Commentary

On April 9, 2014, allegations were made relating to delays experienced by patients accessing care at the Phoenix VA Health Care System (PVAHCS). After an in-depth investigation, multiple administrative problems were discovered related to scheduling processes at PVAHCS as well as many other VA facilities across the country. In Phoenix, there were 1,400 patients on the official electronic waiting list (EWL) in addition to 1,700 patients who had requested care but were not on any official waiting list.¹

The following is a description of the use of an Incident Command System (ICS) model to provide care for these veterans in the face of an existing lack of capacity to do so. This is written from the perspective of frontline physicians representing hospital medicine, the emergency department, and primary care. The authors’ views do not necessarily reflect the official position of the VA or PVAHCS.

Under direction of the President, the VA crafted the official response to meet the needs of veterans awaiting care. The program, called the Accelerating Care Initiative (ACI), was launched on May 21, 2014. With the cooperation of the White House, the VA brought to bear substantial resources to enable PVAHCS to accomplish the task with an “all-hands-on-deck” approach. These resources included the Disaster Emergency Medical Personnel System (DEMPS), Traveling Nurse Corps (TNC), and the VA Locum Tenens program.

This situation was unprecedented, and an administrative framework was needed to organize and manage the extra personnel and resources involved in the response. The decision was made to use the ICS to achieve this aim. Most people involved in health care administration have been exposed to ICS concepts but are not accustomed to approaching an administrative problem the way emergency managers would respond to a natural disaster, such as a flood or hurricane.

According to the Federal Emergency Management Agency, ICS is “a standardized on-scene emergency management construct.”² Incident Command System combines resources and people under a common organizational structure, using a common terminology to facilitate cooperation between any and all entities that may be involved in an incident. It is a modular concept and designed to be adaptable and scalable from isolated local events, such as a traffic accident, to regional catastrophes such as a category 5 hurricane. Incident Command System was developed in the 1970s, but it has become the standard approach for government agencies, law enforcement, first responders, and the military.

The PVAHCS adopted an ICS framework, and the chief of staff (COS) took on the incident commander role full time. The deputy assumed all other COS duties related to hospital operations. Phoenix VA Health Care System used the VA national call center to rapidly contact patients awaiting care and established the other standard ICS branches with Operations, Planning, Logistics, and Finance/Administration with appropriate task forces underneath each department. Within Operations, PVAHCS established task forces for the primary care, medical specialty care, surgical specialty care, and mental health departments.

Efficient command, control, and communication was facilitated by having twice-daily huddles with key staff members for 20 to 30 minutes to share updates and refine operational goals. This worked well and provided the situational awareness for our incident commander to rapidly channel situation reports (SITREPS) to the VA Secretary’s office in Washington without drawing focus away from creating solutions. As a midsize facility that lacks certain specialized medical and surgical services, PVAHCS already had an established system for referring veterans for these services. This enabled PVAHCS to use these channels to provide medical and surgical specialty care where demand exceeded capacity to schedule within a reasonable time frame.

Federal law, at the time, severely limited the ability of PVAHCS to outsource primary care in this fashion, which required finding new ways to create additional capacity. This was a major operational challenge due to very limited physical space as well as an insufficient number of primary care and administrative support staff. The PVAHCS made the equivalent of 5 new primary care teams operational with rotating volunteers from other VAs and our preexisting DEMPS, Locum Tenens, and TNC programs.

Medical subspecialty clinics within the primary care area were promptly moved to create space for the new primary care teams. To create this additional space, PVAHCS postponed a planned expansion of a community living center in the main hospital building complex. While PVAHCS was standing up the ICS, VA facilities from other regions loaned 3 mobile medical units. These vehicles included fully capable examination tables and telehealth capability and were used for intake appointments, new unassigned patients, and as administrative space.

In August 2014, the Veterans Choice Act (VCA) allowed veterans to access care from non-VA providers. Eligibility was based on the distance a veteran lived from a VA facility or the inability to be seen within a specified time period. The VCA provided PVACHS with an additional tool to meet veterans’ care needs as it increased the hiring of permanent staff. After about 3 months, PVAHCS succeeded in contacting > 6,000 veterans and providing > 3,200 veterans with appointments at the either PVAHCS or local civilian partners. Despite the initial successes, the preliminary gains in patient access at PVAHCS will not be sustainable, and wait times will not decrease substantially without increased permanent staff and further improvements in both the facility and its processes. Although these improvements are a priority, progress has been slow.

Efforts are underway to enhance operational integration between providers, nursing, and administrative support personnel. Congress has renewed its support of a larger and more functional health care center along with the addition of 2 more clinics within the metro Phoenix area. The PVAHCS has since stood down the ICS and ACI operations and transferred these operations to a newly created Patient Flow Committee. This group is chaired by the COS and meets monthly to supervise process improvement teams using lean modalities to address issues creating excessive waits or delays in patient care throughout the facility.

