Purpose: Palliative Care is essential to Oncology. The purpose of this abstract is to describe the AVAHO Palliative Care Research subcommittee, its objectives, and evidence of its productive multi-disciplinary and inter-institutional collaboration.

Background: The American Society of Clinical Oncology (ASCO) recommends Palliative Care for all patients with metastatic lung cancer and other symptomatic advanced malignancies. VA mandates Palliative Care inpatient consult teams for all medical facilities. It is not clearly known how Palliative Care is integrated into standard VA outpatient Oncology practice. In addition, questions remain regarding the optimal way(s) to provide Palliative Oncology Care. The AVAHO Palliative Care Research subcommittee was established in 2015 and currently has 7 members from 7 VA institutions. The mission of the subcommittee is to develop partnerships among VA clinicians, pharmacists, social workers, researchers, and VA leadership with the shared goal of providing optimal Palliative Oncology Care within the VA. In laying the groundwork for productive collaboration, we have identified a need to better understand the current interface between VA Oncology Clinics and Palliative Care teams. In particular, we seek to review the evidence for providing on-site Palliative Care to patients with advanced malignancies, and we seek to understand the current availability of outpatient Palliative Care within VA outpatient Oncology clinics.

Methods: We have identified 2 initial approaches to address these questions. First, we have submitted a proposal to the VA Evidence-Based Synthesis Program (ESP) to review the evidence regarding optimal Palliative Care delivery methods for patients with advanced malignancies and
the feasibility of providing on-site Palliative Care embedded into VA Oncology clinics. Second, we plan to survey current VA Oncology providers to understand their Palliative Care referral patterns, available on-site resources, and barriers to providing optimal Palliative Care for their patients.

Analysis/Results: At the AVAHO 2016 meeting, we will provide updated information on the ESP proposal and the Palliative Care in Oncology Survey.

Conclusion: The AVAHO Palliative Care Research subcommittee represents a multidisciplinary and inter-institutional collaboration with a common goal of optimizing VA Palliative Oncology Care. This subcommittee is a model of how AVAHO can foster productive collaborations. We welcome new members.

Purpose: Palliative Care is essential to Oncology. The purpose of this abstract is to describe the AVAHO Palliative Care Research subcommittee, its objectives, and evidence of its productive multi-disciplinary and inter-institutional collaboration.

Background: The American Society of Clinical Oncology (ASCO) recommends Palliative Care for all patients with metastatic lung cancer and other symptomatic advanced malignancies. VA mandates Palliative Care inpatient consult teams for all medical facilities. It is not clearly known how Palliative Care is integrated into standard VA outpatient Oncology practice. In addition, questions remain regarding the optimal way(s) to provide Palliative Oncology Care. The AVAHO Palliative Care Research subcommittee was established in 2015 and currently has 7 members from 7 VA institutions. The mission of the subcommittee is to develop partnerships among VA clinicians, pharmacists, social workers, researchers, and VA leadership with the shared goal of providing optimal Palliative Oncology Care within the VA. In laying the groundwork for productive collaboration, we have identified a need to better understand the current interface between VA Oncology Clinics and Palliative Care teams. In particular, we seek to review the evidence for providing on-site Palliative Care to patients with advanced malignancies, and we seek to understand the current availability of outpatient Palliative Care within VA outpatient Oncology clinics.

Methods: We have identified 2 initial approaches to address these questions. First, we have submitted a proposal to the VA Evidence-Based Synthesis Program (ESP) to review the evidence regarding optimal Palliative Care delivery methods for patients with advanced malignancies and
the feasibility of providing on-site Palliative Care embedded into VA Oncology clinics. Second, we plan to survey current VA Oncology providers to understand their Palliative Care referral patterns, available on-site resources, and barriers to providing optimal Palliative Care for their patients.

Analysis/Results: At the AVAHO 2016 meeting, we will provide updated information on the ESP proposal and the Palliative Care in Oncology Survey.

Conclusion: The AVAHO Palliative Care Research subcommittee represents a multidisciplinary and inter-institutional collaboration with a common goal of optimizing VA Palliative Oncology Care. This subcommittee is a model of how AVAHO can foster productive collaborations. We welcome new members.

Purpose: Palliative Care is essential to Oncology. The purpose of this abstract is to describe the AVAHO Palliative Care Research subcommittee, its objectives, and evidence of its productive multi-disciplinary and inter-institutional collaboration.

Background: The American Society of Clinical Oncology (ASCO) recommends Palliative Care for all patients with metastatic lung cancer and other symptomatic advanced malignancies. VA mandates Palliative Care inpatient consult teams for all medical facilities. It is not clearly known how Palliative Care is integrated into standard VA outpatient Oncology practice. In addition, questions remain regarding the optimal way(s) to provide Palliative Oncology Care. The AVAHO Palliative Care Research subcommittee was established in 2015 and currently has 7 members from 7 VA institutions. The mission of the subcommittee is to develop partnerships among VA clinicians, pharmacists, social workers, researchers, and VA leadership with the shared goal of providing optimal Palliative Oncology Care within the VA. In laying the groundwork for productive collaboration, we have identified a need to better understand the current interface between VA Oncology Clinics and Palliative Care teams. In particular, we seek to review the evidence for providing on-site Palliative Care to patients with advanced malignancies, and we seek to understand the current availability of outpatient Palliative Care within VA outpatient Oncology clinics.

Methods: We have identified 2 initial approaches to address these questions. First, we have submitted a proposal to the VA Evidence-Based Synthesis Program (ESP) to review the evidence regarding optimal Palliative Care delivery methods for patients with advanced malignancies and
the feasibility of providing on-site Palliative Care embedded into VA Oncology clinics. Second, we plan to survey current VA Oncology providers to understand their Palliative Care referral patterns, available on-site resources, and barriers to providing optimal Palliative Care for their patients.

Analysis/Results: At the AVAHO 2016 meeting, we will provide updated information on the ESP proposal and the Palliative Care in Oncology Survey.

Conclusion: The AVAHO Palliative Care Research subcommittee represents a multidisciplinary and inter-institutional collaboration with a common goal of optimizing VA Palliative Oncology Care. This subcommittee is a model of how AVAHO can foster productive collaborations. We welcome new members.

Purpose: To evaluate failure rates of patients from a single institution who underwent salvage and adjuvant radiation therapy (RT) following radical retropubic prostatectomy for adenocarcinoma of the prostate.

Methods: Between 2002 and 2015, 62 patients were treated with Intensity Modulated Radiation Therapy following Radical Retropubic Prostatectomy (RRP). Of these, 45 (72.6%) patients received salvage therapy, all of whom had a Prostate Specific Antigen (PSA) of > 0.2; while 17 (27.4%) patients underwent adjuvant RT at a median of 5 months following RRP, due to having either positive extracapsular extension (ECE) (65%), seminal vesicle invasion (SVI) (29%), and/or positive margins (65%). The median dose delivered to the prostate fossa, as per the Radiation Therapy Oncology Group guidelines for post-prostatectomy radiation therapy, was 6600c Gy at 180-200 cGy a fraction. In the salvage group, 9 patients ended up receiving androgen deprivation therapy (ADT) at some point following RRP, while 7 patients were prescribed ADT in the adjuvant group.

Results: With the median follow-up of 62 months, the median disease free survival rates were 10.8 and 4.3 years (P < 0.011) for the salvage and adjuvant groups, respectively. Biochemical progression free survival (bPFS) for the adjuvant groups was statistically significant (78.9%), when compared to 40% in the salvage group (P < 0.011). The patterns of failure in the salvage group were 9 patients had local failure (LF), 2 distant metastases (DM), and 3 patients had both LF and DM in the salvage group. On the other hand, in the adjuvant treatment group there was 1 patient with LF, 1 with DM and 1 patient with both LF and DM. Of those who failed following RT, the median time to failure was 25 and 99 months in the salvage and adjuvant groups, respectively. No patient experienced any sort of grade 3 toxicity following RT in either of the groups, per the CTCAE v3.0 criteria.

Conclusion: A retrospective review of 62 patients who received radiation therapy in either the salvage or adjuvant setting following prostatectomy revealed that adjuvant patients were with superior local control rates than salvage patients. We conclude that patients with high-risk features following prostatectomy receive adjuvant therapy and not delay radiation therapy until there is biochemical failure.

Purpose: To evaluate failure rates of patients from a single institution who underwent salvage and adjuvant radiation therapy (RT) following radical retropubic prostatectomy for adenocarcinoma of the prostate.

Methods: Between 2002 and 2015, 62 patients were treated with Intensity Modulated Radiation Therapy following Radical Retropubic Prostatectomy (RRP). Of these, 45 (72.6%) patients received salvage therapy, all of whom had a Prostate Specific Antigen (PSA) of > 0.2; while 17 (27.4%) patients underwent adjuvant RT at a median of 5 months following RRP, due to having either positive extracapsular extension (ECE) (65%), seminal vesicle invasion (SVI) (29%), and/or positive margins (65%). The median dose delivered to the prostate fossa, as per the Radiation Therapy Oncology Group guidelines for post-prostatectomy radiation therapy, was 6600c Gy at 180-200 cGy a fraction. In the salvage group, 9 patients ended up receiving androgen deprivation therapy (ADT) at some point following RRP, while 7 patients were prescribed ADT in the adjuvant group.

