Clinical Review

1. CHOOSE YOUR BIOPSY TYPE WISELY
Using the appropriate type of biopsy can have the greatest effect on a proper diagnosis. The decision of which biopsy type to use is not always easy. The most common biopsy types are shave, punch, excisional, and curettage. Several reference articles detail each type of biopsy commonly used in primary care and how to perform them.^1,2

Each type of biopsy has inherent advantages and disadvantages. In general, the shave biopsy is most commonly used for lesions that are solitary and elevated and give the impression that a sufficient amount of tissue can be sampled with this technique. The punch biopsy is the best choice for most “rashes” (inflammatory skin disorders).² Excisional biopsy is used to remove melanocytic neoplasms or larger lesions. And curettage, while still used by some clinicians for melanocytic lesions because of its speed and simplicity, should almost never be used for diagnostic purposes.

Each technique is described in greater detail in the tips that follow.

Continue for tip #2 >>

2. WHEN PERFORMING A SHAVE BIOPSY, AVOID OBTAINING A SAMPLE THAT'S TOO SUPERFICIAL
The advantage of the shave biopsy is that it is minimally invasive and quick to perform. If kept small without compromising the amount of sample retrieved, the scars left by shave biopsies have the potential to blend well. The major disadvantage associated with the shave biopsy is that occasionally, if the shave is not deep enough, an insufficient amount of tissue is obtained. This can make it challenging to establish an accurate diagnosis.

Balancing the need to obtain adequate tissue with the desire to minimize scarring takes skill and experience. Taking a biopsy that is inadequate is a common occurrence. At times, the clinician’s clinical impression may be that a biopsy has obtained adequate tissue, when histologically only the superficial part of the skin surface has been sampled. This often is because of thickening of the superficial skin, whether as a manifestation of the anatomic site (eg, acral skin) or the disease process itself.

Unfortunately, this superficial skin often is nondiagnostic when unaccompanied by underlying epidermis and dermis. It is important to keep this in mind when you are obtaining a skin biopsy, especially when dealing with lesions that are very scaly or keratinized.

An equivocal biopsy wastes time, energy, and money, and it can negatively impact patient care.³ It can be difficult to balance practical aspects of the biopsy (ie, optimizing cosmetic outcomes, minimizing scarring and wound size) with the need to obtain sufficient tissue sampling (see Figure 1).

3. CHOOSE PUNCH OVER SHAVE BIOPSY FOR RASHES
In a punch biopsy, a disposable metal cylinder with a sharpened edge is used to “punch” out a piece of skin that can be examined under the microscope. Punch biopsy is the preferred technique for almost all inflammatory skin conditions (rashes) because the pathologist is able to examine both the superficial and deep portions of the dermis (see Figure 2).⁴  

Pathologists use the pattern of inflammation, in conjunction with epidermal changes, to distinguish different types of inflammatory processes. For example, lichen planus is typically associated with superficial inflammation, while lupus is known to have prominent superficial and deep inflammation.

An inadequate punch biopsy sample can hinder histologic assessment of inflammatory skin disorders that involve both the superficial and deep portions of the dermis and can make arriving at a definitive diagnosis more challenging. The diameter of a punch cylinder ranges from 1 to 8 mm. Smaller punch biopsies often create diagnostic challenges because they provide so little sample. A punch biopsy size of 4 mm is commonly used for rashes.

An advantage of the punch biopsy is that patients are left with linear scars rather than the round, potentially dyspigmented (darker or lighter) scars that are often associated with shave biopsy. A well-sutured punch biopsy can be cosmetically elegant, particularly if closure is oriented along relaxed skin tension lines. For this reason, punch biopsies are well suited for cosmetically sensitive locations (eg, the face), although shave biopsies are also often performed on the face.

Next page: Tip #4 >>

4. CHOOSE AN EXCISIONAL BIOPSY FOR A MELANOCYTIC NEOPLASM, WHEN POSSIBLE
The purpose of an excisional biopsy (which typically includes a 1- to 3-mm rim of normal skin around the lesion) is to completely remove a lesion. Excisional biopsy generally is the preferred technique for clinically atypical melanocytic neoplasms (ie, lesions that are not definitively benign).^4-8

When suspicion for melanoma is high, excisional biopsies should be performed with minimal undermining to preserve the accuracy of any future sentinel lymph node biopsy surgeries. Excisional biopsy is the most involved type of biopsy and has the largest potential for cosmetic disfigurement if not properly planned and performed. While guidelines from the American Academy of Dermatology state that “narrow excisional biopsy that encompasses [the] entire breadth of lesion with clinically negative margins to ensure that the lesion is not transected” is preferred, they also acknowledge that partial sampling (incisional biopsy) is acceptable in select clinical circumstances,⁹ such as when a lesion is large or on a cosmetically sensitive site (eg, the face).¹⁰

While a larger punch biopsy (6 or 8 mm) or even deep shave/saucerization may function as an excisional biopsy for very small lesions, this approach can be problematic. For one thing, these techniques are more likely than an excisional biopsy to leave a portion of the lesion in situ. Another concern is that a shave biopsy of a melanocytic lesion can lead to error or difficulty in obtaining the correct diagnosis on later biopsy.¹¹ For pathologists, small or incomplete samples make it challenging to establish an accurate diagnosis.¹² Among melanomas seen at a tertiary referral center, histopathologic misdiagnosis was more common with a punch or shave biopsy than with an excisional biopsy.⁹

It has been shown that partial biopsy for melanoma results in more residual disease at wide local excision and makes it more challenging to properly stage the lesion.^13,14 If a shave biopsy is used to sample a suspected melanocytic neoplasm, it is imperative to document the specific site of the biopsy, indicate the size of the melanocytic lesion on the pathology requisition form, and ensure that all (or nearly all) of the clinically evident lesion is sampled. Detailing the location of the lesion in the chart is not only essential in evaluating the present lesion, but it will serve you well in the future. Without knowing the patient’s clinical history, benign nevi that recur after a prior biopsy can be difficult to histologically distinguish from melanoma (see Figure 3). For more on this, see tip #7.

5. BE CAREFUL WITH CURETTAGE
Curettage is a biopsy technique in which a curette—a surgical tool with a scoop, ring, or loop at the tip—is used in a scraping motion to retrieve tissue from the patient. This type of biopsy often produces a fragmented tissue sample. Its continued use reflects the speed and simplicity with which it can be done. However, curettage destroys the architecture of the tissue of the lesion, which can make it difficult to establish a proper diagnosis, and therefore it is best avoided when performing a biopsy of a melanocytic lesion (see Figure 4).

Continue for tip #6 >>

6. REMEMBER THE IMPORTANCE OF PROPER FIXATION AND PROCESSING
As obvious as it may sound, it is important to remember to promptly place sampled tissue in an adequate amount of formalin so that the tissue is submersed in it in the container.¹⁵ Failure to do so can result in improper fixation and will make it difficult to render an appropriate diagnosis. Conventionally, a 10:1 formalin-volume-to-tissue-volume ratio is recommended. If the “cold time”—the amount of time a tissue sample is out of formalin—is too long (> a few hours), an appropriate assessment can be impossible.

Appropriate fixation and fixation times are important because molecular testing is being increasingly used to make pathologic diagnoses.¹⁶ Additionally, aggressively manipulating a biopsy sample while extracting it or placing it in formalin can cause “crush” artifact, which can limit interpretability (see Figure 5).

7. PROPERLY PHOTOGRAPH AND DOCUMENT THE BIOPSY LOCATION
When performing a biopsy of a suspicious neoplasm, clinicians often remove all of the lesion’s superficial components, which means that at the patient’s follow-up appointment and subsequent treatments, only a well-healed biopsy site will remain. The biopsy site may be so well healed that it blends seamlessly into the surrounding skin and is nearly impossible for the clinician to identify. This problem is seen most often when patients present for surgical excision or Mohs micrographic surgery.¹⁷

To properly record the site of a biopsy for future dermatologic exams, take pictures of the lesion at the time of biopsy. The photographs should clearly document the lesion in question and should be taken far enough from the site that surrounding lesions and/or other anatomic landmarks are also visible. Biangulation or triangulation (taking a series of two or three measurements, respectively, from the site of the lesion to nearby anatomic landmarks) can be used in conjunction with photographs.

When using measurements, be as specific and accurate as possible with anatomic terms. For example, measuring the distance from the “ear” is not helpful. It would be more helpful to measure the distance from the “tragus” or the “root of the helix.” Without a properly photographed and documented biopsy site, surgical treatment may need to be delayed until the location can be confirmed.

8. GIVE THE PATHOLOGIST A PERTINENT HISTORY
Providing the pathologist with a sufficient history, including the distribution and appearance of the lesion, and how long the patient has had it, can be essential in narrowing the diagnosis or making the differential diagnoses. Things like medication use or new exposures to perfumes, lotions, or plants can be especially helpful and are often overlooked when filling out the pathology requisition form.

When warranted, phone calls are helpful. You might, for example, call the pathologist and give him or her a more detailed physical examination description or additional pertinent history that was discovered after the requisition was filled out. Providing a good history can make the difference between a specific diagnosis and a broad differential.

Tip #9: Next page >>

9. KNOW WHEN TO REFER
There is no shame in asking for a second opinion when evaluating a skin lesion, especially with melanocytic neoplasms, where the stakes can be high, or skin eruptions that do not respond to conventional therapy. Remember, many cases are difficult, even for experts, and require a careful balance of clinical and histopathologic judgment.¹⁸

REFERENCES
1. Pickett H. Shave and punch biopsy for skin lesions. Am Fam Physician. 2011;84:995-1002.
2. Alguire PC, Mathes BM. Skin biopsy techniques for the internist. J Gen Intern Med. 1998;13:46-54.
3. Fernandez EM, Helm T, Ioffreda M, et al. The vanishing biopsy: the trend toward smaller specimens. Cutis. 2005;76:335-339.
4. Hieken TJ, Hernández-Irizarry R, Boll JM, et al. Accuracy of diagnostic biopsy for cutaneous melanoma: implications for surgical oncologists. Int J Surg Oncol. 2013;2013:196493.
5. Scolyer RA, Thompson JF, McCarthy SW, et al. Incomplete biopsy of melanocytic lesions can impair the accuracy of pathological diagnosis. Australas J Dermatol. 2006;47:71-75.
6. McCarthy SW, Scolyer RA. Pitfalls and important issues in the pathologic diagnosis of melanocytic tumors. Ochsner J. 2010;10:66-74.
7. Swanson NA, Lee KK, Gorman A, et al. Biopsy techniques. Diagnosis of melanoma. Dermatol Clin. 2002;20:677-680.
8. Chang TT, Somach SC, Wagamon K, et al. The inadequacy of punch-excised melanocytic lesions: sampling through the block for the determination of “margins.” J Am Acad Dermatol. 2009;60: 990-993.
9. Bichakjian CK, Halpern AC, Johnson TM, et al; American Academy of Dermatology. Guidelines of care for the management of primary cutaneous melanoma. American Academy of Dermatology. J Am Acad Dermatol. 2011;65:1032-1047.
10. Pardasani AG, Leshin B, Hallman JR, et al. Fusiform incisional biopsy for pigmented skin lesions. Dermatol Surg. 2000;26:622-624.
11. King R, Hayzen BA, Page RN, et al. Recurrent nevus phenomenon: a clinicopathologic study of 357 cases and histologic comparison with melanoma with regression. Mod Pathol. 2009;22:611-617.
12. Mills JK, White I, Diggs B, et al. Effect of biopsy type on outcomes in the treatment of primary cutaneous melanoma. Am J Surg. 2013;205:585-590.
13. Stell VH, Norton HJ, Smith KS, et al. Method of biopsy and incidence of positive margins in primary melanoma. Ann Surg Oncol. 2007;14:
893-898.
14. Egnatios GL, Dueck AC, Macdonald JB, et al. The impact of biopsy technique on upstaging, residual disease, and outcome in cutaneous melanoma. Am J Surg. 2011;202:771-778.
15. Ackerman AB, Boer A, Bennin B, et al. Histologic Diagnosis of Inflammatory Skin Disease: An Algorithmic Method Based on Pattern Analysis. New York, NY: Ardor Scribendi; 2005.
16. Hewitt SM, Lewis FA, Cao Y, et al. Tissue handling and specimen preparation in surgical pathology: issues concerning the recovery of nucleic acids from formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med. 2008;132:1929-1935.
17. Nemeth SA, Lawrence N. Site identification challenges in dermatologic surgery: a physician survey. J Am Acad Dermatol. 2012;67: 262-268.
18. Federman DG, Concato J, Kirsner RS. Comparison of dermatologic diagnoses by primary care practitioners and dermatologists. A review of the literature. Arch Fam Med. 1999;8:170-172.

1. CHOOSE YOUR BIOPSY TYPE WISELY
Using the appropriate type of biopsy can have the greatest effect on a proper diagnosis. The decision of which biopsy type to use is not always easy. The most common biopsy types are shave, punch, excisional, and curettage. Several reference articles detail each type of biopsy commonly used in primary care and how to perform them.^1,2

Each type of biopsy has inherent advantages and disadvantages. In general, the shave biopsy is most commonly used for lesions that are solitary and elevated and give the impression that a sufficient amount of tissue can be sampled with this technique. The punch biopsy is the best choice for most “rashes” (inflammatory skin disorders).² Excisional biopsy is used to remove melanocytic neoplasms or larger lesions. And curettage, while still used by some clinicians for melanocytic lesions because of its speed and simplicity, should almost never be used for diagnostic purposes.

Each technique is described in greater detail in the tips that follow.

Continue for tip #2 >>

2. WHEN PERFORMING A SHAVE BIOPSY, AVOID OBTAINING A SAMPLE THAT'S TOO SUPERFICIAL
The advantage of the shave biopsy is that it is minimally invasive and quick to perform. If kept small without compromising the amount of sample retrieved, the scars left by shave biopsies have the potential to blend well. The major disadvantage associated with the shave biopsy is that occasionally, if the shave is not deep enough, an insufficient amount of tissue is obtained. This can make it challenging to establish an accurate diagnosis.

Balancing the need to obtain adequate tissue with the desire to minimize scarring takes skill and experience. Taking a biopsy that is inadequate is a common occurrence. At times, the clinician’s clinical impression may be that a biopsy has obtained adequate tissue, when histologically only the superficial part of the skin surface has been sampled. This often is because of thickening of the superficial skin, whether as a manifestation of the anatomic site (eg, acral skin) or the disease process itself.

Unfortunately, this superficial skin often is nondiagnostic when unaccompanied by underlying epidermis and dermis. It is important to keep this in mind when you are obtaining a skin biopsy, especially when dealing with lesions that are very scaly or keratinized.

An equivocal biopsy wastes time, energy, and money, and it can negatively impact patient care.³ It can be difficult to balance practical aspects of the biopsy (ie, optimizing cosmetic outcomes, minimizing scarring and wound size) with the need to obtain sufficient tissue sampling (see Figure 1).

3. CHOOSE PUNCH OVER SHAVE BIOPSY FOR RASHES
In a punch biopsy, a disposable metal cylinder with a sharpened edge is used to “punch” out a piece of skin that can be examined under the microscope. Punch biopsy is the preferred technique for almost all inflammatory skin conditions (rashes) because the pathologist is able to examine both the superficial and deep portions of the dermis (see Figure 2).⁴  

Pathologists use the pattern of inflammation, in conjunction with epidermal changes, to distinguish different types of inflammatory processes. For example, lichen planus is typically associated with superficial inflammation, while lupus is known to have prominent superficial and deep inflammation.

An inadequate punch biopsy sample can hinder histologic assessment of inflammatory skin disorders that involve both the superficial and deep portions of the dermis and can make arriving at a definitive diagnosis more challenging. The diameter of a punch cylinder ranges from 1 to 8 mm. Smaller punch biopsies often create diagnostic challenges because they provide so little sample. A punch biopsy size of 4 mm is commonly used for rashes.

An advantage of the punch biopsy is that patients are left with linear scars rather than the round, potentially dyspigmented (darker or lighter) scars that are often associated with shave biopsy. A well-sutured punch biopsy can be cosmetically elegant, particularly if closure is oriented along relaxed skin tension lines. For this reason, punch biopsies are well suited for cosmetically sensitive locations (eg, the face), although shave biopsies are also often performed on the face.

Next page: Tip #4 >>

4. CHOOSE AN EXCISIONAL BIOPSY FOR A MELANOCYTIC NEOPLASM, WHEN POSSIBLE
The purpose of an excisional biopsy (which typically includes a 1- to 3-mm rim of normal skin around the lesion) is to completely remove a lesion. Excisional biopsy generally is the preferred technique for clinically atypical melanocytic neoplasms (ie, lesions that are not definitively benign).^4-8

When suspicion for melanoma is high, excisional biopsies should be performed with minimal undermining to preserve the accuracy of any future sentinel lymph node biopsy surgeries. Excisional biopsy is the most involved type of biopsy and has the largest potential for cosmetic disfigurement if not properly planned and performed. While guidelines from the American Academy of Dermatology state that “narrow excisional biopsy that encompasses [the] entire breadth of lesion with clinically negative margins to ensure that the lesion is not transected” is preferred, they also acknowledge that partial sampling (incisional biopsy) is acceptable in select clinical circumstances,⁹ such as when a lesion is large or on a cosmetically sensitive site (eg, the face).¹⁰

While a larger punch biopsy (6 or 8 mm) or even deep shave/saucerization may function as an excisional biopsy for very small lesions, this approach can be problematic. For one thing, these techniques are more likely than an excisional biopsy to leave a portion of the lesion in situ. Another concern is that a shave biopsy of a melanocytic lesion can lead to error or difficulty in obtaining the correct diagnosis on later biopsy.¹¹ For pathologists, small or incomplete samples make it challenging to establish an accurate diagnosis.¹² Among melanomas seen at a tertiary referral center, histopathologic misdiagnosis was more common with a punch or shave biopsy than with an excisional biopsy.⁹

It has been shown that partial biopsy for melanoma results in more residual disease at wide local excision and makes it more challenging to properly stage the lesion.^13,14 If a shave biopsy is used to sample a suspected melanocytic neoplasm, it is imperative to document the specific site of the biopsy, indicate the size of the melanocytic lesion on the pathology requisition form, and ensure that all (or nearly all) of the clinically evident lesion is sampled. Detailing the location of the lesion in the chart is not only essential in evaluating the present lesion, but it will serve you well in the future. Without knowing the patient’s clinical history, benign nevi that recur after a prior biopsy can be difficult to histologically distinguish from melanoma (see Figure 3). For more on this, see tip #7.

5. BE CAREFUL WITH CURETTAGE
Curettage is a biopsy technique in which a curette—a surgical tool with a scoop, ring, or loop at the tip—is used in a scraping motion to retrieve tissue from the patient. This type of biopsy often produces a fragmented tissue sample. Its continued use reflects the speed and simplicity with which it can be done. However, curettage destroys the architecture of the tissue of the lesion, which can make it difficult to establish a proper diagnosis, and therefore it is best avoided when performing a biopsy of a melanocytic lesion (see Figure 4).

Continue for tip #6 >>

6. REMEMBER THE IMPORTANCE OF PROPER FIXATION AND PROCESSING
As obvious as it may sound, it is important to remember to promptly place sampled tissue in an adequate amount of formalin so that the tissue is submersed in it in the container.¹⁵ Failure to do so can result in improper fixation and will make it difficult to render an appropriate diagnosis. Conventionally, a 10:1 formalin-volume-to-tissue-volume ratio is recommended. If the “cold time”—the amount of time a tissue sample is out of formalin—is too long (> a few hours), an appropriate assessment can be impossible.

Appropriate fixation and fixation times are important because molecular testing is being increasingly used to make pathologic diagnoses.¹⁶ Additionally, aggressively manipulating a biopsy sample while extracting it or placing it in formalin can cause “crush” artifact, which can limit interpretability (see Figure 5).

7. PROPERLY PHOTOGRAPH AND DOCUMENT THE BIOPSY LOCATION
When performing a biopsy of a suspicious neoplasm, clinicians often remove all of the lesion’s superficial components, which means that at the patient’s follow-up appointment and subsequent treatments, only a well-healed biopsy site will remain. The biopsy site may be so well healed that it blends seamlessly into the surrounding skin and is nearly impossible for the clinician to identify. This problem is seen most often when patients present for surgical excision or Mohs micrographic surgery.¹⁷

To properly record the site of a biopsy for future dermatologic exams, take pictures of the lesion at the time of biopsy. The photographs should clearly document the lesion in question and should be taken far enough from the site that surrounding lesions and/or other anatomic landmarks are also visible. Biangulation or triangulation (taking a series of two or three measurements, respectively, from the site of the lesion to nearby anatomic landmarks) can be used in conjunction with photographs.

When using measurements, be as specific and accurate as possible with anatomic terms. For example, measuring the distance from the “ear” is not helpful. It would be more helpful to measure the distance from the “tragus” or the “root of the helix.” Without a properly photographed and documented biopsy site, surgical treatment may need to be delayed until the location can be confirmed.

8. GIVE THE PATHOLOGIST A PERTINENT HISTORY
Providing the pathologist with a sufficient history, including the distribution and appearance of the lesion, and how long the patient has had it, can be essential in narrowing the diagnosis or making the differential diagnoses. Things like medication use or new exposures to perfumes, lotions, or plants can be especially helpful and are often overlooked when filling out the pathology requisition form.

When warranted, phone calls are helpful. You might, for example, call the pathologist and give him or her a more detailed physical examination description or additional pertinent history that was discovered after the requisition was filled out. Providing a good history can make the difference between a specific diagnosis and a broad differential.

Tip #9: Next page >>

9. KNOW WHEN TO REFER
There is no shame in asking for a second opinion when evaluating a skin lesion, especially with melanocytic neoplasms, where the stakes can be high, or skin eruptions that do not respond to conventional therapy. Remember, many cases are difficult, even for experts, and require a careful balance of clinical and histopathologic judgment.¹⁸

REFERENCES
1. Pickett H. Shave and punch biopsy for skin lesions. Am Fam Physician. 2011;84:995-1002.
2. Alguire PC, Mathes BM. Skin biopsy techniques for the internist. J Gen Intern Med. 1998;13:46-54.
3. Fernandez EM, Helm T, Ioffreda M, et al. The vanishing biopsy: the trend toward smaller specimens. Cutis. 2005;76:335-339.
4. Hieken TJ, Hernández-Irizarry R, Boll JM, et al. Accuracy of diagnostic biopsy for cutaneous melanoma: implications for surgical oncologists. Int J Surg Oncol. 2013;2013:196493.
5. Scolyer RA, Thompson JF, McCarthy SW, et al. Incomplete biopsy of melanocytic lesions can impair the accuracy of pathological diagnosis. Australas J Dermatol. 2006;47:71-75.
6. McCarthy SW, Scolyer RA. Pitfalls and important issues in the pathologic diagnosis of melanocytic tumors. Ochsner J. 2010;10:66-74.
7. Swanson NA, Lee KK, Gorman A, et al. Biopsy techniques. Diagnosis of melanoma. Dermatol Clin. 2002;20:677-680.
8. Chang TT, Somach SC, Wagamon K, et al. The inadequacy of punch-excised melanocytic lesions: sampling through the block for the determination of “margins.” J Am Acad Dermatol. 2009;60: 990-993.
9. Bichakjian CK, Halpern AC, Johnson TM, et al; American Academy of Dermatology. Guidelines of care for the management of primary cutaneous melanoma. American Academy of Dermatology. J Am Acad Dermatol. 2011;65:1032-1047.
10. Pardasani AG, Leshin B, Hallman JR, et al. Fusiform incisional biopsy for pigmented skin lesions. Dermatol Surg. 2000;26:622-624.
11. King R, Hayzen BA, Page RN, et al. Recurrent nevus phenomenon: a clinicopathologic study of 357 cases and histologic comparison with melanoma with regression. Mod Pathol. 2009;22:611-617.
12. Mills JK, White I, Diggs B, et al. Effect of biopsy type on outcomes in the treatment of primary cutaneous melanoma. Am J Surg. 2013;205:585-590.
13. Stell VH, Norton HJ, Smith KS, et al. Method of biopsy and incidence of positive margins in primary melanoma. Ann Surg Oncol. 2007;14:
893-898.
14. Egnatios GL, Dueck AC, Macdonald JB, et al. The impact of biopsy technique on upstaging, residual disease, and outcome in cutaneous melanoma. Am J Surg. 2011;202:771-778.
15. Ackerman AB, Boer A, Bennin B, et al. Histologic Diagnosis of Inflammatory Skin Disease: An Algorithmic Method Based on Pattern Analysis. New York, NY: Ardor Scribendi; 2005.
16. Hewitt SM, Lewis FA, Cao Y, et al. Tissue handling and specimen preparation in surgical pathology: issues concerning the recovery of nucleic acids from formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med. 2008;132:1929-1935.
17. Nemeth SA, Lawrence N. Site identification challenges in dermatologic surgery: a physician survey. J Am Acad Dermatol. 2012;67: 262-268.
18. Federman DG, Concato J, Kirsner RS. Comparison of dermatologic diagnoses by primary care practitioners and dermatologists. A review of the literature. Arch Fam Med. 1999;8:170-172.

1. CHOOSE YOUR BIOPSY TYPE WISELY
Using the appropriate type of biopsy can have the greatest effect on a proper diagnosis. The decision of which biopsy type to use is not always easy. The most common biopsy types are shave, punch, excisional, and curettage. Several reference articles detail each type of biopsy commonly used in primary care and how to perform them.^1,2

Each type of biopsy has inherent advantages and disadvantages. In general, the shave biopsy is most commonly used for lesions that are solitary and elevated and give the impression that a sufficient amount of tissue can be sampled with this technique. The punch biopsy is the best choice for most “rashes” (inflammatory skin disorders).² Excisional biopsy is used to remove melanocytic neoplasms or larger lesions. And curettage, while still used by some clinicians for melanocytic lesions because of its speed and simplicity, should almost never be used for diagnostic purposes.

Each technique is described in greater detail in the tips that follow.

Continue for tip #2 >>

2. WHEN PERFORMING A SHAVE BIOPSY, AVOID OBTAINING A SAMPLE THAT'S TOO SUPERFICIAL
The advantage of the shave biopsy is that it is minimally invasive and quick to perform. If kept small without compromising the amount of sample retrieved, the scars left by shave biopsies have the potential to blend well. The major disadvantage associated with the shave biopsy is that occasionally, if the shave is not deep enough, an insufficient amount of tissue is obtained. This can make it challenging to establish an accurate diagnosis.

Balancing the need to obtain adequate tissue with the desire to minimize scarring takes skill and experience. Taking a biopsy that is inadequate is a common occurrence. At times, the clinician’s clinical impression may be that a biopsy has obtained adequate tissue, when histologically only the superficial part of the skin surface has been sampled. This often is because of thickening of the superficial skin, whether as a manifestation of the anatomic site (eg, acral skin) or the disease process itself.

Unfortunately, this superficial skin often is nondiagnostic when unaccompanied by underlying epidermis and dermis. It is important to keep this in mind when you are obtaining a skin biopsy, especially when dealing with lesions that are very scaly or keratinized.

An equivocal biopsy wastes time, energy, and money, and it can negatively impact patient care.³ It can be difficult to balance practical aspects of the biopsy (ie, optimizing cosmetic outcomes, minimizing scarring and wound size) with the need to obtain sufficient tissue sampling (see Figure 1).

3. CHOOSE PUNCH OVER SHAVE BIOPSY FOR RASHES
In a punch biopsy, a disposable metal cylinder with a sharpened edge is used to “punch” out a piece of skin that can be examined under the microscope. Punch biopsy is the preferred technique for almost all inflammatory skin conditions (rashes) because the pathologist is able to examine both the superficial and deep portions of the dermis (see Figure 2).⁴  

Pathologists use the pattern of inflammation, in conjunction with epidermal changes, to distinguish different types of inflammatory processes. For example, lichen planus is typically associated with superficial inflammation, while lupus is known to have prominent superficial and deep inflammation.

An inadequate punch biopsy sample can hinder histologic assessment of inflammatory skin disorders that involve both the superficial and deep portions of the dermis and can make arriving at a definitive diagnosis more challenging. The diameter of a punch cylinder ranges from 1 to 8 mm. Smaller punch biopsies often create diagnostic challenges because they provide so little sample. A punch biopsy size of 4 mm is commonly used for rashes.

An advantage of the punch biopsy is that patients are left with linear scars rather than the round, potentially dyspigmented (darker or lighter) scars that are often associated with shave biopsy. A well-sutured punch biopsy can be cosmetically elegant, particularly if closure is oriented along relaxed skin tension lines. For this reason, punch biopsies are well suited for cosmetically sensitive locations (eg, the face), although shave biopsies are also often performed on the face.

Next page: Tip #4 >>

4. CHOOSE AN EXCISIONAL BIOPSY FOR A MELANOCYTIC NEOPLASM, WHEN POSSIBLE
The purpose of an excisional biopsy (which typically includes a 1- to 3-mm rim of normal skin around the lesion) is to completely remove a lesion. Excisional biopsy generally is the preferred technique for clinically atypical melanocytic neoplasms (ie, lesions that are not definitively benign).^4-8

When suspicion for melanoma is high, excisional biopsies should be performed with minimal undermining to preserve the accuracy of any future sentinel lymph node biopsy surgeries. Excisional biopsy is the most involved type of biopsy and has the largest potential for cosmetic disfigurement if not properly planned and performed. While guidelines from the American Academy of Dermatology state that “narrow excisional biopsy that encompasses [the] entire breadth of lesion with clinically negative margins to ensure that the lesion is not transected” is preferred, they also acknowledge that partial sampling (incisional biopsy) is acceptable in select clinical circumstances,⁹ such as when a lesion is large or on a cosmetically sensitive site (eg, the face).¹⁰

While a larger punch biopsy (6 or 8 mm) or even deep shave/saucerization may function as an excisional biopsy for very small lesions, this approach can be problematic. For one thing, these techniques are more likely than an excisional biopsy to leave a portion of the lesion in situ. Another concern is that a shave biopsy of a melanocytic lesion can lead to error or difficulty in obtaining the correct diagnosis on later biopsy.¹¹ For pathologists, small or incomplete samples make it challenging to establish an accurate diagnosis.¹² Among melanomas seen at a tertiary referral center, histopathologic misdiagnosis was more common with a punch or shave biopsy than with an excisional biopsy.⁹

It has been shown that partial biopsy for melanoma results in more residual disease at wide local excision and makes it more challenging to properly stage the lesion.^13,14 If a shave biopsy is used to sample a suspected melanocytic neoplasm, it is imperative to document the specific site of the biopsy, indicate the size of the melanocytic lesion on the pathology requisition form, and ensure that all (or nearly all) of the clinically evident lesion is sampled. Detailing the location of the lesion in the chart is not only essential in evaluating the present lesion, but it will serve you well in the future. Without knowing the patient’s clinical history, benign nevi that recur after a prior biopsy can be difficult to histologically distinguish from melanoma (see Figure 3). For more on this, see tip #7.

5. BE CAREFUL WITH CURETTAGE
Curettage is a biopsy technique in which a curette—a surgical tool with a scoop, ring, or loop at the tip—is used in a scraping motion to retrieve tissue from the patient. This type of biopsy often produces a fragmented tissue sample. Its continued use reflects the speed and simplicity with which it can be done. However, curettage destroys the architecture of the tissue of the lesion, which can make it difficult to establish a proper diagnosis, and therefore it is best avoided when performing a biopsy of a melanocytic lesion (see Figure 4).

Continue for tip #6 >>

6. REMEMBER THE IMPORTANCE OF PROPER FIXATION AND PROCESSING
As obvious as it may sound, it is important to remember to promptly place sampled tissue in an adequate amount of formalin so that the tissue is submersed in it in the container.¹⁵ Failure to do so can result in improper fixation and will make it difficult to render an appropriate diagnosis. Conventionally, a 10:1 formalin-volume-to-tissue-volume ratio is recommended. If the “cold time”—the amount of time a tissue sample is out of formalin—is too long (> a few hours), an appropriate assessment can be impossible.

Appropriate fixation and fixation times are important because molecular testing is being increasingly used to make pathologic diagnoses.¹⁶ Additionally, aggressively manipulating a biopsy sample while extracting it or placing it in formalin can cause “crush” artifact, which can limit interpretability (see Figure 5).

7. PROPERLY PHOTOGRAPH AND DOCUMENT THE BIOPSY LOCATION
When performing a biopsy of a suspicious neoplasm, clinicians often remove all of the lesion’s superficial components, which means that at the patient’s follow-up appointment and subsequent treatments, only a well-healed biopsy site will remain. The biopsy site may be so well healed that it blends seamlessly into the surrounding skin and is nearly impossible for the clinician to identify. This problem is seen most often when patients present for surgical excision or Mohs micrographic surgery.¹⁷

To properly record the site of a biopsy for future dermatologic exams, take pictures of the lesion at the time of biopsy. The photographs should clearly document the lesion in question and should be taken far enough from the site that surrounding lesions and/or other anatomic landmarks are also visible. Biangulation or triangulation (taking a series of two or three measurements, respectively, from the site of the lesion to nearby anatomic landmarks) can be used in conjunction with photographs.