This access to care crisis was exacerbated by intense media and political attention. Further disarray resulted from the abrupt loss of several senior executives at PVAHCS—all the way up to former VA Secretary Eric K. Shinseki. Use of the ICS was highly effective in providing the necessary organizational structure for key staff to focus on solving the immediate problems locally while managing external resources that were in constant flux. The authors strongly recommend consideration of the ICS as a management framework to tackle similar problems.

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.

On April 9, 2014, allegations were made relating to delays experienced by patients accessing care at the Phoenix VA Health Care System (PVAHCS). After an in-depth investigation, multiple administrative problems were discovered related to scheduling processes at PVAHCS as well as many other VA facilities across the country. In Phoenix, there were 1,400 patients on the official electronic waiting list (EWL) in addition to 1,700 patients who had requested care but were not on any official waiting list.¹

The following is a description of the use of an Incident Command System (ICS) model to provide care for these veterans in the face of an existing lack of capacity to do so. This is written from the perspective of frontline physicians representing hospital medicine, the emergency department, and primary care. The authors’ views do not necessarily reflect the official position of the VA or PVAHCS.

Under direction of the President, the VA crafted the official response to meet the needs of veterans awaiting care. The program, called the Accelerating Care Initiative (ACI), was launched on May 21, 2014. With the cooperation of the White House, the VA brought to bear substantial resources to enable PVAHCS to accomplish the task with an “all-hands-on-deck” approach. These resources included the Disaster Emergency Medical Personnel System (DEMPS), Traveling Nurse Corps (TNC), and the VA Locum Tenens program.

This situation was unprecedented, and an administrative framework was needed to organize and manage the extra personnel and resources involved in the response. The decision was made to use the ICS to achieve this aim. Most people involved in health care administration have been exposed to ICS concepts but are not accustomed to approaching an administrative problem the way emergency managers would respond to a natural disaster, such as a flood or hurricane.

According to the Federal Emergency Management Agency, ICS is “a standardized on-scene emergency management construct.”² Incident Command System combines resources and people under a common organizational structure, using a common terminology to facilitate cooperation between any and all entities that may be involved in an incident. It is a modular concept and designed to be adaptable and scalable from isolated local events, such as a traffic accident, to regional catastrophes such as a category 5 hurricane. Incident Command System was developed in the 1970s, but it has become the standard approach for government agencies, law enforcement, first responders, and the military.

The PVAHCS adopted an ICS framework, and the chief of staff (COS) took on the incident commander role full time. The deputy assumed all other COS duties related to hospital operations. Phoenix VA Health Care System used the VA national call center to rapidly contact patients awaiting care and established the other standard ICS branches with Operations, Planning, Logistics, and Finance/Administration with appropriate task forces underneath each department. Within Operations, PVAHCS established task forces for the primary care, medical specialty care, surgical specialty care, and mental health departments.

Efficient command, control, and communication was facilitated by having twice-daily huddles with key staff members for 20 to 30 minutes to share updates and refine operational goals. This worked well and provided the situational awareness for our incident commander to rapidly channel situation reports (SITREPS) to the VA Secretary’s office in Washington without drawing focus away from creating solutions. As a midsize facility that lacks certain specialized medical and surgical services, PVAHCS already had an established system for referring veterans for these services. This enabled PVAHCS to use these channels to provide medical and surgical specialty care where demand exceeded capacity to schedule within a reasonable time frame.

Federal law, at the time, severely limited the ability of PVAHCS to outsource primary care in this fashion, which required finding new ways to create additional capacity. This was a major operational challenge due to very limited physical space as well as an insufficient number of primary care and administrative support staff. The PVAHCS made the equivalent of 5 new primary care teams operational with rotating volunteers from other VAs and our preexisting DEMPS, Locum Tenens, and TNC programs.

Medical subspecialty clinics within the primary care area were promptly moved to create space for the new primary care teams. To create this additional space, PVAHCS postponed a planned expansion of a community living center in the main hospital building complex. While PVAHCS was standing up the ICS, VA facilities from other regions loaned 3 mobile medical units. These vehicles included fully capable examination tables and telehealth capability and were used for intake appointments, new unassigned patients, and as administrative space.

In August 2014, the Veterans Choice Act (VCA) allowed veterans to access care from non-VA providers. Eligibility was based on the distance a veteran lived from a VA facility or the inability to be seen within a specified time period. The VCA provided PVACHS with an additional tool to meet veterans’ care needs as it increased the hiring of permanent staff. After about 3 months, PVAHCS succeeded in contacting > 6,000 veterans and providing > 3,200 veterans with appointments at the either PVAHCS or local civilian partners. Despite the initial successes, the preliminary gains in patient access at PVAHCS will not be sustainable, and wait times will not decrease substantially without increased permanent staff and further improvements in both the facility and its processes. Although these improvements are a priority, progress has been slow.