Results: With the median follow-up of 62 months, the median disease free survival rates were 10.8 and 4.3 years (P < 0.011) for the salvage and adjuvant groups, respectively. Biochemical progression free survival (bPFS) for the adjuvant groups was statistically significant (78.9%), when compared to 40% in the salvage group (P < 0.011). The patterns of failure in the salvage group were 9 patients had local failure (LF), 2 distant metastases (DM), and 3 patients had both LF and DM in the salvage group. On the other hand, in the adjuvant treatment group there was 1 patient with LF, 1 with DM and 1 patient with both LF and DM. Of those who failed following RT, the median time to failure was 25 and 99 months in the salvage and adjuvant groups, respectively. No patient experienced any sort of grade 3 toxicity following RT in either of the groups, per the CTCAE v3.0 criteria.

Conclusion: A retrospective review of 62 patients who received radiation therapy in either the salvage or adjuvant setting following prostatectomy revealed that adjuvant patients were with superior local control rates than salvage patients. We conclude that patients with high-risk features following prostatectomy receive adjuvant therapy and not delay radiation therapy until there is biochemical failure.

Purpose: To evaluate failure rates of patients from a single institution who underwent salvage and adjuvant radiation therapy (RT) following radical retropubic prostatectomy for adenocarcinoma of the prostate.

Methods: Between 2002 and 2015, 62 patients were treated with Intensity Modulated Radiation Therapy following Radical Retropubic Prostatectomy (RRP). Of these, 45 (72.6%) patients received salvage therapy, all of whom had a Prostate Specific Antigen (PSA) of > 0.2; while 17 (27.4%) patients underwent adjuvant RT at a median of 5 months following RRP, due to having either positive extracapsular extension (ECE) (65%), seminal vesicle invasion (SVI) (29%), and/or positive margins (65%). The median dose delivered to the prostate fossa, as per the Radiation Therapy Oncology Group guidelines for post-prostatectomy radiation therapy, was 6600c Gy at 180-200 cGy a fraction. In the salvage group, 9 patients ended up receiving androgen deprivation therapy (ADT) at some point following RRP, while 7 patients were prescribed ADT in the adjuvant group.

Results: With the median follow-up of 62 months, the median disease free survival rates were 10.8 and 4.3 years (P < 0.011) for the salvage and adjuvant groups, respectively. Biochemical progression free survival (bPFS) for the adjuvant groups was statistically significant (78.9%), when compared to 40% in the salvage group (P < 0.011). The patterns of failure in the salvage group were 9 patients had local failure (LF), 2 distant metastases (DM), and 3 patients had both LF and DM in the salvage group. On the other hand, in the adjuvant treatment group there was 1 patient with LF, 1 with DM and 1 patient with both LF and DM. Of those who failed following RT, the median time to failure was 25 and 99 months in the salvage and adjuvant groups, respectively. No patient experienced any sort of grade 3 toxicity following RT in either of the groups, per the CTCAE v3.0 criteria.

Conclusion: A retrospective review of 62 patients who received radiation therapy in either the salvage or adjuvant setting following prostatectomy revealed that adjuvant patients were with superior local control rates than salvage patients. We conclude that patients with high-risk features following prostatectomy receive adjuvant therapy and not delay radiation therapy until there is biochemical failure.

Linden Spital, NP, a psychiatric mental-health nurse practitioner, staffs the Psychiatric Consultation Liaison Service at the University of Michigan in Ann Arbor. Nearly every hospital larger than about 200 beds, she says, could benefit from a similar service, and hospitalists could play an important role in creating it.

I wrote about the idea for a generally similar service in my April 2015 column, but at the time, I didn’t know of an institution that had something like this in place.

Along with her hospitalist colleagues, Anupama (Anu) Goyal, MBChB, and Rob Chang, MD, Linden has launched a service to provide assistance to bedside caregivers dealing with very difficult patients (eg, those who are verbally or physically threatening to staff, unreasonably demanding and angry, have bizarre behavior, etc.).

Sample Cases

Two recent cases illustrate the role of the service. A female patient in her 60s had several admissions characterized by what many caregivers agreed were unreasonably precise demands regarding how her care should be delivered. She was verbally abusive of caregivers, especially those who were young or of a different race, and her family member tended to reinforce these maladaptive behaviors. Staff found it very stressful to care for her and had concerns that her care suffered as a result.

Linden served as a resource and support for staff, plus worked with providers to set limits on the patient and family behavior and to separate patient behaviors that were and weren’t modifiable. Linden’s efforts helped clarify the goals for the patient’s care and reduced staff distress. Even though the patient’s behavior didn’t change significantly, staff anecdotally reported less distress and concern that the patient’s care suffered as a result.

Another case involved a man in his 50s who had a progressive neurodegenerative disease and was admitted because of increasingly aggressive behavior in his skilled-nursing facility (SNF). Providers at the SNF attributed the poor behavior to changes in medications. His behavior was very difficult to manage, and staff asked for Linden’s help. She worked with the patient and realized much of his difficult behavior stemmed from his frustration with communicating verbally because of his neurologic disease. Rather than pursue increasing psychotropics, Linden promoted efforts to develop a system of hand signals the patient could use to communicate needs. His behavior improved, presumably by reducing his own frustration and improving his autonomy.

Atypical Consults

This psychiatric consultation liaison service has some overlap with traditional inpatient psychiatry services, but it is configured so that the caregiver is essentially embedded on the medical units of the hospital and assists in the care of patients who wouldn’t typically be appropriate for a psychiatry consult. For example, patients and/or families who act out because of anger over being on observation status are appropriate for this service but would usually not be appropriate for a psychiatry consult. The two examples above aren’t ideal cases for a standard psychiatry consult; however, the attending hospitalist needed help nonetheless.

Operational Details

The liaison service started with a successful trial on two hospital units in 2013. Linden began serving as the sole clinician on the service in January 2015. She is available during the daytime on weekdays, and any staff can request her participation in the care of a patient. Her visits are billed when appropriate, but many aren’t billed (for example, if her primary work was to conference with staff regarding management of a patient).

Consults can be requested by anyone (nurses, etc., as well as physicians, though only the latter would be billable) via an electronic health record entry that helps ensure whether the request is for this service versus the inpatient psychiatry service. The order includes a standard list of potential reasons for consult that can be selected and amplified with free text comments. She also receives verbal consult requests as she moves through the hospital.

Linden’s position is budgeted through the psychiatry department and funded by the hospital with only modest professional fee collections.

An Idea That Is Catching On?

Anu Goyal made me aware of a study from 2004 that summarized findings from experience with a similar service at Washington University in St. Louis, but the service was cancelled after a short time due to its cost.1 She also found a few studies from the 1990s and a 2001 study from Australia that report on a similar service.

But maybe the idea is catching on again, at least a little.

On April 25, The Wall Street Journal published an article titled “Hospitals Test Putting Psychiatrists on Medical Wards.”2 It described programs at Brigham and Women’s Hospital in Boston, Johns Hopkins Hospital in Baltimore, and NewYork-Presbyterian/Columbia University Medical Center in New York City. They share some similarities with the service at the University of Michigan. However, according to the article, the three big-city programs tilt more toward a traditional consultation model than what Linden does.

I think every hospital should be thinking about a service other than traditional consult psychiatry that could help with challenging patient behavior. The University of Michigan model or similar ones seem like a good place to start. TH

Reference

1. Yakimo R, Kurlowicz L, Murray R. Evaluation of outcomes in psychiatric consultation-liaison nursing practice. Arch Psychiatr Nurs. 2004;18(6):215-227.

   2. Ladnado L. Hospitals test putting psychiatrists on medical wards. The Wall Street Journal website. Accessed July 3, 2016.

Linden Spital, NP, a psychiatric mental-health nurse practitioner, staffs the Psychiatric Consultation Liaison Service at the University of Michigan in Ann Arbor. Nearly every hospital larger than about 200 beds, she says, could benefit from a similar service, and hospitalists could play an important role in creating it.

I wrote about the idea for a generally similar service in my April 2015 column, but at the time, I didn’t know of an institution that had something like this in place.

Along with her hospitalist colleagues, Anupama (Anu) Goyal, MBChB, and Rob Chang, MD, Linden has launched a service to provide assistance to bedside caregivers dealing with very difficult patients (eg, those who are verbally or physically threatening to staff, unreasonably demanding and angry, have bizarre behavior, etc.).

Sample Cases

Two recent cases illustrate the role of the service. A female patient in her 60s had several admissions characterized by what many caregivers agreed were unreasonably precise demands regarding how her care should be delivered. She was verbally abusive of caregivers, especially those who were young or of a different race, and her family member tended to reinforce these maladaptive behaviors. Staff found it very stressful to care for her and had concerns that her care suffered as a result.