When using measurements, be as specific and accurate as possible with anatomic terms. For example, measuring the distance from the “ear” is not helpful. It would be more helpful to measure the distance from the “tragus” or the “root of the helix.” Without a properly photographed and documented biopsy site, surgical treatment may need to be delayed until the location can be confirmed.

8. GIVE THE PATHOLOGIST A PERTINENT HISTORY
Providing the pathologist with a sufficient history, including the distribution and appearance of the lesion, and how long the patient has had it, can be essential in narrowing the diagnosis or making the differential diagnoses. Things like medication use or new exposures to perfumes, lotions, or plants can be especially helpful and are often overlooked when filling out the pathology requisition form.

When warranted, phone calls are helpful. You might, for example, call the pathologist and give him or her a more detailed physical examination description or additional pertinent history that was discovered after the requisition was filled out. Providing a good history can make the difference between a specific diagnosis and a broad differential.

Tip #9: Next page >>

9. KNOW WHEN TO REFER
There is no shame in asking for a second opinion when evaluating a skin lesion, especially with melanocytic neoplasms, where the stakes can be high, or skin eruptions that do not respond to conventional therapy. Remember, many cases are difficult, even for experts, and require a careful balance of clinical and histopathologic judgment.¹⁸

REFERENCES
1. Pickett H. Shave and punch biopsy for skin lesions. Am Fam Physician. 2011;84:995-1002.
2. Alguire PC, Mathes BM. Skin biopsy techniques for the internist. J Gen Intern Med. 1998;13:46-54.
3. Fernandez EM, Helm T, Ioffreda M, et al. The vanishing biopsy: the trend toward smaller specimens. Cutis. 2005;76:335-339.
4. Hieken TJ, Hernández-Irizarry R, Boll JM, et al. Accuracy of diagnostic biopsy for cutaneous melanoma: implications for surgical oncologists. Int J Surg Oncol. 2013;2013:196493.
5. Scolyer RA, Thompson JF, McCarthy SW, et al. Incomplete biopsy of melanocytic lesions can impair the accuracy of pathological diagnosis. Australas J Dermatol. 2006;47:71-75.
6. McCarthy SW, Scolyer RA. Pitfalls and important issues in the pathologic diagnosis of melanocytic tumors. Ochsner J. 2010;10:66-74.
7. Swanson NA, Lee KK, Gorman A, et al. Biopsy techniques. Diagnosis of melanoma. Dermatol Clin. 2002;20:677-680.
8. Chang TT, Somach SC, Wagamon K, et al. The inadequacy of punch-excised melanocytic lesions: sampling through the block for the determination of “margins.” J Am Acad Dermatol. 2009;60: 990-993.
9. Bichakjian CK, Halpern AC, Johnson TM, et al; American Academy of Dermatology. Guidelines of care for the management of primary cutaneous melanoma. American Academy of Dermatology. J Am Acad Dermatol. 2011;65:1032-1047.
10. Pardasani AG, Leshin B, Hallman JR, et al. Fusiform incisional biopsy for pigmented skin lesions. Dermatol Surg. 2000;26:622-624.
11. King R, Hayzen BA, Page RN, et al. Recurrent nevus phenomenon: a clinicopathologic study of 357 cases and histologic comparison with melanoma with regression. Mod Pathol. 2009;22:611-617.
12. Mills JK, White I, Diggs B, et al. Effect of biopsy type on outcomes in the treatment of primary cutaneous melanoma. Am J Surg. 2013;205:585-590.
13. Stell VH, Norton HJ, Smith KS, et al. Method of biopsy and incidence of positive margins in primary melanoma. Ann Surg Oncol. 2007;14:
893-898.
14. Egnatios GL, Dueck AC, Macdonald JB, et al. The impact of biopsy technique on upstaging, residual disease, and outcome in cutaneous melanoma. Am J Surg. 2011;202:771-778.
15. Ackerman AB, Boer A, Bennin B, et al. Histologic Diagnosis of Inflammatory Skin Disease: An Algorithmic Method Based on Pattern Analysis. New York, NY: Ardor Scribendi; 2005.
16. Hewitt SM, Lewis FA, Cao Y, et al. Tissue handling and specimen preparation in surgical pathology: issues concerning the recovery of nucleic acids from formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med. 2008;132:1929-1935.
17. Nemeth SA, Lawrence N. Site identification challenges in dermatologic surgery: a physician survey. J Am Acad Dermatol. 2012;67: 262-268.
18. Federman DG, Concato J, Kirsner RS. Comparison of dermatologic diagnoses by primary care practitioners and dermatologists. A review of the literature. Arch Fam Med. 1999;8:170-172.

Recently, three new drugs have been added to the armamentarium for menopausal symptoms and dyspareunia:

• Paroxetine 7.5 mg
• Conjugated estrogens and bazedoxifene
• Ospemifene.

In this article, I present a case-based approach to incorporating these drugs into practice and restoring sexual function in the setting of vulvovaginal atrophy and dyspareunia. As is often the case, decision-making requires sifting through multiple layers of information.

CASE: LOW DESIRE AND DISCOMFORT DURING INTERCOURSE
A 58-year-old patient mentions during her annual visit that she’s not that interested in sex anymore. Her children are grown, she’s been happily married for 28 years, and she enjoys her job and denies any symptoms of depression. She says her relationship with her husband is good and, aside from her low desire, she has no worries about the marriage. Her only medication is paroxetine 7.5 mg/d for management of her moderate hot flashes, which she initiated at her last annual visit. She reports improvement in her sleep and menopausal symptoms as a result. She has an intact uterus.

You perform a pelvic exam and find atrophic vulva and vagina with mild erythema and thinned epithelium. When you ask if she has experienced any discomfort, she reports that she needs to use lubrication for intercourse and that, even with lubrication, she has pain upon penetration and a burning sensation that continues throughout intercourse. She also reports that it seems to take her much longer to achieve arousal than in the past, and she often fails to reach orgasm.

How would you manage this patient?

Continued on next page >>

AS ALWAYS, BEGIN WITH THE HISTORY
The transition to menopause creates multiple layers of potential symptoms and problems for our patients, and sometimes medical therapy can generate additional ones.

In a patient reporting the onset of low desire and dyspareunia, you would want to first consider her medication history, despite the clear evidence of vaginal atrophy. Begin by asking whether she is taking any new medications prescribed by another provider. In some cases, antihypertensive drugs, psychotropic agents, and other medications can affect sexual function.

This patient has been taking paroxetine for one year and is happy with its effect on her sleep and hot flashes. Simon and colleagues found this nonhormonal agent for moderate to severe vasomotor symptoms produced no notable effects on weight, libido, or sleep, compared with placebo.

Nevertheless, in this case, because selective serotonin reuptake inhibitors such as paroxetine can affect arousal and orgasm, it is unclear whether the ultra-low dose of paroxetine she is taking is contributing to her problems. If you were to discontinue the drug to find out, her vasomotor symptoms and sleep disruption would likely recur.

Your decision-making is important here and should involve the patient in an extensive discussion. If there is not enough time for this discussion at the current visit, schedule a follow-up to address her concerns fully.

VULVOVAGINAL ATROPHY HAS ITS OWN TIMELINE
In many cases, vasomotor symptoms such as hot flashes occur years before the skin begins to atrophy in the vulva and vagina, particularly in women who enter menopause naturally. Among menopausal women who continue to have intercourse on a regular basis, however, these skin changes often are much less troublesome than they are for women who have sex more rarely.

In this patient, one possible scenario is that paroxetine caused a slight reduction in sexual interest, and the frequency of intercourse went down as a ­result. In women who have little or no intercourse, the ­vagina begins to shrink and the tissues lose elasticity. This patient may have been undergoing the natural process of menopause, and that process may have been compounded by a decrease in the frequency of sex.

If you were to discontinue the paroxetine, it would still be necessary to treat the vulvovaginal skin and work on manual techniques to gently dilate the introitus.

Option 1: Systemic hormone therapy >>

Option 1: Systemic hormone therapy
Systemic estrogen is the most effective treatment for menopausal vasomotor symptoms, reducing hot flashes by 50% to 100% within four weeks of initiation. However, because our patient has an intact uterus, any systemic estrogen she opts to use must be opposed by a progestin for safety reasons.

In terms of estrogen, her options are oral or nonoral formulations. Not only would estrogen manage our patient’s hot flashes but, over time, it would improve her sexual problems and atrophy, which might or might not improve her current complaint of low desire. You likely would need to add a short regimen of topical estrogen and perhaps even a dilator to restore her sexual function completely, however.

Since our patient chose the nonhormonal agent paroxetine to manage her menopausal symptoms, she may be worried about the increased risk for breast cancer associated with use of a progestin in combination with estrogen. One hormonal option now available that eliminates the need for a progestin is conjugated estrogens and bazedoxefine. Bazedoxefine is a third-generation selective estrogen receptor modulator. This drug has estrogen-like effects on bone and antiestrogen effects on the uterus.

Conjugated estrogens/bazedoxifene is indicated for use in women with a uterus for treatment of
• Moderate to severe vasomotor symptoms of menopause
• Prevention of postmenopausal osteoporosis.

Among the risks are an increased risk for venous thromboembolism (VTE) and stroke. It is not approved specifically for the treatment of dyspareunia.

Another hormonal option is ospemifene, an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia in menopausal women. Among the drugs in its class, such as tamoxifen and raloxifene, ospemifene is the only agent that maintains a full estrogenic effect on vaginal tissues. Its risks include VTE and stroke.

Although the labeling includes a warning about the risk for endometrial hyperplasia associated with its use, Goldstein and colleagues found no significant difference in the rate of endometrial thickening greater than 5 mm between women taking ospemifene and those taking placebo after one year of daily oral treatment. No carcinomas were found in either group.

Option 2: Local estrogen
If our patient declines all systemic hormone therapy, the topical approach should resolve her vulvovaginal symptoms, and she could continue taking paroxetine for her menopausal symptoms. Vaginal estrogen would address the skin problems, provided the patient applies it correctly. Many women are afraid to use estrogen creams and compensate by applying them only to the vulva, thinking that, by limiting their use to external tissues, they are avoiding any associated risks.

If she opts for the local approach, this patient should be encouraged to use transvaginal estrogen in small doses to increase the elasticity of the vulvovaginal tissue, even though it may require daily use for a week or two to improve her symptoms, after which once- or twice-weekly administration should suffice.

The use of low-dose vaginal cream for a short duration is unlikely to increase her risks in any way.  Local estrogen is available as a tablet, cream, or ring.

Option 3: A nonhormonal approach >>

Option 3: A nonhormonal approach
If the patient refuses any hormonal agent—even topical estrogen—I would recommend the use of silicone-based lubricants and a dilator and prescribe more frequent penetration to increase elasticity and reduce pain. Paroxetine could be continued to address her menopausal symptoms.

DON'T OVERLOOK BEHAVIORAL TECHNIQUES
Before this patient leaves your office with the option of her choice, a bit of counseling is necessary to instruct her about methods of restoring full sexual function.

Pain is a powerful aversive stimulus. This patient clearly states that she has had less frequent intercourse as a result of dyspareunia. It is not unusual for patients to develop a “habit” of avoidance in response to the behavior that causes their pain.

One recommendation is to talk to this patient about putting sex back into her life by encouraging her to increase sexual activity without penetration until she begins to arouse easily again. Arousal produces physiologic effects, increasing the caliber and length of the vagina as well as lubrication. The use of fingers or dilators may help restore caliber.

The patient can be encouraged to engage in snuggling and cuddling to regain those activities without the fear of pain associated with penetration. Follow-up after two weeks of this therapy can confirm the restoration of tissue elasticity, and the green light can be given for penetration to begin again. Couples can be encouraged to plan a “honeymoon weekend” and put some fun back into their sex lives so that this phase of healing doesn’t become an onerous task.

CASE RESOLVED
After a discussion of her options, the patient chooses to stick with paroxetine and use behavioral therapy alone to resolve her dyspareunia. At her follow-up visit two weeks later, she reports that she has enjoyed the period of pain-free “sex” and feels ready to add penetration into her ­activities.

You encourage her to continue sexual intercourse on a regular, relatively frequent basis to prevent a recurrence of dyspareunia. She continues to use silicone-based ­lubricants.

Recently, three new drugs have been added to the armamentarium for menopausal symptoms and dyspareunia:

• Paroxetine 7.5 mg
• Conjugated estrogens and bazedoxifene
• Ospemifene.

In this article, I present a case-based approach to incorporating these drugs into practice and restoring sexual function in the setting of vulvovaginal atrophy and dyspareunia. As is often the case, decision-making requires sifting through multiple layers of information.

CASE: LOW DESIRE AND DISCOMFORT DURING INTERCOURSE
A 58-year-old patient mentions during her annual visit that she’s not that interested in sex anymore. Her children are grown, she’s been happily married for 28 years, and she enjoys her job and denies any symptoms of depression. She says her relationship with her husband is good and, aside from her low desire, she has no worries about the marriage. Her only medication is paroxetine 7.5 mg/d for management of her moderate hot flashes, which she initiated at her last annual visit. She reports improvement in her sleep and menopausal symptoms as a result. She has an intact uterus.

You perform a pelvic exam and find atrophic vulva and vagina with mild erythema and thinned epithelium. When you ask if she has experienced any discomfort, she reports that she needs to use lubrication for intercourse and that, even with lubrication, she has pain upon penetration and a burning sensation that continues throughout intercourse. She also reports that it seems to take her much longer to achieve arousal than in the past, and she often fails to reach orgasm.

How would you manage this patient?

Continued on next page >>

AS ALWAYS, BEGIN WITH THE HISTORY
The transition to menopause creates multiple layers of potential symptoms and problems for our patients, and sometimes medical therapy can generate additional ones.

In a patient reporting the onset of low desire and dyspareunia, you would want to first consider her medication history, despite the clear evidence of vaginal atrophy. Begin by asking whether she is taking any new medications prescribed by another provider. In some cases, antihypertensive drugs, psychotropic agents, and other medications can affect sexual function.

This patient has been taking paroxetine for one year and is happy with its effect on her sleep and hot flashes. Simon and colleagues found this nonhormonal agent for moderate to severe vasomotor symptoms produced no notable effects on weight, libido, or sleep, compared with placebo.

Nevertheless, in this case, because selective serotonin reuptake inhibitors such as paroxetine can affect arousal and orgasm, it is unclear whether the ultra-low dose of paroxetine she is taking is contributing to her problems. If you were to discontinue the drug to find out, her vasomotor symptoms and sleep disruption would likely recur.

Your decision-making is important here and should involve the patient in an extensive discussion. If there is not enough time for this discussion at the current visit, schedule a follow-up to address her concerns fully.

VULVOVAGINAL ATROPHY HAS ITS OWN TIMELINE
In many cases, vasomotor symptoms such as hot flashes occur years before the skin begins to atrophy in the vulva and vagina, particularly in women who enter menopause naturally. Among menopausal women who continue to have intercourse on a regular basis, however, these skin changes often are much less troublesome than they are for women who have sex more rarely.

In this patient, one possible scenario is that paroxetine caused a slight reduction in sexual interest, and the frequency of intercourse went down as a ­result. In women who have little or no intercourse, the ­vagina begins to shrink and the tissues lose elasticity. This patient may have been undergoing the natural process of menopause, and that process may have been compounded by a decrease in the frequency of sex.

If you were to discontinue the paroxetine, it would still be necessary to treat the vulvovaginal skin and work on manual techniques to gently dilate the introitus.

Option 1: Systemic hormone therapy >>

Option 1: Systemic hormone therapy
Systemic estrogen is the most effective treatment for menopausal vasomotor symptoms, reducing hot flashes by 50% to 100% within four weeks of initiation. However, because our patient has an intact uterus, any systemic estrogen she opts to use must be opposed by a progestin for safety reasons.

In terms of estrogen, her options are oral or nonoral formulations. Not only would estrogen manage our patient’s hot flashes but, over time, it would improve her sexual problems and atrophy, which might or might not improve her current complaint of low desire. You likely would need to add a short regimen of topical estrogen and perhaps even a dilator to restore her sexual function completely, however.

Since our patient chose the nonhormonal agent paroxetine to manage her menopausal symptoms, she may be worried about the increased risk for breast cancer associated with use of a progestin in combination with estrogen. One hormonal option now available that eliminates the need for a progestin is conjugated estrogens and bazedoxefine. Bazedoxefine is a third-generation selective estrogen receptor modulator. This drug has estrogen-like effects on bone and antiestrogen effects on the uterus.

Conjugated estrogens/bazedoxifene is indicated for use in women with a uterus for treatment of
• Moderate to severe vasomotor symptoms of menopause
• Prevention of postmenopausal osteoporosis.

Among the risks are an increased risk for venous thromboembolism (VTE) and stroke. It is not approved specifically for the treatment of dyspareunia.

Another hormonal option is ospemifene, an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia in menopausal women. Among the drugs in its class, such as tamoxifen and raloxifene, ospemifene is the only agent that maintains a full estrogenic effect on vaginal tissues. Its risks include VTE and stroke.

Although the labeling includes a warning about the risk for endometrial hyperplasia associated with its use, Goldstein and colleagues found no significant difference in the rate of endometrial thickening greater than 5 mm between women taking ospemifene and those taking placebo after one year of daily oral treatment. No carcinomas were found in either group.

Option 2: Local estrogen
If our patient declines all systemic hormone therapy, the topical approach should resolve her vulvovaginal symptoms, and she could continue taking paroxetine for her menopausal symptoms. Vaginal estrogen would address the skin problems, provided the patient applies it correctly. Many women are afraid to use estrogen creams and compensate by applying them only to the vulva, thinking that, by limiting their use to external tissues, they are avoiding any associated risks.

If she opts for the local approach, this patient should be encouraged to use transvaginal estrogen in small doses to increase the elasticity of the vulvovaginal tissue, even though it may require daily use for a week or two to improve her symptoms, after which once- or twice-weekly administration should suffice.

The use of low-dose vaginal cream for a short duration is unlikely to increase her risks in any way.  Local estrogen is available as a tablet, cream, or ring.

Option 3: A nonhormonal approach >>

Option 3: A nonhormonal approach
If the patient refuses any hormonal agent—even topical estrogen—I would recommend the use of silicone-based lubricants and a dilator and prescribe more frequent penetration to increase elasticity and reduce pain. Paroxetine could be continued to address her menopausal symptoms.

DON'T OVERLOOK BEHAVIORAL TECHNIQUES
Before this patient leaves your office with the option of her choice, a bit of counseling is necessary to instruct her about methods of restoring full sexual function.

Pain is a powerful aversive stimulus. This patient clearly states that she has had less frequent intercourse as a result of dyspareunia. It is not unusual for patients to develop a “habit” of avoidance in response to the behavior that causes their pain.

One recommendation is to talk to this patient about putting sex back into her life by encouraging her to increase sexual activity without penetration until she begins to arouse easily again. Arousal produces physiologic effects, increasing the caliber and length of the vagina as well as lubrication. The use of fingers or dilators may help restore caliber.

The patient can be encouraged to engage in snuggling and cuddling to regain those activities without the fear of pain associated with penetration. Follow-up after two weeks of this therapy can confirm the restoration of tissue elasticity, and the green light can be given for penetration to begin again. Couples can be encouraged to plan a “honeymoon weekend” and put some fun back into their sex lives so that this phase of healing doesn’t become an onerous task.

CASE RESOLVED
After a discussion of her options, the patient chooses to stick with paroxetine and use behavioral therapy alone to resolve her dyspareunia. At her follow-up visit two weeks later, she reports that she has enjoyed the period of pain-free “sex” and feels ready to add penetration into her ­activities.

You encourage her to continue sexual intercourse on a regular, relatively frequent basis to prevent a recurrence of dyspareunia. She continues to use silicone-based ­lubricants.

Recently, three new drugs have been added to the armamentarium for menopausal symptoms and dyspareunia:

• Paroxetine 7.5 mg
• Conjugated estrogens and bazedoxifene
• Ospemifene.

In this article, I present a case-based approach to incorporating these drugs into practice and restoring sexual function in the setting of vulvovaginal atrophy and dyspareunia. As is often the case, decision-making requires sifting through multiple layers of information.

CASE: LOW DESIRE AND DISCOMFORT DURING INTERCOURSE
A 58-year-old patient mentions during her annual visit that she’s not that interested in sex anymore. Her children are grown, she’s been happily married for 28 years, and she enjoys her job and denies any symptoms of depression. She says her relationship with her husband is good and, aside from her low desire, she has no worries about the marriage. Her only medication is paroxetine 7.5 mg/d for management of her moderate hot flashes, which she initiated at her last annual visit. She reports improvement in her sleep and menopausal symptoms as a result. She has an intact uterus.

You perform a pelvic exam and find atrophic vulva and vagina with mild erythema and thinned epithelium. When you ask if she has experienced any discomfort, she reports that she needs to use lubrication for intercourse and that, even with lubrication, she has pain upon penetration and a burning sensation that continues throughout intercourse. She also reports that it seems to take her much longer to achieve arousal than in the past, and she often fails to reach orgasm.

How would you manage this patient?

Continued on next page >>

AS ALWAYS, BEGIN WITH THE HISTORY
The transition to menopause creates multiple layers of potential symptoms and problems for our patients, and sometimes medical therapy can generate additional ones.

In a patient reporting the onset of low desire and dyspareunia, you would want to first consider her medication history, despite the clear evidence of vaginal atrophy. Begin by asking whether she is taking any new medications prescribed by another provider. In some cases, antihypertensive drugs, psychotropic agents, and other medications can affect sexual function.

This patient has been taking paroxetine for one year and is happy with its effect on her sleep and hot flashes. Simon and colleagues found this nonhormonal agent for moderate to severe vasomotor symptoms produced no notable effects on weight, libido, or sleep, compared with placebo.

Nevertheless, in this case, because selective serotonin reuptake inhibitors such as paroxetine can affect arousal and orgasm, it is unclear whether the ultra-low dose of paroxetine she is taking is contributing to her problems. If you were to discontinue the drug to find out, her vasomotor symptoms and sleep disruption would likely recur.

Your decision-making is important here and should involve the patient in an extensive discussion. If there is not enough time for this discussion at the current visit, schedule a follow-up to address her concerns fully.

VULVOVAGINAL ATROPHY HAS ITS OWN TIMELINE
In many cases, vasomotor symptoms such as hot flashes occur years before the skin begins to atrophy in the vulva and vagina, particularly in women who enter menopause naturally. Among menopausal women who continue to have intercourse on a regular basis, however, these skin changes often are much less troublesome than they are for women who have sex more rarely.

In this patient, one possible scenario is that paroxetine caused a slight reduction in sexual interest, and the frequency of intercourse went down as a ­result. In women who have little or no intercourse, the ­vagina begins to shrink and the tissues lose elasticity. This patient may have been undergoing the natural process of menopause, and that process may have been compounded by a decrease in the frequency of sex.

If you were to discontinue the paroxetine, it would still be necessary to treat the vulvovaginal skin and work on manual techniques to gently dilate the introitus.

Option 1: Systemic hormone therapy >>

Option 1: Systemic hormone therapy
Systemic estrogen is the most effective treatment for menopausal vasomotor symptoms, reducing hot flashes by 50% to 100% within four weeks of initiation. However, because our patient has an intact uterus, any systemic estrogen she opts to use must be opposed by a progestin for safety reasons.

In terms of estrogen, her options are oral or nonoral formulations. Not only would estrogen manage our patient’s hot flashes but, over time, it would improve her sexual problems and atrophy, which might or might not improve her current complaint of low desire. You likely would need to add a short regimen of topical estrogen and perhaps even a dilator to restore her sexual function completely, however.

Since our patient chose the nonhormonal agent paroxetine to manage her menopausal symptoms, she may be worried about the increased risk for breast cancer associated with use of a progestin in combination with estrogen. One hormonal option now available that eliminates the need for a progestin is conjugated estrogens and bazedoxefine. Bazedoxefine is a third-generation selective estrogen receptor modulator. This drug has estrogen-like effects on bone and antiestrogen effects on the uterus.

Conjugated estrogens/bazedoxifene is indicated for use in women with a uterus for treatment of
• Moderate to severe vasomotor symptoms of menopause
• Prevention of postmenopausal osteoporosis.

Among the risks are an increased risk for venous thromboembolism (VTE) and stroke. It is not approved specifically for the treatment of dyspareunia.

Another hormonal option is ospemifene, an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia in menopausal women. Among the drugs in its class, such as tamoxifen and raloxifene, ospemifene is the only agent that maintains a full estrogenic effect on vaginal tissues. Its risks include VTE and stroke.

Although the labeling includes a warning about the risk for endometrial hyperplasia associated with its use, Goldstein and colleagues found no significant difference in the rate of endometrial thickening greater than 5 mm between women taking ospemifene and those taking placebo after one year of daily oral treatment. No carcinomas were found in either group.

Option 2: Local estrogen
If our patient declines all systemic hormone therapy, the topical approach should resolve her vulvovaginal symptoms, and she could continue taking paroxetine for her menopausal symptoms. Vaginal estrogen would address the skin problems, provided the patient applies it correctly. Many women are afraid to use estrogen creams and compensate by applying them only to the vulva, thinking that, by limiting their use to external tissues, they are avoiding any associated risks.

If she opts for the local approach, this patient should be encouraged to use transvaginal estrogen in small doses to increase the elasticity of the vulvovaginal tissue, even though it may require daily use for a week or two to improve her symptoms, after which once- or twice-weekly administration should suffice.

The use of low-dose vaginal cream for a short duration is unlikely to increase her risks in any way.  Local estrogen is available as a tablet, cream, or ring.

Option 3: A nonhormonal approach >>

Option 3: A nonhormonal approach
If the patient refuses any hormonal agent—even topical estrogen—I would recommend the use of silicone-based lubricants and a dilator and prescribe more frequent penetration to increase elasticity and reduce pain. Paroxetine could be continued to address her menopausal symptoms.

DON'T OVERLOOK BEHAVIORAL TECHNIQUES
Before this patient leaves your office with the option of her choice, a bit of counseling is necessary to instruct her about methods of restoring full sexual function.

Pain is a powerful aversive stimulus. This patient clearly states that she has had less frequent intercourse as a result of dyspareunia. It is not unusual for patients to develop a “habit” of avoidance in response to the behavior that causes their pain.

One recommendation is to talk to this patient about putting sex back into her life by encouraging her to increase sexual activity without penetration until she begins to arouse easily again. Arousal produces physiologic effects, increasing the caliber and length of the vagina as well as lubrication. The use of fingers or dilators may help restore caliber.

The patient can be encouraged to engage in snuggling and cuddling to regain those activities without the fear of pain associated with penetration. Follow-up after two weeks of this therapy can confirm the restoration of tissue elasticity, and the green light can be given for penetration to begin again. Couples can be encouraged to plan a “honeymoon weekend” and put some fun back into their sex lives so that this phase of healing doesn’t become an onerous task.

CASE RESOLVED
After a discussion of her options, the patient chooses to stick with paroxetine and use behavioral therapy alone to resolve her dyspareunia. At her follow-up visit two weeks later, she reports that she has enjoyed the period of pain-free “sex” and feels ready to add penetration into her ­activities.

You encourage her to continue sexual intercourse on a regular, relatively frequent basis to prevent a recurrence of dyspareunia. She continues to use silicone-based ­lubricants.

Understanding the pathomechanics of throwing and the accompanying elbow injuries is the groundwork for conducting a directed history taking and a physical examination that produce an accurate diagnosis of elbow injuries in throwing athletes. Advances in physical examination techniques have improved our ability to accurately diagnose and treat throwers’ athletic elbow disorders.

Throwing imposes an extremely high valgus stress (approaching 60-65 Nm) across the elbow. This high stress occurs during the cocking and acceleration phases of the overhead throwing motion.^1-3 The valgus stress generates tension on the medial elbow, compression on the lateral elbow, and shear on the posterior aspect of the elbow. These forces cause predictable injury patterns in different parts of throwers’ elbows. Physical examination performed in a systematic anatomical fashion can enhance predictable and accurate elbow injury diagnosis. In this article, we outline 5 points in a systematic approach to physical examination of a throwing athlete’s elbow.

1. Perform a general upper extremity examination

Cervical spine and shoulder girdle

In the initial examination, the cervical spine and the entire affected upper extremity should be quickly assessed. Assessment of the cervical spine should include palpation, range of motion (ROM), and basic provocative testing, such as the Spurling test, to evaluate for radiculopathy caused by foraminal compression. Posture, asymmetry, atrophy, edema, ecchymosis, and any other deformity should be noted. For example, atrophy of the neck and shoulders suggests underlying neuropathy. In addition, fullness of the supraclavicular region and local tenderness or bruit suggest vasculopathy. Symptomatic compression of the subclavian artery and vein between the anterior and middle scalene muscles may present as weakness, fullness, heaviness, and early fatigue. Physical signs include coolness, pallor, claudication, engorgement, and edema in the arm.⁴ Thoracic outlet syndrome can manifest as effort-induced vague pain at the arm and elbow.⁵ If this syndrome is suspected, an Adson test should be performed. With the patient’s neck extended and rotated away from the affected side, the examiner, standing next to the patient, palpates the radial pulse with the patient’s elbow extended (Figure 1A). Next, the examiner abducts, extends, and externally rotates the patient’s shoulder (Figure 1B) while the patient alternates between opening and closing the fist (Figure 1C). A decrease or absence in pulse strength from the starting position is a positive test result.

Last, the shoulder and scapulae should be assessed, as an affected shoulder or dyskinetic scapula can lead to improper mechanics of the kinetic chain at the elbow. The shoulder should be palpated, and ROM, strength, and stability should be assessed. Glenohumeral internal rotation deficit is associated with medial collateral ligament (MCL) tears; if present, this deficit should be addressed.⁶

Elbow

Inspection should reveal a normal carrying angle of about 11° to 14° of valgus in men and 13° to 16° in women. In immature athletes, increased valgus stresses from repetitive overhead throwing can cause medial epicondylar hypertrophy, and carrying angles of more than 15° are common.^7-9

Active and passive ROM should be assessed. Normal ROM is about 0° extension and 140° flexion with 80° of supination and pronation. For determination of pathologic differences, ROM should always be compared between the affected and the contralateral sides. Painful loss of motion may be caused by soft-tissue swelling or contracture, effusion, bony impingement, or loose bodies. Crepitus, locking, catching, or another mechanical symptom may indicate loose bodies or chondral injury. Firm, mechanical blocks to ROM during flexion may indicate osteophyte formation in the coronoid fossa, and mechanical blocks to ROM during extension may indicate osteophyte formation in the olecranon fossa. Pain elicited at the end points of motion is caused by osteophytes and impingement, whereas pain elicited during the mid-arc of motion is often caused by osteochondral lesions. Terminal extension, often the first motion lost after injury, may signal intra-articular pathology, if symptomatic. However, throwing athletes may present with developmental flexion contractures of up to 20°.¹⁰

2. Examine the medial aspect of the elbow

The medial epicondyle, easy to recognize as a bony prominence on the medial side of the distal humerus, serves as an attachment site for the MCL, pronator teres, and the common flexor tendon. In throwers, assessing the MCL is crucial. The MCL should be palpated from its origin on the inferior aspect of the medial epicondyle moving distally to the sublime tubercle of the proximal ulna. Tenderness at any point along the ligament can indicate a range of ligament pathology, from attenuation to complete rupture.

The MCL is further assessed with stress tests, most commonly the valgus stress test, the milking maneuver, and the moving valgus stress test. Of these 3 procedures, the moving valgus stress test is perhaps the most sensitive and specific for MCL injury, and is the test preferred by the authors.¹¹ This test takes into account shoulder position, simulates the position of throwing, and can account for bony structures that provide stability at more than 120° of flexion. We prefer to position the patient supine on the examining table to help stabilize the shoulder and humerus and to relax the patient. The shoulder is placed in abduction and external rotation while the examiner holds the thumb with one hand and supports the elbow with the other. The elbow is extended (Figure 2A) and flexed (Figure 2B) while valgus stress is applied. A positive test elicits pain localized to the MCL at the arc of motion between 80° to 120°.¹² Pain at positions near full extension with the moving valgus stress test may also indicate chondral damage at the posteromedial trochlea.¹³

During pitching, the tensile demand on the MCL is reduced by the action of the flexor-pronator mass. It is common to see a flexor-pronator mass injury concurrent with MCL injury.¹⁴ Medial epicondyle tenderness that increases with resisted wrist flexion may signal flexor-pronator injury, though, classically, flexor-pronator muscle strains and tears produce pain anterior and distal to the medial epicondyle.¹⁵

Traction, compression, and friction at the medial elbow can irritate the ulnar nerve. This nerve should be inspected and palpated along its course at the cubital tunnel to determine its location and stability. Ulnar nerve hypermobility, which has been identified in 37% of elbows, can be determined by having the patient actively flex the elbow with the forearm in supination, placing a finger at the posteromedial aspect of the medial humeral epicondyle, and having the patient actively extend the elbow.¹⁶ The nerve dislocates if trapped anterior to the examiner’s finger, perches if under the examiner’s finger, or is stable if still palpable in the groove posterior to the medial epicondyle.¹⁶

The distal band of the medial triceps tendon may also sublux over the medial epicondyle with elbow flexion. This subluxation, also known as snapping triceps syndrome, may cause pain or ulnar nerve symptoms.¹⁷ Bringing the elbow from extension to flexion may produce subluxation, first of the ulnar nerve and then of the medial triceps, in 2 separate “snaps.” Tenderness can be elicited along the medial triceps muscle.