Efforts are underway to enhance operational integration between providers, nursing, and administrative support personnel. Congress has renewed its support of a larger and more functional health care center along with the addition of 2 more clinics within the metro Phoenix area. The PVAHCS has since stood down the ICS and ACI operations and transferred these operations to a newly created Patient Flow Committee. This group is chaired by the COS and meets monthly to supervise process improvement teams using lean modalities to address issues creating excessive waits or delays in patient care throughout the facility.

This access to care crisis was exacerbated by intense media and political attention. Further disarray resulted from the abrupt loss of several senior executives at PVAHCS—all the way up to former VA Secretary Eric K. Shinseki. Use of the ICS was highly effective in providing the necessary organizational structure for key staff to focus on solving the immediate problems locally while managing external resources that were in constant flux. The authors strongly recommend consideration of the ICS as a management framework to tackle similar problems.

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.

On April 9, 2014, allegations were made relating to delays experienced by patients accessing care at the Phoenix VA Health Care System (PVAHCS). After an in-depth investigation, multiple administrative problems were discovered related to scheduling processes at PVAHCS as well as many other VA facilities across the country. In Phoenix, there were 1,400 patients on the official electronic waiting list (EWL) in addition to 1,700 patients who had requested care but were not on any official waiting list.¹

The following is a description of the use of an Incident Command System (ICS) model to provide care for these veterans in the face of an existing lack of capacity to do so. This is written from the perspective of frontline physicians representing hospital medicine, the emergency department, and primary care. The authors’ views do not necessarily reflect the official position of the VA or PVAHCS.

Under direction of the President, the VA crafted the official response to meet the needs of veterans awaiting care. The program, called the Accelerating Care Initiative (ACI), was launched on May 21, 2014. With the cooperation of the White House, the VA brought to bear substantial resources to enable PVAHCS to accomplish the task with an “all-hands-on-deck” approach. These resources included the Disaster Emergency Medical Personnel System (DEMPS), Traveling Nurse Corps (TNC), and the VA Locum Tenens program.

This situation was unprecedented, and an administrative framework was needed to organize and manage the extra personnel and resources involved in the response. The decision was made to use the ICS to achieve this aim. Most people involved in health care administration have been exposed to ICS concepts but are not accustomed to approaching an administrative problem the way emergency managers would respond to a natural disaster, such as a flood or hurricane.

According to the Federal Emergency Management Agency, ICS is “a standardized on-scene emergency management construct.”² Incident Command System combines resources and people under a common organizational structure, using a common terminology to facilitate cooperation between any and all entities that may be involved in an incident. It is a modular concept and designed to be adaptable and scalable from isolated local events, such as a traffic accident, to regional catastrophes such as a category 5 hurricane. Incident Command System was developed in the 1970s, but it has become the standard approach for government agencies, law enforcement, first responders, and the military.

The PVAHCS adopted an ICS framework, and the chief of staff (COS) took on the incident commander role full time. The deputy assumed all other COS duties related to hospital operations. Phoenix VA Health Care System used the VA national call center to rapidly contact patients awaiting care and established the other standard ICS branches with Operations, Planning, Logistics, and Finance/Administration with appropriate task forces underneath each department. Within Operations, PVAHCS established task forces for the primary care, medical specialty care, surgical specialty care, and mental health departments.

Efficient command, control, and communication was facilitated by having twice-daily huddles with key staff members for 20 to 30 minutes to share updates and refine operational goals. This worked well and provided the situational awareness for our incident commander to rapidly channel situation reports (SITREPS) to the VA Secretary’s office in Washington without drawing focus away from creating solutions. As a midsize facility that lacks certain specialized medical and surgical services, PVAHCS already had an established system for referring veterans for these services. This enabled PVAHCS to use these channels to provide medical and surgical specialty care where demand exceeded capacity to schedule within a reasonable time frame.

Federal law, at the time, severely limited the ability of PVAHCS to outsource primary care in this fashion, which required finding new ways to create additional capacity. This was a major operational challenge due to very limited physical space as well as an insufficient number of primary care and administrative support staff. The PVAHCS made the equivalent of 5 new primary care teams operational with rotating volunteers from other VAs and our preexisting DEMPS, Locum Tenens, and TNC programs.

Medical subspecialty clinics within the primary care area were promptly moved to create space for the new primary care teams. To create this additional space, PVAHCS postponed a planned expansion of a community living center in the main hospital building complex. While PVAHCS was standing up the ICS, VA facilities from other regions loaned 3 mobile medical units. These vehicles included fully capable examination tables and telehealth capability and were used for intake appointments, new unassigned patients, and as administrative space.