Linden served as a resource and support for staff, plus worked with providers to set limits on the patient and family behavior and to separate patient behaviors that were and weren’t modifiable. Linden’s efforts helped clarify the goals for the patient’s care and reduced staff distress. Even though the patient’s behavior didn’t change significantly, staff anecdotally reported less distress and concern that the patient’s care suffered as a result.

Another case involved a man in his 50s who had a progressive neurodegenerative disease and was admitted because of increasingly aggressive behavior in his skilled-nursing facility (SNF). Providers at the SNF attributed the poor behavior to changes in medications. His behavior was very difficult to manage, and staff asked for Linden’s help. She worked with the patient and realized much of his difficult behavior stemmed from his frustration with communicating verbally because of his neurologic disease. Rather than pursue increasing psychotropics, Linden promoted efforts to develop a system of hand signals the patient could use to communicate needs. His behavior improved, presumably by reducing his own frustration and improving his autonomy.

Atypical Consults

This psychiatric consultation liaison service has some overlap with traditional inpatient psychiatry services, but it is configured so that the caregiver is essentially embedded on the medical units of the hospital and assists in the care of patients who wouldn’t typically be appropriate for a psychiatry consult. For example, patients and/or families who act out because of anger over being on observation status are appropriate for this service but would usually not be appropriate for a psychiatry consult. The two examples above aren’t ideal cases for a standard psychiatry consult; however, the attending hospitalist needed help nonetheless.

Operational Details

The liaison service started with a successful trial on two hospital units in 2013. Linden began serving as the sole clinician on the service in January 2015. She is available during the daytime on weekdays, and any staff can request her participation in the care of a patient. Her visits are billed when appropriate, but many aren’t billed (for example, if her primary work was to conference with staff regarding management of a patient).

Consults can be requested by anyone (nurses, etc., as well as physicians, though only the latter would be billable) via an electronic health record entry that helps ensure whether the request is for this service versus the inpatient psychiatry service. The order includes a standard list of potential reasons for consult that can be selected and amplified with free text comments. She also receives verbal consult requests as she moves through the hospital.

Linden’s position is budgeted through the psychiatry department and funded by the hospital with only modest professional fee collections.

An Idea That Is Catching On?

Anu Goyal made me aware of a study from 2004 that summarized findings from experience with a similar service at Washington University in St. Louis, but the service was cancelled after a short time due to its cost.1 She also found a few studies from the 1990s and a 2001 study from Australia that report on a similar service.

But maybe the idea is catching on again, at least a little.

On April 25, The Wall Street Journal published an article titled “Hospitals Test Putting Psychiatrists on Medical Wards.”2 It described programs at Brigham and Women’s Hospital in Boston, Johns Hopkins Hospital in Baltimore, and NewYork-Presbyterian/Columbia University Medical Center in New York City. They share some similarities with the service at the University of Michigan. However, according to the article, the three big-city programs tilt more toward a traditional consultation model than what Linden does.

I think every hospital should be thinking about a service other than traditional consult psychiatry that could help with challenging patient behavior. The University of Michigan model or similar ones seem like a good place to start. TH

Reference

1. Yakimo R, Kurlowicz L, Murray R. Evaluation of outcomes in psychiatric consultation-liaison nursing practice. Arch Psychiatr Nurs. 2004;18(6):215-227.

   2. Ladnado L. Hospitals test putting psychiatrists on medical wards. The Wall Street Journal website. Accessed July 3, 2016.

Linden Spital, NP, a psychiatric mental-health nurse practitioner, staffs the Psychiatric Consultation Liaison Service at the University of Michigan in Ann Arbor. Nearly every hospital larger than about 200 beds, she says, could benefit from a similar service, and hospitalists could play an important role in creating it.

I wrote about the idea for a generally similar service in my April 2015 column, but at the time, I didn’t know of an institution that had something like this in place.

Along with her hospitalist colleagues, Anupama (Anu) Goyal, MBChB, and Rob Chang, MD, Linden has launched a service to provide assistance to bedside caregivers dealing with very difficult patients (eg, those who are verbally or physically threatening to staff, unreasonably demanding and angry, have bizarre behavior, etc.).

Sample Cases

Two recent cases illustrate the role of the service. A female patient in her 60s had several admissions characterized by what many caregivers agreed were unreasonably precise demands regarding how her care should be delivered. She was verbally abusive of caregivers, especially those who were young or of a different race, and her family member tended to reinforce these maladaptive behaviors. Staff found it very stressful to care for her and had concerns that her care suffered as a result.

Linden served as a resource and support for staff, plus worked with providers to set limits on the patient and family behavior and to separate patient behaviors that were and weren’t modifiable. Linden’s efforts helped clarify the goals for the patient’s care and reduced staff distress. Even though the patient’s behavior didn’t change significantly, staff anecdotally reported less distress and concern that the patient’s care suffered as a result.

Another case involved a man in his 50s who had a progressive neurodegenerative disease and was admitted because of increasingly aggressive behavior in his skilled-nursing facility (SNF). Providers at the SNF attributed the poor behavior to changes in medications. His behavior was very difficult to manage, and staff asked for Linden’s help. She worked with the patient and realized much of his difficult behavior stemmed from his frustration with communicating verbally because of his neurologic disease. Rather than pursue increasing psychotropics, Linden promoted efforts to develop a system of hand signals the patient could use to communicate needs. His behavior improved, presumably by reducing his own frustration and improving his autonomy.

Atypical Consults

This psychiatric consultation liaison service has some overlap with traditional inpatient psychiatry services, but it is configured so that the caregiver is essentially embedded on the medical units of the hospital and assists in the care of patients who wouldn’t typically be appropriate for a psychiatry consult. For example, patients and/or families who act out because of anger over being on observation status are appropriate for this service but would usually not be appropriate for a psychiatry consult. The two examples above aren’t ideal cases for a standard psychiatry consult; however, the attending hospitalist needed help nonetheless.

Operational Details

The liaison service started with a successful trial on two hospital units in 2013. Linden began serving as the sole clinician on the service in January 2015. She is available during the daytime on weekdays, and any staff can request her participation in the care of a patient. Her visits are billed when appropriate, but many aren’t billed (for example, if her primary work was to conference with staff regarding management of a patient).

Consults can be requested by anyone (nurses, etc., as well as physicians, though only the latter would be billable) via an electronic health record entry that helps ensure whether the request is for this service versus the inpatient psychiatry service. The order includes a standard list of potential reasons for consult that can be selected and amplified with free text comments. She also receives verbal consult requests as she moves through the hospital.

Linden’s position is budgeted through the psychiatry department and funded by the hospital with only modest professional fee collections.

An Idea That Is Catching On?

Anu Goyal made me aware of a study from 2004 that summarized findings from experience with a similar service at Washington University in St. Louis, but the service was cancelled after a short time due to its cost.1 She also found a few studies from the 1990s and a 2001 study from Australia that report on a similar service.

But maybe the idea is catching on again, at least a little.

On April 25, The Wall Street Journal published an article titled “Hospitals Test Putting Psychiatrists on Medical Wards.”2 It described programs at Brigham and Women’s Hospital in Boston, Johns Hopkins Hospital in Baltimore, and NewYork-Presbyterian/Columbia University Medical Center in New York City. They share some similarities with the service at the University of Michigan. However, according to the article, the three big-city programs tilt more toward a traditional consultation model than what Linden does.

I think every hospital should be thinking about a service other than traditional consult psychiatry that could help with challenging patient behavior. The University of Michigan model or similar ones seem like a good place to start. TH

Reference

1. Yakimo R, Kurlowicz L, Murray R. Evaluation of outcomes in psychiatric consultation-liaison nursing practice. Arch Psychiatr Nurs. 2004;18(6):215-227.

   2. Ladnado L. Hospitals test putting psychiatrists on medical wards. The Wall Street Journal website. Accessed July 3, 2016.

An 88-year-old male with locally advanced basal-cell carcinoma (BCC) of the scalp who had received multiple resections, stem cell graft, and amniotic allograft continued to progress with severe ulcerations that extended into the dura. Patient was initiated on vismodegib 150 mg daily and subsequently developed a diffuse maculopapular rash within 14 days of treatment. The rash resolved with topical triamcinolone 0.1% and discontinuation of vismodegib. Loratadine 10 mg daily was concurrently administered for rash prophylaxis upon vismodegib re-initiation. Within 7 days of therapy, the rash returned, and subsequently vismodegib was discontinued and oral prednisone taper was initiated. Given limited effective treatment options, vismodegib was continued at a modified schedule of 150 mg daily for 2 weeks then 1 week off with prednisone 5 mg daily. To date, patient has completed 2 years of treatment with no return of rash or disease progression.