Ulnar neuritis is caused by traction injury, such as with dynamic pitching, nerve subluxation, or compression at the cubital tunnel. With MCL injury and valgus instability, the ulnar nerve can become irritated as it becomes stretched because of medial elbow laxity.¹⁸ The nerve can also be damaged during flexion as the cubital tunnel retinaculum tightens, decreasing the space available for the nerve.¹⁹ This concept is applied during the elbow flexion compression test. A positive test may elicit tingling radiating toward the small finger or pain at the elbow or medial forearm when manual pressure is directly applied over the ulnar nerve between the posteromedial olecranon and the medial humeral epicondyle as the elbow is maximally flexed.²⁰

3. Examine the lateral aspect of the elbow

Palpation of the lateral epicondyle, the radial head, and the olecranon tip assists in defining injury to the underlying anatomy. The anconeus “soft spot” (infracondylar recess) within the triangle formed by these 3 bony landmarks should be palpated for fullness, indicating a joint effusion, hemarthrosis, or even a subluxed or dislocated radial head.

While the medial elbow endures a large tensile load, throwing imposes a tremendous compressive force at the lateral elbow, particularly at the radiocapitellar joint. This joint may be tender and produce clicking with pronation and supination in patients with radiocapitellar arthrosis, symptomatic posterolateral synovial plica, or an inflamed radial bursa. Tenderness with crepitus that can be exacerbated with forceful flexion and extension may indicate radiocapitellar overload or loose bodies.

Long-term load transmission and subsequent degeneration of the articular surface may advance to osteochondritis dissecans (OCD). Examination for capitellar OCD reveals tenderness over the radiocapitellar joint and commonly a loss of 15° to 20° of extension. The active radiocapitellar compression test is positive for OCD lesions and elicits pain in the lateral compartment of the elbow when the patient pronates (Figure 3A) and supinates (Figure 3B) the forearm with the elbow axially loaded in extension.²¹

Microtrauma and inflammation may occur with repetitive eccentric overload. Although rare in throwing athletes, “tennis elbow” causes pain with gripping, and decreased grip strength. Tenderness caused by lateral epicondylitis is just anterior and distal to the epicondyle, at the origin of the extensor carpi radialis brevis. Pain is reproducible with passive wrist flexion and resisted wrist extension with the elbow extended (Cozen test).

Less commonly, athletes may complain of mechanical symptoms, such as snapping or catching with posterolateral elbow pain.²² These symptoms may be due to thickened or inflamed synovial plica causing impingement. A posterior radiocapitellar plica can be examined by bringing the elbow to full extension while applying valgus stress with the forearm in supination. Conversely, an anterior radiocapitellar plica can be examined with a valgus load on the elbow and passive flexion with the forearm in pronation.²³ A palpable painful snap over the radiocapitellar joint is a positive test.

4. Examine the posterior aspect of the elbow

Posteriorly, palpation is focused on the triceps tendon and the olecranon tip. The elbow should be flexed to 30° to relax the triceps, isolate the olecranon, and allow for palpation of the olecranon fossa on either side of the triceps tendon. Tenderness at the posterolateral or posteromedial aspect of the olecranon should be noted. Warmth, fluctuance, or distension at the elbow may be caused by olecranon bursitis. The 3 heads of the triceps muscle should be palpated where they converge to form an aponeurosis, and tenderness or a palpable gap on any of the heads should be noted.

A combination of valgus force and a rapidly decelerating arm at the follow-through phase of pitching causes a shear force between the medial aspect of the olecranon tip and the olecranon fossa. This shear force can result in chondrolysis, osteophyte formation, and loose bodies, particularly in the posteromedial elbow. This valgus extension overload (VEO) syndrome often results in loss of full extension and symptoms, which may be attributed to osteophytes or fractured and nonunited fragments in the olecranon fossa or the olecranon tip. Frank crepitus may also be present with extension testing caused by loose bodies or synovial reaction over osteophytes. Assessing for VEO using the extension impingement test, the examiner places continuous valgus stress on the elbow while quickly extending from 20° to 30° of flexion (Figure 4A) to terminal extension (Figure 4B) repeatedly. The examiner repeats this without valgus load while palpating the posteromedial olecranon for tenderness to differentiate impingement caused by instability from pain over the medial olecranon without instability (Figure 4C). Particular attention should be focused posteriorly in athletes with medial instability, as MCL injuries and VEO syndrome often occur in conjunction in the throwing athlete.

Repetitive acceleration and deceleration of the arm can also cause stress fractures. With stress fractures, pain is often noted more distal and lateral on the olecranon, but tenderness may be palpable medially from posteromedial impaction that occurs from the valgus load during the overhead throwing motion. In immature athletes, the repetitive sudden snap of full extension in the deceleration phase of throwing can cause olecranon apophysitis. Frank avulsions can occur as well but are usually preceded by chronic posterior elbow pain with possible loss of full extension.

The late cocking phase of the throwing motion (just before throwing) hyperextends the elbow and places significant strain on the elbow. Repetitive strain can cause painful posterior impingement. The arm bar test is extremely sensitive (Figure 5).¹³ With the patient’s elbow extended, shoulder internally rotated, and hand on the examiner’s shoulder, the examiner pulls down on the olecranon to simulate forced extension and reproduces the pain associated with posteromedial impingement.

Last, though triceps tendon injuries are rare, ruptures most often occur at the origin of the lateral head of the triceps. As the initial swelling and ecchymosis subside, a palpable gap is pathognomonic for rupture. Extensor weakness can often be observed, but extension may still be possible from anconeus triceps expansion with the aid of gravity. With the elbow overhead, the athlete must extend the elbow against gravity and will exhibit weakness against resistance.

5. Examine the anterior aspect of the elbow

Anteriorly, the bulk of the flexor-pronator group restricts the extent of joint palpation, and the soft tissues are usually injured. The antecubital fossa is a triangular area on the anterior aspect of the elbow that is bounded superiorly by a horizontal line connecting the medial epicondyle to the lateral epicondyle of the humerus, medially by the lateral border of the pronator teres muscle and laterally by the medial border of the brachioradialis muscle. From lateral to medial, the antecubital fossa contains the radial nerve, the biceps brachii tendon, the brachial artery, and the median nerve. Evaluating this area is important because a visible defect, change in muscle contour, or proximal retraction of a muscle belly can indicate a muscular rupture. In particular, a distal biceps rupture (rare) may be accompanied by weakness and pain in supination and, to a lesser degree, in flexion. It is important to note that, in the case of a partial biceps rupture, ecchymosis may not appear, as the hematoma is confined by the intact lacertus fibrosis.²⁴ The hook test can be used to evaluate for the presence of an intact distal biceps tendon (Figure 6).²⁵ The patient abducts the shoulder, flexes the elbow to 90°, and actively supinates the forearm while the examiner attempts to hook an index finger laterally under the tendon. The test is negative if the finger can be inserted 1 cm under the tendon and positive if no cordlike structure can be hooked. Partial biceps tendon ruptures or tendinitis may exhibit tenderness of the distal biceps tendon and pain on resisted supination with a negative hook test. Often, resisted elbow flexion with the elbow at maximal extension elicits pain at the biceps insertion. Clicking with forearm rotation near the insertion of the tendon, which may be caused by an inflamed radial bursa between the distal biceps tendon and the radial tuberosity, may be associated with impending rupture.

Conclusion

Physical examination combined with thorough history taking usually provides a solid basis for a diagnosis, which in turn makes the value of surgical treatment more assured.

Understanding the pathomechanics of throwing and the accompanying elbow injuries is the groundwork for conducting a directed history taking and a physical examination that produce an accurate diagnosis of elbow injuries in throwing athletes. Advances in physical examination techniques have improved our ability to accurately diagnose and treat throwers’ athletic elbow disorders.

Throwing imposes an extremely high valgus stress (approaching 60-65 Nm) across the elbow. This high stress occurs during the cocking and acceleration phases of the overhead throwing motion.^1-3 The valgus stress generates tension on the medial elbow, compression on the lateral elbow, and shear on the posterior aspect of the elbow. These forces cause predictable injury patterns in different parts of throwers’ elbows. Physical examination performed in a systematic anatomical fashion can enhance predictable and accurate elbow injury diagnosis. In this article, we outline 5 points in a systematic approach to physical examination of a throwing athlete’s elbow.

1. Perform a general upper extremity examination

Cervical spine and shoulder girdle

In the initial examination, the cervical spine and the entire affected upper extremity should be quickly assessed. Assessment of the cervical spine should include palpation, range of motion (ROM), and basic provocative testing, such as the Spurling test, to evaluate for radiculopathy caused by foraminal compression. Posture, asymmetry, atrophy, edema, ecchymosis, and any other deformity should be noted. For example, atrophy of the neck and shoulders suggests underlying neuropathy. In addition, fullness of the supraclavicular region and local tenderness or bruit suggest vasculopathy. Symptomatic compression of the subclavian artery and vein between the anterior and middle scalene muscles may present as weakness, fullness, heaviness, and early fatigue. Physical signs include coolness, pallor, claudication, engorgement, and edema in the arm.⁴ Thoracic outlet syndrome can manifest as effort-induced vague pain at the arm and elbow.⁵ If this syndrome is suspected, an Adson test should be performed. With the patient’s neck extended and rotated away from the affected side, the examiner, standing next to the patient, palpates the radial pulse with the patient’s elbow extended (Figure 1A). Next, the examiner abducts, extends, and externally rotates the patient’s shoulder (Figure 1B) while the patient alternates between opening and closing the fist (Figure 1C). A decrease or absence in pulse strength from the starting position is a positive test result.

Last, the shoulder and scapulae should be assessed, as an affected shoulder or dyskinetic scapula can lead to improper mechanics of the kinetic chain at the elbow. The shoulder should be palpated, and ROM, strength, and stability should be assessed. Glenohumeral internal rotation deficit is associated with medial collateral ligament (MCL) tears; if present, this deficit should be addressed.⁶

Elbow

Inspection should reveal a normal carrying angle of about 11° to 14° of valgus in men and 13° to 16° in women. In immature athletes, increased valgus stresses from repetitive overhead throwing can cause medial epicondylar hypertrophy, and carrying angles of more than 15° are common.^7-9

Active and passive ROM should be assessed. Normal ROM is about 0° extension and 140° flexion with 80° of supination and pronation. For determination of pathologic differences, ROM should always be compared between the affected and the contralateral sides. Painful loss of motion may be caused by soft-tissue swelling or contracture, effusion, bony impingement, or loose bodies. Crepitus, locking, catching, or another mechanical symptom may indicate loose bodies or chondral injury. Firm, mechanical blocks to ROM during flexion may indicate osteophyte formation in the coronoid fossa, and mechanical blocks to ROM during extension may indicate osteophyte formation in the olecranon fossa. Pain elicited at the end points of motion is caused by osteophytes and impingement, whereas pain elicited during the mid-arc of motion is often caused by osteochondral lesions. Terminal extension, often the first motion lost after injury, may signal intra-articular pathology, if symptomatic. However, throwing athletes may present with developmental flexion contractures of up to 20°.¹⁰

2. Examine the medial aspect of the elbow

The medial epicondyle, easy to recognize as a bony prominence on the medial side of the distal humerus, serves as an attachment site for the MCL, pronator teres, and the common flexor tendon. In throwers, assessing the MCL is crucial. The MCL should be palpated from its origin on the inferior aspect of the medial epicondyle moving distally to the sublime tubercle of the proximal ulna. Tenderness at any point along the ligament can indicate a range of ligament pathology, from attenuation to complete rupture.

The MCL is further assessed with stress tests, most commonly the valgus stress test, the milking maneuver, and the moving valgus stress test. Of these 3 procedures, the moving valgus stress test is perhaps the most sensitive and specific for MCL injury, and is the test preferred by the authors.¹¹ This test takes into account shoulder position, simulates the position of throwing, and can account for bony structures that provide stability at more than 120° of flexion. We prefer to position the patient supine on the examining table to help stabilize the shoulder and humerus and to relax the patient. The shoulder is placed in abduction and external rotation while the examiner holds the thumb with one hand and supports the elbow with the other. The elbow is extended (Figure 2A) and flexed (Figure 2B) while valgus stress is applied. A positive test elicits pain localized to the MCL at the arc of motion between 80° to 120°.¹² Pain at positions near full extension with the moving valgus stress test may also indicate chondral damage at the posteromedial trochlea.¹³

During pitching, the tensile demand on the MCL is reduced by the action of the flexor-pronator mass. It is common to see a flexor-pronator mass injury concurrent with MCL injury.¹⁴ Medial epicondyle tenderness that increases with resisted wrist flexion may signal flexor-pronator injury, though, classically, flexor-pronator muscle strains and tears produce pain anterior and distal to the medial epicondyle.¹⁵

Traction, compression, and friction at the medial elbow can irritate the ulnar nerve. This nerve should be inspected and palpated along its course at the cubital tunnel to determine its location and stability. Ulnar nerve hypermobility, which has been identified in 37% of elbows, can be determined by having the patient actively flex the elbow with the forearm in supination, placing a finger at the posteromedial aspect of the medial humeral epicondyle, and having the patient actively extend the elbow.¹⁶ The nerve dislocates if trapped anterior to the examiner’s finger, perches if under the examiner’s finger, or is stable if still palpable in the groove posterior to the medial epicondyle.¹⁶

The distal band of the medial triceps tendon may also sublux over the medial epicondyle with elbow flexion. This subluxation, also known as snapping triceps syndrome, may cause pain or ulnar nerve symptoms.¹⁷ Bringing the elbow from extension to flexion may produce subluxation, first of the ulnar nerve and then of the medial triceps, in 2 separate “snaps.” Tenderness can be elicited along the medial triceps muscle.

Ulnar neuritis is caused by traction injury, such as with dynamic pitching, nerve subluxation, or compression at the cubital tunnel. With MCL injury and valgus instability, the ulnar nerve can become irritated as it becomes stretched because of medial elbow laxity.¹⁸ The nerve can also be damaged during flexion as the cubital tunnel retinaculum tightens, decreasing the space available for the nerve.¹⁹ This concept is applied during the elbow flexion compression test. A positive test may elicit tingling radiating toward the small finger or pain at the elbow or medial forearm when manual pressure is directly applied over the ulnar nerve between the posteromedial olecranon and the medial humeral epicondyle as the elbow is maximally flexed.²⁰

3. Examine the lateral aspect of the elbow

Palpation of the lateral epicondyle, the radial head, and the olecranon tip assists in defining injury to the underlying anatomy. The anconeus “soft spot” (infracondylar recess) within the triangle formed by these 3 bony landmarks should be palpated for fullness, indicating a joint effusion, hemarthrosis, or even a subluxed or dislocated radial head.

While the medial elbow endures a large tensile load, throwing imposes a tremendous compressive force at the lateral elbow, particularly at the radiocapitellar joint. This joint may be tender and produce clicking with pronation and supination in patients with radiocapitellar arthrosis, symptomatic posterolateral synovial plica, or an inflamed radial bursa. Tenderness with crepitus that can be exacerbated with forceful flexion and extension may indicate radiocapitellar overload or loose bodies.

Long-term load transmission and subsequent degeneration of the articular surface may advance to osteochondritis dissecans (OCD). Examination for capitellar OCD reveals tenderness over the radiocapitellar joint and commonly a loss of 15° to 20° of extension. The active radiocapitellar compression test is positive for OCD lesions and elicits pain in the lateral compartment of the elbow when the patient pronates (Figure 3A) and supinates (Figure 3B) the forearm with the elbow axially loaded in extension.²¹

Microtrauma and inflammation may occur with repetitive eccentric overload. Although rare in throwing athletes, “tennis elbow” causes pain with gripping, and decreased grip strength. Tenderness caused by lateral epicondylitis is just anterior and distal to the epicondyle, at the origin of the extensor carpi radialis brevis. Pain is reproducible with passive wrist flexion and resisted wrist extension with the elbow extended (Cozen test).

Less commonly, athletes may complain of mechanical symptoms, such as snapping or catching with posterolateral elbow pain.²² These symptoms may be due to thickened or inflamed synovial plica causing impingement. A posterior radiocapitellar plica can be examined by bringing the elbow to full extension while applying valgus stress with the forearm in supination. Conversely, an anterior radiocapitellar plica can be examined with a valgus load on the elbow and passive flexion with the forearm in pronation.²³ A palpable painful snap over the radiocapitellar joint is a positive test.

4. Examine the posterior aspect of the elbow

Posteriorly, palpation is focused on the triceps tendon and the olecranon tip. The elbow should be flexed to 30° to relax the triceps, isolate the olecranon, and allow for palpation of the olecranon fossa on either side of the triceps tendon. Tenderness at the posterolateral or posteromedial aspect of the olecranon should be noted. Warmth, fluctuance, or distension at the elbow may be caused by olecranon bursitis. The 3 heads of the triceps muscle should be palpated where they converge to form an aponeurosis, and tenderness or a palpable gap on any of the heads should be noted.

A combination of valgus force and a rapidly decelerating arm at the follow-through phase of pitching causes a shear force between the medial aspect of the olecranon tip and the olecranon fossa. This shear force can result in chondrolysis, osteophyte formation, and loose bodies, particularly in the posteromedial elbow. This valgus extension overload (VEO) syndrome often results in loss of full extension and symptoms, which may be attributed to osteophytes or fractured and nonunited fragments in the olecranon fossa or the olecranon tip. Frank crepitus may also be present with extension testing caused by loose bodies or synovial reaction over osteophytes. Assessing for VEO using the extension impingement test, the examiner places continuous valgus stress on the elbow while quickly extending from 20° to 30° of flexion (Figure 4A) to terminal extension (Figure 4B) repeatedly. The examiner repeats this without valgus load while palpating the posteromedial olecranon for tenderness to differentiate impingement caused by instability from pain over the medial olecranon without instability (Figure 4C). Particular attention should be focused posteriorly in athletes with medial instability, as MCL injuries and VEO syndrome often occur in conjunction in the throwing athlete.

Repetitive acceleration and deceleration of the arm can also cause stress fractures. With stress fractures, pain is often noted more distal and lateral on the olecranon, but tenderness may be palpable medially from posteromedial impaction that occurs from the valgus load during the overhead throwing motion. In immature athletes, the repetitive sudden snap of full extension in the deceleration phase of throwing can cause olecranon apophysitis. Frank avulsions can occur as well but are usually preceded by chronic posterior elbow pain with possible loss of full extension.

The late cocking phase of the throwing motion (just before throwing) hyperextends the elbow and places significant strain on the elbow. Repetitive strain can cause painful posterior impingement. The arm bar test is extremely sensitive (Figure 5).¹³ With the patient’s elbow extended, shoulder internally rotated, and hand on the examiner’s shoulder, the examiner pulls down on the olecranon to simulate forced extension and reproduces the pain associated with posteromedial impingement.

Last, though triceps tendon injuries are rare, ruptures most often occur at the origin of the lateral head of the triceps. As the initial swelling and ecchymosis subside, a palpable gap is pathognomonic for rupture. Extensor weakness can often be observed, but extension may still be possible from anconeus triceps expansion with the aid of gravity. With the elbow overhead, the athlete must extend the elbow against gravity and will exhibit weakness against resistance.

5. Examine the anterior aspect of the elbow

Anteriorly, the bulk of the flexor-pronator group restricts the extent of joint palpation, and the soft tissues are usually injured. The antecubital fossa is a triangular area on the anterior aspect of the elbow that is bounded superiorly by a horizontal line connecting the medial epicondyle to the lateral epicondyle of the humerus, medially by the lateral border of the pronator teres muscle and laterally by the medial border of the brachioradialis muscle. From lateral to medial, the antecubital fossa contains the radial nerve, the biceps brachii tendon, the brachial artery, and the median nerve. Evaluating this area is important because a visible defect, change in muscle contour, or proximal retraction of a muscle belly can indicate a muscular rupture. In particular, a distal biceps rupture (rare) may be accompanied by weakness and pain in supination and, to a lesser degree, in flexion. It is important to note that, in the case of a partial biceps rupture, ecchymosis may not appear, as the hematoma is confined by the intact lacertus fibrosis.²⁴ The hook test can be used to evaluate for the presence of an intact distal biceps tendon (Figure 6).²⁵ The patient abducts the shoulder, flexes the elbow to 90°, and actively supinates the forearm while the examiner attempts to hook an index finger laterally under the tendon. The test is negative if the finger can be inserted 1 cm under the tendon and positive if no cordlike structure can be hooked. Partial biceps tendon ruptures or tendinitis may exhibit tenderness of the distal biceps tendon and pain on resisted supination with a negative hook test. Often, resisted elbow flexion with the elbow at maximal extension elicits pain at the biceps insertion. Clicking with forearm rotation near the insertion of the tendon, which may be caused by an inflamed radial bursa between the distal biceps tendon and the radial tuberosity, may be associated with impending rupture.

Conclusion

Physical examination combined with thorough history taking usually provides a solid basis for a diagnosis, which in turn makes the value of surgical treatment more assured.

Understanding the pathomechanics of throwing and the accompanying elbow injuries is the groundwork for conducting a directed history taking and a physical examination that produce an accurate diagnosis of elbow injuries in throwing athletes. Advances in physical examination techniques have improved our ability to accurately diagnose and treat throwers’ athletic elbow disorders.

Throwing imposes an extremely high valgus stress (approaching 60-65 Nm) across the elbow. This high stress occurs during the cocking and acceleration phases of the overhead throwing motion.^1-3 The valgus stress generates tension on the medial elbow, compression on the lateral elbow, and shear on the posterior aspect of the elbow. These forces cause predictable injury patterns in different parts of throwers’ elbows. Physical examination performed in a systematic anatomical fashion can enhance predictable and accurate elbow injury diagnosis. In this article, we outline 5 points in a systematic approach to physical examination of a throwing athlete’s elbow.

1. Perform a general upper extremity examination

Cervical spine and shoulder girdle

In the initial examination, the cervical spine and the entire affected upper extremity should be quickly assessed. Assessment of the cervical spine should include palpation, range of motion (ROM), and basic provocative testing, such as the Spurling test, to evaluate for radiculopathy caused by foraminal compression. Posture, asymmetry, atrophy, edema, ecchymosis, and any other deformity should be noted. For example, atrophy of the neck and shoulders suggests underlying neuropathy. In addition, fullness of the supraclavicular region and local tenderness or bruit suggest vasculopathy. Symptomatic compression of the subclavian artery and vein between the anterior and middle scalene muscles may present as weakness, fullness, heaviness, and early fatigue. Physical signs include coolness, pallor, claudication, engorgement, and edema in the arm.⁴ Thoracic outlet syndrome can manifest as effort-induced vague pain at the arm and elbow.⁵ If this syndrome is suspected, an Adson test should be performed. With the patient’s neck extended and rotated away from the affected side, the examiner, standing next to the patient, palpates the radial pulse with the patient’s elbow extended (Figure 1A). Next, the examiner abducts, extends, and externally rotates the patient’s shoulder (Figure 1B) while the patient alternates between opening and closing the fist (Figure 1C). A decrease or absence in pulse strength from the starting position is a positive test result.

Last, the shoulder and scapulae should be assessed, as an affected shoulder or dyskinetic scapula can lead to improper mechanics of the kinetic chain at the elbow. The shoulder should be palpated, and ROM, strength, and stability should be assessed. Glenohumeral internal rotation deficit is associated with medial collateral ligament (MCL) tears; if present, this deficit should be addressed.⁶

Elbow

Inspection should reveal a normal carrying angle of about 11° to 14° of valgus in men and 13° to 16° in women. In immature athletes, increased valgus stresses from repetitive overhead throwing can cause medial epicondylar hypertrophy, and carrying angles of more than 15° are common.^7-9

Active and passive ROM should be assessed. Normal ROM is about 0° extension and 140° flexion with 80° of supination and pronation. For determination of pathologic differences, ROM should always be compared between the affected and the contralateral sides. Painful loss of motion may be caused by soft-tissue swelling or contracture, effusion, bony impingement, or loose bodies. Crepitus, locking, catching, or another mechanical symptom may indicate loose bodies or chondral injury. Firm, mechanical blocks to ROM during flexion may indicate osteophyte formation in the coronoid fossa, and mechanical blocks to ROM during extension may indicate osteophyte formation in the olecranon fossa. Pain elicited at the end points of motion is caused by osteophytes and impingement, whereas pain elicited during the mid-arc of motion is often caused by osteochondral lesions. Terminal extension, often the first motion lost after injury, may signal intra-articular pathology, if symptomatic. However, throwing athletes may present with developmental flexion contractures of up to 20°.¹⁰

2. Examine the medial aspect of the elbow

The medial epicondyle, easy to recognize as a bony prominence on the medial side of the distal humerus, serves as an attachment site for the MCL, pronator teres, and the common flexor tendon. In throwers, assessing the MCL is crucial. The MCL should be palpated from its origin on the inferior aspect of the medial epicondyle moving distally to the sublime tubercle of the proximal ulna. Tenderness at any point along the ligament can indicate a range of ligament pathology, from attenuation to complete rupture.

The MCL is further assessed with stress tests, most commonly the valgus stress test, the milking maneuver, and the moving valgus stress test. Of these 3 procedures, the moving valgus stress test is perhaps the most sensitive and specific for MCL injury, and is the test preferred by the authors.¹¹ This test takes into account shoulder position, simulates the position of throwing, and can account for bony structures that provide stability at more than 120° of flexion. We prefer to position the patient supine on the examining table to help stabilize the shoulder and humerus and to relax the patient. The shoulder is placed in abduction and external rotation while the examiner holds the thumb with one hand and supports the elbow with the other. The elbow is extended (Figure 2A) and flexed (Figure 2B) while valgus stress is applied. A positive test elicits pain localized to the MCL at the arc of motion between 80° to 120°.¹² Pain at positions near full extension with the moving valgus stress test may also indicate chondral damage at the posteromedial trochlea.¹³

During pitching, the tensile demand on the MCL is reduced by the action of the flexor-pronator mass. It is common to see a flexor-pronator mass injury concurrent with MCL injury.¹⁴ Medial epicondyle tenderness that increases with resisted wrist flexion may signal flexor-pronator injury, though, classically, flexor-pronator muscle strains and tears produce pain anterior and distal to the medial epicondyle.¹⁵

Traction, compression, and friction at the medial elbow can irritate the ulnar nerve. This nerve should be inspected and palpated along its course at the cubital tunnel to determine its location and stability. Ulnar nerve hypermobility, which has been identified in 37% of elbows, can be determined by having the patient actively flex the elbow with the forearm in supination, placing a finger at the posteromedial aspect of the medial humeral epicondyle, and having the patient actively extend the elbow.¹⁶ The nerve dislocates if trapped anterior to the examiner’s finger, perches if under the examiner’s finger, or is stable if still palpable in the groove posterior to the medial epicondyle.¹⁶

The distal band of the medial triceps tendon may also sublux over the medial epicondyle with elbow flexion. This subluxation, also known as snapping triceps syndrome, may cause pain or ulnar nerve symptoms.¹⁷ Bringing the elbow from extension to flexion may produce subluxation, first of the ulnar nerve and then of the medial triceps, in 2 separate “snaps.” Tenderness can be elicited along the medial triceps muscle.

Ulnar neuritis is caused by traction injury, such as with dynamic pitching, nerve subluxation, or compression at the cubital tunnel. With MCL injury and valgus instability, the ulnar nerve can become irritated as it becomes stretched because of medial elbow laxity.¹⁸ The nerve can also be damaged during flexion as the cubital tunnel retinaculum tightens, decreasing the space available for the nerve.¹⁹ This concept is applied during the elbow flexion compression test. A positive test may elicit tingling radiating toward the small finger or pain at the elbow or medial forearm when manual pressure is directly applied over the ulnar nerve between the posteromedial olecranon and the medial humeral epicondyle as the elbow is maximally flexed.²⁰

3. Examine the lateral aspect of the elbow

Palpation of the lateral epicondyle, the radial head, and the olecranon tip assists in defining injury to the underlying anatomy. The anconeus “soft spot” (infracondylar recess) within the triangle formed by these 3 bony landmarks should be palpated for fullness, indicating a joint effusion, hemarthrosis, or even a subluxed or dislocated radial head.

While the medial elbow endures a large tensile load, throwing imposes a tremendous compressive force at the lateral elbow, particularly at the radiocapitellar joint. This joint may be tender and produce clicking with pronation and supination in patients with radiocapitellar arthrosis, symptomatic posterolateral synovial plica, or an inflamed radial bursa. Tenderness with crepitus that can be exacerbated with forceful flexion and extension may indicate radiocapitellar overload or loose bodies.

Long-term load transmission and subsequent degeneration of the articular surface may advance to osteochondritis dissecans (OCD). Examination for capitellar OCD reveals tenderness over the radiocapitellar joint and commonly a loss of 15° to 20° of extension. The active radiocapitellar compression test is positive for OCD lesions and elicits pain in the lateral compartment of the elbow when the patient pronates (Figure 3A) and supinates (Figure 3B) the forearm with the elbow axially loaded in extension.²¹

Microtrauma and inflammation may occur with repetitive eccentric overload. Although rare in throwing athletes, “tennis elbow” causes pain with gripping, and decreased grip strength. Tenderness caused by lateral epicondylitis is just anterior and distal to the epicondyle, at the origin of the extensor carpi radialis brevis. Pain is reproducible with passive wrist flexion and resisted wrist extension with the elbow extended (Cozen test).

Less commonly, athletes may complain of mechanical symptoms, such as snapping or catching with posterolateral elbow pain.²² These symptoms may be due to thickened or inflamed synovial plica causing impingement. A posterior radiocapitellar plica can be examined by bringing the elbow to full extension while applying valgus stress with the forearm in supination. Conversely, an anterior radiocapitellar plica can be examined with a valgus load on the elbow and passive flexion with the forearm in pronation.²³ A palpable painful snap over the radiocapitellar joint is a positive test.

4. Examine the posterior aspect of the elbow

Posteriorly, palpation is focused on the triceps tendon and the olecranon tip. The elbow should be flexed to 30° to relax the triceps, isolate the olecranon, and allow for palpation of the olecranon fossa on either side of the triceps tendon. Tenderness at the posterolateral or posteromedial aspect of the olecranon should be noted. Warmth, fluctuance, or distension at the elbow may be caused by olecranon bursitis. The 3 heads of the triceps muscle should be palpated where they converge to form an aponeurosis, and tenderness or a palpable gap on any of the heads should be noted.

A combination of valgus force and a rapidly decelerating arm at the follow-through phase of pitching causes a shear force between the medial aspect of the olecranon tip and the olecranon fossa. This shear force can result in chondrolysis, osteophyte formation, and loose bodies, particularly in the posteromedial elbow. This valgus extension overload (VEO) syndrome often results in loss of full extension and symptoms, which may be attributed to osteophytes or fractured and nonunited fragments in the olecranon fossa or the olecranon tip. Frank crepitus may also be present with extension testing caused by loose bodies or synovial reaction over osteophytes. Assessing for VEO using the extension impingement test, the examiner places continuous valgus stress on the elbow while quickly extending from 20° to 30° of flexion (Figure 4A) to terminal extension (Figure 4B) repeatedly. The examiner repeats this without valgus load while palpating the posteromedial olecranon for tenderness to differentiate impingement caused by instability from pain over the medial olecranon without instability (Figure 4C). Particular attention should be focused posteriorly in athletes with medial instability, as MCL injuries and VEO syndrome often occur in conjunction in the throwing athlete.

Repetitive acceleration and deceleration of the arm can also cause stress fractures. With stress fractures, pain is often noted more distal and lateral on the olecranon, but tenderness may be palpable medially from posteromedial impaction that occurs from the valgus load during the overhead throwing motion. In immature athletes, the repetitive sudden snap of full extension in the deceleration phase of throwing can cause olecranon apophysitis. Frank avulsions can occur as well but are usually preceded by chronic posterior elbow pain with possible loss of full extension.