In August 2014, the Veterans Choice Act (VCA) allowed veterans to access care from non-VA providers. Eligibility was based on the distance a veteran lived from a VA facility or the inability to be seen within a specified time period. The VCA provided PVACHS with an additional tool to meet veterans’ care needs as it increased the hiring of permanent staff. After about 3 months, PVAHCS succeeded in contacting > 6,000 veterans and providing > 3,200 veterans with appointments at the either PVAHCS or local civilian partners. Despite the initial successes, the preliminary gains in patient access at PVAHCS will not be sustainable, and wait times will not decrease substantially without increased permanent staff and further improvements in both the facility and its processes. Although these improvements are a priority, progress has been slow.

Efforts are underway to enhance operational integration between providers, nursing, and administrative support personnel. Congress has renewed its support of a larger and more functional health care center along with the addition of 2 more clinics within the metro Phoenix area. The PVAHCS has since stood down the ICS and ACI operations and transferred these operations to a newly created Patient Flow Committee. This group is chaired by the COS and meets monthly to supervise process improvement teams using lean modalities to address issues creating excessive waits or delays in patient care throughout the facility.

This access to care crisis was exacerbated by intense media and political attention. Further disarray resulted from the abrupt loss of several senior executives at PVAHCS—all the way up to former VA Secretary Eric K. Shinseki. Use of the ICS was highly effective in providing the necessary organizational structure for key staff to focus on solving the immediate problems locally while managing external resources that were in constant flux. The authors strongly recommend consideration of the ICS as a management framework to tackle similar problems.

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.

Procalcitonin (PCT) is a precursor to the hormone calcitonin and is a serum biomarker of interest in infectious diseases. Many studies have analyzed its utility and role in assisting clinical decision making, especially in conditions that result in inflammation due to a bacterial infection. A systemic inflammatory response from a bacterial infection begins with the release of endotoxins/exotoxins and a response from immune system mediators that release cytokines, such as interleukin-1β and tumor necrosis factor-α. These cytokines contribute to the development of a fever, the release of stress hormones, such as cortisone and epinephrine, and interleukin-6, which stimulates acute phase reactants, such as C-reactive protein (CRP) and PCT.^1,2

C-reactive protein and white blood cell count (WBC) are commonly used clinically as biomarkers that assist in the recognition of the infectious process and may be indicators of disease prognosis, but both lack specificity for bacterial infections. Consequentially, using CRP and WBC as clinical decision aids may result in unnecessary antibiotic therapy, which may result in an increase in drug-related adverse events and antibiotic resistance. A major distinction of PCT is that it has greater specificity than does CRP, because it tends to be elevated primarily as a result of inflammation due to bacterial infections. Procalcitonin can be used to distinguish bacterial from viral infections because its up-regulation is attenuated by interferon-gamma, a cytokine released in response to viral infections.² Thus, PCT may be a more effective clinical marker for optimizing the diagnosis, monitoring, and treatment in patients with systemic bacterial infections.

Procalcitonin as a Marker

A study evaluating infectious markers compared the use of PCT, lactate, and CRP as diagnostic tools in patients with septic shock. The results of this study indicated that PCT was the only marker significantly elevated in patients with septic shock that was also normal in patients not in septic shock (14 µg/mL vs 1 µg/mL, P = .0003).³ This and other studies led the FDA to approve PCT use in 2005 as an aid to clinical decision making in the assessment of critically ill patients with sepsis.⁴ Overall, the literature supports the use of PCT as a diagnostic tool in infections requiring antimicrobial therapy within appropriate clinical settings.

Strong evidence exists confirming PCT’s role as an aid to clinical decision making in bronchitis, chronic obstructive pulmonary disease exacerbations, pneumonia, and severe sepsis/shock management.² Procalcitonin’s kinetic profile makes it a good monitoring tool, because its levels promptly increase within 3 to 6 hours of infection, peak at 12 to 48 hours, and rapidly decline during recovery. Additionally, its levels closely parallel the extent and severity of present inflammation, making it a useful prognostic marker of disease progression and response to antibiotic therapy.^2,4,5

Related: Mass Transit for Viruses

Christ-Crain and colleagues studied the outcome of PCT-guided antibiotic algorithms for patients with lower respiratory tract infections (RTIs) presenting to the emergency department. A serum PCT level of 0.25 to 0.5 µg/L suggested a likely bacterial infection, and physicians were advised to initiate antimicrobial therapy. Serum levels above 0.5 µg/L were suggestive of a bacterial infection, and initiation of antimicrobial therapy was strongly recommended. The results showed that PCT-guided algorithms significantly reduced the number of antibiotic-treated patients (n = 99 [83%] vs n = 55 [44%]; P < .0001), reduced the duration of antibiotic treatment (12.8 days vs 10.9 days; P = .03), and decreased the antibiotic cost per patient ($202.5 vs $96.3; P < .0001) compared with the standard group (n = 119) without a significant difference in mortality.⁶