BCC occurs in 2 million patients annually in the US. Fortunately, most of these cases are responsive to local therapy with rare metastatic progression. The emergence of novel Hedgehog pathway inhibitors (vismodegib, sonidegib) provide effective options for advanced BCC. Although vismodegib has been reported to cause Grade 3-4 adverse events in 25% of patients, there are no reports of vismodegib-induced rash nor recommendations regarding management.

For many novel targeted therapies, the appropriate management of toxicities has not been well described. This case study presents a patient that continues to respond to therapy with a novel modified dosing scheme in addition to low-dose prednisone. We present this case report to offer a potential treatment option in patients who experience a vismodegib-induced rash.

An 88-year-old male with locally advanced basal-cell carcinoma (BCC) of the scalp who had received multiple resections, stem cell graft, and amniotic allograft continued to progress with severe ulcerations that extended into the dura. Patient was initiated on vismodegib 150 mg daily and subsequently developed a diffuse maculopapular rash within 14 days of treatment. The rash resolved with topical triamcinolone 0.1% and discontinuation of vismodegib. Loratadine 10 mg daily was concurrently administered for rash prophylaxis upon vismodegib re-initiation. Within 7 days of therapy, the rash returned, and subsequently vismodegib was discontinued and oral prednisone taper was initiated. Given limited effective treatment options, vismodegib was continued at a modified schedule of 150 mg daily for 2 weeks then 1 week off with prednisone 5 mg daily. To date, patient has completed 2 years of treatment with no return of rash or disease progression.

BCC occurs in 2 million patients annually in the US. Fortunately, most of these cases are responsive to local therapy with rare metastatic progression. The emergence of novel Hedgehog pathway inhibitors (vismodegib, sonidegib) provide effective options for advanced BCC. Although vismodegib has been reported to cause Grade 3-4 adverse events in 25% of patients, there are no reports of vismodegib-induced rash nor recommendations regarding management.

For many novel targeted therapies, the appropriate management of toxicities has not been well described. This case study presents a patient that continues to respond to therapy with a novel modified dosing scheme in addition to low-dose prednisone. We present this case report to offer a potential treatment option in patients who experience a vismodegib-induced rash.

An 88-year-old male with locally advanced basal-cell carcinoma (BCC) of the scalp who had received multiple resections, stem cell graft, and amniotic allograft continued to progress with severe ulcerations that extended into the dura. Patient was initiated on vismodegib 150 mg daily and subsequently developed a diffuse maculopapular rash within 14 days of treatment. The rash resolved with topical triamcinolone 0.1% and discontinuation of vismodegib. Loratadine 10 mg daily was concurrently administered for rash prophylaxis upon vismodegib re-initiation. Within 7 days of therapy, the rash returned, and subsequently vismodegib was discontinued and oral prednisone taper was initiated. Given limited effective treatment options, vismodegib was continued at a modified schedule of 150 mg daily for 2 weeks then 1 week off with prednisone 5 mg daily. To date, patient has completed 2 years of treatment with no return of rash or disease progression.

BCC occurs in 2 million patients annually in the US. Fortunately, most of these cases are responsive to local therapy with rare metastatic progression. The emergence of novel Hedgehog pathway inhibitors (vismodegib, sonidegib) provide effective options for advanced BCC. Although vismodegib has been reported to cause Grade 3-4 adverse events in 25% of patients, there are no reports of vismodegib-induced rash nor recommendations regarding management.

For many novel targeted therapies, the appropriate management of toxicities has not been well described. This case study presents a patient that continues to respond to therapy with a novel modified dosing scheme in addition to low-dose prednisone. We present this case report to offer a potential treatment option in patients who experience a vismodegib-induced rash.

Purpose: In 2015, the New Mexico VA Health Care System completion of colorectal cancer screening fell below the national VA average of 82%. The facility Healthcare Effectiveness Data and Information Set (HEDIS) mean aggregated data for Colorectal Cancer Screening was 74.14%. This presents an alarming truth: the failure to screen 25% of the Veteran population served.

The projects purpose stands to improve quality outcomes through the early detection and prevention of colorectal cancer by increasing provider and Veteran awareness.

Relevant Background/Problem: Colorectal cancer is the third leading cause of cancer deaths and remains preventable through appropriate and timely screening. In 2012, 134,784 people in the United States were diagnosed with colorectal cancer, of which 51,516 people died.

Barriers leading to low screening compliance include knowledge deficits, fear, access, and common myths and misconceptions. Providers and Veterans fail to understand the difference of recommended screening anddiagnostic guidelines; available prevention/ detection options/ personal risk factors; ultimately neglecting screening completion due to lack of symptoms.

Methods: We held an Outreach Colorectal Cancer Awareness Fair for the community. A 20-foot long inflatable colon, depicting various stages of abnormalities was brought in. Attendees completed screening questionnaires, focusing on risk factors/ history/ symptoms. These were reviewed on site with providers, and appropriate care was ordered: colonoscopy or FIT testing. Various educational booths served to provide education using evidence-based data. Follow-up letters and calls after the event served to increase Veteran compliance. The local news station showcased the VAMC in a positive light.

Results: We had 355 attendees. 104 Veterans completed screening. 71% of Veterans were identified as needing further diagnostic testing based on provider assessment. 6 Veterans were given FIT packets on that day; an additional 17 were later identified based on review of forms (total 22%). Initial return rate of FIT cards was 83%, exceeding facility norm, and 51 Veterans were scheduled for colonoscopy (49%).

Implications: The overall outcome from this event has been to greatly improve attitudes from the level of the patient and employee volunteers to the community and upper management: improving the overall awareness to screening and diagnostic modalities for colorectal cancer.

Purpose: In 2015, the New Mexico VA Health Care System completion of colorectal cancer screening fell below the national VA average of 82%. The facility Healthcare Effectiveness Data and Information Set (HEDIS) mean aggregated data for Colorectal Cancer Screening was 74.14%. This presents an alarming truth: the failure to screen 25% of the Veteran population served.

The projects purpose stands to improve quality outcomes through the early detection and prevention of colorectal cancer by increasing provider and Veteran awareness.

Relevant Background/Problem: Colorectal cancer is the third leading cause of cancer deaths and remains preventable through appropriate and timely screening. In 2012, 134,784 people in the United States were diagnosed with colorectal cancer, of which 51,516 people died.

Barriers leading to low screening compliance include knowledge deficits, fear, access, and common myths and misconceptions. Providers and Veterans fail to understand the difference of recommended screening anddiagnostic guidelines; available prevention/ detection options/ personal risk factors; ultimately neglecting screening completion due to lack of symptoms.

Methods: We held an Outreach Colorectal Cancer Awareness Fair for the community. A 20-foot long inflatable colon, depicting various stages of abnormalities was brought in. Attendees completed screening questionnaires, focusing on risk factors/ history/ symptoms. These were reviewed on site with providers, and appropriate care was ordered: colonoscopy or FIT testing. Various educational booths served to provide education using evidence-based data. Follow-up letters and calls after the event served to increase Veteran compliance. The local news station showcased the VAMC in a positive light.

Results: We had 355 attendees. 104 Veterans completed screening. 71% of Veterans were identified as needing further diagnostic testing based on provider assessment. 6 Veterans were given FIT packets on that day; an additional 17 were later identified based on review of forms (total 22%). Initial return rate of FIT cards was 83%, exceeding facility norm, and 51 Veterans were scheduled for colonoscopy (49%).

Implications: The overall outcome from this event has been to greatly improve attitudes from the level of the patient and employee volunteers to the community and upper management: improving the overall awareness to screening and diagnostic modalities for colorectal cancer.

Purpose: In 2015, the New Mexico VA Health Care System completion of colorectal cancer screening fell below the national VA average of 82%. The facility Healthcare Effectiveness Data and Information Set (HEDIS) mean aggregated data for Colorectal Cancer Screening was 74.14%. This presents an alarming truth: the failure to screen 25% of the Veteran population served.

The projects purpose stands to improve quality outcomes through the early detection and prevention of colorectal cancer by increasing provider and Veteran awareness.

Relevant Background/Problem: Colorectal cancer is the third leading cause of cancer deaths and remains preventable through appropriate and timely screening. In 2012, 134,784 people in the United States were diagnosed with colorectal cancer, of which 51,516 people died.

Barriers leading to low screening compliance include knowledge deficits, fear, access, and common myths and misconceptions. Providers and Veterans fail to understand the difference of recommended screening anddiagnostic guidelines; available prevention/ detection options/ personal risk factors; ultimately neglecting screening completion due to lack of symptoms.

Methods: We held an Outreach Colorectal Cancer Awareness Fair for the community. A 20-foot long inflatable colon, depicting various stages of abnormalities was brought in. Attendees completed screening questionnaires, focusing on risk factors/ history/ symptoms. These were reviewed on site with providers, and appropriate care was ordered: colonoscopy or FIT testing. Various educational booths served to provide education using evidence-based data. Follow-up letters and calls after the event served to increase Veteran compliance. The local news station showcased the VAMC in a positive light.