The late cocking phase of the throwing motion (just before throwing) hyperextends the elbow and places significant strain on the elbow. Repetitive strain can cause painful posterior impingement. The arm bar test is extremely sensitive (Figure 5).¹³ With the patient’s elbow extended, shoulder internally rotated, and hand on the examiner’s shoulder, the examiner pulls down on the olecranon to simulate forced extension and reproduces the pain associated with posteromedial impingement.

Last, though triceps tendon injuries are rare, ruptures most often occur at the origin of the lateral head of the triceps. As the initial swelling and ecchymosis subside, a palpable gap is pathognomonic for rupture. Extensor weakness can often be observed, but extension may still be possible from anconeus triceps expansion with the aid of gravity. With the elbow overhead, the athlete must extend the elbow against gravity and will exhibit weakness against resistance.

5. Examine the anterior aspect of the elbow

Anteriorly, the bulk of the flexor-pronator group restricts the extent of joint palpation, and the soft tissues are usually injured. The antecubital fossa is a triangular area on the anterior aspect of the elbow that is bounded superiorly by a horizontal line connecting the medial epicondyle to the lateral epicondyle of the humerus, medially by the lateral border of the pronator teres muscle and laterally by the medial border of the brachioradialis muscle. From lateral to medial, the antecubital fossa contains the radial nerve, the biceps brachii tendon, the brachial artery, and the median nerve. Evaluating this area is important because a visible defect, change in muscle contour, or proximal retraction of a muscle belly can indicate a muscular rupture. In particular, a distal biceps rupture (rare) may be accompanied by weakness and pain in supination and, to a lesser degree, in flexion. It is important to note that, in the case of a partial biceps rupture, ecchymosis may not appear, as the hematoma is confined by the intact lacertus fibrosis.²⁴ The hook test can be used to evaluate for the presence of an intact distal biceps tendon (Figure 6).²⁵ The patient abducts the shoulder, flexes the elbow to 90°, and actively supinates the forearm while the examiner attempts to hook an index finger laterally under the tendon. The test is negative if the finger can be inserted 1 cm under the tendon and positive if no cordlike structure can be hooked. Partial biceps tendon ruptures or tendinitis may exhibit tenderness of the distal biceps tendon and pain on resisted supination with a negative hook test. Often, resisted elbow flexion with the elbow at maximal extension elicits pain at the biceps insertion. Clicking with forearm rotation near the insertion of the tendon, which may be caused by an inflamed radial bursa between the distal biceps tendon and the radial tuberosity, may be associated with impending rupture.

Conclusion

Physical examination combined with thorough history taking usually provides a solid basis for a diagnosis, which in turn makes the value of surgical treatment more assured.

The VA and the DoD operate completely independent health care systems. Integrated provision of health care for the populations served is a compellingly attractive goal given the obvious overlaps, but has proven deceptively difficult to implement.

Despite efforts begun in 1998 to accomplish a reliable, comprehensive, bidirectional exchange of patient-specific health care information between systems, 16 years later this has yet to be reliably available. In most locales, VHA practitioners cannot easily access details of the medical care provided to DoD personnel. Attempts to merge the 2 electronic medical record (EMR) systems have also been fraught with difficulty.¹ Even at the new, joint VHA/DoD Captain James A. Lovell Federal Health Care Center in North Chicago, Illinois (which opened in October 2010 to serve a mix of active-duty servicemen, TRICARE beneficiaries, and VA enrollees under a single roof), care using a single EMR system has not been possible.

The Institute of Medicine, in an invited review, has specifically criticized the unsatisfactory, piecemeal EMR integration.² On February 5, 2013, the Secretary of the VA and the Secretary of Defense formally abandoned efforts to construct a single VA/DoD integrated EMR system by 2017. Instead, both organizations would, in then Secretary of Defense Leon Panetta’s words, “…focus our immediate efforts on integrating VA and DoD health data as quickly as possible, by focusing on interoperability and using existing solutions.”³

Joint VA/DoD health care programs in Northern California have abandoned merged structures in favor of mutual alignment. The practical value of aligning care systems is to extract benefit from structured, economically rational, win-win collaborations, as opposed to the forced merger approach. Mutual alignment generates relatively prompt, reliable results, to the benefit of all concerned.

Related: Developing Joint VA and DoD Health Programs

This report details a consistently favorable experience with this philosophy, which has considerable relevance as federal and nonfederal systems explore future joint ventures. Specifically, this report describes the substantial multiyear savings from a combination of various DoD/VA Joint Incentive Fund (JIF) and Sharing Agreement projects conducted by the VA Northern California Health Care System (VANCHCS) and the U.S. Air Force (USAF) 60th Medical Group’s (60MDG’s) David Grant Medical Center (DGMC).

Background and Methods

VA Northern California Health Care System currently serves 92,000 unique veteran patients in a service area of 40,000 square miles through a network of facilities and clinics at 9 sites across northern California. Rapid year-over-year growth of VANCHCS continues, and in fiscal year (FY) 2013, so-called unique enrolled veterans increased by 4.7%. David Grant Medical Center is a 116-bed DoD flagship hospital at Travis Air Force Base in Fairfield, California, which is home to the 60MDG. In 2013, VANCHCS and DGMC celebrated the 20th year of collaborative projects.

Congressional mandates encompassed in sections 101, 1701, 1782, 1783, and 8111 of Title 38, United States Code, as well as sections 1074, 1079, 1086, 1104, and Chapter 61 of Title 10, United States Code, have been addressed through a variety of DoD and VA Health Care Resource Sharing Program directives. The most recent instruction covering these agreements was reissued on January 23, 2012 (DoD instruction 6010.23). Sharing Agreements and joint ventures are permitted when such arrangements “…will improve access to quality health care or increase cost-effectiveness of the health care provided … to beneficiaries of both departments.” A Joint Executive Council (JEC), co-chaired by the VA Deputy Secretary and the DoD Acting Under Secretary of Defense for Personnel and Readiness, oversees joint VA/DoD activities.

The collaborative initiatives described in this article have all blossomed into sustainable, ongoing, valuable programs. Aided by JIF grants, they transitioned to standard VHA and DoD budgetary mechanisms in the third year of operation. For the VHA, such ongoing funding is accomplished through the Veterans Equitable Resource Allocation (VERA) budgeting system. Despite overall national/regional advantages, this funding model can result in substantial fiscal pressure for rapidly growing VHA systems, such as VANCHCS. DoD facilities and deployable operational teams, such as the 60MDG, are funded through separate DoD mechanisms. TRICARE services are funded through an entirely different budget. The complexities of this process preclude easy summary in this paper.

Recognizing that new collaborative initiatives inevitably add fiscal stress to involved facilities, the JEC has periodically offered 2-year competitive grant funding on a national basis to support winning proposals. Such JIF grants offer financial support to initiate potentially value-added collaborations. The VHA and DoD equally fund the annual award pool for these JIF grants. In response to periodic solicitations, VHA facilities team with DoD partners to jointly submit concept proposals.

Proposals emerging from separate review, revision, and approval by VHA/VA and USAF/DoD leadership are subjected to a rigorous business case analysis. The JEC then competitively scores the proposals according to transparent weighted criteria. High-scoring proposals enjoy support for renovation, equipment, and personnel for a transition period of 2 years. In the third year of ongoing operation, VHA funding (ie, VERA funding) and DoD funding, sometimes modified by a specific Memoranda of Understanding, pay for the third year, based on the workload during the first year of the program. As a result of third-year reimbursement based on previous volume and care provided, productivity under any new JIF-funded program is financially incentivized from day 1.

Each JIF proposal enumerates specific workload targets and time lines. In northern California, at quarterly intervals, a local VANCHCS-DGMC Joint Venture Executive Management Team (EMT) formally reviews clinical and financial metrics. This local EMT also reports results to the national-level JEC. Clinical metrics for most programs include visit count, consult count, procedure count, and the number of individuals treated in a given year, with breakdown tallies according to patients’ VA or DoD affiliation. Financial metrics include personnel costs, equipment costs, and revenue generated or saved. Savings for VHA patients can be calculated using CPT codes, Diagnosis Related Groups (DRG), and set CHAMPUS Maximum Allowable Charge (CMAC) rates, as calculated by the TRICARE Management Calculator (TMA Calculator).

Personnel serving in joint, integrated programs remain employees of either VHA or DoD, according to the staffing plan specified in the original JIF grant. Beyond the 2-year term of the original JIF grant, VANCHCS and DGMC can jointly adjust/expand staffing to meet increasing demand and programmatic needs. Personnel in joint programs work side by side and treat patients equally regardless of VA or DoD affiliation.

By agreement, EMR orders and EMR patient care documentation are entered according to norms for the organization where the care is delivered (usually DGMC for new inpatient programs). This facilitates identical treatment of patients in JIF programs. However, specific accommodations for inadequate cross talk between VHA and DoD EMR systems have proven necessary. Such accommodations have added cost, but not to a degree that jeopardizes any particular venture.

Findings

The mutual alignment approach shows a uniformly favorable 9-year experience with 9 joint VA/DoD clinical programs initiated through JIF grants totaling $29.6 million.  Formal JIF closeout reports at the 2-year mark are available for 5 programs and document positive return on investment (ROI) for all programs averaging 83%. 

The Joint Neurosurgery Program, planned through a 2005 JIF grant and implemented in 2006, offers a practical example of mutual alignment at work. Pre-JIF, both organizations had limited neurosurgery capability. War-related deployments undermined DGMC service, and ongoing community care expenses beyond $1.5 million per year for DoD beneficiaries seemed inevitable. VANCHCS in 2004-2005 referred nearly all cases to either neighboring VA systems or to community hospitals, suffering both lost VERA revenue on one hand and direct cost on the other. Unreliable care, long wait times, inefficiency, and dissatisfaction plagued the arrangements, which the staff at VANCHCS considered unacceptable.

Combining forces to provide better care made sense, but reorganizing for a fully merged Neurosurgical Service revealed daunting roadblocks. Eventually, merger frustration conceived a more productive, outcome-oriented, practical philosophy: mutual alignment. We recognized that minimizing change, flexibly capitalizing on opportunity, and reinforcing areas of strength could best achieve mutual joint goals. This mind-set facilitated speedy program assembly, in a “can do” collaborative atmosphere, and with gratifyingly little disruption.

Joint Neurosurgery JIF

The joint Neurosurgery JIF fused outpatient clinics to 1 hub location (a VA clinic adjacent to DGMC), left VA and DoD EMR arrangements intact, and established a single site (DGMC) for inpatient neurosurgical procedures. Dual-trained practitioners accessed both DoD and VA EMR systems, often using side-by-side computer stations. Inpatient work, by mutual agreement, used the DoD EMR exclusively. On inpatient discharge, however, a duplicate care summary was entered into the VHA CPRS EMR system.

Using JIF grants, a sophisticated image-guided surgery system was installed at DGMC, an underused operating room (OR) at DGMC was dedicated to neurosurgery, instruments were purchased, and VA nurses were hired to augment OR/ward/intensive care unit staffing at DGMC to support neurosurgical needs. The 3-year neurosurgery JIF budget totaled $5.5 million, 90% of which was dedicated to salaries for additional personnel to expand the service at DGMC. Deliverables included volume increases of 1,100 neurosurgical consultations per year, and at least 100 major procedures per year.

At the completion of the first 3 years of operation, the final report of the JIF noted a 12% ROI. In the post-JIF sustainment years, as joint volume increased further, the program added an additional VA neurosurgeon, a physician assistant, and other staff. Volume has steadily expanded, with 318 major neurosurgical procedures completed in FY 2013. In maintenance mode, consultations remain essentially free to each organization; VANCHCS is reimbursed for salary/benefits for hospital-based VHA personnel working at DGMC; and DGMC charges VANCHCS 75% of CMAC rates for the inpatient care delivered. The arrangement remains financially desirable for both organizations. For FY 2013 the joint relationship in neurosurgery generated a 22% ROI, saving taxpayers nearly $1 million per year. Most important, patients received prompt, excellent care. Waiting times for elective consults were routinely < 14 days, emergency care was reliably available, outcomes were excellent, and satisfaction at all levels have vastly improved.

Measuring Program Success

The funded and implemented JIF programs have all been successful, with positive ROI ranging from 10% to 284% (Table 1). Newer programs lacking a final closeout report are all on track for positive ROI. One additional JIF program, for a joint hematology-oncology center, was delayed by staffing challenges but has now commenced.

Over the past 7 years, outpatient volume and services provided by DGMC have increased. Outpatient support services provided by VANCHCS for DoD personnel at remote sites, while still substantial, diminished (Figures 1 and 2). Such changes reflect intentional concentration at DGMC. Also, a VHA pharmacy service provided to USAF personnel at a site distant from DGMC was intentionally downsized to embrace a mailed-medication program.

Inpatient hospital discharges for VHA enrollees and bed-days of care at DGMC have increased substantially (Figure 3). As a result of sharing programs and JIF programs, VHA enrollees currently account for about 40% of total hospital census at DGMC. About 108 professionals paid by VANCHCS currently work at DGMC. In most cases, as formalized in specific post-JIF sustainment agreements, VANCHCS is reimbursed for clinical staff salary and benefits if such staff are working at DGMC within a JIF program. For inpatient and procedural care, unless charges are specifically excluded as part of specific JIF agreements, VANCHCS pays DGMC at a rate of 75% of CMAC (ie, about 75% of Medicare rates) for every admission. Given geographic constraints, a VHA mandate to keep waits for specialty care under 14 days, and finite assistance levels from other VAMCs in VISN 21, a majority of these cases would otherwise be treated in community fee programs (at a higher cost of 100% of CMAC plus professional fees).

Volume has grown in all such programs (Table 2). Growth in the category of “open cardiac procedures,” however, has been intentionally limited by a VISN 21 requirement that care for VHA patients be provided only when existing VISN 21 cardiac programs cannot accommodate a particular case.

Since FY 2011, as a result of improved analytics, VANCHCS has been able to calculate its global savings (cost avoidance) stemming from all JIF and other sharing programs. Calculating the difference between community fee cost and DGMC cost as about 25% of CMAC (which offers a floor estimate of actual savings), these ongoing programs now save the VANCHCS $7.78 million per year (Table 3).

Positive overall federal ROI (ie, ROI from the taxpayer’s perspective), measured in dollars, is reported at the end of year 3 for every JIF-funded program. Substantial additional ROI could be captured by other metrics, such as timeliness of care and patient satisfaction, and would be favorable for all listed programs (data not shown).

Discussion

Had VANCHCS and DGMC attempted a merged information and management structure for the JIF programs, implementation would have been seriously delayed, if not entirely thwarted. Instead, by explicitly aligning efforts around each organization’s existing capabilities, assets and attributes, new valuable services were quickly developed. Patients now receive high-quality treatment in specialty areas not previously offered (and in some instances, not previously offered by either system).

As noted previously, the DoD and the VHA health care systems vary considerably. For DGMC and the 60MDG, during a time of war, optimal triage practices, safe/speedy transport, and the reliable delivery of appropriate trauma care for the injured warrior represent core missions. The VHA, on the other hand, is dedicated to the well-being, health, and lifetime medical-surgical care of enrolled veterans. The VHA population has relatively high numbers of elderly patients with serious chronic health conditions, such as heart disease, vascular disease, and cancer. VHA also provides subacute and rehabilitative care for younger veterans who served more recently in Iraq and Afghanistan. Overall, the VHA population stands quite distinct from that of our young active-duty forces and their dependents.

The VHA patient population (6.3 million patients receiving treatment and over 8.7 million enrolled) greatly exceeds that of the DoD. For this and other reasons, experience, current skills, and training differ considerably between VHA and DoD practitioners. For active-duty DoD practitioners, especially surgeons, the JIF projects provide avenues for development/maintenance of skills. Further, the JIF-enabled influx of VHA personnel at DGMC enhances staffing at DGMC, thereby improving the capacity of DGMC and the 60MDG’s potential surge capacity. Finally, ongoing joint programs have fostered provider relationships, academic opportunities, and training for DoD personnel between deployments.

The effort also helps personnel satisfy new, quantitative, procedural volume standards (aka currency standards) for DoD/USAF surgeons. For VANCHCS, which is seriously pressed for acute inpatient capacity, the DGMC facility space and beds supporting the joint programs represent an attractive alternative to other options, such as new hospital construction, distant transfers, or reliance on community care (Table 4).

The JIF submission process encourages thoughtful planning and specific identification of resources necessary for success. The intra-and extra-organizational review process, as well as competitive national-level scoring, encourages thrift and innovation. Funded project proposals are generally compelling. Some JIF programs are constructed anew, combining space, bed capacity, and commitment with the requisite staffing, equipment, and team development to ensure safe startup. Examples include the neurosurgery and heart-lung-vascular programs. Others, like the orthopedics program, expand existing capabilities. In each instance, the new programs benefit all concerned: the federal taxpayer, each organization, and patients.

Outside Support and New Programs

The UC Davis Health System (UCDHS), through high-level education, training, and staffing, has explicitly supported these joint programs. Reliable, safe initiation, particularly for the cardiac and vascular programs, would not have been otherwise possible. Key staff members often hold academic faculty appointments, teach, write, and participate in UCDHS programs at all levels. Research in trauma care and other topics has also been facilitated. The positive relationship has supported joint program infrastructure, recruitment, and enhanced/maintained quality.

Multiple successful JIF collaborations and sharing projects, have generated a further, unforeseen benefit: The emergence of an intra-agency, financially relevant, federal market for innovative proposals. This has been coupled in the northern California setting with an emerging willingness by both organizations to potentially sustain a short-term loss for long-term financial or programmatic gain. Strict accounting between organizations, with real dollars going back and forth, has created pools of uncommitted profit, which organizational leaders can use to fund proposals not previously feasible given otherwise daunting fiscal constraints.

One recent example is a non-JIF program for patients requiring general surgery care. Under a no-load pilot program, some DoD surgeons work without additional compensation at VANCHCS facilities, and some general surgery operations are performed at DGMC. This serves to both maintain DoD practitioners’ clinical volume between deployments, and simultaneously address temporary VHA backlogs. Previous and current sharing agreement revenue, complemented by goodwill, supports the exchange. In this particular instance, previous JIF experience has cultivated innovation. Analysis and market discipline will determine its fate.

Limitations

Obstacles thwarting potential joint projects include inadequate projected case volume, logistical constraints, and inadequate ROI. Geographic challenges also limit collaboration in certain areas. The VANCHCS system covers 40,000 square miles. Emergency acute care for a patient mandates use of the nearest capable facility, often a local nonfederal facility. Inadequate communication between VHA and DoD EMR systems, exacerbated by privacy and security protections initiated by both organizations, also tends to block collaboration.

Notwithstanding the alignment over merger philosophy, merged information systems, or at least a faster, more reliable cross talk tool would certainly help. Bidirectional Healthcare Information Exchange (BHIE), if implemented more reliably, might still work. As a work-around, practitioners in joint programs usually practice with a VHA computer and a DoD computer side by side in order to obtain complete information for a given patient. Providers view this as ridiculous. However, all involved respect the need for intact DoD and VHA firewall/security systems.

These collaborative ventures have been created in a unique budgetary environment. Wars end. Congress adjusts budgets. Health care systems change. One or the other partner periodically experiences serious budgetary stress. However, the back-and-forth revenue streams described here tend to smooth the transitions. Despite budgetary and programmatic stress, we are maintaining/expanding all of the joint programs described herein. These programs deliver sustained, cost-effective care with improved access for veterans and military beneficiaries alike and continue to do so through planned, mutually aligned effort, not merger.

Acknowledgements
Current and former commanders of the 60th Medical Group at DGMC: Col Rawson Wood (current commander); Col Kevin Connelly, MD ; Col Brian Hayes, MD; Col Lee Payne, MD.

Current and former directors of VANCHCS: David Stockwell (current director); Brian O’Neill, MD; Lawrence Sandler; Lucille Swanson. UC Davis: Kenneth W. Kizer, MD, MPH, The Institute for Population Health Improvement, and The Center for Veterans and Military Health.

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 the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

The VA and the DoD operate completely independent health care systems. Integrated provision of health care for the populations served is a compellingly attractive goal given the obvious overlaps, but has proven deceptively difficult to implement.

Despite efforts begun in 1998 to accomplish a reliable, comprehensive, bidirectional exchange of patient-specific health care information between systems, 16 years later this has yet to be reliably available. In most locales, VHA practitioners cannot easily access details of the medical care provided to DoD personnel. Attempts to merge the 2 electronic medical record (EMR) systems have also been fraught with difficulty.¹ Even at the new, joint VHA/DoD Captain James A. Lovell Federal Health Care Center in North Chicago, Illinois (which opened in October 2010 to serve a mix of active-duty servicemen, TRICARE beneficiaries, and VA enrollees under a single roof), care using a single EMR system has not been possible.

The Institute of Medicine, in an invited review, has specifically criticized the unsatisfactory, piecemeal EMR integration.² On February 5, 2013, the Secretary of the VA and the Secretary of Defense formally abandoned efforts to construct a single VA/DoD integrated EMR system by 2017. Instead, both organizations would, in then Secretary of Defense Leon Panetta’s words, “…focus our immediate efforts on integrating VA and DoD health data as quickly as possible, by focusing on interoperability and using existing solutions.”³

Joint VA/DoD health care programs in Northern California have abandoned merged structures in favor of mutual alignment. The practical value of aligning care systems is to extract benefit from structured, economically rational, win-win collaborations, as opposed to the forced merger approach. Mutual alignment generates relatively prompt, reliable results, to the benefit of all concerned.

Related: Developing Joint VA and DoD Health Programs

This report details a consistently favorable experience with this philosophy, which has considerable relevance as federal and nonfederal systems explore future joint ventures. Specifically, this report describes the substantial multiyear savings from a combination of various DoD/VA Joint Incentive Fund (JIF) and Sharing Agreement projects conducted by the VA Northern California Health Care System (VANCHCS) and the U.S. Air Force (USAF) 60th Medical Group’s (60MDG’s) David Grant Medical Center (DGMC).

Background and Methods

VA Northern California Health Care System currently serves 92,000 unique veteran patients in a service area of 40,000 square miles through a network of facilities and clinics at 9 sites across northern California. Rapid year-over-year growth of VANCHCS continues, and in fiscal year (FY) 2013, so-called unique enrolled veterans increased by 4.7%. David Grant Medical Center is a 116-bed DoD flagship hospital at Travis Air Force Base in Fairfield, California, which is home to the 60MDG. In 2013, VANCHCS and DGMC celebrated the 20th year of collaborative projects.

Congressional mandates encompassed in sections 101, 1701, 1782, 1783, and 8111 of Title 38, United States Code, as well as sections 1074, 1079, 1086, 1104, and Chapter 61 of Title 10, United States Code, have been addressed through a variety of DoD and VA Health Care Resource Sharing Program directives. The most recent instruction covering these agreements was reissued on January 23, 2012 (DoD instruction 6010.23). Sharing Agreements and joint ventures are permitted when such arrangements “…will improve access to quality health care or increase cost-effectiveness of the health care provided … to beneficiaries of both departments.” A Joint Executive Council (JEC), co-chaired by the VA Deputy Secretary and the DoD Acting Under Secretary of Defense for Personnel and Readiness, oversees joint VA/DoD activities.

The collaborative initiatives described in this article have all blossomed into sustainable, ongoing, valuable programs. Aided by JIF grants, they transitioned to standard VHA and DoD budgetary mechanisms in the third year of operation. For the VHA, such ongoing funding is accomplished through the Veterans Equitable Resource Allocation (VERA) budgeting system. Despite overall national/regional advantages, this funding model can result in substantial fiscal pressure for rapidly growing VHA systems, such as VANCHCS. DoD facilities and deployable operational teams, such as the 60MDG, are funded through separate DoD mechanisms. TRICARE services are funded through an entirely different budget. The complexities of this process preclude easy summary in this paper.

Recognizing that new collaborative initiatives inevitably add fiscal stress to involved facilities, the JEC has periodically offered 2-year competitive grant funding on a national basis to support winning proposals. Such JIF grants offer financial support to initiate potentially value-added collaborations. The VHA and DoD equally fund the annual award pool for these JIF grants. In response to periodic solicitations, VHA facilities team with DoD partners to jointly submit concept proposals.

Proposals emerging from separate review, revision, and approval by VHA/VA and USAF/DoD leadership are subjected to a rigorous business case analysis. The JEC then competitively scores the proposals according to transparent weighted criteria. High-scoring proposals enjoy support for renovation, equipment, and personnel for a transition period of 2 years. In the third year of ongoing operation, VHA funding (ie, VERA funding) and DoD funding, sometimes modified by a specific Memoranda of Understanding, pay for the third year, based on the workload during the first year of the program. As a result of third-year reimbursement based on previous volume and care provided, productivity under any new JIF-funded program is financially incentivized from day 1.

Each JIF proposal enumerates specific workload targets and time lines. In northern California, at quarterly intervals, a local VANCHCS-DGMC Joint Venture Executive Management Team (EMT) formally reviews clinical and financial metrics. This local EMT also reports results to the national-level JEC. Clinical metrics for most programs include visit count, consult count, procedure count, and the number of individuals treated in a given year, with breakdown tallies according to patients’ VA or DoD affiliation. Financial metrics include personnel costs, equipment costs, and revenue generated or saved. Savings for VHA patients can be calculated using CPT codes, Diagnosis Related Groups (DRG), and set CHAMPUS Maximum Allowable Charge (CMAC) rates, as calculated by the TRICARE Management Calculator (TMA Calculator).

Personnel serving in joint, integrated programs remain employees of either VHA or DoD, according to the staffing plan specified in the original JIF grant. Beyond the 2-year term of the original JIF grant, VANCHCS and DGMC can jointly adjust/expand staffing to meet increasing demand and programmatic needs. Personnel in joint programs work side by side and treat patients equally regardless of VA or DoD affiliation.

By agreement, EMR orders and EMR patient care documentation are entered according to norms for the organization where the care is delivered (usually DGMC for new inpatient programs). This facilitates identical treatment of patients in JIF programs. However, specific accommodations for inadequate cross talk between VHA and DoD EMR systems have proven necessary. Such accommodations have added cost, but not to a degree that jeopardizes any particular venture.

Findings

The mutual alignment approach shows a uniformly favorable 9-year experience with 9 joint VA/DoD clinical programs initiated through JIF grants totaling $29.6 million.  Formal JIF closeout reports at the 2-year mark are available for 5 programs and document positive return on investment (ROI) for all programs averaging 83%. 

The Joint Neurosurgery Program, planned through a 2005 JIF grant and implemented in 2006, offers a practical example of mutual alignment at work. Pre-JIF, both organizations had limited neurosurgery capability. War-related deployments undermined DGMC service, and ongoing community care expenses beyond $1.5 million per year for DoD beneficiaries seemed inevitable. VANCHCS in 2004-2005 referred nearly all cases to either neighboring VA systems or to community hospitals, suffering both lost VERA revenue on one hand and direct cost on the other. Unreliable care, long wait times, inefficiency, and dissatisfaction plagued the arrangements, which the staff at VANCHCS considered unacceptable.

Combining forces to provide better care made sense, but reorganizing for a fully merged Neurosurgical Service revealed daunting roadblocks. Eventually, merger frustration conceived a more productive, outcome-oriented, practical philosophy: mutual alignment. We recognized that minimizing change, flexibly capitalizing on opportunity, and reinforcing areas of strength could best achieve mutual joint goals. This mind-set facilitated speedy program assembly, in a “can do” collaborative atmosphere, and with gratifyingly little disruption.

Joint Neurosurgery JIF

The joint Neurosurgery JIF fused outpatient clinics to 1 hub location (a VA clinic adjacent to DGMC), left VA and DoD EMR arrangements intact, and established a single site (DGMC) for inpatient neurosurgical procedures. Dual-trained practitioners accessed both DoD and VA EMR systems, often using side-by-side computer stations. Inpatient work, by mutual agreement, used the DoD EMR exclusively. On inpatient discharge, however, a duplicate care summary was entered into the VHA CPRS EMR system.

Using JIF grants, a sophisticated image-guided surgery system was installed at DGMC, an underused operating room (OR) at DGMC was dedicated to neurosurgery, instruments were purchased, and VA nurses were hired to augment OR/ward/intensive care unit staffing at DGMC to support neurosurgical needs. The 3-year neurosurgery JIF budget totaled $5.5 million, 90% of which was dedicated to salaries for additional personnel to expand the service at DGMC. Deliverables included volume increases of 1,100 neurosurgical consultations per year, and at least 100 major procedures per year.

At the completion of the first 3 years of operation, the final report of the JIF noted a 12% ROI. In the post-JIF sustainment years, as joint volume increased further, the program added an additional VA neurosurgeon, a physician assistant, and other staff. Volume has steadily expanded, with 318 major neurosurgical procedures completed in FY 2013. In maintenance mode, consultations remain essentially free to each organization; VANCHCS is reimbursed for salary/benefits for hospital-based VHA personnel working at DGMC; and DGMC charges VANCHCS 75% of CMAC rates for the inpatient care delivered. The arrangement remains financially desirable for both organizations. For FY 2013 the joint relationship in neurosurgery generated a 22% ROI, saving taxpayers nearly $1 million per year. Most important, patients received prompt, excellent care. Waiting times for elective consults were routinely < 14 days, emergency care was reliably available, outcomes were excellent, and satisfaction at all levels have vastly improved.

Measuring Program Success

The funded and implemented JIF programs have all been successful, with positive ROI ranging from 10% to 284% (Table 1). Newer programs lacking a final closeout report are all on track for positive ROI. One additional JIF program, for a joint hematology-oncology center, was delayed by staffing challenges but has now commenced.

Over the past 7 years, outpatient volume and services provided by DGMC have increased. Outpatient support services provided by VANCHCS for DoD personnel at remote sites, while still substantial, diminished (Figures 1 and 2). Such changes reflect intentional concentration at DGMC. Also, a VHA pharmacy service provided to USAF personnel at a site distant from DGMC was intentionally downsized to embrace a mailed-medication program.

Inpatient hospital discharges for VHA enrollees and bed-days of care at DGMC have increased substantially (Figure 3). As a result of sharing programs and JIF programs, VHA enrollees currently account for about 40% of total hospital census at DGMC. About 108 professionals paid by VANCHCS currently work at DGMC. In most cases, as formalized in specific post-JIF sustainment agreements, VANCHCS is reimbursed for clinical staff salary and benefits if such staff are working at DGMC within a JIF program. For inpatient and procedural care, unless charges are specifically excluded as part of specific JIF agreements, VANCHCS pays DGMC at a rate of 75% of CMAC (ie, about 75% of Medicare rates) for every admission. Given geographic constraints, a VHA mandate to keep waits for specialty care under 14 days, and finite assistance levels from other VAMCs in VISN 21, a majority of these cases would otherwise be treated in community fee programs (at a higher cost of 100% of CMAC plus professional fees).

Volume has grown in all such programs (Table 2). Growth in the category of “open cardiac procedures,” however, has been intentionally limited by a VISN 21 requirement that care for VHA patients be provided only when existing VISN 21 cardiac programs cannot accommodate a particular case.

Since FY 2011, as a result of improved analytics, VANCHCS has been able to calculate its global savings (cost avoidance) stemming from all JIF and other sharing programs. Calculating the difference between community fee cost and DGMC cost as about 25% of CMAC (which offers a floor estimate of actual savings), these ongoing programs now save the VANCHCS $7.78 million per year (Table 3).

Positive overall federal ROI (ie, ROI from the taxpayer’s perspective), measured in dollars, is reported at the end of year 3 for every JIF-funded program. Substantial additional ROI could be captured by other metrics, such as timeliness of care and patient satisfaction, and would be favorable for all listed programs (data not shown).

Discussion

Had VANCHCS and DGMC attempted a merged information and management structure for the JIF programs, implementation would have been seriously delayed, if not entirely thwarted. Instead, by explicitly aligning efforts around each organization’s existing capabilities, assets and attributes, new valuable services were quickly developed. Patients now receive high-quality treatment in specialty areas not previously offered (and in some instances, not previously offered by either system).

As noted previously, the DoD and the VHA health care systems vary considerably. For DGMC and the 60MDG, during a time of war, optimal triage practices, safe/speedy transport, and the reliable delivery of appropriate trauma care for the injured warrior represent core missions. The VHA, on the other hand, is dedicated to the well-being, health, and lifetime medical-surgical care of enrolled veterans. The VHA population has relatively high numbers of elderly patients with serious chronic health conditions, such as heart disease, vascular disease, and cancer. VHA also provides subacute and rehabilitative care for younger veterans who served more recently in Iraq and Afghanistan. Overall, the VHA population stands quite distinct from that of our young active-duty forces and their dependents.

The VHA patient population (6.3 million patients receiving treatment and over 8.7 million enrolled) greatly exceeds that of the DoD. For this and other reasons, experience, current skills, and training differ considerably between VHA and DoD practitioners. For active-duty DoD practitioners, especially surgeons, the JIF projects provide avenues for development/maintenance of skills. Further, the JIF-enabled influx of VHA personnel at DGMC enhances staffing at DGMC, thereby improving the capacity of DGMC and the 60MDG’s potential surge capacity. Finally, ongoing joint programs have fostered provider relationships, academic opportunities, and training for DoD personnel between deployments.