Sepsis/septic shock is another area in which PCT has been studied. Use of a PCT-guided algorithm in critically ill patients with suspected or documented severe sepsis or septic shock to guide discontinuation of antimicrobial therapy resulted in reduced duration of antibiotic therapy (10 days vs 6 days; P = .003) in the PCT group (n = 31) compared with the standard of care group (n = 37) while maintaining similar mortality and infection recurrence rates between the 2 groups. The PCT algorithm in this study recommended discontinuing antimicrobial therapy when PCT levels had decreased by > 90% from identification of sepsis/septic shock but not prior to 3 or 5 days of therapy, depending on the baseline PCT level.⁷

Systematic reviews of multiple trials have confirmed these representative results. Using a PCT algorithm to withhold or de-escalate antibiotics in patients with suspected bacterial infection leads to a significant reduction in antimicrobial utilization without adversely affecting patient outcome.⁸

Related: Health Care Use Among Iraq and Afghanistan Veterans With Infectious Diseases

Procalcitonin levels should be rechecked 48 to 72 hours after beginning antimicrobial therapy in clinically stable patients with RTIs in order to reevaluate patient need for continued therapy. In patients whose antibiotics are withheld due to low PCT levels, it is recommended to obtain a repeat level 12 to 48 hours after the decision if clinical improvement is not seen.^6,9-12 Literature suggests that it is reasonable to check PCT levels every 48 to 72 hours in patients with sepsis for considering discontinuation of antibiotic therapy as well as in patients who are not clinically improving and may need to broaden antibiotic therapy.^7,12

Limitations of the use of PCT as a clinical biomarker include its inability to be used in immunocompromised patients. In addition, PCT levels are increased in severe, noninfectious inflammatory conditions, such as inhalation injury, pulmonary aspiration, severe burns, pancreatitis, heat stroke, mesenteric infarction, trauma, surgery, and pneumonitis.¹² The presence of low-grade inflammation from a bacterial infection can lead to slightly elevated PCT levels that are difficult to quantify due to the low sensitivity of current PCT assays.¹³

The level of PCT up-regulation may depend on the infecting pathogen. One study showed that PCT was highly elevated in patients with pneumococcal community-acquired pneumonia (CAP), and another study demonstrated that PCT levels did not increase in CAP due to atypical organisms.^14,15 Thus, atypical antimicrobial coverage should be continued per current guidelines in patients in whom there is high suspicion of atypical organism-involvement in CAP.

Related: The Importance of an Antimicrobial Stewardship Program

Conclusion

Many studies have analyzed the use of PCT as a biomarker for infectious disease diagnosis, monitoring, and treatment. Current evidence supports its use in RTIs and sepsis, although it may be useful in other conditions as well, such as bacteremia and postoperative infections.² Due to its limitations and controversy, PCT should not be used as a sole marker but as an adjunct to a patient’s clinical presentation, overall clinical picture, and other biomarkers. 

Additional Note
An earlier version of this article appeared in the Pharmacy Related Newsletter: The Capsule, of the William S. Middleton Memorial Veterans Hospital.

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.

Procalcitonin (PCT) is a precursor to the hormone calcitonin and is a serum biomarker of interest in infectious diseases. Many studies have analyzed its utility and role in assisting clinical decision making, especially in conditions that result in inflammation due to a bacterial infection. A systemic inflammatory response from a bacterial infection begins with the release of endotoxins/exotoxins and a response from immune system mediators that release cytokines, such as interleukin-1β and tumor necrosis factor-α. These cytokines contribute to the development of a fever, the release of stress hormones, such as cortisone and epinephrine, and interleukin-6, which stimulates acute phase reactants, such as C-reactive protein (CRP) and PCT.^1,2

C-reactive protein and white blood cell count (WBC) are commonly used clinically as biomarkers that assist in the recognition of the infectious process and may be indicators of disease prognosis, but both lack specificity for bacterial infections. Consequentially, using CRP and WBC as clinical decision aids may result in unnecessary antibiotic therapy, which may result in an increase in drug-related adverse events and antibiotic resistance. A major distinction of PCT is that it has greater specificity than does CRP, because it tends to be elevated primarily as a result of inflammation due to bacterial infections. Procalcitonin can be used to distinguish bacterial from viral infections because its up-regulation is attenuated by interferon-gamma, a cytokine released in response to viral infections.² Thus, PCT may be a more effective clinical marker for optimizing the diagnosis, monitoring, and treatment in patients with systemic bacterial infections.