Results: We had 355 attendees. 104 Veterans completed screening. 71% of Veterans were identified as needing further diagnostic testing based on provider assessment. 6 Veterans were given FIT packets on that day; an additional 17 were later identified based on review of forms (total 22%). Initial return rate of FIT cards was 83%, exceeding facility norm, and 51 Veterans were scheduled for colonoscopy (49%).

Implications: The overall outcome from this event has been to greatly improve attitudes from the level of the patient and employee volunteers to the community and upper management: improving the overall awareness to screening and diagnostic modalities for colorectal cancer.

Background: Peripherally Inserted Central Catheter (PICC) is an intravenous line placed into the patient’s upper arm to safely administer chemotherapy. For years, many patients receiving chemotherapy through a PICC line in the Outpatient Chemotherapy Clinic developed skin irritation and dermatitis at the insertion site. Interventions included, but were not limited to, corticosteroid spray, anti-histamine, occlusive dressing change, and covering the PICC site with gauze. Sometimes, replacement was needed for severe irritation or infection. These complications can lead to chronic discomfort, hospitalization, and delayed treatment.

Purpose: The purpose of this project was to reduce the incidence of PICC line skin irritation and dermatitis in patients receiving outpatient chemotherapy.

Methods: Nursing procedure required the PICC line dressing to be changed weekly. The site was cleansed with chlorhexidine, dried, and a chlorhexidine-soaked sponge was applied at the catheter exit site. The catheter was then secured with a catheter stabilization device and covered with a transparent occlusive dressing. The revised method added Cavilon No-Sting Barrier Film. The film was applied except to the area around the catheter exit site after the chlorhexidine was dried to create a barrier between the skin and the occlusive dressing. Skin condition was measured using the International Contact Dermatitis Research Group Scoring Scale.

Results: Results were evaluated through retrospective chart review. During the 3-months pre-implementation, 33 PICC lines were placed, 5 were replaced, and 32% had documented skin irritation. During the 3-months post-implementation, 28 PICC lines were placed, 3 were replaced, and 4% had documented skin irritation.

Conclusion: The results demonstrate a significant reduction of skin irritation incidence and support the use of Cavilon No-Sting Barrier Film as part of the PICC line dressing change. Evaluation in different settings with different PICC line populations is needed to fully evaluate efficacy.

Background: Peripherally Inserted Central Catheter (PICC) is an intravenous line placed into the patient’s upper arm to safely administer chemotherapy. For years, many patients receiving chemotherapy through a PICC line in the Outpatient Chemotherapy Clinic developed skin irritation and dermatitis at the insertion site. Interventions included, but were not limited to, corticosteroid spray, anti-histamine, occlusive dressing change, and covering the PICC site with gauze. Sometimes, replacement was needed for severe irritation or infection. These complications can lead to chronic discomfort, hospitalization, and delayed treatment.

Purpose: The purpose of this project was to reduce the incidence of PICC line skin irritation and dermatitis in patients receiving outpatient chemotherapy.

Methods: Nursing procedure required the PICC line dressing to be changed weekly. The site was cleansed with chlorhexidine, dried, and a chlorhexidine-soaked sponge was applied at the catheter exit site. The catheter was then secured with a catheter stabilization device and covered with a transparent occlusive dressing. The revised method added Cavilon No-Sting Barrier Film. The film was applied except to the area around the catheter exit site after the chlorhexidine was dried to create a barrier between the skin and the occlusive dressing. Skin condition was measured using the International Contact Dermatitis Research Group Scoring Scale.

Results: Results were evaluated through retrospective chart review. During the 3-months pre-implementation, 33 PICC lines were placed, 5 were replaced, and 32% had documented skin irritation. During the 3-months post-implementation, 28 PICC lines were placed, 3 were replaced, and 4% had documented skin irritation.

Conclusion: The results demonstrate a significant reduction of skin irritation incidence and support the use of Cavilon No-Sting Barrier Film as part of the PICC line dressing change. Evaluation in different settings with different PICC line populations is needed to fully evaluate efficacy.

Background: Peripherally Inserted Central Catheter (PICC) is an intravenous line placed into the patient’s upper arm to safely administer chemotherapy. For years, many patients receiving chemotherapy through a PICC line in the Outpatient Chemotherapy Clinic developed skin irritation and dermatitis at the insertion site. Interventions included, but were not limited to, corticosteroid spray, anti-histamine, occlusive dressing change, and covering the PICC site with gauze. Sometimes, replacement was needed for severe irritation or infection. These complications can lead to chronic discomfort, hospitalization, and delayed treatment.

Purpose: The purpose of this project was to reduce the incidence of PICC line skin irritation and dermatitis in patients receiving outpatient chemotherapy.

Methods: Nursing procedure required the PICC line dressing to be changed weekly. The site was cleansed with chlorhexidine, dried, and a chlorhexidine-soaked sponge was applied at the catheter exit site. The catheter was then secured with a catheter stabilization device and covered with a transparent occlusive dressing. The revised method added Cavilon No-Sting Barrier Film. The film was applied except to the area around the catheter exit site after the chlorhexidine was dried to create a barrier between the skin and the occlusive dressing. Skin condition was measured using the International Contact Dermatitis Research Group Scoring Scale.

Results: Results were evaluated through retrospective chart review. During the 3-months pre-implementation, 33 PICC lines were placed, 5 were replaced, and 32% had documented skin irritation. During the 3-months post-implementation, 28 PICC lines were placed, 3 were replaced, and 4% had documented skin irritation.

Conclusion: The results demonstrate a significant reduction of skin irritation incidence and support the use of Cavilon No-Sting Barrier Film as part of the PICC line dressing change. Evaluation in different settings with different PICC line populations is needed to fully evaluate efficacy.

Purpose: The purpose of this study was to assess the incidence of venous thromboembolism (VTE) in high-risk surgical oncology patients at a Veterans Affairs institution.

Background: Oncology patients undergoing abdominal or pelvic surgeries are at high-risk of developing postoperativeVTE. Current guidelines published by the American Societyof Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and American College of Chest Physicians(ACCP) recommend at least 4 weeks of pharmacologic thromboprophylaxis postoperatively in high-risk oncology patients.

Methods: Electronic medical records were utilized to identify oncology patients aged 18 to 89 years undergoing general or urologic surgeries from June 1, 2013 to June 30, 2015. The primary objective was the incidence of VTE up to 30 days postoperatively in patients receiving optimal (OT) (4 weeks of anticoagulation if no contraindications) versus suboptimal (ST) thromboprophylaxis. Secondary objectives included incidence of early (days 0 to 7) and late (days 8 to 30) postoperative VTE, severity of VTE, and hematologic toxicities associated with VTE prophylaxis.

Data Analysis: Logistics regression with an alpha of 0.05 was utilized to analyze the primary outcome. Other outcomes were reported as descriptive statistics.

Results: A total of 167 patients were assessed (136 patients in the ST group and 31 patients in the OT group). There were 4 (2.9%) and 1 (3.2%) VTEs in the ST and OT groups, respectively (OR = 0.10; 95% CI, -2.13 to 2.32; P > 0.05). All VTEs occurred during the late postoperative period. In the ST group, 3 patients had an uncomplicated pulmonary embolism (PE) or deep venous thromboembolism, and 1 patient died due to thromboembolic complications. In the OT group, 1 patient had an uncomplicated PE. There were no significant differences in postoperative bleeding (11.4% versus 14.4%) or thrombocytopenia (45.7% versus 47.4%) in patients receiving pharmacologic versus non-pharmacologic thromboprophylaxis.

Implications: Provision of optimal thromboprophylaxis was low for high-risk surgical oncology patients; however, this was not associated with an increase in VTEs. Use of pharmacologic thromboprophylaxis did not increase rates of bleeding or thrombocytopenia. Education is needed to increase compliance with guideline recommendations for postoperative thromboprophylaxis in high-risk surgical oncology patients at our institution.

Purpose: The purpose of this study was to assess the incidence of venous thromboembolism (VTE) in high-risk surgical oncology patients at a Veterans Affairs institution.

Background: Oncology patients undergoing abdominal or pelvic surgeries are at high-risk of developing postoperativeVTE. Current guidelines published by the American Societyof Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and American College of Chest Physicians(ACCP) recommend at least 4 weeks of pharmacologic thromboprophylaxis postoperatively in high-risk oncology patients.

Methods: Electronic medical records were utilized to identify oncology patients aged 18 to 89 years undergoing general or urologic surgeries from June 1, 2013 to June 30, 2015. The primary objective was the incidence of VTE up to 30 days postoperatively in patients receiving optimal (OT) (4 weeks of anticoagulation if no contraindications) versus suboptimal (ST) thromboprophylaxis. Secondary objectives included incidence of early (days 0 to 7) and late (days 8 to 30) postoperative VTE, severity of VTE, and hematologic toxicities associated with VTE prophylaxis.