The effort also helps personnel satisfy new, quantitative, procedural volume standards (aka currency standards) for DoD/USAF surgeons. For VANCHCS, which is seriously pressed for acute inpatient capacity, the DGMC facility space and beds supporting the joint programs represent an attractive alternative to other options, such as new hospital construction, distant transfers, or reliance on community care (Table 4).

The JIF submission process encourages thoughtful planning and specific identification of resources necessary for success. The intra-and extra-organizational review process, as well as competitive national-level scoring, encourages thrift and innovation. Funded project proposals are generally compelling. Some JIF programs are constructed anew, combining space, bed capacity, and commitment with the requisite staffing, equipment, and team development to ensure safe startup. Examples include the neurosurgery and heart-lung-vascular programs. Others, like the orthopedics program, expand existing capabilities. In each instance, the new programs benefit all concerned: the federal taxpayer, each organization, and patients.

Outside Support and New Programs

The UC Davis Health System (UCDHS), through high-level education, training, and staffing, has explicitly supported these joint programs. Reliable, safe initiation, particularly for the cardiac and vascular programs, would not have been otherwise possible. Key staff members often hold academic faculty appointments, teach, write, and participate in UCDHS programs at all levels. Research in trauma care and other topics has also been facilitated. The positive relationship has supported joint program infrastructure, recruitment, and enhanced/maintained quality.

Multiple successful JIF collaborations and sharing projects, have generated a further, unforeseen benefit: The emergence of an intra-agency, financially relevant, federal market for innovative proposals. This has been coupled in the northern California setting with an emerging willingness by both organizations to potentially sustain a short-term loss for long-term financial or programmatic gain. Strict accounting between organizations, with real dollars going back and forth, has created pools of uncommitted profit, which organizational leaders can use to fund proposals not previously feasible given otherwise daunting fiscal constraints.

One recent example is a non-JIF program for patients requiring general surgery care. Under a no-load pilot program, some DoD surgeons work without additional compensation at VANCHCS facilities, and some general surgery operations are performed at DGMC. This serves to both maintain DoD practitioners’ clinical volume between deployments, and simultaneously address temporary VHA backlogs. Previous and current sharing agreement revenue, complemented by goodwill, supports the exchange. In this particular instance, previous JIF experience has cultivated innovation. Analysis and market discipline will determine its fate.

Limitations

Obstacles thwarting potential joint projects include inadequate projected case volume, logistical constraints, and inadequate ROI. Geographic challenges also limit collaboration in certain areas. The VANCHCS system covers 40,000 square miles. Emergency acute care for a patient mandates use of the nearest capable facility, often a local nonfederal facility. Inadequate communication between VHA and DoD EMR systems, exacerbated by privacy and security protections initiated by both organizations, also tends to block collaboration.

Notwithstanding the alignment over merger philosophy, merged information systems, or at least a faster, more reliable cross talk tool would certainly help. Bidirectional Healthcare Information Exchange (BHIE), if implemented more reliably, might still work. As a work-around, practitioners in joint programs usually practice with a VHA computer and a DoD computer side by side in order to obtain complete information for a given patient. Providers view this as ridiculous. However, all involved respect the need for intact DoD and VHA firewall/security systems.

These collaborative ventures have been created in a unique budgetary environment. Wars end. Congress adjusts budgets. Health care systems change. One or the other partner periodically experiences serious budgetary stress. However, the back-and-forth revenue streams described here tend to smooth the transitions. Despite budgetary and programmatic stress, we are maintaining/expanding all of the joint programs described herein. These programs deliver sustained, cost-effective care with improved access for veterans and military beneficiaries alike and continue to do so through planned, mutually aligned effort, not merger.

Acknowledgements
Current and former commanders of the 60th Medical Group at DGMC: Col Rawson Wood (current commander); Col Kevin Connelly, MD ; Col Brian Hayes, MD; Col Lee Payne, MD.

Current and former directors of VANCHCS: David Stockwell (current director); Brian O’Neill, MD; Lawrence Sandler; Lucille Swanson. UC Davis: Kenneth W. Kizer, MD, MPH, The Institute for Population Health Improvement, and The Center for Veterans and Military Health.

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 the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

The VA and the DoD operate completely independent health care systems. Integrated provision of health care for the populations served is a compellingly attractive goal given the obvious overlaps, but has proven deceptively difficult to implement.

Despite efforts begun in 1998 to accomplish a reliable, comprehensive, bidirectional exchange of patient-specific health care information between systems, 16 years later this has yet to be reliably available. In most locales, VHA practitioners cannot easily access details of the medical care provided to DoD personnel. Attempts to merge the 2 electronic medical record (EMR) systems have also been fraught with difficulty.¹ Even at the new, joint VHA/DoD Captain James A. Lovell Federal Health Care Center in North Chicago, Illinois (which opened in October 2010 to serve a mix of active-duty servicemen, TRICARE beneficiaries, and VA enrollees under a single roof), care using a single EMR system has not been possible.

The Institute of Medicine, in an invited review, has specifically criticized the unsatisfactory, piecemeal EMR integration.² On February 5, 2013, the Secretary of the VA and the Secretary of Defense formally abandoned efforts to construct a single VA/DoD integrated EMR system by 2017. Instead, both organizations would, in then Secretary of Defense Leon Panetta’s words, “…focus our immediate efforts on integrating VA and DoD health data as quickly as possible, by focusing on interoperability and using existing solutions.”³

Joint VA/DoD health care programs in Northern California have abandoned merged structures in favor of mutual alignment. The practical value of aligning care systems is to extract benefit from structured, economically rational, win-win collaborations, as opposed to the forced merger approach. Mutual alignment generates relatively prompt, reliable results, to the benefit of all concerned.

Related: Developing Joint VA and DoD Health Programs

This report details a consistently favorable experience with this philosophy, which has considerable relevance as federal and nonfederal systems explore future joint ventures. Specifically, this report describes the substantial multiyear savings from a combination of various DoD/VA Joint Incentive Fund (JIF) and Sharing Agreement projects conducted by the VA Northern California Health Care System (VANCHCS) and the U.S. Air Force (USAF) 60th Medical Group’s (60MDG’s) David Grant Medical Center (DGMC).

Background and Methods

VA Northern California Health Care System currently serves 92,000 unique veteran patients in a service area of 40,000 square miles through a network of facilities and clinics at 9 sites across northern California. Rapid year-over-year growth of VANCHCS continues, and in fiscal year (FY) 2013, so-called unique enrolled veterans increased by 4.7%. David Grant Medical Center is a 116-bed DoD flagship hospital at Travis Air Force Base in Fairfield, California, which is home to the 60MDG. In 2013, VANCHCS and DGMC celebrated the 20th year of collaborative projects.

Congressional mandates encompassed in sections 101, 1701, 1782, 1783, and 8111 of Title 38, United States Code, as well as sections 1074, 1079, 1086, 1104, and Chapter 61 of Title 10, United States Code, have been addressed through a variety of DoD and VA Health Care Resource Sharing Program directives. The most recent instruction covering these agreements was reissued on January 23, 2012 (DoD instruction 6010.23). Sharing Agreements and joint ventures are permitted when such arrangements “…will improve access to quality health care or increase cost-effectiveness of the health care provided … to beneficiaries of both departments.” A Joint Executive Council (JEC), co-chaired by the VA Deputy Secretary and the DoD Acting Under Secretary of Defense for Personnel and Readiness, oversees joint VA/DoD activities.

The collaborative initiatives described in this article have all blossomed into sustainable, ongoing, valuable programs. Aided by JIF grants, they transitioned to standard VHA and DoD budgetary mechanisms in the third year of operation. For the VHA, such ongoing funding is accomplished through the Veterans Equitable Resource Allocation (VERA) budgeting system. Despite overall national/regional advantages, this funding model can result in substantial fiscal pressure for rapidly growing VHA systems, such as VANCHCS. DoD facilities and deployable operational teams, such as the 60MDG, are funded through separate DoD mechanisms. TRICARE services are funded through an entirely different budget. The complexities of this process preclude easy summary in this paper.

Recognizing that new collaborative initiatives inevitably add fiscal stress to involved facilities, the JEC has periodically offered 2-year competitive grant funding on a national basis to support winning proposals. Such JIF grants offer financial support to initiate potentially value-added collaborations. The VHA and DoD equally fund the annual award pool for these JIF grants. In response to periodic solicitations, VHA facilities team with DoD partners to jointly submit concept proposals.

Proposals emerging from separate review, revision, and approval by VHA/VA and USAF/DoD leadership are subjected to a rigorous business case analysis. The JEC then competitively scores the proposals according to transparent weighted criteria. High-scoring proposals enjoy support for renovation, equipment, and personnel for a transition period of 2 years. In the third year of ongoing operation, VHA funding (ie, VERA funding) and DoD funding, sometimes modified by a specific Memoranda of Understanding, pay for the third year, based on the workload during the first year of the program. As a result of third-year reimbursement based on previous volume and care provided, productivity under any new JIF-funded program is financially incentivized from day 1.

Each JIF proposal enumerates specific workload targets and time lines. In northern California, at quarterly intervals, a local VANCHCS-DGMC Joint Venture Executive Management Team (EMT) formally reviews clinical and financial metrics. This local EMT also reports results to the national-level JEC. Clinical metrics for most programs include visit count, consult count, procedure count, and the number of individuals treated in a given year, with breakdown tallies according to patients’ VA or DoD affiliation. Financial metrics include personnel costs, equipment costs, and revenue generated or saved. Savings for VHA patients can be calculated using CPT codes, Diagnosis Related Groups (DRG), and set CHAMPUS Maximum Allowable Charge (CMAC) rates, as calculated by the TRICARE Management Calculator (TMA Calculator).

Personnel serving in joint, integrated programs remain employees of either VHA or DoD, according to the staffing plan specified in the original JIF grant. Beyond the 2-year term of the original JIF grant, VANCHCS and DGMC can jointly adjust/expand staffing to meet increasing demand and programmatic needs. Personnel in joint programs work side by side and treat patients equally regardless of VA or DoD affiliation.

By agreement, EMR orders and EMR patient care documentation are entered according to norms for the organization where the care is delivered (usually DGMC for new inpatient programs). This facilitates identical treatment of patients in JIF programs. However, specific accommodations for inadequate cross talk between VHA and DoD EMR systems have proven necessary. Such accommodations have added cost, but not to a degree that jeopardizes any particular venture.

Findings

The mutual alignment approach shows a uniformly favorable 9-year experience with 9 joint VA/DoD clinical programs initiated through JIF grants totaling $29.6 million.  Formal JIF closeout reports at the 2-year mark are available for 5 programs and document positive return on investment (ROI) for all programs averaging 83%. 

The Joint Neurosurgery Program, planned through a 2005 JIF grant and implemented in 2006, offers a practical example of mutual alignment at work. Pre-JIF, both organizations had limited neurosurgery capability. War-related deployments undermined DGMC service, and ongoing community care expenses beyond $1.5 million per year for DoD beneficiaries seemed inevitable. VANCHCS in 2004-2005 referred nearly all cases to either neighboring VA systems or to community hospitals, suffering both lost VERA revenue on one hand and direct cost on the other. Unreliable care, long wait times, inefficiency, and dissatisfaction plagued the arrangements, which the staff at VANCHCS considered unacceptable.

Combining forces to provide better care made sense, but reorganizing for a fully merged Neurosurgical Service revealed daunting roadblocks. Eventually, merger frustration conceived a more productive, outcome-oriented, practical philosophy: mutual alignment. We recognized that minimizing change, flexibly capitalizing on opportunity, and reinforcing areas of strength could best achieve mutual joint goals. This mind-set facilitated speedy program assembly, in a “can do” collaborative atmosphere, and with gratifyingly little disruption.

Joint Neurosurgery JIF

The joint Neurosurgery JIF fused outpatient clinics to 1 hub location (a VA clinic adjacent to DGMC), left VA and DoD EMR arrangements intact, and established a single site (DGMC) for inpatient neurosurgical procedures. Dual-trained practitioners accessed both DoD and VA EMR systems, often using side-by-side computer stations. Inpatient work, by mutual agreement, used the DoD EMR exclusively. On inpatient discharge, however, a duplicate care summary was entered into the VHA CPRS EMR system.

Using JIF grants, a sophisticated image-guided surgery system was installed at DGMC, an underused operating room (OR) at DGMC was dedicated to neurosurgery, instruments were purchased, and VA nurses were hired to augment OR/ward/intensive care unit staffing at DGMC to support neurosurgical needs. The 3-year neurosurgery JIF budget totaled $5.5 million, 90% of which was dedicated to salaries for additional personnel to expand the service at DGMC. Deliverables included volume increases of 1,100 neurosurgical consultations per year, and at least 100 major procedures per year.

At the completion of the first 3 years of operation, the final report of the JIF noted a 12% ROI. In the post-JIF sustainment years, as joint volume increased further, the program added an additional VA neurosurgeon, a physician assistant, and other staff. Volume has steadily expanded, with 318 major neurosurgical procedures completed in FY 2013. In maintenance mode, consultations remain essentially free to each organization; VANCHCS is reimbursed for salary/benefits for hospital-based VHA personnel working at DGMC; and DGMC charges VANCHCS 75% of CMAC rates for the inpatient care delivered. The arrangement remains financially desirable for both organizations. For FY 2013 the joint relationship in neurosurgery generated a 22% ROI, saving taxpayers nearly $1 million per year. Most important, patients received prompt, excellent care. Waiting times for elective consults were routinely < 14 days, emergency care was reliably available, outcomes were excellent, and satisfaction at all levels have vastly improved.

Measuring Program Success

The funded and implemented JIF programs have all been successful, with positive ROI ranging from 10% to 284% (Table 1). Newer programs lacking a final closeout report are all on track for positive ROI. One additional JIF program, for a joint hematology-oncology center, was delayed by staffing challenges but has now commenced.

Over the past 7 years, outpatient volume and services provided by DGMC have increased. Outpatient support services provided by VANCHCS for DoD personnel at remote sites, while still substantial, diminished (Figures 1 and 2). Such changes reflect intentional concentration at DGMC. Also, a VHA pharmacy service provided to USAF personnel at a site distant from DGMC was intentionally downsized to embrace a mailed-medication program.

Inpatient hospital discharges for VHA enrollees and bed-days of care at DGMC have increased substantially (Figure 3). As a result of sharing programs and JIF programs, VHA enrollees currently account for about 40% of total hospital census at DGMC. About 108 professionals paid by VANCHCS currently work at DGMC. In most cases, as formalized in specific post-JIF sustainment agreements, VANCHCS is reimbursed for clinical staff salary and benefits if such staff are working at DGMC within a JIF program. For inpatient and procedural care, unless charges are specifically excluded as part of specific JIF agreements, VANCHCS pays DGMC at a rate of 75% of CMAC (ie, about 75% of Medicare rates) for every admission. Given geographic constraints, a VHA mandate to keep waits for specialty care under 14 days, and finite assistance levels from other VAMCs in VISN 21, a majority of these cases would otherwise be treated in community fee programs (at a higher cost of 100% of CMAC plus professional fees).

Volume has grown in all such programs (Table 2). Growth in the category of “open cardiac procedures,” however, has been intentionally limited by a VISN 21 requirement that care for VHA patients be provided only when existing VISN 21 cardiac programs cannot accommodate a particular case.

Since FY 2011, as a result of improved analytics, VANCHCS has been able to calculate its global savings (cost avoidance) stemming from all JIF and other sharing programs. Calculating the difference between community fee cost and DGMC cost as about 25% of CMAC (which offers a floor estimate of actual savings), these ongoing programs now save the VANCHCS $7.78 million per year (Table 3).

Positive overall federal ROI (ie, ROI from the taxpayer’s perspective), measured in dollars, is reported at the end of year 3 for every JIF-funded program. Substantial additional ROI could be captured by other metrics, such as timeliness of care and patient satisfaction, and would be favorable for all listed programs (data not shown).

Discussion

Had VANCHCS and DGMC attempted a merged information and management structure for the JIF programs, implementation would have been seriously delayed, if not entirely thwarted. Instead, by explicitly aligning efforts around each organization’s existing capabilities, assets and attributes, new valuable services were quickly developed. Patients now receive high-quality treatment in specialty areas not previously offered (and in some instances, not previously offered by either system).

As noted previously, the DoD and the VHA health care systems vary considerably. For DGMC and the 60MDG, during a time of war, optimal triage practices, safe/speedy transport, and the reliable delivery of appropriate trauma care for the injured warrior represent core missions. The VHA, on the other hand, is dedicated to the well-being, health, and lifetime medical-surgical care of enrolled veterans. The VHA population has relatively high numbers of elderly patients with serious chronic health conditions, such as heart disease, vascular disease, and cancer. VHA also provides subacute and rehabilitative care for younger veterans who served more recently in Iraq and Afghanistan. Overall, the VHA population stands quite distinct from that of our young active-duty forces and their dependents.

The VHA patient population (6.3 million patients receiving treatment and over 8.7 million enrolled) greatly exceeds that of the DoD. For this and other reasons, experience, current skills, and training differ considerably between VHA and DoD practitioners. For active-duty DoD practitioners, especially surgeons, the JIF projects provide avenues for development/maintenance of skills. Further, the JIF-enabled influx of VHA personnel at DGMC enhances staffing at DGMC, thereby improving the capacity of DGMC and the 60MDG’s potential surge capacity. Finally, ongoing joint programs have fostered provider relationships, academic opportunities, and training for DoD personnel between deployments.

The effort also helps personnel satisfy new, quantitative, procedural volume standards (aka currency standards) for DoD/USAF surgeons. For VANCHCS, which is seriously pressed for acute inpatient capacity, the DGMC facility space and beds supporting the joint programs represent an attractive alternative to other options, such as new hospital construction, distant transfers, or reliance on community care (Table 4).

The JIF submission process encourages thoughtful planning and specific identification of resources necessary for success. The intra-and extra-organizational review process, as well as competitive national-level scoring, encourages thrift and innovation. Funded project proposals are generally compelling. Some JIF programs are constructed anew, combining space, bed capacity, and commitment with the requisite staffing, equipment, and team development to ensure safe startup. Examples include the neurosurgery and heart-lung-vascular programs. Others, like the orthopedics program, expand existing capabilities. In each instance, the new programs benefit all concerned: the federal taxpayer, each organization, and patients.

Outside Support and New Programs

The UC Davis Health System (UCDHS), through high-level education, training, and staffing, has explicitly supported these joint programs. Reliable, safe initiation, particularly for the cardiac and vascular programs, would not have been otherwise possible. Key staff members often hold academic faculty appointments, teach, write, and participate in UCDHS programs at all levels. Research in trauma care and other topics has also been facilitated. The positive relationship has supported joint program infrastructure, recruitment, and enhanced/maintained quality.

Multiple successful JIF collaborations and sharing projects, have generated a further, unforeseen benefit: The emergence of an intra-agency, financially relevant, federal market for innovative proposals. This has been coupled in the northern California setting with an emerging willingness by both organizations to potentially sustain a short-term loss for long-term financial or programmatic gain. Strict accounting between organizations, with real dollars going back and forth, has created pools of uncommitted profit, which organizational leaders can use to fund proposals not previously feasible given otherwise daunting fiscal constraints.

One recent example is a non-JIF program for patients requiring general surgery care. Under a no-load pilot program, some DoD surgeons work without additional compensation at VANCHCS facilities, and some general surgery operations are performed at DGMC. This serves to both maintain DoD practitioners’ clinical volume between deployments, and simultaneously address temporary VHA backlogs. Previous and current sharing agreement revenue, complemented by goodwill, supports the exchange. In this particular instance, previous JIF experience has cultivated innovation. Analysis and market discipline will determine its fate.

Limitations

Obstacles thwarting potential joint projects include inadequate projected case volume, logistical constraints, and inadequate ROI. Geographic challenges also limit collaboration in certain areas. The VANCHCS system covers 40,000 square miles. Emergency acute care for a patient mandates use of the nearest capable facility, often a local nonfederal facility. Inadequate communication between VHA and DoD EMR systems, exacerbated by privacy and security protections initiated by both organizations, also tends to block collaboration.

Notwithstanding the alignment over merger philosophy, merged information systems, or at least a faster, more reliable cross talk tool would certainly help. Bidirectional Healthcare Information Exchange (BHIE), if implemented more reliably, might still work. As a work-around, practitioners in joint programs usually practice with a VHA computer and a DoD computer side by side in order to obtain complete information for a given patient. Providers view this as ridiculous. However, all involved respect the need for intact DoD and VHA firewall/security systems.

These collaborative ventures have been created in a unique budgetary environment. Wars end. Congress adjusts budgets. Health care systems change. One or the other partner periodically experiences serious budgetary stress. However, the back-and-forth revenue streams described here tend to smooth the transitions. Despite budgetary and programmatic stress, we are maintaining/expanding all of the joint programs described herein. These programs deliver sustained, cost-effective care with improved access for veterans and military beneficiaries alike and continue to do so through planned, mutually aligned effort, not merger.

Acknowledgements
Current and former commanders of the 60th Medical Group at DGMC: Col Rawson Wood (current commander); Col Kevin Connelly, MD ; Col Brian Hayes, MD; Col Lee Payne, MD.

Current and former directors of VANCHCS: David Stockwell (current director); Brian O’Neill, MD; Lawrence Sandler; Lucille Swanson. UC Davis: Kenneth W. Kizer, MD, MPH, The Institute for Population Health Improvement, and The Center for Veterans and Military Health.

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 the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Type 2 diabetes mellitus (T2DM) is a significant, growing health problem that results in increased morbidity and mortality. In adults, T2DM accounts for about 90% to 95% of all diagnosed cases of diabetes.¹ Diabetes is the leading cause of kidney failure and blindness; moreover, diabetic patients are 2 to 4 times more likely to die of complications of heart disease and/or have a stroke.² Other complications of diabetes include nervous system damage and nontraumatic lower limb amputation. Increased morbidity and mortality not only diminishes quality of life (QOL) for patients with diabetes, but also produces a financial health care burden. The cost of diabetes in the U.S. in 2012 was more than $245 billion compared with $174 billion in 2007.¹

The Centers for Disease Control and Prevention (CDC) predicts that 1 in 3 American adults will develop diabetes by 2050; thus, optimal approaches to diabetic care need to be developed and evaluated to determine best practices.^3,4 Better control of blood sugar, cholesterol, and blood pressure levels in people with diabetes will help reduce the risk of complications of kidney disease, eye disease, nervous system disease, heart attack, and stroke.⁵ Optimal approaches to diabetes management must now be developed to prepare for the forecasted increase of T2DM.

A review of the literature confirms that lack of continuity of care often leads to patient dissatisfaction with health care, to fragmented health care, and a greater propensity to disregard a defined health care treatment plan.^6,7 In addition to improved patient satisfaction and adherence to medical management, improved continuity of care is cost-effective. A longitudinal study based on claims data from 2000 to 2008, using the continuity of care index, indicated that improved continuity of care was associated with less health care waste and lower health care expenses for patients with T2DM.⁸ An average savings of $737 in total health care expenses per person was achieved with better continuity of care.⁸ These studies demonstrate that improving continuity of care improves outcomes in patients with diabetes and helps prevent excessive health care costs and waste.

Medical Center NonContinuity

Lack of continuity of care has been identified as a potential obstacle to optimal diabetic outcomes at William Beaumont Army Medical Center (WBAMC) in El Paso, Texas, based on a recent data analysis provided by TRICARE Regional Office West.^9,10 As of March 2010, 56,936 patients were enrolled in TRICARE Prime. Of these patients, only 29.92% had appointments with their assigned primary care manager (PCM).⁹

In 2009, WBAMC developed a database to track the Healthcare Effectiveness Data and Information Set (HEDIS) measures to monitor A_1c as well as other indicators of performance of health care services, such as mammography, Pap smear, bone densitometry, and colorectal screening. A recent American Diabetic Association expert committee recommendation endorsed the use of A_1c value > 6.5% to confirm the diagnosis of diabetes.¹¹ The A_1c test may be confirmed with a repeat test unless clinical symptoms exist or the patient has random glucose levels > 200 mg/dL. Importantly, individuals with an A_1c between 6% and 6.5% have a higher risk for developing diabetes and may be diagnosed with prediabetes.³

From 2008 to 2009, the HEDIS database tracking the progress of A_1c demonstrated a 0.3% positive change and improvement in A_1c ≤ 9% (normal 4%-6%). The goal for people with diabetes is A_1c < 7%. Uncontrolled diabetes, (ie, A_1c > 9%), is associated with greater diabetes-related complications.¹² Using the HEDIS benchmark of ≥ 9%, the HEDIS A_1c data for fiscal year (FY) 2008 were 71.1 (p50) and 81 (p90), and for FY 2009 were 72.2 (p50) and 81.3 (p90), reflecting p90 0.3% improvement.¹³ Therefore, these data reflect poor outcomes of patients with T2DM with A_1c levels that were not controlled at WBAMC.

Uncontrolled diabetes accrues significant health care costs and adverse diabetic outcomes.¹⁰ Consequently, the WBAMC clinical operations division, which was tasked to monitor the HEDIS database, identified and contacted individuals to schedule health care appointments. The primary endeavor was an attempt to substantially increase benchmarks and maintain levels of A_1c < 9%, demonstrate improvement in quality of care, and reduce health care costs. Unfortunately, these goals were not met for the aggregate of patients with T2DM.

Figure 1 illustrates how the diabetic population at WBAMC had experienced decreased continuity of care and the adverse effects on their diabetes management. Figure 1 also illustrates how beneficiaries of TRICARE are assigned a PCM and how this process results in a lack of continuity of care for patients with T2DM. An Army medical center (MEDCEN) typically uses PCMs who may be a physician, nurse practitioner (NP), or physician assistant. Unfortunately, the majority of these PCMs are active-duty military or civil service personnel who commonly undergo permanent change of station moves or deployments every 3 years. Additionally, military providers are often rotated through department-chief positions, thereby dissolving their patient relationships.

Frequent rotations offer a valid means to foster leadership skills much needed in a military conflict zone and maximize military professional development; however, rotations also contribute to the lack of continuity of patient care. This PCM instability and the distinctive military dynamic volatility are characteristic of standard military operating procedure and are unlikely to change.

New solutions are needed to promote improved continuity of care for patients with diabetes at a MEDCEN. According to Lt Gen Eric Schoomaker, former Surgeon General of the Army, “The Patient-Centered Medical Home concept is being adopted throughout the military health system.”¹⁴ The goal of the trend toward patient-centered medical home (PCMH) care delivery is to improve access to high-quality health care services.¹³

Patient-Centered Medical Home

The term patient-centered medical home was introduced in 1967 by the American Academy of Pediatrics (AAP).¹⁵ In 2008, PCMH principles became integral in most health care reform initiatives.¹⁶ In most PCMH models, increased continuity of care is the single common denominator of practice. Continuity of care is defined as intensified integration, coordination, and sharing of information between disciplines that result in improved patient outcomes.^10,17,18

In 2007, a consensus statement was provided by the American Academy of Family Practice, the AAP, American College of Physicians, and the American Osteopathic Association stating that quality and safety are hallmarks of the PCMH and may improve outcomes for chronic disease, such as diabetes.¹⁹

Quality improvement is vital in health care organizations because of demands by government agencies, health maintenance organizations, and the public to continually improve services and to provide the highest quality health care at the best cost.²⁰ Diabetes has become a public health crisis, as previously discussed, and a comprehensive approach to care management is essential. Developing an optimal process for diabetes health care and methods for evaluation of the delivery process is foundational for all stakeholders involved, including health care organizations, health care providers, and patients.²⁰

Diabetic outcomes were evaluated at a recent 2-year trial PCMH approach T2DM clinic at a MEDCEN at WBAMC. The purpose of the project was to determine whether a PCMH approach improves disease management compared with routine primary care management.

Methods

The process and manner of care delivery was the focus of this analysis and evaluation, not clinician knowledge of treatment management. A comparison of care delivery approaches of PCM management and PCMH care delivery is displayed in the Table. The treatment algorithm for T2DM was not in question, because guidelines for practice are established based on scientific evidence, and medication management is based on evidence-based practice.^21,22 Evaluation consisted of T2DM delivery of care process and the efficacy of outcome achieved by the specified delivery of care: (a) increased access to care; (b) intensive, repeated education; and (3) a multidisciplinary approach focused on patient empowerment. The following is a description of the specified delivery of care.

Increased Access to Care

Increased access to care addressed through frequent telecommunication provided by the registered nurse (RN) case manager who regularly called patients within 72 hours of insulin adjustment or 24 hours for insulin initiation or significant medication changes. Additionally, the diabetes team providers requested a follow-up appointment in 1 week when injectable medication was added or changes were made in insulin management. One exception was for the addition of livaglutide, in which a 2-week follow-up was made, to allow for titration of the medication. For oral medication adjustment, a 1-month follow-up was generally made, with a 2-month follow-up when a glucose histogram indicated optimal glycemic control, an average blood glucose of 7% (estimated average glucose of 154 mg/dL) or less. Time for appointments was increased by 10 minutes for a total of 30-minute  appointments, compared with 20 minutes for PCM delivery.

Informational continuity was thought to be improved by use of an electronic medical record (EMR), allowing for an uninterrupted patient record. Providers were expected to document medication reconciliation with a clear explanation of medication adjustments listed in the plan. Patient teaching was documented, describing the specific patient education concerns addressed. Other data included a glucometer statistical report from the last appointment to the current appointment, to track negative or positive changes in glycemic control.

Patient Education

The management technique used in the clinic was intensive, repeated education with the goal of improving learning and retention with repeated instruction and positive reinforcement. Skinner theorized that learning is the acquisition of new behavior through conditioning (eg, repeated instruction), is in close proximity of time, and is likely to result in learning retention, which remain relevant education practice.^23,24 The T2DM clinic operates on Skinner’s principles of repeated, intensive education. For example, patients must bring their glucometer to every appointment. The statistical analysis downloaded from the glucometer provides immediate reinforcement and information about patients’ glycemic control. Patients are typically excited to see an improvement from previous levels and are encouraged to continue behavior modification. Conversely, statistical analysis demonstrating poor glycemic control generally encourages the patient to make needed lifestyle changes. Thus, changes in behavior due to intensive, repeated education, followed by a reinforcing stimulus results in an increased probability of that behavior occurring in the future.^23,25 The interdisciplinary team provides education during each T2DM patient encounter.

Multidisciplinary Approach

The multidisciplinary team formed at the trial T2DM clinic consisted of a medical doctor, family NP, pharmacist, RN, licensed vocational nurse, and registered dietician. The team members were each encouraged to obtain Certified Diabetes Educator (CDE) certification. For the first 6 months of developing the clinic, staff scheduled weekly team-building meetings to encourage esprit de corps. The weekly meetings were also used to discuss difficult patient cases. The RN case manager provided the patients with individualized plans to help them meet specified goals and provided easy accessibility for patient questions and concerns. The pharmacist was integral in helping patients understand the role of their medication and was also certified to make medication adjustments related to diabetes.

A recent Institute of Medicine (IOM) report encouraged the expansion of roles for nurse practitioners (NPs) in coordination and primary care delivery.²⁶ The IOM collaborative statement is based on numerous studies showing that NPs provided equivalent quality of care compared with that of primary care physicians in routine chronic disease management.²⁶ Nurse case managers functioned as an integral part of the intensive therapy involved in the landmark Diabetes Control and Complication Trial.²⁷

The intended policy analysis and outcome evaluation was confined to data collected from a disease-specific (T2DM) clinic with a PCMH approach developed April 2011 at WBAMC. Data were obtained from the WBAMC database designed to track the HEDIS measures.

Enrollees of the clinic were restricted to patients diagnosed with T2DM who were TRICARE beneficiaries. Males and females, aged > 20 years with an established A_1c > 6.5% comprised the patient population of the clinic. Individuals who were managed by WBAMC or were TRICARE standard beneficiaries were excluded from the study. Because patients with T1DM have a different pathology than those with T2DM, they were referred to endocrinology. Patients with gestational diabetes were referred to obstetrics for management.

Data Collection

Existing data in the Armed Forces Health Longitudinal Technology Application (AHLTA) EMR were used for this analysis. Data were accessed by a Common Access Card (CAC card) enhanced security system accessed only through secure CAC applications.

Diabetic outcomes of glycemic control as measured by the A_1c value were examined prior to clinic enrollment (time 1: PCM care delivery) and subsequently (time 2: PCMH care delivery) at the health care provider’s discretion. The second time varied between 2 and 6 months, depending on (1) provider need to determine quickly (2 months) whether  a downward trend was occurring because of multiple comorbidities; (2) provider discretion to wait an additional 3 months (A_1c turnover x 2 = 6 months), while medication adjustments are being made; and (3) according to feasibility of follow-up based on patient’s scheduling. Low-density lipoprotein cholesterol (LDL-C) was also examined at both PCM care delivery and PCMH care delivery.