Procalcitonin as a Marker

A study evaluating infectious markers compared the use of PCT, lactate, and CRP as diagnostic tools in patients with septic shock. The results of this study indicated that PCT was the only marker significantly elevated in patients with septic shock that was also normal in patients not in septic shock (14 µg/mL vs 1 µg/mL, P = .0003).³ This and other studies led the FDA to approve PCT use in 2005 as an aid to clinical decision making in the assessment of critically ill patients with sepsis.⁴ Overall, the literature supports the use of PCT as a diagnostic tool in infections requiring antimicrobial therapy within appropriate clinical settings.

Strong evidence exists confirming PCT’s role as an aid to clinical decision making in bronchitis, chronic obstructive pulmonary disease exacerbations, pneumonia, and severe sepsis/shock management.² Procalcitonin’s kinetic profile makes it a good monitoring tool, because its levels promptly increase within 3 to 6 hours of infection, peak at 12 to 48 hours, and rapidly decline during recovery. Additionally, its levels closely parallel the extent and severity of present inflammation, making it a useful prognostic marker of disease progression and response to antibiotic therapy.^2,4,5

Related: Mass Transit for Viruses

Christ-Crain and colleagues studied the outcome of PCT-guided antibiotic algorithms for patients with lower respiratory tract infections (RTIs) presenting to the emergency department. A serum PCT level of 0.25 to 0.5 µg/L suggested a likely bacterial infection, and physicians were advised to initiate antimicrobial therapy. Serum levels above 0.5 µg/L were suggestive of a bacterial infection, and initiation of antimicrobial therapy was strongly recommended. The results showed that PCT-guided algorithms significantly reduced the number of antibiotic-treated patients (n = 99 [83%] vs n = 55 [44%]; P < .0001), reduced the duration of antibiotic treatment (12.8 days vs 10.9 days; P = .03), and decreased the antibiotic cost per patient ($202.5 vs $96.3; P < .0001) compared with the standard group (n = 119) without a significant difference in mortality.⁶

Sepsis/septic shock is another area in which PCT has been studied. Use of a PCT-guided algorithm in critically ill patients with suspected or documented severe sepsis or septic shock to guide discontinuation of antimicrobial therapy resulted in reduced duration of antibiotic therapy (10 days vs 6 days; P = .003) in the PCT group (n = 31) compared with the standard of care group (n = 37) while maintaining similar mortality and infection recurrence rates between the 2 groups. The PCT algorithm in this study recommended discontinuing antimicrobial therapy when PCT levels had decreased by > 90% from identification of sepsis/septic shock but not prior to 3 or 5 days of therapy, depending on the baseline PCT level.⁷

Systematic reviews of multiple trials have confirmed these representative results. Using a PCT algorithm to withhold or de-escalate antibiotics in patients with suspected bacterial infection leads to a significant reduction in antimicrobial utilization without adversely affecting patient outcome.⁸

Related: Health Care Use Among Iraq and Afghanistan Veterans With Infectious Diseases

Procalcitonin levels should be rechecked 48 to 72 hours after beginning antimicrobial therapy in clinically stable patients with RTIs in order to reevaluate patient need for continued therapy. In patients whose antibiotics are withheld due to low PCT levels, it is recommended to obtain a repeat level 12 to 48 hours after the decision if clinical improvement is not seen.^6,9-12 Literature suggests that it is reasonable to check PCT levels every 48 to 72 hours in patients with sepsis for considering discontinuation of antibiotic therapy as well as in patients who are not clinically improving and may need to broaden antibiotic therapy.^7,12

Limitations of the use of PCT as a clinical biomarker include its inability to be used in immunocompromised patients. In addition, PCT levels are increased in severe, noninfectious inflammatory conditions, such as inhalation injury, pulmonary aspiration, severe burns, pancreatitis, heat stroke, mesenteric infarction, trauma, surgery, and pneumonitis.¹² The presence of low-grade inflammation from a bacterial infection can lead to slightly elevated PCT levels that are difficult to quantify due to the low sensitivity of current PCT assays.¹³

The level of PCT up-regulation may depend on the infecting pathogen. One study showed that PCT was highly elevated in patients with pneumococcal community-acquired pneumonia (CAP), and another study demonstrated that PCT levels did not increase in CAP due to atypical organisms.^14,15 Thus, atypical antimicrobial coverage should be continued per current guidelines in patients in whom there is high suspicion of atypical organism-involvement in CAP.

Related: The Importance of an Antimicrobial Stewardship Program

Conclusion

Many studies have analyzed the use of PCT as a biomarker for infectious disease diagnosis, monitoring, and treatment. Current evidence supports its use in RTIs and sepsis, although it may be useful in other conditions as well, such as bacteremia and postoperative infections.² Due to its limitations and controversy, PCT should not be used as a sole marker but as an adjunct to a patient’s clinical presentation, overall clinical picture, and other biomarkers. 

