mm) metal heads on highly cross-linked polyethylene bearings. At a mean follow-up of 5 years (range, 4-8.4 years), the large-head cohort had a mean HHS of 90 points (range, 50-100 points) and no dislocations or radiographic evidence of stem or cup loosening. Similarly, Meftah and colleagues⁹³ reported 100% stem survivorship and excellent clinical outcomes—a mean Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of 30 points—for 72 hips with use of large ceramic heads (≥ 32 mm) on highly cross-linked polyethylene at a mean follow-up of 3 years. Gagala and colleagues⁹⁴ reported excellent clinical and radiographic outcomes in 50 hips (18 ceramic on ceramic, 32 ceramic on polyethylene; 36-mm heads) at a mean follow-up of 3.5 years. Mean HHS was 94 points, and there was no evidence of liner fractures, aseptic loosening, or osteolysis.

In summary, large-diameter femoral heads in THA have become increasingly popular because of improvements in the material properties and wear characteristics of highly cross-linked polyethylene and fourth-generation ceramics. Despite the potential advantages of large heads in preventing dislocations, the basic surgical tenets of placing the acetabular component in appropriate alignment remain firmly established. Implants with functionally large heads (eg, dual-mobility bearings, constrained tripolar liners) may play an important role in patients at high risk for dislocation—particularly elderly patients with poor neuromuscular muscle coordination or deficient abductors, trauma patients, and patients with prior dislocations. Short-term and midterm results are excellent; rates of wear, aseptic loosening, and osteolysis are low. However, long-term outcomes data are needed to support widespread use of large heads in younger and more active patients.