The endpoints of a reduction in A_1c by 1% and an LDL-C that is ≤ 100 mg/dL determined improved diabetes outcomes. Existing data (eg, glycemic control [A_1c], lipid control [LDL-C]), from April 1, 2011, to December 31, 2011, were logged in a clinic database. These data served to demonstrate the effectiveness of the T2DM PCMH approach to clinic management. The PCMH principles that were examined included the standard operating procedure for the T2DM-PCMH clinic: frequent appointments > 2 in a 3-month period), a multidisciplinary team, and intensive, repeated education.

Data analysis was conducted with descriptive statistics (frequencies, means, SDs) and t test analysis to determine relationships between variables of A_1c, LDL-C, and frequency of visits. Improved diabetic outcomes, as previously defined, inferred that developing principles of a T2DM-PCMH clinic based on the principles of a PCMH provided a solution to optimal T2DM management compared with routine primary care delivery, consisting of a TRICARE-assigned PCM.

Results

A total of 638 unique patients were seen at the T2DM-PCMH clinic. Of these, 237 patient records in the database met the inclusion criteria and were acceptable for analysis and evaluation. Patients were omitted for the following reasons: 255 patients did not meet protocol of a minimum 2 visits during the evaluation period, 77 patients were omitted due to no second A_1c available, 65 patients did not meet the clinic protocol of a A_1c of > 6.5%, and 4 were omitted because no A_1c was available for pre- or postanalysis. Data analysis and evaluation of the remaining 237 acceptable patients demonstrated that a T2DM-PCMH approach provided improved diabetic care compared with routine, PCM management.

Patients enrolled at the WBAMC T2DM clinic demonstrated clinically significant improvement (P < .001), and 80.5% achieved > 1% improvement in glycemic control. The greatest number of visits of 26 visits, an outlier not typical of the frequency of patient visits, was attributed to brittle T2DM requiring more frequent monitoring. Most patients had 3 T2DM-PCMH clinic appointments (2 were the minimum visits described in clinic protocol).

Low-density lipoprotein cholesterol levels were analyzed to determine whether patients with diabetes managed at the WBAMC T2DM clinic also had improved lipid control. A total of 638 patients had an initial LDL-C level drawn prior to clinic management. Of these patients, 282 were acceptable for analysis (Figure 2). Low-density lipoprotein cholesterol data were omitted because 93 did not have a paired pre- and postvalues, 8 values were invalid due to nonfasting laboratory status; and 255 values were omitted due to having < 2 clinic visits. Results of the data analysis demonstrated that LDL-C was well managed by the T2DM clinic, with levels ≤ 100 mg/dL (P < .001) (Figure 3).

Discussion

The WBAMC T2DM clinic was formed as a trial clinic at a medical treatment facility (MTF) MEDCEN due to the failure of routine PCM care to improve outcomes in the management of the diabetes population (A_1c < 7.0%). Overall, improved endpoints of A_1c, LDL-C were achieved with the disease-specific PCMH approach compared with routine PCM approach. The results indicate that disease-specific management leads to improved diabetic endpoints (A_1c reduction by at least 1% and LDL-C < 100 mg/dL). The clinic’s protocol (listed in the methods) was intended to improve continuity.

A review of the literature confirmed that continuity of care is integral to patient satisfaction and improved diabetes management.^{8,10,17,28,29} The results of the study were consistent with those in the literature. The review of the literature established that patients who develop a trusting relationship with the health care provider as the T2DM clinic promoted (eg, frequent patient appointments, telecommunication by nurse, and patient participation) are more likely to follow medical therapy and take a proactive role in disease management.^6,28,30

Conclusion

This study demonstrated that PCMH-delivered care offers a solution to suboptimal management of chronic disease, such as T2DM, and that chronic disease is best managed by implementation of a disease-specific PCMH. It is recommended that a MTF develop other disease-specific PCMH and pilot-test these programs. Long-term follow-up studies and additional data collection, such as blood pressure control, abdominal circumference, body mass index, and triglyceride levels would be useful to determine effectiveness.

Based on principles of a PCMH, the efficacy of the T2DM clinic at WBAMC demonstrated that improved diabetes management was achieved by increased continuity of care; intensive, repeated patient education; and a multidisciplinary team approach. The CDC identifies self-management training as foundational to improving health outcomes and QOL for individuals with diabetes.¹ Primary care providers in a MTF may improve diabetic patient outcomes by referring patients to a T2DM clinic, such as the WBAMC T2DM clinic. The multidisciplinary team facilitated patient empowerment by educating patients on the management of their disease and the problem-solving and coping skills required to manage a chronic disease.

The WBAMC T2DM-PCMH based mission of fostering patient empowerment and a team approach is a comprehensive approach to diabetes care. Currently, the PCMH model is being adapted by the military in the latest health care reform initiatives.¹⁴ However, the move toward the PCMH model does not incorporate disease-specific PCMH clinics. This study demonstrates that the disease-specific PCMH approach provides improved disease management and may be effective in other chronic disease management. A benefit of the T2DM-PCMH approach is the reduced burden of escalating health care costs related to increased morbidity and mortality, which is associated with the growing health care problem of poorly controlled T2DM.^1,4,31

The disease-specific clinic evaluated at WBAMC provides an effective solution to fragmented health care for the optimal management of T2DM. The clinic’s conceptual framework of increased access to care, with consistent education at closer time intervals when compared with PCM management resulted in improved continuity and T2DM control. Future research in this area should assess measurable cost reduction. Improved disease management as demonstrated by the T2DM disease-specific clinic at WBAMC provides sufficient incentive to incorporate similar T2DM continuity clinics and changes throughout MTFs.  

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.

Type 2 diabetes mellitus (T2DM) is a significant, growing health problem that results in increased morbidity and mortality. In adults, T2DM accounts for about 90% to 95% of all diagnosed cases of diabetes.¹ Diabetes is the leading cause of kidney failure and blindness; moreover, diabetic patients are 2 to 4 times more likely to die of complications of heart disease and/or have a stroke.² Other complications of diabetes include nervous system damage and nontraumatic lower limb amputation. Increased morbidity and mortality not only diminishes quality of life (QOL) for patients with diabetes, but also produces a financial health care burden. The cost of diabetes in the U.S. in 2012 was more than $245 billion compared with $174 billion in 2007.¹

The Centers for Disease Control and Prevention (CDC) predicts that 1 in 3 American adults will develop diabetes by 2050; thus, optimal approaches to diabetic care need to be developed and evaluated to determine best practices.^3,4 Better control of blood sugar, cholesterol, and blood pressure levels in people with diabetes will help reduce the risk of complications of kidney disease, eye disease, nervous system disease, heart attack, and stroke.⁵ Optimal approaches to diabetes management must now be developed to prepare for the forecasted increase of T2DM.

A review of the literature confirms that lack of continuity of care often leads to patient dissatisfaction with health care, to fragmented health care, and a greater propensity to disregard a defined health care treatment plan.^6,7 In addition to improved patient satisfaction and adherence to medical management, improved continuity of care is cost-effective. A longitudinal study based on claims data from 2000 to 2008, using the continuity of care index, indicated that improved continuity of care was associated with less health care waste and lower health care expenses for patients with T2DM.⁸ An average savings of $737 in total health care expenses per person was achieved with better continuity of care.⁸ These studies demonstrate that improving continuity of care improves outcomes in patients with diabetes and helps prevent excessive health care costs and waste.

Medical Center NonContinuity

Lack of continuity of care has been identified as a potential obstacle to optimal diabetic outcomes at William Beaumont Army Medical Center (WBAMC) in El Paso, Texas, based on a recent data analysis provided by TRICARE Regional Office West.^9,10 As of March 2010, 56,936 patients were enrolled in TRICARE Prime. Of these patients, only 29.92% had appointments with their assigned primary care manager (PCM).⁹

In 2009, WBAMC developed a database to track the Healthcare Effectiveness Data and Information Set (HEDIS) measures to monitor A_1c as well as other indicators of performance of health care services, such as mammography, Pap smear, bone densitometry, and colorectal screening. A recent American Diabetic Association expert committee recommendation endorsed the use of A_1c value > 6.5% to confirm the diagnosis of diabetes.¹¹ The A_1c test may be confirmed with a repeat test unless clinical symptoms exist or the patient has random glucose levels > 200 mg/dL. Importantly, individuals with an A_1c between 6% and 6.5% have a higher risk for developing diabetes and may be diagnosed with prediabetes.³

From 2008 to 2009, the HEDIS database tracking the progress of A_1c demonstrated a 0.3% positive change and improvement in A_1c ≤ 9% (normal 4%-6%). The goal for people with diabetes is A_1c < 7%. Uncontrolled diabetes, (ie, A_1c > 9%), is associated with greater diabetes-related complications.¹² Using the HEDIS benchmark of ≥ 9%, the HEDIS A_1c data for fiscal year (FY) 2008 were 71.1 (p50) and 81 (p90), and for FY 2009 were 72.2 (p50) and 81.3 (p90), reflecting p90 0.3% improvement.¹³ Therefore, these data reflect poor outcomes of patients with T2DM with A_1c levels that were not controlled at WBAMC.

Uncontrolled diabetes accrues significant health care costs and adverse diabetic outcomes.¹⁰ Consequently, the WBAMC clinical operations division, which was tasked to monitor the HEDIS database, identified and contacted individuals to schedule health care appointments. The primary endeavor was an attempt to substantially increase benchmarks and maintain levels of A_1c < 9%, demonstrate improvement in quality of care, and reduce health care costs. Unfortunately, these goals were not met for the aggregate of patients with T2DM.

Figure 1 illustrates how the diabetic population at WBAMC had experienced decreased continuity of care and the adverse effects on their diabetes management. Figure 1 also illustrates how beneficiaries of TRICARE are assigned a PCM and how this process results in a lack of continuity of care for patients with T2DM. An Army medical center (MEDCEN) typically uses PCMs who may be a physician, nurse practitioner (NP), or physician assistant. Unfortunately, the majority of these PCMs are active-duty military or civil service personnel who commonly undergo permanent change of station moves or deployments every 3 years. Additionally, military providers are often rotated through department-chief positions, thereby dissolving their patient relationships.

Frequent rotations offer a valid means to foster leadership skills much needed in a military conflict zone and maximize military professional development; however, rotations also contribute to the lack of continuity of patient care. This PCM instability and the distinctive military dynamic volatility are characteristic of standard military operating procedure and are unlikely to change.

New solutions are needed to promote improved continuity of care for patients with diabetes at a MEDCEN. According to Lt Gen Eric Schoomaker, former Surgeon General of the Army, “The Patient-Centered Medical Home concept is being adopted throughout the military health system.”¹⁴ The goal of the trend toward patient-centered medical home (PCMH) care delivery is to improve access to high-quality health care services.¹³

Patient-Centered Medical Home

The term patient-centered medical home was introduced in 1967 by the American Academy of Pediatrics (AAP).¹⁵ In 2008, PCMH principles became integral in most health care reform initiatives.¹⁶ In most PCMH models, increased continuity of care is the single common denominator of practice. Continuity of care is defined as intensified integration, coordination, and sharing of information between disciplines that result in improved patient outcomes.^10,17,18

In 2007, a consensus statement was provided by the American Academy of Family Practice, the AAP, American College of Physicians, and the American Osteopathic Association stating that quality and safety are hallmarks of the PCMH and may improve outcomes for chronic disease, such as diabetes.¹⁹

Quality improvement is vital in health care organizations because of demands by government agencies, health maintenance organizations, and the public to continually improve services and to provide the highest quality health care at the best cost.²⁰ Diabetes has become a public health crisis, as previously discussed, and a comprehensive approach to care management is essential. Developing an optimal process for diabetes health care and methods for evaluation of the delivery process is foundational for all stakeholders involved, including health care organizations, health care providers, and patients.²⁰

Diabetic outcomes were evaluated at a recent 2-year trial PCMH approach T2DM clinic at a MEDCEN at WBAMC. The purpose of the project was to determine whether a PCMH approach improves disease management compared with routine primary care management.

Methods

The process and manner of care delivery was the focus of this analysis and evaluation, not clinician knowledge of treatment management. A comparison of care delivery approaches of PCM management and PCMH care delivery is displayed in the Table. The treatment algorithm for T2DM was not in question, because guidelines for practice are established based on scientific evidence, and medication management is based on evidence-based practice.^21,22 Evaluation consisted of T2DM delivery of care process and the efficacy of outcome achieved by the specified delivery of care: (a) increased access to care; (b) intensive, repeated education; and (3) a multidisciplinary approach focused on patient empowerment. The following is a description of the specified delivery of care.

Increased Access to Care

Increased access to care addressed through frequent telecommunication provided by the registered nurse (RN) case manager who regularly called patients within 72 hours of insulin adjustment or 24 hours for insulin initiation or significant medication changes. Additionally, the diabetes team providers requested a follow-up appointment in 1 week when injectable medication was added or changes were made in insulin management. One exception was for the addition of livaglutide, in which a 2-week follow-up was made, to allow for titration of the medication. For oral medication adjustment, a 1-month follow-up was generally made, with a 2-month follow-up when a glucose histogram indicated optimal glycemic control, an average blood glucose of 7% (estimated average glucose of 154 mg/dL) or less. Time for appointments was increased by 10 minutes for a total of 30-minute  appointments, compared with 20 minutes for PCM delivery.

Informational continuity was thought to be improved by use of an electronic medical record (EMR), allowing for an uninterrupted patient record. Providers were expected to document medication reconciliation with a clear explanation of medication adjustments listed in the plan. Patient teaching was documented, describing the specific patient education concerns addressed. Other data included a glucometer statistical report from the last appointment to the current appointment, to track negative or positive changes in glycemic control.

Patient Education

The management technique used in the clinic was intensive, repeated education with the goal of improving learning and retention with repeated instruction and positive reinforcement. Skinner theorized that learning is the acquisition of new behavior through conditioning (eg, repeated instruction), is in close proximity of time, and is likely to result in learning retention, which remain relevant education practice.^23,24 The T2DM clinic operates on Skinner’s principles of repeated, intensive education. For example, patients must bring their glucometer to every appointment. The statistical analysis downloaded from the glucometer provides immediate reinforcement and information about patients’ glycemic control. Patients are typically excited to see an improvement from previous levels and are encouraged to continue behavior modification. Conversely, statistical analysis demonstrating poor glycemic control generally encourages the patient to make needed lifestyle changes. Thus, changes in behavior due to intensive, repeated education, followed by a reinforcing stimulus results in an increased probability of that behavior occurring in the future.^23,25 The interdisciplinary team provides education during each T2DM patient encounter.

Multidisciplinary Approach

The multidisciplinary team formed at the trial T2DM clinic consisted of a medical doctor, family NP, pharmacist, RN, licensed vocational nurse, and registered dietician. The team members were each encouraged to obtain Certified Diabetes Educator (CDE) certification. For the first 6 months of developing the clinic, staff scheduled weekly team-building meetings to encourage esprit de corps. The weekly meetings were also used to discuss difficult patient cases. The RN case manager provided the patients with individualized plans to help them meet specified goals and provided easy accessibility for patient questions and concerns. The pharmacist was integral in helping patients understand the role of their medication and was also certified to make medication adjustments related to diabetes.

A recent Institute of Medicine (IOM) report encouraged the expansion of roles for nurse practitioners (NPs) in coordination and primary care delivery.²⁶ The IOM collaborative statement is based on numerous studies showing that NPs provided equivalent quality of care compared with that of primary care physicians in routine chronic disease management.²⁶ Nurse case managers functioned as an integral part of the intensive therapy involved in the landmark Diabetes Control and Complication Trial.²⁷

The intended policy analysis and outcome evaluation was confined to data collected from a disease-specific (T2DM) clinic with a PCMH approach developed April 2011 at WBAMC. Data were obtained from the WBAMC database designed to track the HEDIS measures.

Enrollees of the clinic were restricted to patients diagnosed with T2DM who were TRICARE beneficiaries. Males and females, aged > 20 years with an established A_1c > 6.5% comprised the patient population of the clinic. Individuals who were managed by WBAMC or were TRICARE standard beneficiaries were excluded from the study. Because patients with T1DM have a different pathology than those with T2DM, they were referred to endocrinology. Patients with gestational diabetes were referred to obstetrics for management.

Data Collection

Existing data in the Armed Forces Health Longitudinal Technology Application (AHLTA) EMR were used for this analysis. Data were accessed by a Common Access Card (CAC card) enhanced security system accessed only through secure CAC applications.

Diabetic outcomes of glycemic control as measured by the A_1c value were examined prior to clinic enrollment (time 1: PCM care delivery) and subsequently (time 2: PCMH care delivery) at the health care provider’s discretion. The second time varied between 2 and 6 months, depending on (1) provider need to determine quickly (2 months) whether  a downward trend was occurring because of multiple comorbidities; (2) provider discretion to wait an additional 3 months (A_1c turnover x 2 = 6 months), while medication adjustments are being made; and (3) according to feasibility of follow-up based on patient’s scheduling. Low-density lipoprotein cholesterol (LDL-C) was also examined at both PCM care delivery and PCMH care delivery.

The endpoints of a reduction in A_1c by 1% and an LDL-C that is ≤ 100 mg/dL determined improved diabetes outcomes. Existing data (eg, glycemic control [A_1c], lipid control [LDL-C]), from April 1, 2011, to December 31, 2011, were logged in a clinic database. These data served to demonstrate the effectiveness of the T2DM PCMH approach to clinic management. The PCMH principles that were examined included the standard operating procedure for the T2DM-PCMH clinic: frequent appointments > 2 in a 3-month period), a multidisciplinary team, and intensive, repeated education.

Data analysis was conducted with descriptive statistics (frequencies, means, SDs) and t test analysis to determine relationships between variables of A_1c, LDL-C, and frequency of visits. Improved diabetic outcomes, as previously defined, inferred that developing principles of a T2DM-PCMH clinic based on the principles of a PCMH provided a solution to optimal T2DM management compared with routine primary care delivery, consisting of a TRICARE-assigned PCM.

Results

A total of 638 unique patients were seen at the T2DM-PCMH clinic. Of these, 237 patient records in the database met the inclusion criteria and were acceptable for analysis and evaluation. Patients were omitted for the following reasons: 255 patients did not meet protocol of a minimum 2 visits during the evaluation period, 77 patients were omitted due to no second A_1c available, 65 patients did not meet the clinic protocol of a A_1c of > 6.5%, and 4 were omitted because no A_1c was available for pre- or postanalysis. Data analysis and evaluation of the remaining 237 acceptable patients demonstrated that a T2DM-PCMH approach provided improved diabetic care compared with routine, PCM management.

Patients enrolled at the WBAMC T2DM clinic demonstrated clinically significant improvement (P < .001), and 80.5% achieved > 1% improvement in glycemic control. The greatest number of visits of 26 visits, an outlier not typical of the frequency of patient visits, was attributed to brittle T2DM requiring more frequent monitoring. Most patients had 3 T2DM-PCMH clinic appointments (2 were the minimum visits described in clinic protocol).

Low-density lipoprotein cholesterol levels were analyzed to determine whether patients with diabetes managed at the WBAMC T2DM clinic also had improved lipid control. A total of 638 patients had an initial LDL-C level drawn prior to clinic management. Of these patients, 282 were acceptable for analysis (Figure 2). Low-density lipoprotein cholesterol data were omitted because 93 did not have a paired pre- and postvalues, 8 values were invalid due to nonfasting laboratory status; and 255 values were omitted due to having < 2 clinic visits. Results of the data analysis demonstrated that LDL-C was well managed by the T2DM clinic, with levels ≤ 100 mg/dL (P < .001) (Figure 3).

Discussion

The WBAMC T2DM clinic was formed as a trial clinic at a medical treatment facility (MTF) MEDCEN due to the failure of routine PCM care to improve outcomes in the management of the diabetes population (A_1c < 7.0%). Overall, improved endpoints of A_1c, LDL-C were achieved with the disease-specific PCMH approach compared with routine PCM approach. The results indicate that disease-specific management leads to improved diabetic endpoints (A_1c reduction by at least 1% and LDL-C < 100 mg/dL). The clinic’s protocol (listed in the methods) was intended to improve continuity.

A review of the literature confirmed that continuity of care is integral to patient satisfaction and improved diabetes management.^{8,10,17,28,29} The results of the study were consistent with those in the literature. The review of the literature established that patients who develop a trusting relationship with the health care provider as the T2DM clinic promoted (eg, frequent patient appointments, telecommunication by nurse, and patient participation) are more likely to follow medical therapy and take a proactive role in disease management.^6,28,30

Conclusion

This study demonstrated that PCMH-delivered care offers a solution to suboptimal management of chronic disease, such as T2DM, and that chronic disease is best managed by implementation of a disease-specific PCMH. It is recommended that a MTF develop other disease-specific PCMH and pilot-test these programs. Long-term follow-up studies and additional data collection, such as blood pressure control, abdominal circumference, body mass index, and triglyceride levels would be useful to determine effectiveness.

Based on principles of a PCMH, the efficacy of the T2DM clinic at WBAMC demonstrated that improved diabetes management was achieved by increased continuity of care; intensive, repeated patient education; and a multidisciplinary team approach. The CDC identifies self-management training as foundational to improving health outcomes and QOL for individuals with diabetes.¹ Primary care providers in a MTF may improve diabetic patient outcomes by referring patients to a T2DM clinic, such as the WBAMC T2DM clinic. The multidisciplinary team facilitated patient empowerment by educating patients on the management of their disease and the problem-solving and coping skills required to manage a chronic disease.

The WBAMC T2DM-PCMH based mission of fostering patient empowerment and a team approach is a comprehensive approach to diabetes care. Currently, the PCMH model is being adapted by the military in the latest health care reform initiatives.¹⁴ However, the move toward the PCMH model does not incorporate disease-specific PCMH clinics. This study demonstrates that the disease-specific PCMH approach provides improved disease management and may be effective in other chronic disease management. A benefit of the T2DM-PCMH approach is the reduced burden of escalating health care costs related to increased morbidity and mortality, which is associated with the growing health care problem of poorly controlled T2DM.^1,4,31

The disease-specific clinic evaluated at WBAMC provides an effective solution to fragmented health care for the optimal management of T2DM. The clinic’s conceptual framework of increased access to care, with consistent education at closer time intervals when compared with PCM management resulted in improved continuity and T2DM control. Future research in this area should assess measurable cost reduction. Improved disease management as demonstrated by the T2DM disease-specific clinic at WBAMC provides sufficient incentive to incorporate similar T2DM continuity clinics and changes throughout MTFs.  

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.

Type 2 diabetes mellitus (T2DM) is a significant, growing health problem that results in increased morbidity and mortality. In adults, T2DM accounts for about 90% to 95% of all diagnosed cases of diabetes.¹ Diabetes is the leading cause of kidney failure and blindness; moreover, diabetic patients are 2 to 4 times more likely to die of complications of heart disease and/or have a stroke.² Other complications of diabetes include nervous system damage and nontraumatic lower limb amputation. Increased morbidity and mortality not only diminishes quality of life (QOL) for patients with diabetes, but also produces a financial health care burden. The cost of diabetes in the U.S. in 2012 was more than $245 billion compared with $174 billion in 2007.¹

The Centers for Disease Control and Prevention (CDC) predicts that 1 in 3 American adults will develop diabetes by 2050; thus, optimal approaches to diabetic care need to be developed and evaluated to determine best practices.^3,4 Better control of blood sugar, cholesterol, and blood pressure levels in people with diabetes will help reduce the risk of complications of kidney disease, eye disease, nervous system disease, heart attack, and stroke.⁵ Optimal approaches to diabetes management must now be developed to prepare for the forecasted increase of T2DM.

A review of the literature confirms that lack of continuity of care often leads to patient dissatisfaction with health care, to fragmented health care, and a greater propensity to disregard a defined health care treatment plan.^6,7 In addition to improved patient satisfaction and adherence to medical management, improved continuity of care is cost-effective. A longitudinal study based on claims data from 2000 to 2008, using the continuity of care index, indicated that improved continuity of care was associated with less health care waste and lower health care expenses for patients with T2DM.⁸ An average savings of $737 in total health care expenses per person was achieved with better continuity of care.⁸ These studies demonstrate that improving continuity of care improves outcomes in patients with diabetes and helps prevent excessive health care costs and waste.

Medical Center NonContinuity

Lack of continuity of care has been identified as a potential obstacle to optimal diabetic outcomes at William Beaumont Army Medical Center (WBAMC) in El Paso, Texas, based on a recent data analysis provided by TRICARE Regional Office West.^9,10 As of March 2010, 56,936 patients were enrolled in TRICARE Prime. Of these patients, only 29.92% had appointments with their assigned primary care manager (PCM).⁹

In 2009, WBAMC developed a database to track the Healthcare Effectiveness Data and Information Set (HEDIS) measures to monitor A_1c as well as other indicators of performance of health care services, such as mammography, Pap smear, bone densitometry, and colorectal screening. A recent American Diabetic Association expert committee recommendation endorsed the use of A_1c value > 6.5% to confirm the diagnosis of diabetes.¹¹ The A_1c test may be confirmed with a repeat test unless clinical symptoms exist or the patient has random glucose levels > 200 mg/dL. Importantly, individuals with an A_1c between 6% and 6.5% have a higher risk for developing diabetes and may be diagnosed with prediabetes.³

From 2008 to 2009, the HEDIS database tracking the progress of A_1c demonstrated a 0.3% positive change and improvement in A_1c ≤ 9% (normal 4%-6%). The goal for people with diabetes is A_1c < 7%. Uncontrolled diabetes, (ie, A_1c > 9%), is associated with greater diabetes-related complications.¹² Using the HEDIS benchmark of ≥ 9%, the HEDIS A_1c data for fiscal year (FY) 2008 were 71.1 (p50) and 81 (p90), and for FY 2009 were 72.2 (p50) and 81.3 (p90), reflecting p90 0.3% improvement.¹³ Therefore, these data reflect poor outcomes of patients with T2DM with A_1c levels that were not controlled at WBAMC.

Uncontrolled diabetes accrues significant health care costs and adverse diabetic outcomes.¹⁰ Consequently, the WBAMC clinical operations division, which was tasked to monitor the HEDIS database, identified and contacted individuals to schedule health care appointments. The primary endeavor was an attempt to substantially increase benchmarks and maintain levels of A_1c < 9%, demonstrate improvement in quality of care, and reduce health care costs. Unfortunately, these goals were not met for the aggregate of patients with T2DM.

Figure 1 illustrates how the diabetic population at WBAMC had experienced decreased continuity of care and the adverse effects on their diabetes management. Figure 1 also illustrates how beneficiaries of TRICARE are assigned a PCM and how this process results in a lack of continuity of care for patients with T2DM. An Army medical center (MEDCEN) typically uses PCMs who may be a physician, nurse practitioner (NP), or physician assistant. Unfortunately, the majority of these PCMs are active-duty military or civil service personnel who commonly undergo permanent change of station moves or deployments every 3 years. Additionally, military providers are often rotated through department-chief positions, thereby dissolving their patient relationships.

Frequent rotations offer a valid means to foster leadership skills much needed in a military conflict zone and maximize military professional development; however, rotations also contribute to the lack of continuity of patient care. This PCM instability and the distinctive military dynamic volatility are characteristic of standard military operating procedure and are unlikely to change.

New solutions are needed to promote improved continuity of care for patients with diabetes at a MEDCEN. According to Lt Gen Eric Schoomaker, former Surgeon General of the Army, “The Patient-Centered Medical Home concept is being adopted throughout the military health system.”¹⁴ The goal of the trend toward patient-centered medical home (PCMH) care delivery is to improve access to high-quality health care services.¹³

Patient-Centered Medical Home

The term patient-centered medical home was introduced in 1967 by the American Academy of Pediatrics (AAP).¹⁵ In 2008, PCMH principles became integral in most health care reform initiatives.¹⁶ In most PCMH models, increased continuity of care is the single common denominator of practice. Continuity of care is defined as intensified integration, coordination, and sharing of information between disciplines that result in improved patient outcomes.^10,17,18

In 2007, a consensus statement was provided by the American Academy of Family Practice, the AAP, American College of Physicians, and the American Osteopathic Association stating that quality and safety are hallmarks of the PCMH and may improve outcomes for chronic disease, such as diabetes.¹⁹

Quality improvement is vital in health care organizations because of demands by government agencies, health maintenance organizations, and the public to continually improve services and to provide the highest quality health care at the best cost.²⁰ Diabetes has become a public health crisis, as previously discussed, and a comprehensive approach to care management is essential. Developing an optimal process for diabetes health care and methods for evaluation of the delivery process is foundational for all stakeholders involved, including health care organizations, health care providers, and patients.²⁰

Diabetic outcomes were evaluated at a recent 2-year trial PCMH approach T2DM clinic at a MEDCEN at WBAMC. The purpose of the project was to determine whether a PCMH approach improves disease management compared with routine primary care management.

Methods

The process and manner of care delivery was the focus of this analysis and evaluation, not clinician knowledge of treatment management. A comparison of care delivery approaches of PCM management and PCMH care delivery is displayed in the Table. The treatment algorithm for T2DM was not in question, because guidelines for practice are established based on scientific evidence, and medication management is based on evidence-based practice.^21,22 Evaluation consisted of T2DM delivery of care process and the efficacy of outcome achieved by the specified delivery of care: (a) increased access to care; (b) intensive, repeated education; and (3) a multidisciplinary approach focused on patient empowerment. The following is a description of the specified delivery of care.

Increased Access to Care

Increased access to care addressed through frequent telecommunication provided by the registered nurse (RN) case manager who regularly called patients within 72 hours of insulin adjustment or 24 hours for insulin initiation or significant medication changes. Additionally, the diabetes team providers requested a follow-up appointment in 1 week when injectable medication was added or changes were made in insulin management. One exception was for the addition of livaglutide, in which a 2-week follow-up was made, to allow for titration of the medication. For oral medication adjustment, a 1-month follow-up was generally made, with a 2-month follow-up when a glucose histogram indicated optimal glycemic control, an average blood glucose of 7% (estimated average glucose of 154 mg/dL) or less. Time for appointments was increased by 10 minutes for a total of 30-minute  appointments, compared with 20 minutes for PCM delivery.

Informational continuity was thought to be improved by use of an electronic medical record (EMR), allowing for an uninterrupted patient record. Providers were expected to document medication reconciliation with a clear explanation of medication adjustments listed in the plan. Patient teaching was documented, describing the specific patient education concerns addressed. Other data included a glucometer statistical report from the last appointment to the current appointment, to track negative or positive changes in glycemic control.

Patient Education

The management technique used in the clinic was intensive, repeated education with the goal of improving learning and retention with repeated instruction and positive reinforcement. Skinner theorized that learning is the acquisition of new behavior through conditioning (eg, repeated instruction), is in close proximity of time, and is likely to result in learning retention, which remain relevant education practice.^23,24 The T2DM clinic operates on Skinner’s principles of repeated, intensive education. For example, patients must bring their glucometer to every appointment. The statistical analysis downloaded from the glucometer provides immediate reinforcement and information about patients’ glycemic control. Patients are typically excited to see an improvement from previous levels and are encouraged to continue behavior modification. Conversely, statistical analysis demonstrating poor glycemic control generally encourages the patient to make needed lifestyle changes. Thus, changes in behavior due to intensive, repeated education, followed by a reinforcing stimulus results in an increased probability of that behavior occurring in the future.^23,25 The interdisciplinary team provides education during each T2DM patient encounter.

Multidisciplinary Approach

The multidisciplinary team formed at the trial T2DM clinic consisted of a medical doctor, family NP, pharmacist, RN, licensed vocational nurse, and registered dietician. The team members were each encouraged to obtain Certified Diabetes Educator (CDE) certification. For the first 6 months of developing the clinic, staff scheduled weekly team-building meetings to encourage esprit de corps. The weekly meetings were also used to discuss difficult patient cases. The RN case manager provided the patients with individualized plans to help them meet specified goals and provided easy accessibility for patient questions and concerns. The pharmacist was integral in helping patients understand the role of their medication and was also certified to make medication adjustments related to diabetes.

A recent Institute of Medicine (IOM) report encouraged the expansion of roles for nurse practitioners (NPs) in coordination and primary care delivery.²⁶ The IOM collaborative statement is based on numerous studies showing that NPs provided equivalent quality of care compared with that of primary care physicians in routine chronic disease management.²⁶ Nurse case managers functioned as an integral part of the intensive therapy involved in the landmark Diabetes Control and Complication Trial.²⁷

The intended policy analysis and outcome evaluation was confined to data collected from a disease-specific (T2DM) clinic with a PCMH approach developed April 2011 at WBAMC. Data were obtained from the WBAMC database designed to track the HEDIS measures.