Additional Note
An earlier version of this article appeared in the Pharmacy Related Newsletter: The Capsule, of the William S. Middleton Memorial Veterans Hospital.

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.

Procalcitonin (PCT) is a precursor to the hormone calcitonin and is a serum biomarker of interest in infectious diseases. Many studies have analyzed its utility and role in assisting clinical decision making, especially in conditions that result in inflammation due to a bacterial infection. A systemic inflammatory response from a bacterial infection begins with the release of endotoxins/exotoxins and a response from immune system mediators that release cytokines, such as interleukin-1β and tumor necrosis factor-α. These cytokines contribute to the development of a fever, the release of stress hormones, such as cortisone and epinephrine, and interleukin-6, which stimulates acute phase reactants, such as C-reactive protein (CRP) and PCT.^1,2

C-reactive protein and white blood cell count (WBC) are commonly used clinically as biomarkers that assist in the recognition of the infectious process and may be indicators of disease prognosis, but both lack specificity for bacterial infections. Consequentially, using CRP and WBC as clinical decision aids may result in unnecessary antibiotic therapy, which may result in an increase in drug-related adverse events and antibiotic resistance. A major distinction of PCT is that it has greater specificity than does CRP, because it tends to be elevated primarily as a result of inflammation due to bacterial infections. Procalcitonin can be used to distinguish bacterial from viral infections because its up-regulation is attenuated by interferon-gamma, a cytokine released in response to viral infections.² Thus, PCT may be a more effective clinical marker for optimizing the diagnosis, monitoring, and treatment in patients with systemic bacterial infections.

Procalcitonin as a Marker

A study evaluating infectious markers compared the use of PCT, lactate, and CRP as diagnostic tools in patients with septic shock. The results of this study indicated that PCT was the only marker significantly elevated in patients with septic shock that was also normal in patients not in septic shock (14 µg/mL vs 1 µg/mL, P = .0003).³ This and other studies led the FDA to approve PCT use in 2005 as an aid to clinical decision making in the assessment of critically ill patients with sepsis.⁴ Overall, the literature supports the use of PCT as a diagnostic tool in infections requiring antimicrobial therapy within appropriate clinical settings.

Strong evidence exists confirming PCT’s role as an aid to clinical decision making in bronchitis, chronic obstructive pulmonary disease exacerbations, pneumonia, and severe sepsis/shock management.² Procalcitonin’s kinetic profile makes it a good monitoring tool, because its levels promptly increase within 3 to 6 hours of infection, peak at 12 to 48 hours, and rapidly decline during recovery. Additionally, its levels closely parallel the extent and severity of present inflammation, making it a useful prognostic marker of disease progression and response to antibiotic therapy.^2,4,5

Related: Mass Transit for Viruses

Christ-Crain and colleagues studied the outcome of PCT-guided antibiotic algorithms for patients with lower respiratory tract infections (RTIs) presenting to the emergency department. A serum PCT level of 0.25 to 0.5 µg/L suggested a likely bacterial infection, and physicians were advised to initiate antimicrobial therapy. Serum levels above 0.5 µg/L were suggestive of a bacterial infection, and initiation of antimicrobial therapy was strongly recommended. The results showed that PCT-guided algorithms significantly reduced the number of antibiotic-treated patients (n = 99 [83%] vs n = 55 [44%]; P < .0001), reduced the duration of antibiotic treatment (12.8 days vs 10.9 days; P = .03), and decreased the antibiotic cost per patient ($202.5 vs $96.3; P < .0001) compared with the standard group (n = 119) without a significant difference in mortality.⁶

Sepsis/septic shock is another area in which PCT has been studied. Use of a PCT-guided algorithm in critically ill patients with suspected or documented severe sepsis or septic shock to guide discontinuation of antimicrobial therapy resulted in reduced duration of antibiotic therapy (10 days vs 6 days; P = .003) in the PCT group (n = 31) compared with the standard of care group (n = 37) while maintaining similar mortality and infection recurrence rates between the 2 groups. The PCT algorithm in this study recommended discontinuing antimicrobial therapy when PCT levels had decreased by > 90% from identification of sepsis/septic shock but not prior to 3 or 5 days of therapy, depending on the baseline PCT level.⁷

Systematic reviews of multiple trials have confirmed these representative results. Using a PCT algorithm to withhold or de-escalate antibiotics in patients with suspected bacterial infection leads to a significant reduction in antimicrobial utilization without adversely affecting patient outcome.⁸

Related: Health Care Use Among Iraq and Afghanistan Veterans With Infectious Diseases