Data Analysis: Logistics regression with an alpha of 0.05 was utilized to analyze the primary outcome. Other outcomes were reported as descriptive statistics.

Results: A total of 167 patients were assessed (136 patients in the ST group and 31 patients in the OT group). There were 4 (2.9%) and 1 (3.2%) VTEs in the ST and OT groups, respectively (OR = 0.10; 95% CI, -2.13 to 2.32; P > 0.05). All VTEs occurred during the late postoperative period. In the ST group, 3 patients had an uncomplicated pulmonary embolism (PE) or deep venous thromboembolism, and 1 patient died due to thromboembolic complications. In the OT group, 1 patient had an uncomplicated PE. There were no significant differences in postoperative bleeding (11.4% versus 14.4%) or thrombocytopenia (45.7% versus 47.4%) in patients receiving pharmacologic versus non-pharmacologic thromboprophylaxis.

Implications: Provision of optimal thromboprophylaxis was low for high-risk surgical oncology patients; however, this was not associated with an increase in VTEs. Use of pharmacologic thromboprophylaxis did not increase rates of bleeding or thrombocytopenia. Education is needed to increase compliance with guideline recommendations for postoperative thromboprophylaxis in high-risk surgical oncology patients at our institution.

Purpose: The purpose of this study was to assess the incidence of venous thromboembolism (VTE) in high-risk surgical oncology patients at a Veterans Affairs institution.

Background: Oncology patients undergoing abdominal or pelvic surgeries are at high-risk of developing postoperativeVTE. Current guidelines published by the American Societyof Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and American College of Chest Physicians(ACCP) recommend at least 4 weeks of pharmacologic thromboprophylaxis postoperatively in high-risk oncology patients.

Methods: Electronic medical records were utilized to identify oncology patients aged 18 to 89 years undergoing general or urologic surgeries from June 1, 2013 to June 30, 2015. The primary objective was the incidence of VTE up to 30 days postoperatively in patients receiving optimal (OT) (4 weeks of anticoagulation if no contraindications) versus suboptimal (ST) thromboprophylaxis. Secondary objectives included incidence of early (days 0 to 7) and late (days 8 to 30) postoperative VTE, severity of VTE, and hematologic toxicities associated with VTE prophylaxis.

Data Analysis: Logistics regression with an alpha of 0.05 was utilized to analyze the primary outcome. Other outcomes were reported as descriptive statistics.

Results: A total of 167 patients were assessed (136 patients in the ST group and 31 patients in the OT group). There were 4 (2.9%) and 1 (3.2%) VTEs in the ST and OT groups, respectively (OR = 0.10; 95% CI, -2.13 to 2.32; P > 0.05). All VTEs occurred during the late postoperative period. In the ST group, 3 patients had an uncomplicated pulmonary embolism (PE) or deep venous thromboembolism, and 1 patient died due to thromboembolic complications. In the OT group, 1 patient had an uncomplicated PE. There were no significant differences in postoperative bleeding (11.4% versus 14.4%) or thrombocytopenia (45.7% versus 47.4%) in patients receiving pharmacologic versus non-pharmacologic thromboprophylaxis.

Implications: Provision of optimal thromboprophylaxis was low for high-risk surgical oncology patients; however, this was not associated with an increase in VTEs. Use of pharmacologic thromboprophylaxis did not increase rates of bleeding or thrombocytopenia. Education is needed to increase compliance with guideline recommendations for postoperative thromboprophylaxis in high-risk surgical oncology patients at our institution.

Purpose: Decrease turn-around time (TAT) and increase customer satisfaction.

Relevant Background: Cytologic screening (PAP test) lowered mortality of cervical carcinoma. As high-risk papilloma viruses (HPV) were associated with dysplasia and carcinoma, “co-testing” (HPV status and cytological screening on same specimen)was introduced. Women with negative Pap smear and positive high-risk HPV are at elevated risk.

Previous Status: Pap smears were signed-out; HPV Cotests were sent to reference laboratory; results were informed in supplementary report. This caused slow TAT for HPV Co-test (24% > 12 days) and distress when negative Pap smear was followed by a positive HPV Co-test.

Methods: A team of relevant individuals was convened to decrease TAT for HPV Co-test to 6 days, and to create an integrated Pap-smear/HPV Co-test report. The decision was made to bring HPV testing in-house, utilizing polymerase chain reaction-based assay. The technique was validated; precision, accuracy and lower levels of detection were determined. Standard Operating Procedures were written, and personnel competency was verified. Proficiency tests were performed. Staff met to coordinate logistics of sample transfer.

Data Analysis: In-house HPV testing twice weekly decreased TAT from 10.1 to 5.6 days. Integrated report: HPV test is performed when ordered by clinician or “reflex” if Pap smear is atypical; in both instances, final report is withheld until Co-test result is available. HPV is run inhouse in batches twice a week (5-hour test TAT). When HPV result is available, cytology technician enters Pap smear interpretation and HPV Co-test in a single, integrated report into VistA, it is released by the pathologist or cytotechnologist (day 3-5) and “view-alert” is issued for provider in CPRS. Integrated report consists of a section with cytology findings, and section with HPV status including subtype and risk information.

Results: Average TAT for release of integrated report decreased from 10.1 to 2.7 days. The laboratory achieved a 35% reduction in expenditure costs. Clinicians’ response was uniformly positive.

Implications: It is important to know how VA Medical Centers address PAP-HPV Co-test, and how the system can be modified; particularly, as our female Veteran population increases.

Purpose: Decrease turn-around time (TAT) and increase customer satisfaction.

Relevant Background: Cytologic screening (PAP test) lowered mortality of cervical carcinoma. As high-risk papilloma viruses (HPV) were associated with dysplasia and carcinoma, “co-testing” (HPV status and cytological screening on same specimen)was introduced. Women with negative Pap smear and positive high-risk HPV are at elevated risk.

Previous Status: Pap smears were signed-out; HPV Cotests were sent to reference laboratory; results were informed in supplementary report. This caused slow TAT for HPV Co-test (24% > 12 days) and distress when negative Pap smear was followed by a positive HPV Co-test.

Methods: A team of relevant individuals was convened to decrease TAT for HPV Co-test to 6 days, and to create an integrated Pap-smear/HPV Co-test report. The decision was made to bring HPV testing in-house, utilizing polymerase chain reaction-based assay. The technique was validated; precision, accuracy and lower levels of detection were determined. Standard Operating Procedures were written, and personnel competency was verified. Proficiency tests were performed. Staff met to coordinate logistics of sample transfer.

Data Analysis: In-house HPV testing twice weekly decreased TAT from 10.1 to 5.6 days. Integrated report: HPV test is performed when ordered by clinician or “reflex” if Pap smear is atypical; in both instances, final report is withheld until Co-test result is available. HPV is run inhouse in batches twice a week (5-hour test TAT). When HPV result is available, cytology technician enters Pap smear interpretation and HPV Co-test in a single, integrated report into VistA, it is released by the pathologist or cytotechnologist (day 3-5) and “view-alert” is issued for provider in CPRS. Integrated report consists of a section with cytology findings, and section with HPV status including subtype and risk information.

Results: Average TAT for release of integrated report decreased from 10.1 to 2.7 days. The laboratory achieved a 35% reduction in expenditure costs. Clinicians’ response was uniformly positive.

Implications: It is important to know how VA Medical Centers address PAP-HPV Co-test, and how the system can be modified; particularly, as our female Veteran population increases.

Purpose: Decrease turn-around time (TAT) and increase customer satisfaction.

Relevant Background: Cytologic screening (PAP test) lowered mortality of cervical carcinoma. As high-risk papilloma viruses (HPV) were associated with dysplasia and carcinoma, “co-testing” (HPV status and cytological screening on same specimen)was introduced. Women with negative Pap smear and positive high-risk HPV are at elevated risk.

Previous Status: Pap smears were signed-out; HPV Cotests were sent to reference laboratory; results were informed in supplementary report. This caused slow TAT for HPV Co-test (24% > 12 days) and distress when negative Pap smear was followed by a positive HPV Co-test.

Methods: A team of relevant individuals was convened to decrease TAT for HPV Co-test to 6 days, and to create an integrated Pap-smear/HPV Co-test report. The decision was made to bring HPV testing in-house, utilizing polymerase chain reaction-based assay. The technique was validated; precision, accuracy and lower levels of detection were determined. Standard Operating Procedures were written, and personnel competency was verified. Proficiency tests were performed. Staff met to coordinate logistics of sample transfer.

Data Analysis: In-house HPV testing twice weekly decreased TAT from 10.1 to 5.6 days. Integrated report: HPV test is performed when ordered by clinician or “reflex” if Pap smear is atypical; in both instances, final report is withheld until Co-test result is available. HPV is run inhouse in batches twice a week (5-hour test TAT). When HPV result is available, cytology technician enters Pap smear interpretation and HPV Co-test in a single, integrated report into VistA, it is released by the pathologist or cytotechnologist (day 3-5) and “view-alert” is issued for provider in CPRS. Integrated report consists of a section with cytology findings, and section with HPV status including subtype and risk information.