Enrollees of the clinic were restricted to patients diagnosed with T2DM who were TRICARE beneficiaries. Males and females, aged > 20 years with an established A_1c > 6.5% comprised the patient population of the clinic. Individuals who were managed by WBAMC or were TRICARE standard beneficiaries were excluded from the study. Because patients with T1DM have a different pathology than those with T2DM, they were referred to endocrinology. Patients with gestational diabetes were referred to obstetrics for management.

Data Collection

Existing data in the Armed Forces Health Longitudinal Technology Application (AHLTA) EMR were used for this analysis. Data were accessed by a Common Access Card (CAC card) enhanced security system accessed only through secure CAC applications.

Diabetic outcomes of glycemic control as measured by the A_1c value were examined prior to clinic enrollment (time 1: PCM care delivery) and subsequently (time 2: PCMH care delivery) at the health care provider’s discretion. The second time varied between 2 and 6 months, depending on (1) provider need to determine quickly (2 months) whether  a downward trend was occurring because of multiple comorbidities; (2) provider discretion to wait an additional 3 months (A_1c turnover x 2 = 6 months), while medication adjustments are being made; and (3) according to feasibility of follow-up based on patient’s scheduling. Low-density lipoprotein cholesterol (LDL-C) was also examined at both PCM care delivery and PCMH care delivery.

The endpoints of a reduction in A_1c by 1% and an LDL-C that is ≤ 100 mg/dL determined improved diabetes outcomes. Existing data (eg, glycemic control [A_1c], lipid control [LDL-C]), from April 1, 2011, to December 31, 2011, were logged in a clinic database. These data served to demonstrate the effectiveness of the T2DM PCMH approach to clinic management. The PCMH principles that were examined included the standard operating procedure for the T2DM-PCMH clinic: frequent appointments > 2 in a 3-month period), a multidisciplinary team, and intensive, repeated education.

Data analysis was conducted with descriptive statistics (frequencies, means, SDs) and t test analysis to determine relationships between variables of A_1c, LDL-C, and frequency of visits. Improved diabetic outcomes, as previously defined, inferred that developing principles of a T2DM-PCMH clinic based on the principles of a PCMH provided a solution to optimal T2DM management compared with routine primary care delivery, consisting of a TRICARE-assigned PCM.

Results

A total of 638 unique patients were seen at the T2DM-PCMH clinic. Of these, 237 patient records in the database met the inclusion criteria and were acceptable for analysis and evaluation. Patients were omitted for the following reasons: 255 patients did not meet protocol of a minimum 2 visits during the evaluation period, 77 patients were omitted due to no second A_1c available, 65 patients did not meet the clinic protocol of a A_1c of > 6.5%, and 4 were omitted because no A_1c was available for pre- or postanalysis. Data analysis and evaluation of the remaining 237 acceptable patients demonstrated that a T2DM-PCMH approach provided improved diabetic care compared with routine, PCM management.

Patients enrolled at the WBAMC T2DM clinic demonstrated clinically significant improvement (P < .001), and 80.5% achieved > 1% improvement in glycemic control. The greatest number of visits of 26 visits, an outlier not typical of the frequency of patient visits, was attributed to brittle T2DM requiring more frequent monitoring. Most patients had 3 T2DM-PCMH clinic appointments (2 were the minimum visits described in clinic protocol).

Low-density lipoprotein cholesterol levels were analyzed to determine whether patients with diabetes managed at the WBAMC T2DM clinic also had improved lipid control. A total of 638 patients had an initial LDL-C level drawn prior to clinic management. Of these patients, 282 were acceptable for analysis (Figure 2). Low-density lipoprotein cholesterol data were omitted because 93 did not have a paired pre- and postvalues, 8 values were invalid due to nonfasting laboratory status; and 255 values were omitted due to having < 2 clinic visits. Results of the data analysis demonstrated that LDL-C was well managed by the T2DM clinic, with levels ≤ 100 mg/dL (P < .001) (Figure 3).

Discussion

The WBAMC T2DM clinic was formed as a trial clinic at a medical treatment facility (MTF) MEDCEN due to the failure of routine PCM care to improve outcomes in the management of the diabetes population (A_1c < 7.0%). Overall, improved endpoints of A_1c, LDL-C were achieved with the disease-specific PCMH approach compared with routine PCM approach. The results indicate that disease-specific management leads to improved diabetic endpoints (A_1c reduction by at least 1% and LDL-C < 100 mg/dL). The clinic’s protocol (listed in the methods) was intended to improve continuity.

A review of the literature confirmed that continuity of care is integral to patient satisfaction and improved diabetes management.^{8,10,17,28,29} The results of the study were consistent with those in the literature. The review of the literature established that patients who develop a trusting relationship with the health care provider as the T2DM clinic promoted (eg, frequent patient appointments, telecommunication by nurse, and patient participation) are more likely to follow medical therapy and take a proactive role in disease management.^6,28,30

Conclusion

This study demonstrated that PCMH-delivered care offers a solution to suboptimal management of chronic disease, such as T2DM, and that chronic disease is best managed by implementation of a disease-specific PCMH. It is recommended that a MTF develop other disease-specific PCMH and pilot-test these programs. Long-term follow-up studies and additional data collection, such as blood pressure control, abdominal circumference, body mass index, and triglyceride levels would be useful to determine effectiveness.

Based on principles of a PCMH, the efficacy of the T2DM clinic at WBAMC demonstrated that improved diabetes management was achieved by increased continuity of care; intensive, repeated patient education; and a multidisciplinary team approach. The CDC identifies self-management training as foundational to improving health outcomes and QOL for individuals with diabetes.¹ Primary care providers in a MTF may improve diabetic patient outcomes by referring patients to a T2DM clinic, such as the WBAMC T2DM clinic. The multidisciplinary team facilitated patient empowerment by educating patients on the management of their disease and the problem-solving and coping skills required to manage a chronic disease.

The WBAMC T2DM-PCMH based mission of fostering patient empowerment and a team approach is a comprehensive approach to diabetes care. Currently, the PCMH model is being adapted by the military in the latest health care reform initiatives.¹⁴ However, the move toward the PCMH model does not incorporate disease-specific PCMH clinics. This study demonstrates that the disease-specific PCMH approach provides improved disease management and may be effective in other chronic disease management. A benefit of the T2DM-PCMH approach is the reduced burden of escalating health care costs related to increased morbidity and mortality, which is associated with the growing health care problem of poorly controlled T2DM.^1,4,31

The disease-specific clinic evaluated at WBAMC provides an effective solution to fragmented health care for the optimal management of T2DM. The clinic’s conceptual framework of increased access to care, with consistent education at closer time intervals when compared with PCM management resulted in improved continuity and T2DM control. Future research in this area should assess measurable cost reduction. Improved disease management as demonstrated by the T2DM disease-specific clinic at WBAMC provides sufficient incentive to incorporate similar T2DM continuity clinics and changes throughout MTFs.  

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.

A 32-year-old G1P0 woman at 7 4/7 weeks’ gestation (intrauterine pregnancy confirmed by ultrasound) with a history of hypertension and anxiety presented to the emergency department reporting right upper quadrant and right flank pain. The patient did not report taking any medications. Her symptoms had begun about 6 hours prior to presentation. She did not report fever, chills, nausea, vomiting, anorexia, or urinary or bowels symptoms. She was afebrile, and her initial blood pressure was 174/84 mm Hg, but within an hour of presentation had decreased to 137/82 mm Hg.

On exam she was in moderate-to-severe discomfort. She was tender to palpation in the right flank as well as the right upper quadrant and had a positive Murphy sign. Her white blood cell (WBC) count was 18,800/μL, hemoglobin and hematocrit were normal, liver function tests were within normal limits, and sodium was 133 mmol/L; otherwise, electrolytes were normal. The urinalysis showed a specific gravity of 1.022 with 3 red blood cells per high powered field, but was otherwise normal. A right upper quadrant ultrasound showed a normal gallbladder without cholelithiasis. Subsequently, a magnetic resonance imaging (MRI) of the abdomen was obtained (Figure 1).

• What is your diagnosis?
• How would you treat this patient? 

[Click through to the next page to see the answer.]

Our Treatment

An MRI of the abdomen revealed a right adrenal hematoma (Figure 2). This diagnosis was made after common causes of the right upper quadrant and right flank pain were excluded and was confirmed with an MRI of the abdomen.

Discussion

Common causes of right flank and right upper quadrant pain include urolithiasis, pyelonephritis, and acute cholecystitis (Table). Patients with urolithiasis will typically present with sudden onset of colicky flank pain, which may radiate to the inguinal region, with or without nausea and vomiting.^1,2 Microhematuria may be absent in as many as 10% to 20% of patients.² Computed tomography is nearly 97% sensitive and 96% specific for urolithiasis.² Although only 37% to 64% sensitive in detecting urolithiasis, abdominal ultrasound is 85% to 94% specific for detecting hydronephrosis.²

Symptoms of pyelonephritis range from mild to severe costovertebral angle pain with or without fever and/or lower urinary tract symptoms to sepsis.³ Urinalysis typically shows leukocyte esterase (72%-97% sensitive, 41%-86% specific for culture-confirmed urinary tract infection) and microscopic pyuria (90%-96% sensitive, 47%-50% specific for culture-confirmed urinary tract infection).^3,4 Urine culture will reveal 10⁵ colony-forming units in 95% of patients with acute uncomplicated pyelonephritis.³ Imaging is typically reserved for atypical presentations or in cases of nonresolution of symptoms despite treatment in order to rule out structural anomalies, an obstructive process, or abscess formation.³

Acute cholecystitis is suggested by right upper quadrant pain, often following a meal. Symptoms include fever, leukocytosis, and an elevated serum bilirubin level.⁵ Ultrasound findings of acute cholecystitis are gallbladder wall thickening, pericholecystic fluid, or sonographic Murphy sign.⁶ Ultrasound has a sensitivity of 81% and a specificity of 83% for detecting acute cholecystitis, whereas hepatobiliary iminodiacetic acid scan (cholescintigraphy) is 96% sensitive and 90% specific and is used in cases where ultrasound is indeterminate.⁶

Spontaneous adrenal hemorrhage (SAH) typically presents with symptoms of upper abdominal pain and/or flank pain. If hemorrhage is significant, hypotension and a drop in hematocrit may occur. Alternatively, if SAH is bilateral and results in a deficiency of adrenal hormones, hypotension may be secondary to adrenal insufficiency. Due to its ready availability, most SAHs are diagnosed by CT scan ordered for alternate reasons.⁷

In the pregnant patient, to avoid exposing the developing fetus to radiation, ultrasound is typically the first imaging modality to investigate right upper quadrant or flank pain. However, ultrasound is less sensitive for evaluating anomalies of the adrenal gland.⁸ An MRI is the most accurate imaging modality for diagnosing adrenal hemorrhage and avoids exposing the developing fetus to radiation.⁹ In this case, the absence of an etiology of the patient’s symptoms on right upper quadrant ultrasound led to further evaluation, with abdominal MRI revealing the diagnosis.

In a review of 141 cases of adrenal hemorrhage at the Mayo Clinic in Rochester, Minnesota, 16 patients had a spontaneous adrenal hemorrhage, which presented with severe abdominal and flank pain of sudden onset.⁷ Seven of these patients required surgery to control the bleeding.⁷ None of the 13 patients with a functioning contralateral adrenal gland required adrenal replacement therapy.⁷ Gavrilova-Jordan and colleagues reported a case of a spontaneous unilateral adrenal hemorrhage in the third trimester of pregnancy that was managed conservatively with favorable outcomes.¹⁰ Potential causes of spontaneous adrenal hemorrhage include:

   • Antiphospholipid antibody syndrome

   • Heparin-induced thrombocytopenia

   • Trauma

   • Physiologic stress (eg, sepsis)

   • Adrenal mass (pheochromocytoma, angiomyolipoma, or metastatic cancer).^6,11

Case Outcome

Initial right upper quadrant ultrasound in this patient revealed a normal gallbladder and a small amount of perinephric fluid surrounding the right kidney. On the night of admission she experienced an elevated temperature of 101.9°F. Due to the fever and leukocytosis, she was initiated on antibiotics (ampicillin-sulbactam 3 g IV every 6 hours) covering a urinary source. On hospital day 2, right lower quadrant and right upper quadrant ultrasounds  were performed, revealing decreased fluid surrounding her right kidney and without evidence of appendicitis. Due to persistent leukocytosis (WBC count peaked at 26,400/μL), essentially normal urinalysis, and negative urine culture, an abdominal MRI was obtained to evaluate for a perinephric abscess. The MRI revealed the spontaneous adrenal hemorrhage.

The patient was observed as an inpatient for the following 48 hours. Her electrolytes remained normal and hemoglobin decreased to 9.5 g/dL. She remained hemodynamically stable. Serum cortisol and angiotensin levels were normal, antibiotics were discontinued, and the patient was discharged to outpatient follow-up.

A repeat MRI of the abdomen obtained 6 weeks later revealed a resolving right adrenal hematoma. At 39 weeks’ gestation, she delivered a vigorous female infant weighing 3,200 g (7 lb 1 oz) with an Apgar score at birth of 8/9.

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 complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

A 32-year-old G1P0 woman at 7 4/7 weeks’ gestation (intrauterine pregnancy confirmed by ultrasound) with a history of hypertension and anxiety presented to the emergency department reporting right upper quadrant and right flank pain. The patient did not report taking any medications. Her symptoms had begun about 6 hours prior to presentation. She did not report fever, chills, nausea, vomiting, anorexia, or urinary or bowels symptoms. She was afebrile, and her initial blood pressure was 174/84 mm Hg, but within an hour of presentation had decreased to 137/82 mm Hg.

On exam she was in moderate-to-severe discomfort. She was tender to palpation in the right flank as well as the right upper quadrant and had a positive Murphy sign. Her white blood cell (WBC) count was 18,800/μL, hemoglobin and hematocrit were normal, liver function tests were within normal limits, and sodium was 133 mmol/L; otherwise, electrolytes were normal. The urinalysis showed a specific gravity of 1.022 with 3 red blood cells per high powered field, but was otherwise normal. A right upper quadrant ultrasound showed a normal gallbladder without cholelithiasis. Subsequently, a magnetic resonance imaging (MRI) of the abdomen was obtained (Figure 1).

• What is your diagnosis?
• How would you treat this patient? 

[Click through to the next page to see the answer.]

Our Treatment

An MRI of the abdomen revealed a right adrenal hematoma (Figure 2). This diagnosis was made after common causes of the right upper quadrant and right flank pain were excluded and was confirmed with an MRI of the abdomen.

Discussion

Common causes of right flank and right upper quadrant pain include urolithiasis, pyelonephritis, and acute cholecystitis (Table). Patients with urolithiasis will typically present with sudden onset of colicky flank pain, which may radiate to the inguinal region, with or without nausea and vomiting.^1,2 Microhematuria may be absent in as many as 10% to 20% of patients.² Computed tomography is nearly 97% sensitive and 96% specific for urolithiasis.² Although only 37% to 64% sensitive in detecting urolithiasis, abdominal ultrasound is 85% to 94% specific for detecting hydronephrosis.²

Symptoms of pyelonephritis range from mild to severe costovertebral angle pain with or without fever and/or lower urinary tract symptoms to sepsis.³ Urinalysis typically shows leukocyte esterase (72%-97% sensitive, 41%-86% specific for culture-confirmed urinary tract infection) and microscopic pyuria (90%-96% sensitive, 47%-50% specific for culture-confirmed urinary tract infection).^3,4 Urine culture will reveal 10⁵ colony-forming units in 95% of patients with acute uncomplicated pyelonephritis.³ Imaging is typically reserved for atypical presentations or in cases of nonresolution of symptoms despite treatment in order to rule out structural anomalies, an obstructive process, or abscess formation.³

Acute cholecystitis is suggested by right upper quadrant pain, often following a meal. Symptoms include fever, leukocytosis, and an elevated serum bilirubin level.⁵ Ultrasound findings of acute cholecystitis are gallbladder wall thickening, pericholecystic fluid, or sonographic Murphy sign.⁶ Ultrasound has a sensitivity of 81% and a specificity of 83% for detecting acute cholecystitis, whereas hepatobiliary iminodiacetic acid scan (cholescintigraphy) is 96% sensitive and 90% specific and is used in cases where ultrasound is indeterminate.⁶

Spontaneous adrenal hemorrhage (SAH) typically presents with symptoms of upper abdominal pain and/or flank pain. If hemorrhage is significant, hypotension and a drop in hematocrit may occur. Alternatively, if SAH is bilateral and results in a deficiency of adrenal hormones, hypotension may be secondary to adrenal insufficiency. Due to its ready availability, most SAHs are diagnosed by CT scan ordered for alternate reasons.⁷

In the pregnant patient, to avoid exposing the developing fetus to radiation, ultrasound is typically the first imaging modality to investigate right upper quadrant or flank pain. However, ultrasound is less sensitive for evaluating anomalies of the adrenal gland.⁸ An MRI is the most accurate imaging modality for diagnosing adrenal hemorrhage and avoids exposing the developing fetus to radiation.⁹ In this case, the absence of an etiology of the patient’s symptoms on right upper quadrant ultrasound led to further evaluation, with abdominal MRI revealing the diagnosis.

In a review of 141 cases of adrenal hemorrhage at the Mayo Clinic in Rochester, Minnesota, 16 patients had a spontaneous adrenal hemorrhage, which presented with severe abdominal and flank pain of sudden onset.⁷ Seven of these patients required surgery to control the bleeding.⁷ None of the 13 patients with a functioning contralateral adrenal gland required adrenal replacement therapy.⁷ Gavrilova-Jordan and colleagues reported a case of a spontaneous unilateral adrenal hemorrhage in the third trimester of pregnancy that was managed conservatively with favorable outcomes.¹⁰ Potential causes of spontaneous adrenal hemorrhage include:

   • Antiphospholipid antibody syndrome

   • Heparin-induced thrombocytopenia

   • Trauma

   • Physiologic stress (eg, sepsis)

   • Adrenal mass (pheochromocytoma, angiomyolipoma, or metastatic cancer).^6,11

Case Outcome

Initial right upper quadrant ultrasound in this patient revealed a normal gallbladder and a small amount of perinephric fluid surrounding the right kidney. On the night of admission she experienced an elevated temperature of 101.9°F. Due to the fever and leukocytosis, she was initiated on antibiotics (ampicillin-sulbactam 3 g IV every 6 hours) covering a urinary source. On hospital day 2, right lower quadrant and right upper quadrant ultrasounds  were performed, revealing decreased fluid surrounding her right kidney and without evidence of appendicitis. Due to persistent leukocytosis (WBC count peaked at 26,400/μL), essentially normal urinalysis, and negative urine culture, an abdominal MRI was obtained to evaluate for a perinephric abscess. The MRI revealed the spontaneous adrenal hemorrhage.

The patient was observed as an inpatient for the following 48 hours. Her electrolytes remained normal and hemoglobin decreased to 9.5 g/dL. She remained hemodynamically stable. Serum cortisol and angiotensin levels were normal, antibiotics were discontinued, and the patient was discharged to outpatient follow-up.

A repeat MRI of the abdomen obtained 6 weeks later revealed a resolving right adrenal hematoma. At 39 weeks’ gestation, she delivered a vigorous female infant weighing 3,200 g (7 lb 1 oz) with an Apgar score at birth of 8/9.

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 complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

A 32-year-old G1P0 woman at 7 4/7 weeks’ gestation (intrauterine pregnancy confirmed by ultrasound) with a history of hypertension and anxiety presented to the emergency department reporting right upper quadrant and right flank pain. The patient did not report taking any medications. Her symptoms had begun about 6 hours prior to presentation. She did not report fever, chills, nausea, vomiting, anorexia, or urinary or bowels symptoms. She was afebrile, and her initial blood pressure was 174/84 mm Hg, but within an hour of presentation had decreased to 137/82 mm Hg.

On exam she was in moderate-to-severe discomfort. She was tender to palpation in the right flank as well as the right upper quadrant and had a positive Murphy sign. Her white blood cell (WBC) count was 18,800/μL, hemoglobin and hematocrit were normal, liver function tests were within normal limits, and sodium was 133 mmol/L; otherwise, electrolytes were normal. The urinalysis showed a specific gravity of 1.022 with 3 red blood cells per high powered field, but was otherwise normal. A right upper quadrant ultrasound showed a normal gallbladder without cholelithiasis. Subsequently, a magnetic resonance imaging (MRI) of the abdomen was obtained (Figure 1).

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Our Treatment

An MRI of the abdomen revealed a right adrenal hematoma (Figure 2). This diagnosis was made after common causes of the right upper quadrant and right flank pain were excluded and was confirmed with an MRI of the abdomen.

Discussion

Common causes of right flank and right upper quadrant pain include urolithiasis, pyelonephritis, and acute cholecystitis (Table). Patients with urolithiasis will typically present with sudden onset of colicky flank pain, which may radiate to the inguinal region, with or without nausea and vomiting.^1,2 Microhematuria may be absent in as many as 10% to 20% of patients.² Computed tomography is nearly 97% sensitive and 96% specific for urolithiasis.² Although only 37% to 64% sensitive in detecting urolithiasis, abdominal ultrasound is 85% to 94% specific for detecting hydronephrosis.²

Symptoms of pyelonephritis range from mild to severe costovertebral angle pain with or without fever and/or lower urinary tract symptoms to sepsis.³ Urinalysis typically shows leukocyte esterase (72%-97% sensitive, 41%-86% specific for culture-confirmed urinary tract infection) and microscopic pyuria (90%-96% sensitive, 47%-50% specific for culture-confirmed urinary tract infection).^3,4 Urine culture will reveal 10⁵ colony-forming units in 95% of patients with acute uncomplicated pyelonephritis.³ Imaging is typically reserved for atypical presentations or in cases of nonresolution of symptoms despite treatment in order to rule out structural anomalies, an obstructive process, or abscess formation.³

Acute cholecystitis is suggested by right upper quadrant pain, often following a meal. Symptoms include fever, leukocytosis, and an elevated serum bilirubin level.⁵ Ultrasound findings of acute cholecystitis are gallbladder wall thickening, pericholecystic fluid, or sonographic Murphy sign.⁶ Ultrasound has a sensitivity of 81% and a specificity of 83% for detecting acute cholecystitis, whereas hepatobiliary iminodiacetic acid scan (cholescintigraphy) is 96% sensitive and 90% specific and is used in cases where ultrasound is indeterminate.⁶

Spontaneous adrenal hemorrhage (SAH) typically presents with symptoms of upper abdominal pain and/or flank pain. If hemorrhage is significant, hypotension and a drop in hematocrit may occur. Alternatively, if SAH is bilateral and results in a deficiency of adrenal hormones, hypotension may be secondary to adrenal insufficiency. Due to its ready availability, most SAHs are diagnosed by CT scan ordered for alternate reasons.⁷

In the pregnant patient, to avoid exposing the developing fetus to radiation, ultrasound is typically the first imaging modality to investigate right upper quadrant or flank pain. However, ultrasound is less sensitive for evaluating anomalies of the adrenal gland.⁸ An MRI is the most accurate imaging modality for diagnosing adrenal hemorrhage and avoids exposing the developing fetus to radiation.⁹ In this case, the absence of an etiology of the patient’s symptoms on right upper quadrant ultrasound led to further evaluation, with abdominal MRI revealing the diagnosis.

In a review of 141 cases of adrenal hemorrhage at the Mayo Clinic in Rochester, Minnesota, 16 patients had a spontaneous adrenal hemorrhage, which presented with severe abdominal and flank pain of sudden onset.⁷ Seven of these patients required surgery to control the bleeding.⁷ None of the 13 patients with a functioning contralateral adrenal gland required adrenal replacement therapy.⁷ Gavrilova-Jordan and colleagues reported a case of a spontaneous unilateral adrenal hemorrhage in the third trimester of pregnancy that was managed conservatively with favorable outcomes.¹⁰ Potential causes of spontaneous adrenal hemorrhage include:

   • Antiphospholipid antibody syndrome

   • Heparin-induced thrombocytopenia

   • Trauma

   • Physiologic stress (eg, sepsis)

   • Adrenal mass (pheochromocytoma, angiomyolipoma, or metastatic cancer).^6,11

Case Outcome

Initial right upper quadrant ultrasound in this patient revealed a normal gallbladder and a small amount of perinephric fluid surrounding the right kidney. On the night of admission she experienced an elevated temperature of 101.9°F. Due to the fever and leukocytosis, she was initiated on antibiotics (ampicillin-sulbactam 3 g IV every 6 hours) covering a urinary source. On hospital day 2, right lower quadrant and right upper quadrant ultrasounds  were performed, revealing decreased fluid surrounding her right kidney and without evidence of appendicitis. Due to persistent leukocytosis (WBC count peaked at 26,400/μL), essentially normal urinalysis, and negative urine culture, an abdominal MRI was obtained to evaluate for a perinephric abscess. The MRI revealed the spontaneous adrenal hemorrhage.

The patient was observed as an inpatient for the following 48 hours. Her electrolytes remained normal and hemoglobin decreased to 9.5 g/dL. She remained hemodynamically stable. Serum cortisol and angiotensin levels were normal, antibiotics were discontinued, and the patient was discharged to outpatient follow-up.

A repeat MRI of the abdomen obtained 6 weeks later revealed a resolving right adrenal hematoma. At 39 weeks’ gestation, she delivered a vigorous female infant weighing 3,200 g (7 lb 1 oz) with an Apgar score at birth of 8/9.

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 complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Pulmonary vein thrombosis (PVT) is rare and underdiagnosed in clinical practice. It has been described following lobectomy, lung transplant, and in association with metastatic carcinoma.^1-4 Some cases have been described as idiopathic.^5-7 Its exact incidence is unknown, and treatment depends on etiology. On the other hand, pulmonary artery thromboembolism is a well-known entity with identified risk factors as well as clearly defined modalities of management. The following is a case of PVT, which occurred in the setting of small cell carcinoma of the lung (SCLC) and mantle cell lymphoma of the small intestine.

CASE PRESENTATION

A 66-year-old male veteran with a past medical history of type 2 diabetes mellitus, hypertension, and chronic obstructive pulmonary disease, who had a 40 pack-year history of cigarette smoking, was admitted to the hospital for severe, sudden onset abdominal pain. The pain was localized in the right lower quadrant and then became generalized. It was sharp, aggravated by movement, and relieved by rest. The patient reported being constipated for the past couple of days.

A review of systems revealed that he had been coughing for about 3 days prior to admission. A computed tomography (CT) scan of the abdomen showed pneumoperitoneum and a mass with mural thickening around the distal ileum/cecal area (Figure 1). There was also a partially visualized mass in the infrahilar area of the right lower lobe and bilateral adrenal masses seen on the scan. A chest CT with contrast was then performed, which showed a 7.5 x 6.6 x 6.6-cm mass in the right lower lobe posterior to the right hilum. The mass encased the right mainstem bronchus, and there was a low-density-filling defect in the inferior branch of the right pulmonary vein (Figure 2). An echocardiography did not show any thrombus within the atria or ventricles.

The patient underwent emergent exploratory laparotomy for bowel perforation. The operative finding was a small perforation of the small intestine with an associated mass. There were metastatic lesions throughout the abdomen. A partial small bowel resection was performed. Post exploratory laparotomy, a fiberoptic bronchoscopy was performed, which revealed a 1-cm fungating lesion at the takeoff of the superior segment of the right lower lobe. Brushings were obtained from the mass. The pathology of the lung mass was small cell carcinoma, whereas that of the bowel mass was mantle cell lymphoma. Brain magnetic resonance imaging revealed that he had metastasis to the brain with a 4-cm mass in the cerebellum. He was anticoagulated with heparin for the PVT. Based on his poor functional status and his overall clinical condition, his prognosis was poor. He received hospice care and died 3 months later.

DISCUSSION

Pulmonary vein thrombosis is a rare condition. The incidence is unclear, as most of the literature includes case reports. The majority of PVT cases are reported following lobectomy for malignancy and lung transplantation.^1-3 The incidence following lung transplant was reported in the early postoperative period to be 15% in a center during the first 2 years of the study.³ Pulmonary vein thrombosis has also been described following metastatic cancer, such as liposarcoma.⁴

This patient’s case was discovered in the setting of SCLC and mantle cell lymphoma of the small intestine. Small cell carcinoma of the lung was reported to invade the pulmonary vein into the left atrium.⁸ In this patient, the left atrium was not invaded. There have been cases of spontaneous or idiopathic PVT described, presenting as abdominal pain, hemoptysis, and chest pain.^5-7 No precipitating causes were detected in these patients.

The pathogenesis of PVT from a tumor is unclear, although several theories have been postulated: It could result from direct extension of the tumor into the vein, from compression of the vein by the tumor, or from epithelial damage as a result of tumor invasion. The tumor thrombus has been described to extend into the right atrium.^6,8 The mechanism of thrombosis remains unclear in the patient postlobectomy or postlung transplantation, although intraoperative torsion and injury of vessels are implicated. Similar to deep vein thrombosis, PVT could also result from intimal damage or sluggish flow in the pulmonary stump in the postoperative patient.^2,9,10

The presentation of PVT is usually nonspecific, including dyspnea, cough, pleuritic chest pain, and hemoptysis. It has been reported as causing massive hemoptysis due to acute pulmonary infarction.⁷ Acute PVT occurring postoperatively in the lung transplant patient may be disastrous and lead to early postoperative allograft failure.¹¹ Pulmonary vein thrombosis may also present more insidiously with recurrent pulmonary edema and pulmonary fibrosis.¹² This patient presented with abdominal pain; further workup led to the finding of a lung mass. Pulmonary vein thrombosis has been reported to result in systemic emboli, resulting in cerebrovascular accidents, or it can manifest as aseptic and tumor emboli.^2,5,10,13,14

Newer CT techniques have made identifying PVT possible in a similar manner to which pulmonary arterial emboli are detected by using the pulmonary venous phase of a contrast CT of the chest.⁵ Echocardiography may demonstrate the extension of the thrombus into the atrium; a transesophageal echocardiogram would be preferable over a transthoracic echocardiogram. Magnetic resonance imaging of the chest is another useful modality for diagnosis, because it is able to distinguish between a bland thrombus and a tumor thrombus in the pulmonary vein.¹⁵

Treatment of PVT depends on the overall clinical condition of the patient. Irrespective of the etiology, a review of the literature does not indicate the preferred duration of anticoagulation or preference for modality of anticoagulation between oral vitamin K antagonists or heparin—low molecular or unfractionated.^1,3-6 Patients who develop PVT following malignancy are usually anticoagulated with therapy for the cancer. The treatment of PVT in the setting of lung transplant is more challenging and includes systemic heparinization, thrombolytics, and surgical thrombectomy.^3,11,16 The majority of the literature includes case reports with varying morbidity and mortality, depending on the etiology. Ninety-day mortality of 38% was reported following lung transplant.³

CONCLUSION

Pulmonary vein thrombosis presents in a nonspecific manner. The diagnosis is now more readily made with the advent of a variety of diagnostic modalities, especially with transesophageal echocardiography, which may be performed at the bedside in the intensive care unit. The treatment remains challenging with mortality dependent on the etiology. A diagnosis of PVT needs to be considered in patients with appropriate risk factors. A high index of suspicion will enable the diagnosis in the proper clinical scenario.

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 complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Pulmonary vein thrombosis (PVT) is rare and underdiagnosed in clinical practice. It has been described following lobectomy, lung transplant, and in association with metastatic carcinoma.^1-4 Some cases have been described as idiopathic.^5-7 Its exact incidence is unknown, and treatment depends on etiology. On the other hand, pulmonary artery thromboembolism is a well-known entity with identified risk factors as well as clearly defined modalities of management. The following is a case of PVT, which occurred in the setting of small cell carcinoma of the lung (SCLC) and mantle cell lymphoma of the small intestine.

CASE PRESENTATION

A 66-year-old male veteran with a past medical history of type 2 diabetes mellitus, hypertension, and chronic obstructive pulmonary disease, who had a 40 pack-year history of cigarette smoking, was admitted to the hospital for severe, sudden onset abdominal pain. The pain was localized in the right lower quadrant and then became generalized. It was sharp, aggravated by movement, and relieved by rest. The patient reported being constipated for the past couple of days.

A review of systems revealed that he had been coughing for about 3 days prior to admission. A computed tomography (CT) scan of the abdomen showed pneumoperitoneum and a mass with mural thickening around the distal ileum/cecal area (Figure 1). There was also a partially visualized mass in the infrahilar area of the right lower lobe and bilateral adrenal masses seen on the scan. A chest CT with contrast was then performed, which showed a 7.5 x 6.6 x 6.6-cm mass in the right lower lobe posterior to the right hilum. The mass encased the right mainstem bronchus, and there was a low-density-filling defect in the inferior branch of the right pulmonary vein (Figure 2). An echocardiography did not show any thrombus within the atria or ventricles.

The patient underwent emergent exploratory laparotomy for bowel perforation. The operative finding was a small perforation of the small intestine with an associated mass. There were metastatic lesions throughout the abdomen. A partial small bowel resection was performed. Post exploratory laparotomy, a fiberoptic bronchoscopy was performed, which revealed a 1-cm fungating lesion at the takeoff of the superior segment of the right lower lobe. Brushings were obtained from the mass. The pathology of the lung mass was small cell carcinoma, whereas that of the bowel mass was mantle cell lymphoma. Brain magnetic resonance imaging revealed that he had metastasis to the brain with a 4-cm mass in the cerebellum. He was anticoagulated with heparin for the PVT. Based on his poor functional status and his overall clinical condition, his prognosis was poor. He received hospice care and died 3 months later.

DISCUSSION

Pulmonary vein thrombosis is a rare condition. The incidence is unclear, as most of the literature includes case reports. The majority of PVT cases are reported following lobectomy for malignancy and lung transplantation.^1-3 The incidence following lung transplant was reported in the early postoperative period to be 15% in a center during the first 2 years of the study.³ Pulmonary vein thrombosis has also been described following metastatic cancer, such as liposarcoma.⁴

This patient’s case was discovered in the setting of SCLC and mantle cell lymphoma of the small intestine. Small cell carcinoma of the lung was reported to invade the pulmonary vein into the left atrium.⁸ In this patient, the left atrium was not invaded. There have been cases of spontaneous or idiopathic PVT described, presenting as abdominal pain, hemoptysis, and chest pain.^5-7 No precipitating causes were detected in these patients.

The pathogenesis of PVT from a tumor is unclear, although several theories have been postulated: It could result from direct extension of the tumor into the vein, from compression of the vein by the tumor, or from epithelial damage as a result of tumor invasion. The tumor thrombus has been described to extend into the right atrium.^6,8 The mechanism of thrombosis remains unclear in the patient postlobectomy or postlung transplantation, although intraoperative torsion and injury of vessels are implicated. Similar to deep vein thrombosis, PVT could also result from intimal damage or sluggish flow in the pulmonary stump in the postoperative patient.^2,9,10

The presentation of PVT is usually nonspecific, including dyspnea, cough, pleuritic chest pain, and hemoptysis. It has been reported as causing massive hemoptysis due to acute pulmonary infarction.⁷ Acute PVT occurring postoperatively in the lung transplant patient may be disastrous and lead to early postoperative allograft failure.¹¹ Pulmonary vein thrombosis may also present more insidiously with recurrent pulmonary edema and pulmonary fibrosis.¹² This patient presented with abdominal pain; further workup led to the finding of a lung mass. Pulmonary vein thrombosis has been reported to result in systemic emboli, resulting in cerebrovascular accidents, or it can manifest as aseptic and tumor emboli.^2,5,10,13,14

Newer CT techniques have made identifying PVT possible in a similar manner to which pulmonary arterial emboli are detected by using the pulmonary venous phase of a contrast CT of the chest.⁵ Echocardiography may demonstrate the extension of the thrombus into the atrium; a transesophageal echocardiogram would be preferable over a transthoracic echocardiogram. Magnetic resonance imaging of the chest is another useful modality for diagnosis, because it is able to distinguish between a bland thrombus and a tumor thrombus in the pulmonary vein.¹⁵

Treatment of PVT depends on the overall clinical condition of the patient. Irrespective of the etiology, a review of the literature does not indicate the preferred duration of anticoagulation or preference for modality of anticoagulation between oral vitamin K antagonists or heparin—low molecular or unfractionated.^1,3-6 Patients who develop PVT following malignancy are usually anticoagulated with therapy for the cancer. The treatment of PVT in the setting of lung transplant is more challenging and includes systemic heparinization, thrombolytics, and surgical thrombectomy.^3,11,16 The majority of the literature includes case reports with varying morbidity and mortality, depending on the etiology. Ninety-day mortality of 38% was reported following lung transplant.³

CONCLUSION

Pulmonary vein thrombosis presents in a nonspecific manner. The diagnosis is now more readily made with the advent of a variety of diagnostic modalities, especially with transesophageal echocardiography, which may be performed at the bedside in the intensive care unit. The treatment remains challenging with mortality dependent on the etiology. A diagnosis of PVT needs to be considered in patients with appropriate risk factors. A high index of suspicion will enable the diagnosis in the proper clinical scenario.

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 complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Pulmonary vein thrombosis (PVT) is rare and underdiagnosed in clinical practice. It has been described following lobectomy, lung transplant, and in association with metastatic carcinoma.^1-4 Some cases have been described as idiopathic.^5-7 Its exact incidence is unknown, and treatment depends on etiology. On the other hand, pulmonary artery thromboembolism is a well-known entity with identified risk factors as well as clearly defined modalities of management. The following is a case of PVT, which occurred in the setting of small cell carcinoma of the lung (SCLC) and mantle cell lymphoma of the small intestine.

CASE PRESENTATION

A 66-year-old male veteran with a past medical history of type 2 diabetes mellitus, hypertension, and chronic obstructive pulmonary disease, who had a 40 pack-year history of cigarette smoking, was admitted to the hospital for severe, sudden onset abdominal pain. The pain was localized in the right lower quadrant and then became generalized. It was sharp, aggravated by movement, and relieved by rest. The patient reported being constipated for the past couple of days.

A review of systems revealed that he had been coughing for about 3 days prior to admission. A computed tomography (CT) scan of the abdomen showed pneumoperitoneum and a mass with mural thickening around the distal ileum/cecal area (Figure 1). There was also a partially visualized mass in the infrahilar area of the right lower lobe and bilateral adrenal masses seen on the scan. A chest CT with contrast was then performed, which showed a 7.5 x 6.6 x 6.6-cm mass in the right lower lobe posterior to the right hilum. The mass encased the right mainstem bronchus, and there was a low-density-filling defect in the inferior branch of the right pulmonary vein (Figure 2). An echocardiography did not show any thrombus within the atria or ventricles.

The patient underwent emergent exploratory laparotomy for bowel perforation. The operative finding was a small perforation of the small intestine with an associated mass. There were metastatic lesions throughout the abdomen. A partial small bowel resection was performed. Post exploratory laparotomy, a fiberoptic bronchoscopy was performed, which revealed a 1-cm fungating lesion at the takeoff of the superior segment of the right lower lobe. Brushings were obtained from the mass. The pathology of the lung mass was small cell carcinoma, whereas that of the bowel mass was mantle cell lymphoma. Brain magnetic resonance imaging revealed that he had metastasis to the brain with a 4-cm mass in the cerebellum. He was anticoagulated with heparin for the PVT. Based on his poor functional status and his overall clinical condition, his prognosis was poor. He received hospice care and died 3 months later.

DISCUSSION

Pulmonary vein thrombosis is a rare condition. The incidence is unclear, as most of the literature includes case reports. The majority of PVT cases are reported following lobectomy for malignancy and lung transplantation.^1-3 The incidence following lung transplant was reported in the early postoperative period to be 15% in a center during the first 2 years of the study.³ Pulmonary vein thrombosis has also been described following metastatic cancer, such as liposarcoma.⁴

This patient’s case was discovered in the setting of SCLC and mantle cell lymphoma of the small intestine. Small cell carcinoma of the lung was reported to invade the pulmonary vein into the left atrium.⁸ In this patient, the left atrium was not invaded. There have been cases of spontaneous or idiopathic PVT described, presenting as abdominal pain, hemoptysis, and chest pain.^5-7 No precipitating causes were detected in these patients.

The pathogenesis of PVT from a tumor is unclear, although several theories have been postulated: It could result from direct extension of the tumor into the vein, from compression of the vein by the tumor, or from epithelial damage as a result of tumor invasion. The tumor thrombus has been described to extend into the right atrium.^6,8 The mechanism of thrombosis remains unclear in the patient postlobectomy or postlung transplantation, although intraoperative torsion and injury of vessels are implicated. Similar to deep vein thrombosis, PVT could also result from intimal damage or sluggish flow in the pulmonary stump in the postoperative patient.^2,9,10

The presentation of PVT is usually nonspecific, including dyspnea, cough, pleuritic chest pain, and hemoptysis. It has been reported as causing massive hemoptysis due to acute pulmonary infarction.⁷ Acute PVT occurring postoperatively in the lung transplant patient may be disastrous and lead to early postoperative allograft failure.¹¹ Pulmonary vein thrombosis may also present more insidiously with recurrent pulmonary edema and pulmonary fibrosis.¹² This patient presented with abdominal pain; further workup led to the finding of a lung mass. Pulmonary vein thrombosis has been reported to result in systemic emboli, resulting in cerebrovascular accidents, or it can manifest as aseptic and tumor emboli.^2,5,10,13,14

Newer CT techniques have made identifying PVT possible in a similar manner to which pulmonary arterial emboli are detected by using the pulmonary venous phase of a contrast CT of the chest.⁵ Echocardiography may demonstrate the extension of the thrombus into the atrium; a transesophageal echocardiogram would be preferable over a transthoracic echocardiogram. Magnetic resonance imaging of the chest is another useful modality for diagnosis, because it is able to distinguish between a bland thrombus and a tumor thrombus in the pulmonary vein.¹⁵

Treatment of PVT depends on the overall clinical condition of the patient. Irrespective of the etiology, a review of the literature does not indicate the preferred duration of anticoagulation or preference for modality of anticoagulation between oral vitamin K antagonists or heparin—low molecular or unfractionated.^1,3-6 Patients who develop PVT following malignancy are usually anticoagulated with therapy for the cancer. The treatment of PVT in the setting of lung transplant is more challenging and includes systemic heparinization, thrombolytics, and surgical thrombectomy.^3,11,16 The majority of the literature includes case reports with varying morbidity and mortality, depending on the etiology. Ninety-day mortality of 38% was reported following lung transplant.³

CONCLUSION

Pulmonary vein thrombosis presents in a nonspecific manner. The diagnosis is now more readily made with the advent of a variety of diagnostic modalities, especially with transesophageal echocardiography, which may be performed at the bedside in the intensive care unit. The treatment remains challenging with mortality dependent on the etiology. A diagnosis of PVT needs to be considered in patients with appropriate risk factors. A high index of suspicion will enable the diagnosis in the proper clinical scenario.

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 complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Carcinoma of the lung is the most common lethal form of cancer in both men and women worldwide.¹ It accounts for more deaths than the next 3 most common cancers combined. In 2012, 160,000 Americans are estimated to have died from lung cancer.¹ Lung cancer is known to have a high metastatic potential for the brain, bones, adrenal glands, lungs, and liver.² Orthopedic manifestations frequently include bony metastasis, most commonly the vertebrae (42%), ribs (20%), and pelvis (18%).³ Acral metastatic disease is defined as metastasis distal to the elbow or the knee. Bony acral metastases from lung carcinoma to the upper and lower extremities are extremely uncommon, accounting for only 1% each of total bone metastases from carcinoma of the lung.³ Metastases to the bones of the hand are even rarer. Only 0.1% of metastatic disease from any type of carcinoma or sarcoma manifests as metastasis in the hand.⁴ There are only a few reports in the literature of soft-tissue or muscular metastasis to the hand from a carcinoma. Of these cases, the majority are caused by metastatic lung carcinoma.^5-9 There are no reports in the literature of metastatic disease of squamous cell origin affecting the soft tissues of the hand.

We present a case of a man with known metastatic squamous cell carcinoma of the lung who presented with acral soft-tissue metastatic disease. This report highlights a rare clinical scenario that has not been reported in the literature. The report also emphasizes a rare but important consideration for clinicians who encounter acral soft-tissue lesions in patients with a history of a primary carcinoma. The patient provided written informed consent for print and electronic publication of this case report.

Continue for case report >>

Case Report

A 56-year-old man presented with right-sided pleuritic flank pain, along with a 30-lb weight loss over a 6-month period. A computed tomographic scan revealed a 5.58×3.7-cm cavitary lesion in the right lower lobe with abutment of the posterior chest wall (Figure 1). He underwent biopsy and staging, and was found to be T3N1, with biopsy-proven well-differentiated bronchogenic squamous cell carcinoma. The patient then underwent right lower and middle lobectomy with concomitant en-bloc resection of the posterior portion of ribs 7 to 11, along with mediastinal lymph-node dissection with negative margins. After surgery, he was treated with 4 cycles of adjuvant chemotherapy with cisplatin and docetaxel.

Six months after surgery, the patient began to complain of right-hand pain isolated to the thenar eminence. He also described swelling and significant pain with active or passive movement of the thumb and with relatively mild-to-moderate palpation of the area. The patient reported that the functioning of his thumb deteriorated rapidly over the course of about 1 month. On physical examination, he was neurovascularly intact with no apparent deficit in sensation of his right hand. There was no erythema or overlying skin changes. His right thenar eminence was mildly enlarged as compared with the left, and a firm, focal mass was readily palpated. Range of motion at the metacarpophalangeal joint of the thumb and index finger was limited because of pain. Thumb opposition was markedly limited. After a detailed history and physical examination, we were concerned about possible deep space infection, old hematoma, or possible metastatic disease. Magnetic resonance imaging (MRI) was ordered to evaluate the palpable mass.

Radiographically, localized soft-tissue swelling was present on the palmar surface of the hand obliquely overlying the index finger metacarpal (Figures 2, 3). On MRI, the lesion measured approximately 1.8×3.3 cm and was isointense to slightly hyperintense diffusely with central hyperintensity on T1 images (Figure 4). On T2 and short tau inversion recovery images, the lesion was more strikingly hyperintense and infiltrative in appearance (Figure 5). Postcontrast images showed avid enhancement peripherally, with central nonenhancement consistent with necrosis in the adductor pollicis.

Continue for biopsy results and discussion >>

We performed a biopsy of the lesion with the aid of immediate adequacy by fine needle aspiration cytology. We saw mitotically active malignant cells with large nuclei, high nuclear-to-cytoplasmic ratios, nucleoli, and dense cytoplasm, suggesting a metastatic squamous cell carcinoma. Because infection was part of the differential, it is pertinent to note that there was no significant inflammatory infiltrate. The core biopsy was consistent with metastatic lung cancer (Figure 6).

Discussion

This patient presented an interesting diagnostic challenge, particularly because of his previous malignancy. The differential diagnosis of acute onset thenar pain without history of trauma would include encompassing soft-tissue abscess, osteomyelitis, and infectious myositis. Soft-tissue hematoma is also in the differential for this patient, especially given the malignancy. Bony metastasis should be considered in this patient given the propensity of lung carcinoma to metastasize to bone. The location would certainly be atypical, with metastasis to the bones of the forearm or hand representing only 0.1% of all metastasis of any type of primary carcinoma or sarcoma.⁴ Primary bone or soft-tissue sarcoma should also be considered. Some authors have also suggested that necrosis, peritumoral edema-like signal, and lobulation are more common with skeletal muscle metastasis than with a primary sarcoma.¹⁰ In this case, the degree of surrounding postcontrast enhancement made simple muscle tear with hematoma unlikely, despite the  presence of increased T1 signal. The lack of evidence for localized infection and the presence of a firm focal mass on physical examination made tumor more likely than infection.        

Acrometastasis

Metastatic disease distal to the elbow and knee is very rare; specifically, metastatic disease of the hands or feet accounts for approximately 0.1% of all metastases.⁴ Carcinoma of the lung accounts for 44% to 47% of all acrometastasis.^11,12 When hand acrometastasis is considered, the right hand accounts for 55% of bony cases, likely because of hand dominance, although approximately 10% of patients had bilateral acral metastatic disease.¹² The underlying mechanism of acrometastasis remains unclear; however, some authors have postulated that it may result from an increase in vascularity or a trauma to the affected extremity.^12,13 Flynn and colleagues¹² reviewed the literature and reported a total of 257 cases of acral metastasis to the hand; they found that the median age at presentation was 58 years. Men were more than twice as likely to be affected when compared with women. Most commonly, the primary malignancies were in the lung (44%), kidney (12%), and breast (10%). The authors also reported less common cases of acral metastasis with primary malignancies located in the stomach, liver, rectum, prostate, and colon. Most commonly, these metastases were found in the distal phalynx, followed by the metacarpals, proximal phalynx, and middle phalynx.¹²

Soft-Tissue Metastasis

Skeletal muscle metastasis occurs in 0.8% to 17.5% of metastatic neoplasms.^14-17 Studies in lung cancer patients have also revealed a low prevalence of muscular metastasis (0% to 0.8%).¹⁶ The rarity of muscular metastatic disease has been attributed to local inhibition of tumor survival secondary to muscle contraction, increased diffusing capacity of enzymes and immune cells, and extreme variability in blood flow and pH, lactate, and oxygen concentration. Skeletal muscular metastases most commonly arise from the lung, kidneys, colon, or melanoma.¹⁶ In a recent large series of more than 1400 patients imaged for soft-tissue masses, 2.5% were metastatic.¹⁸ There are only 2 reports of soft-tissue metastatic disease involving the hand: one from a patient with a thyroid carcinoma and the other from a patient with a lung adenocarcinoma.¹⁸ Soft-tissue metastatic disease from squamous cell carcinoma distal to the wrist has never been reported in the literature.  

Acral Soft-Tissue Metastasis

A review from 2012 found 264 cases of skeletal muscle metastasis from 151 articles.⁶ Only 2 (0.75%) of these patients, as reported above, had a soft-tissue metastasis distal to the wrist.^6,17

Continue for conclusion >>

Conclusion

We report the first known case of a soft-tissue metastasis distal to the wrist from a primary bronchogenic squamous cell carcinoma. This report highlights the extremely uncommon presentation of soft-tissue acral metastatic disease of a bronchogenic squamous cell carcinoma of the lung. Although exceedingly rare, oncologists and physicians who manage pathology of the hand should consider metastatic disease when evaluating a patient with complaints of hand pain and a soft-tissue mass, especially in a patient with a known primary malignancy.

Carcinoma of the lung is the most common lethal form of cancer in both men and women worldwide.¹ It accounts for more deaths than the next 3 most common cancers combined. In 2012, 160,000 Americans are estimated to have died from lung cancer.¹ Lung cancer is known to have a high metastatic potential for the brain, bones, adrenal glands, lungs, and liver.² Orthopedic manifestations frequently include bony metastasis, most commonly the vertebrae (42%), ribs (20%), and pelvis (18%).³ Acral metastatic disease is defined as metastasis distal to the elbow or the knee. Bony acral metastases from lung carcinoma to the upper and lower extremities are extremely uncommon, accounting for only 1% each of total bone metastases from carcinoma of the lung.³ Metastases to the bones of the hand are even rarer. Only 0.1% of metastatic disease from any type of carcinoma or sarcoma manifests as metastasis in the hand.⁴ There are only a few reports in the literature of soft-tissue or muscular metastasis to the hand from a carcinoma. Of these cases, the majority are caused by metastatic lung carcinoma.^5-9 There are no reports in the literature of metastatic disease of squamous cell origin affecting the soft tissues of the hand.

We present a case of a man with known metastatic squamous cell carcinoma of the lung who presented with acral soft-tissue metastatic disease. This report highlights a rare clinical scenario that has not been reported in the literature. The report also emphasizes a rare but important consideration for clinicians who encounter acral soft-tissue lesions in patients with a history of a primary carcinoma. The patient provided written informed consent for print and electronic publication of this case report.

Continue for case report >>

Case Report

A 56-year-old man presented with right-sided pleuritic flank pain, along with a 30-lb weight loss over a 6-month period. A computed tomographic scan revealed a 5.58×3.7-cm cavitary lesion in the right lower lobe with abutment of the posterior chest wall (Figure 1). He underwent biopsy and staging, and was found to be T3N1, with biopsy-proven well-differentiated bronchogenic squamous cell carcinoma. The patient then underwent right lower and middle lobectomy with concomitant en-bloc resection of the posterior portion of ribs 7 to 11, along with mediastinal lymph-node dissection with negative margins. After surgery, he was treated with 4 cycles of adjuvant chemotherapy with cisplatin and docetaxel.

Six months after surgery, the patient began to complain of right-hand pain isolated to the thenar eminence. He also described swelling and significant pain with active or passive movement of the thumb and with relatively mild-to-moderate palpation of the area. The patient reported that the functioning of his thumb deteriorated rapidly over the course of about 1 month. On physical examination, he was neurovascularly intact with no apparent deficit in sensation of his right hand. There was no erythema or overlying skin changes. His right thenar eminence was mildly enlarged as compared with the left, and a firm, focal mass was readily palpated. Range of motion at the metacarpophalangeal joint of the thumb and index finger was limited because of pain. Thumb opposition was markedly limited. After a detailed history and physical examination, we were concerned about possible deep space infection, old hematoma, or possible metastatic disease. Magnetic resonance imaging (MRI) was ordered to evaluate the palpable mass.

Radiographically, localized soft-tissue swelling was present on the palmar surface of the hand obliquely overlying the index finger metacarpal (Figures 2, 3). On MRI, the lesion measured approximately 1.8×3.3 cm and was isointense to slightly hyperintense diffusely with central hyperintensity on T1 images (Figure 4). On T2 and short tau inversion recovery images, the lesion was more strikingly hyperintense and infiltrative in appearance (Figure 5). Postcontrast images showed avid enhancement peripherally, with central nonenhancement consistent with necrosis in the adductor pollicis.

Continue for biopsy results and discussion >>

We performed a biopsy of the lesion with the aid of immediate adequacy by fine needle aspiration cytology. We saw mitotically active malignant cells with large nuclei, high nuclear-to-cytoplasmic ratios, nucleoli, and dense cytoplasm, suggesting a metastatic squamous cell carcinoma. Because infection was part of the differential, it is pertinent to note that there was no significant inflammatory infiltrate. The core biopsy was consistent with metastatic lung cancer (Figure 6).

Discussion

This patient presented an interesting diagnostic challenge, particularly because of his previous malignancy. The differential diagnosis of acute onset thenar pain without history of trauma would include encompassing soft-tissue abscess, osteomyelitis, and infectious myositis. Soft-tissue hematoma is also in the differential for this patient, especially given the malignancy. Bony metastasis should be considered in this patient given the propensity of lung carcinoma to metastasize to bone. The location would certainly be atypical, with metastasis to the bones of the forearm or hand representing only 0.1% of all metastasis of any type of primary carcinoma or sarcoma.⁴ Primary bone or soft-tissue sarcoma should also be considered. Some authors have also suggested that necrosis, peritumoral edema-like signal, and lobulation are more common with skeletal muscle metastasis than with a primary sarcoma.¹⁰ In this case, the degree of surrounding postcontrast enhancement made simple muscle tear with hematoma unlikely, despite the  presence of increased T1 signal. The lack of evidence for localized infection and the presence of a firm focal mass on physical examination made tumor more likely than infection.        

Acrometastasis

Metastatic disease distal to the elbow and knee is very rare; specifically, metastatic disease of the hands or feet accounts for approximately 0.1% of all metastases.⁴ Carcinoma of the lung accounts for 44% to 47% of all acrometastasis.^11,12 When hand acrometastasis is considered, the right hand accounts for 55% of bony cases, likely because of hand dominance, although approximately 10% of patients had bilateral acral metastatic disease.¹² The underlying mechanism of acrometastasis remains unclear; however, some authors have postulated that it may result from an increase in vascularity or a trauma to the affected extremity.^12,13 Flynn and colleagues¹² reviewed the literature and reported a total of 257 cases of acral metastasis to the hand; they found that the median age at presentation was 58 years. Men were more than twice as likely to be affected when compared with women. Most commonly, the primary malignancies were in the lung (44%), kidney (12%), and breast (10%). The authors also reported less common cases of acral metastasis with primary malignancies located in the stomach, liver, rectum, prostate, and colon. Most commonly, these metastases were found in the distal phalynx, followed by the metacarpals, proximal phalynx, and middle phalynx.¹²

Soft-Tissue Metastasis

Skeletal muscle metastasis occurs in 0.8% to 17.5% of metastatic neoplasms.^14-17 Studies in lung cancer patients have also revealed a low prevalence of muscular metastasis (0% to 0.8%).¹⁶ The rarity of muscular metastatic disease has been attributed to local inhibition of tumor survival secondary to muscle contraction, increased diffusing capacity of enzymes and immune cells, and extreme variability in blood flow and pH, lactate, and oxygen concentration. Skeletal muscular metastases most commonly arise from the lung, kidneys, colon, or melanoma.¹⁶ In a recent large series of more than 1400 patients imaged for soft-tissue masses, 2.5% were metastatic.¹⁸ There are only 2 reports of soft-tissue metastatic disease involving the hand: one from a patient with a thyroid carcinoma and the other from a patient with a lung adenocarcinoma.¹⁸ Soft-tissue metastatic disease from squamous cell carcinoma distal to the wrist has never been reported in the literature.  

Acral Soft-Tissue Metastasis

A review from 2012 found 264 cases of skeletal muscle metastasis from 151 articles.⁶ Only 2 (0.75%) of these patients, as reported above, had a soft-tissue metastasis distal to the wrist.^6,17

Continue for conclusion >>

Conclusion

We report the first known case of a soft-tissue metastasis distal to the wrist from a primary bronchogenic squamous cell carcinoma. This report highlights the extremely uncommon presentation of soft-tissue acral metastatic disease of a bronchogenic squamous cell carcinoma of the lung. Although exceedingly rare, oncologists and physicians who manage pathology of the hand should consider metastatic disease when evaluating a patient with complaints of hand pain and a soft-tissue mass, especially in a patient with a known primary malignancy.

Carcinoma of the lung is the most common lethal form of cancer in both men and women worldwide.¹ It accounts for more deaths than the next 3 most common cancers combined. In 2012, 160,000 Americans are estimated to have died from lung cancer.¹ Lung cancer is known to have a high metastatic potential for the brain, bones, adrenal glands, lungs, and liver.² Orthopedic manifestations frequently include bony metastasis, most commonly the vertebrae (42%), ribs (20%), and pelvis (18%).³ Acral metastatic disease is defined as metastasis distal to the elbow or the knee. Bony acral metastases from lung carcinoma to the upper and lower extremities are extremely uncommon, accounting for only 1% each of total bone metastases from carcinoma of the lung.³ Metastases to the bones of the hand are even rarer. Only 0.1% of metastatic disease from any type of carcinoma or sarcoma manifests as metastasis in the hand.⁴ There are only a few reports in the literature of soft-tissue or muscular metastasis to the hand from a carcinoma. Of these cases, the majority are caused by metastatic lung carcinoma.^5-9 There are no reports in the literature of metastatic disease of squamous cell origin affecting the soft tissues of the hand.

We present a case of a man with known metastatic squamous cell carcinoma of the lung who presented with acral soft-tissue metastatic disease. This report highlights a rare clinical scenario that has not been reported in the literature. The report also emphasizes a rare but important consideration for clinicians who encounter acral soft-tissue lesions in patients with a history of a primary carcinoma. The patient provided written informed consent for print and electronic publication of this case report.

Continue for case report >>

Case Report

A 56-year-old man presented with right-sided pleuritic flank pain, along with a 30-lb weight loss over a 6-month period. A computed tomographic scan revealed a 5.58×3.7-cm cavitary lesion in the right lower lobe with abutment of the posterior chest wall (Figure 1). He underwent biopsy and staging, and was found to be T3N1, with biopsy-proven well-differentiated bronchogenic squamous cell carcinoma. The patient then underwent right lower and middle lobectomy with concomitant en-bloc resection of the posterior portion of ribs 7 to 11, along with mediastinal lymph-node dissection with negative margins. After surgery, he was treated with 4 cycles of adjuvant chemotherapy with cisplatin and docetaxel.

Six months after surgery, the patient began to complain of right-hand pain isolated to the thenar eminence. He also described swelling and significant pain with active or passive movement of the thumb and with relatively mild-to-moderate palpation of the area. The patient reported that the functioning of his thumb deteriorated rapidly over the course of about 1 month. On physical examination, he was neurovascularly intact with no apparent deficit in sensation of his right hand. There was no erythema or overlying skin changes. His right thenar eminence was mildly enlarged as compared with the left, and a firm, focal mass was readily palpated. Range of motion at the metacarpophalangeal joint of the thumb and index finger was limited because of pain. Thumb opposition was markedly limited. After a detailed history and physical examination, we were concerned about possible deep space infection, old hematoma, or possible metastatic disease. Magnetic resonance imaging (MRI) was ordered to evaluate the palpable mass.

Radiographically, localized soft-tissue swelling was present on the palmar surface of the hand obliquely overlying the index finger metacarpal (Figures 2, 3). On MRI, the lesion measured approximately 1.8×3.3 cm and was isointense to slightly hyperintense diffusely with central hyperintensity on T1 images (Figure 4). On T2 and short tau inversion recovery images, the lesion was more strikingly hyperintense and infiltrative in appearance (Figure 5). Postcontrast images showed avid enhancement peripherally, with central nonenhancement consistent with necrosis in the adductor pollicis.

Continue for biopsy results and discussion >>

We performed a biopsy of the lesion with the aid of immediate adequacy by fine needle aspiration cytology. We saw mitotically active malignant cells with large nuclei, high nuclear-to-cytoplasmic ratios, nucleoli, and dense cytoplasm, suggesting a metastatic squamous cell carcinoma. Because infection was part of the differential, it is pertinent to note that there was no significant inflammatory infiltrate. The core biopsy was consistent with metastatic lung cancer (Figure 6).

Discussion

This patient presented an interesting diagnostic challenge, particularly because of his previous malignancy. The differential diagnosis of acute onset thenar pain without history of trauma would include encompassing soft-tissue abscess, osteomyelitis, and infectious myositis. Soft-tissue hematoma is also in the differential for this patient, especially given the malignancy. Bony metastasis should be considered in this patient given the propensity of lung carcinoma to metastasize to bone. The location would certainly be atypical, with metastasis to the bones of the forearm or hand representing only 0.1% of all metastasis of any type of primary carcinoma or sarcoma.⁴ Primary bone or soft-tissue sarcoma should also be considered. Some authors have also suggested that necrosis, peritumoral edema-like signal, and lobulation are more common with skeletal muscle metastasis than with a primary sarcoma.¹⁰ In this case, the degree of surrounding postcontrast enhancement made simple muscle tear with hematoma unlikely, despite the  presence of increased T1 signal. The lack of evidence for localized infection and the presence of a firm focal mass on physical examination made tumor more likely than infection.        

Acrometastasis

Metastatic disease distal to the elbow and knee is very rare; specifically, metastatic disease of the hands or feet accounts for approximately 0.1% of all metastases.⁴ Carcinoma of the lung accounts for 44% to 47% of all acrometastasis.^11,12 When hand acrometastasis is considered, the right hand accounts for 55% of bony cases, likely because of hand dominance, although approximately 10% of patients had bilateral acral metastatic disease.¹² The underlying mechanism of acrometastasis remains unclear; however, some authors have postulated that it may result from an increase in vascularity or a trauma to the affected extremity.^12,13 Flynn and colleagues¹² reviewed the literature and reported a total of 257 cases of acral metastasis to the hand; they found that the median age at presentation was 58 years. Men were more than twice as likely to be affected when compared with women. Most commonly, the primary malignancies were in the lung (44%), kidney (12%), and breast (10%). The authors also reported less common cases of acral metastasis with primary malignancies located in the stomach, liver, rectum, prostate, and colon. Most commonly, these metastases were found in the distal phalynx, followed by the metacarpals, proximal phalynx, and middle phalynx.¹²

Soft-Tissue Metastasis

Skeletal muscle metastasis occurs in 0.8% to 17.5% of metastatic neoplasms.^14-17 Studies in lung cancer patients have also revealed a low prevalence of muscular metastasis (0% to 0.8%).¹⁶ The rarity of muscular metastatic disease has been attributed to local inhibition of tumor survival secondary to muscle contraction, increased diffusing capacity of enzymes and immune cells, and extreme variability in blood flow and pH, lactate, and oxygen concentration. Skeletal muscular metastases most commonly arise from the lung, kidneys, colon, or melanoma.¹⁶ In a recent large series of more than 1400 patients imaged for soft-tissue masses, 2.5% were metastatic.¹⁸ There are only 2 reports of soft-tissue metastatic disease involving the hand: one from a patient with a thyroid carcinoma and the other from a patient with a lung adenocarcinoma.¹⁸ Soft-tissue metastatic disease from squamous cell carcinoma distal to the wrist has never been reported in the literature.  

Acral Soft-Tissue Metastasis

A review from 2012 found 264 cases of skeletal muscle metastasis from 151 articles.⁶ Only 2 (0.75%) of these patients, as reported above, had a soft-tissue metastasis distal to the wrist.^6,17

Continue for conclusion >>

Conclusion

We report the first known case of a soft-tissue metastasis distal to the wrist from a primary bronchogenic squamous cell carcinoma. This report highlights the extremely uncommon presentation of soft-tissue acral metastatic disease of a bronchogenic squamous cell carcinoma of the lung. Although exceedingly rare, oncologists and physicians who manage pathology of the hand should consider metastatic disease when evaluating a patient with complaints of hand pain and a soft-tissue mass, especially in a patient with a known primary malignancy.