Results: Average TAT for release of integrated report decreased from 10.1 to 2.7 days. The laboratory achieved a 35% reduction in expenditure costs. Clinicians’ response was uniformly positive.

Implications: It is important to know how VA Medical Centers address PAP-HPV Co-test, and how the system can be modified; particularly, as our female Veteran population increases.

DNA helix

Image by Spencer Phillips

ORLANDO—An investigational gene therapy can safely reduce bleeding in patients with severe hemophilia A, a phase 1/2 study suggests.

The therapy is BMN 270, a recombinant adeno-associated virus (AAV) vector coding for human coagulation factor VIII (FVIII).

Six of the 7 patients treated with the highest dose of BMN 270 had FVIII levels above 50%, and the number of bleeding events fell substantially from baseline.

None of the patients developed inhibitors to FVIII, there were no serious adverse events, and none of the patients discontinued the therapy due to safety reasons.

John Pasi, PhD, of Barts and the London School of Medicine and Dentistry in London, UK, presented the results of this study in a late-breaking oral presentation at the World Federation of Hemophilia 2016 World Congress.* The research was funded by BioMarin Pharmaceutical Inc.

This phase 1/2 dose-escalation study was designed to evaluate the safety and efficacy of BMN 270 in up to 12 patients with severe hemophilia A.

The primary endpoints are to assess the safety of a single dose of BMN 270 and the change from baseline of FVIII expression level at 16 weeks after infusion.

Secondary endpoints include assessing the impact of BMN 270 on the frequency of FVIII replacement therapy, the number of bleeding episodes requiring treatment, and any potential immune responses. Patients will be monitored for safety and durability of effect for 5 years.

Thus far, 9 patients with severe hemophilia A have received a single dose of BMN 270—1 at 6×10¹² vg/kg, 1 at 2×10¹³ vg/kg, and 7 at 6 x 10¹³ vg/kg.

As of the July 6 data cutoff, post-treatment follow-up ranges from 12 weeks to 28 weeks.

Safety

The most common adverse events were arthralgia (9 events in 6 subjects), contusion (6 events in 3 subjects), back pain (4 events in 3 subjects), and ALT elevation (6 events in 6 subjects).

No clinically relevant sustained rises in ALT levels or other markers of liver toxicity have been observed.

The maximum ALT levels were between 23 U/L and 82 U/L (less than 2 times the upper limit of normal, which is 43 U/L for the central laboratory in this study) approximately 12 weeks after gene delivery and generally declined over the next few weeks. ALT rises have not been associated with any decrease in FVIII levels.

A steroid regimen administered to all high-dose patients has been well-tolerated. Patients are successfully tapering off of steroids. Two patients have been off steroid therapy for up to 2.5 weeks, with no adverse impact on FVIII expression or ALT levels.

Efficacy

The patient treated at the lowest dose (6×10¹² vg/kg) had no change from baseline in FVIII levels. The patient treated at the mid-dose (2×10¹³ vg/kg) had a stable FVIII activity level greater than 2 IU/dL for more than 28 weeks.

All 7 patients treated at the highest dose (6×10¹³ vg/kg) had FVIII activity levels greater than 10 IU/dL after week 10.

As of each patient’s most recent reading, 6 of the 7 patients in the high-dose group had FVIII levels above 50%, as a percentage calculated based on the numbers of IU/dL. The seventh patient had levels above 10%.

Four patients who have been followed the longest had a mean FVIII level of 146% at their 20-week visit. Two patients with FVIII levels above 200% had no unexpected events or need for medical intervention.

For the 7 patients treated at the high dose, the median annualized bleeding rate measured from the day of gene transfer to the data cutoff fell from 20 to 5.

After week 7 post-infusion, there were no bleeds in 6 of the 7 patients. There were 10 bleeds from weeks 0 through 2 post-infusion, 7 bleeds from weeks 3 through 8, and 2 bleeds from weeks 9 through 28. From weeks 2 through 28, all but 1 bleed occurred in a single subject who is the lowest responder.

All of the patients in the high-dose cohort have switched to receiving FVIII therapy on-demand. Six of them were previously receiving FVIII therapy as prophylaxis.

“These data provide strong proof-of-concept evidence that restoration of clotting function may be achieved by gene therapy,” Dr Pasi said. “For the first time, patients have reason to hope to avoid bleeding and the opportunity to live a normal life.”

*Pasi J et al, Interim results of an open-label, phase 1/2 study of BMN 270, an AAV5-FVIII gene transfer in severe hemophilia A, WFH 2016 World Congress, July 2016.

DNA helix

Image by Spencer Phillips

ORLANDO—An investigational gene therapy can safely reduce bleeding in patients with severe hemophilia A, a phase 1/2 study suggests.

The therapy is BMN 270, a recombinant adeno-associated virus (AAV) vector coding for human coagulation factor VIII (FVIII).

Six of the 7 patients treated with the highest dose of BMN 270 had FVIII levels above 50%, and the number of bleeding events fell substantially from baseline.

None of the patients developed inhibitors to FVIII, there were no serious adverse events, and none of the patients discontinued the therapy due to safety reasons.

John Pasi, PhD, of Barts and the London School of Medicine and Dentistry in London, UK, presented the results of this study in a late-breaking oral presentation at the World Federation of Hemophilia 2016 World Congress.* The research was funded by BioMarin Pharmaceutical Inc.

This phase 1/2 dose-escalation study was designed to evaluate the safety and efficacy of BMN 270 in up to 12 patients with severe hemophilia A.

The primary endpoints are to assess the safety of a single dose of BMN 270 and the change from baseline of FVIII expression level at 16 weeks after infusion.

Secondary endpoints include assessing the impact of BMN 270 on the frequency of FVIII replacement therapy, the number of bleeding episodes requiring treatment, and any potential immune responses. Patients will be monitored for safety and durability of effect for 5 years.

Thus far, 9 patients with severe hemophilia A have received a single dose of BMN 270—1 at 6×10¹² vg/kg, 1 at 2×10¹³ vg/kg, and 7 at 6 x 10¹³ vg/kg.

As of the July 6 data cutoff, post-treatment follow-up ranges from 12 weeks to 28 weeks.

Safety

The most common adverse events were arthralgia (9 events in 6 subjects), contusion (6 events in 3 subjects), back pain (4 events in 3 subjects), and ALT elevation (6 events in 6 subjects).

No clinically relevant sustained rises in ALT levels or other markers of liver toxicity have been observed.

The maximum ALT levels were between 23 U/L and 82 U/L (less than 2 times the upper limit of normal, which is 43 U/L for the central laboratory in this study) approximately 12 weeks after gene delivery and generally declined over the next few weeks. ALT rises have not been associated with any decrease in FVIII levels.

A steroid regimen administered to all high-dose patients has been well-tolerated. Patients are successfully tapering off of steroids. Two patients have been off steroid therapy for up to 2.5 weeks, with no adverse impact on FVIII expression or ALT levels.

Efficacy

The patient treated at the lowest dose (6×10¹² vg/kg) had no change from baseline in FVIII levels. The patient treated at the mid-dose (2×10¹³ vg/kg) had a stable FVIII activity level greater than 2 IU/dL for more than 28 weeks.

All 7 patients treated at the highest dose (6×10¹³ vg/kg) had FVIII activity levels greater than 10 IU/dL after week 10.

As of each patient’s most recent reading, 6 of the 7 patients in the high-dose group had FVIII levels above 50%, as a percentage calculated based on the numbers of IU/dL. The seventh patient had levels above 10%.

Four patients who have been followed the longest had a mean FVIII level of 146% at their 20-week visit. Two patients with FVIII levels above 200% had no unexpected events or need for medical intervention.

For the 7 patients treated at the high dose, the median annualized bleeding rate measured from the day of gene transfer to the data cutoff fell from 20 to 5.

After week 7 post-infusion, there were no bleeds in 6 of the 7 patients. There were 10 bleeds from weeks 0 through 2 post-infusion, 7 bleeds from weeks 3 through 8, and 2 bleeds from weeks 9 through 28. From weeks 2 through 28, all but 1 bleed occurred in a single subject who is the lowest responder.

All of the patients in the high-dose cohort have switched to receiving FVIII therapy on-demand. Six of them were previously receiving FVIII therapy as prophylaxis.

“These data provide strong proof-of-concept evidence that restoration of clotting function may be achieved by gene therapy,” Dr Pasi said. “For the first time, patients have reason to hope to avoid bleeding and the opportunity to live a normal life.”

*Pasi J et al, Interim results of an open-label, phase 1/2 study of BMN 270, an AAV5-FVIII gene transfer in severe hemophilia A, WFH 2016 World Congress, July 2016.

DNA helix

Image by Spencer Phillips

ORLANDO—An investigational gene therapy can safely reduce bleeding in patients with severe hemophilia A, a phase 1/2 study suggests.

The therapy is BMN 270, a recombinant adeno-associated virus (AAV) vector coding for human coagulation factor VIII (FVIII).

Six of the 7 patients treated with the highest dose of BMN 270 had FVIII levels above 50%, and the number of bleeding events fell substantially from baseline.

None of the patients developed inhibitors to FVIII, there were no serious adverse events, and none of the patients discontinued the therapy due to safety reasons.

John Pasi, PhD, of Barts and the London School of Medicine and Dentistry in London, UK, presented the results of this study in a late-breaking oral presentation at the World Federation of Hemophilia 2016 World Congress.* The research was funded by BioMarin Pharmaceutical Inc.

This phase 1/2 dose-escalation study was designed to evaluate the safety and efficacy of BMN 270 in up to 12 patients with severe hemophilia A.

The primary endpoints are to assess the safety of a single dose of BMN 270 and the change from baseline of FVIII expression level at 16 weeks after infusion.

Secondary endpoints include assessing the impact of BMN 270 on the frequency of FVIII replacement therapy, the number of bleeding episodes requiring treatment, and any potential immune responses. Patients will be monitored for safety and durability of effect for 5 years.

Thus far, 9 patients with severe hemophilia A have received a single dose of BMN 270—1 at 6×10¹² vg/kg, 1 at 2×10¹³ vg/kg, and 7 at 6 x 10¹³ vg/kg.

As of the July 6 data cutoff, post-treatment follow-up ranges from 12 weeks to 28 weeks.

Safety

The most common adverse events were arthralgia (9 events in 6 subjects), contusion (6 events in 3 subjects), back pain (4 events in 3 subjects), and ALT elevation (6 events in 6 subjects).

No clinically relevant sustained rises in ALT levels or other markers of liver toxicity have been observed.

The maximum ALT levels were between 23 U/L and 82 U/L (less than 2 times the upper limit of normal, which is 43 U/L for the central laboratory in this study) approximately 12 weeks after gene delivery and generally declined over the next few weeks. ALT rises have not been associated with any decrease in FVIII levels.

A steroid regimen administered to all high-dose patients has been well-tolerated. Patients are successfully tapering off of steroids. Two patients have been off steroid therapy for up to 2.5 weeks, with no adverse impact on FVIII expression or ALT levels.

Efficacy

The patient treated at the lowest dose (6×10¹² vg/kg) had no change from baseline in FVIII levels. The patient treated at the mid-dose (2×10¹³ vg/kg) had a stable FVIII activity level greater than 2 IU/dL for more than 28 weeks.

All 7 patients treated at the highest dose (6×10¹³ vg/kg) had FVIII activity levels greater than 10 IU/dL after week 10.

As of each patient’s most recent reading, 6 of the 7 patients in the high-dose group had FVIII levels above 50%, as a percentage calculated based on the numbers of IU/dL. The seventh patient had levels above 10%.

Four patients who have been followed the longest had a mean FVIII level of 146% at their 20-week visit. Two patients with FVIII levels above 200% had no unexpected events or need for medical intervention.

For the 7 patients treated at the high dose, the median annualized bleeding rate measured from the day of gene transfer to the data cutoff fell from 20 to 5.

After week 7 post-infusion, there were no bleeds in 6 of the 7 patients. There were 10 bleeds from weeks 0 through 2 post-infusion, 7 bleeds from weeks 3 through 8, and 2 bleeds from weeks 9 through 28. From weeks 2 through 28, all but 1 bleed occurred in a single subject who is the lowest responder.

All of the patients in the high-dose cohort have switched to receiving FVIII therapy on-demand. Six of them were previously receiving FVIII therapy as prophylaxis.

“These data provide strong proof-of-concept evidence that restoration of clotting function may be achieved by gene therapy,” Dr Pasi said. “For the first time, patients have reason to hope to avoid bleeding and the opportunity to live a normal life.”

*Pasi J et al, Interim results of an open-label, phase 1/2 study of BMN 270, an AAV5-FVIII gene transfer in severe hemophilia A, WFH 2016 World Congress, July 2016.

Lab mouse

A genetically engineered coagulation factor can reverse the effects of direct oral anticoagulants in vitro and in vivo, according to research published in Nature Medicine.

Researchers altered the shape of the coagulation factor, factor Xa (FXa), into a variant that appears to be more potent and longer-lasting than wild-type FXa.

The team found this variant, FXa^I16L, could counteract the effects of rivaroxaban, apixaban, and dabigatran.

“This molecule holds the potential to fill an important unmet clinical need,” said study author Rodney A. Camire, PhD, of The Children’s Hospital of Philadelphia in Pennsylvania.

“There are limited treatment options to stop uncontrolled bleeding in patients who are using the newer anticoagulant medications.”

Dr Camire and his colleagues first found that FXa^I16L could reverse the effects of rivaroxaban and apixaban in vitro, increasing peak thrombin generation to near-normal levels.

The team then showed that FXa^I16L restores hemostasis in mice treated with rivaroxaban and significantly decreases blood loss in injured mice treated with the drug.

FXa^I16L also significantly decreased blood loss in injured mice treated with dabigatran.

FXa^I16L was more than 50 times more potent in the hemostasis models tested than andexanet alfa, a FXa inhibitor antidote currently in clinical development.

The researchers said FXa^I16L’s ability to reverse the effects of anticoagulants depends, at least partly, on the ability of the active site inhibitor to hinder antithrombin-dependent FXa inactivation, which allows uninhibited FXa to persist in plasma.

“Our next steps will be to test this approach in large animals to help determine whether this variant is effective and safe and may progress to clinical trials,” Dr Camire said. “If so, we may be able to develop an important treatment to rapidly control bleeding in both children and adults.”

Lab mouse

A genetically engineered coagulation factor can reverse the effects of direct oral anticoagulants in vitro and in vivo, according to research published in Nature Medicine.

Researchers altered the shape of the coagulation factor, factor Xa (FXa), into a variant that appears to be more potent and longer-lasting than wild-type FXa.

The team found this variant, FXa^I16L, could counteract the effects of rivaroxaban, apixaban, and dabigatran.

“This molecule holds the potential to fill an important unmet clinical need,” said study author Rodney A. Camire, PhD, of The Children’s Hospital of Philadelphia in Pennsylvania.

“There are limited treatment options to stop uncontrolled bleeding in patients who are using the newer anticoagulant medications.”

Dr Camire and his colleagues first found that FXa^I16L could reverse the effects of rivaroxaban and apixaban in vitro, increasing peak thrombin generation to near-normal levels.

The team then showed that FXa^I16L restores hemostasis in mice treated with rivaroxaban and significantly decreases blood loss in injured mice treated with the drug.

FXa^I16L also significantly decreased blood loss in injured mice treated with dabigatran.

FXa^I16L was more than 50 times more potent in the hemostasis models tested than andexanet alfa, a FXa inhibitor antidote currently in clinical development.

The researchers said FXa^I16L’s ability to reverse the effects of anticoagulants depends, at least partly, on the ability of the active site inhibitor to hinder antithrombin-dependent FXa inactivation, which allows uninhibited FXa to persist in plasma.

“Our next steps will be to test this approach in large animals to help determine whether this variant is effective and safe and may progress to clinical trials,” Dr Camire said. “If so, we may be able to develop an important treatment to rapidly control bleeding in both children and adults.”

Lab mouse

A genetically engineered coagulation factor can reverse the effects of direct oral anticoagulants in vitro and in vivo, according to research published in Nature Medicine.

Researchers altered the shape of the coagulation factor, factor Xa (FXa), into a variant that appears to be more potent and longer-lasting than wild-type FXa.

The team found this variant, FXa^I16L, could counteract the effects of rivaroxaban, apixaban, and dabigatran.

“This molecule holds the potential to fill an important unmet clinical need,” said study author Rodney A. Camire, PhD, of The Children’s Hospital of Philadelphia in Pennsylvania.

“There are limited treatment options to stop uncontrolled bleeding in patients who are using the newer anticoagulant medications.”

Dr Camire and his colleagues first found that FXa^I16L could reverse the effects of rivaroxaban and apixaban in vitro, increasing peak thrombin generation to near-normal levels.

The team then showed that FXa^I16L restores hemostasis in mice treated with rivaroxaban and significantly decreases blood loss in injured mice treated with the drug.

FXa^I16L also significantly decreased blood loss in injured mice treated with dabigatran.

FXa^I16L was more than 50 times more potent in the hemostasis models tested than andexanet alfa, a FXa inhibitor antidote currently in clinical development.

The researchers said FXa^I16L’s ability to reverse the effects of anticoagulants depends, at least partly, on the ability of the active site inhibitor to hinder antithrombin-dependent FXa inactivation, which allows uninhibited FXa to persist in plasma.

“Our next steps will be to test this approach in large animals to help determine whether this variant is effective and safe and may progress to clinical trials,” Dr Camire said. “If so, we may be able to develop an important treatment to rapidly control bleeding in both children and adults.”