Procalcitonin levels should be rechecked 48 to 72 hours after beginning antimicrobial therapy in clinically stable patients with RTIs in order to reevaluate patient need for continued therapy. In patients whose antibiotics are withheld due to low PCT levels, it is recommended to obtain a repeat level 12 to 48 hours after the decision if clinical improvement is not seen.^6,9-12 Literature suggests that it is reasonable to check PCT levels every 48 to 72 hours in patients with sepsis for considering discontinuation of antibiotic therapy as well as in patients who are not clinically improving and may need to broaden antibiotic therapy.^7,12

Limitations of the use of PCT as a clinical biomarker include its inability to be used in immunocompromised patients. In addition, PCT levels are increased in severe, noninfectious inflammatory conditions, such as inhalation injury, pulmonary aspiration, severe burns, pancreatitis, heat stroke, mesenteric infarction, trauma, surgery, and pneumonitis.¹² The presence of low-grade inflammation from a bacterial infection can lead to slightly elevated PCT levels that are difficult to quantify due to the low sensitivity of current PCT assays.¹³

The level of PCT up-regulation may depend on the infecting pathogen. One study showed that PCT was highly elevated in patients with pneumococcal community-acquired pneumonia (CAP), and another study demonstrated that PCT levels did not increase in CAP due to atypical organisms.^14,15 Thus, atypical antimicrobial coverage should be continued per current guidelines in patients in whom there is high suspicion of atypical organism-involvement in CAP.

Related: The Importance of an Antimicrobial Stewardship Program

Conclusion

Many studies have analyzed the use of PCT as a biomarker for infectious disease diagnosis, monitoring, and treatment. Current evidence supports its use in RTIs and sepsis, although it may be useful in other conditions as well, such as bacteremia and postoperative infections.² Due to its limitations and controversy, PCT should not be used as a sole marker but as an adjunct to a patient’s clinical presentation, overall clinical picture, and other biomarkers. 

Additional Note
An earlier version of this article appeared in the Pharmacy Related Newsletter: The Capsule, of the William S. Middleton Memorial Veterans Hospital.

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.

In my 16 years of practice, there has been tremendous change in the field of pediatric orthopedics in both demographics and scope of practice. Because of scientific and technological advances, efforts of the Pediatric Orthopaedic Society of North America (POSNA), and a changing workforce, the nature of pediatric orthopedics is changing dramatically and will continue to do so.

In the late 1990s, a “typical” pediatric orthopedic surgeon was treating fractures, developmental dysplasia of the hip, clubfeet, and other congenital deformities. Surgery for adolescent idiopathic scoliosis was moving toward anterior instrumentation and correction of the spine. The concepts of early-onset scoliosis and thoracic insufficiency syndrome were in their infancy. Children with anterior cruciate ligament tears were treated with braces until skeletal maturity, often leading to life-altering meniscal pathology. Essential medical treatments for genetic conditions, including bisphosphonates for osteogenesis imperfecta and corticosteroids for Duchenne muscular dystrophy, were considered experimental.

The field itself also was at a crossroads. In 1993, there were 410 active members in POSNA (vs 653 in 2014), and the vast majority were male.¹ In the late 1990s, there were approximately 30 pediatric fellowship spots and 10 fellows being trained per year. Simultaneously, approximately 20 to 30 active POSNA members were retiring annually, leading to a projected shortage of pediatric orthopedic surgeons.¹ A 2007 American Orthopaedic Association survey found that 59% of members believed that pediatric orthopedics was the most underserved specialty for a variety of reasons, including perceived lower reimbursement, higher volume of nonoperative treatment, and lifestyle issues (such as on-call burden).²

Owing in part to efforts of POSNA in resident/fellow education and mentorship, the practice of pediatric orthopedics in 2016 is dramatically different from a decade ago. The number of fellowship programs has increased to 44 programs, offering a total of 71 fellowship spots, of which 60 were filled by US applicants in 2014. Interestingly, the current active membership of POSNA is 19% female, and the 2014 fellowship class was 34% female. This is in contrast to the 4.4% of all AAOS members who are female. If current trends continue, POSNA could be 40% female by 2025 as senior, predominantly male members retire.¹

Pediatric orthopedic practice in 2016 is also dramatically different owing to the development of subspecialization in areas of pediatric sports medicine, hand surgery, trauma, and the treatment of adolescent hip pathology. In fact, a recent survey of fellowship graduates showed that 30% of graduating fellows were going to do a second fellowship.³

While technological advances have driven the care of many pediatric orthopedic conditions such as spinal deformity and sports injuries, there also has been a resurgence of interest in the nonoperative treatment of clubfeet using the Ponseti method and of early-onset scoliosis using Mehta casting. Children with clubfeet even a decade ago were being treated with wide comprehensive releases and capsulotomies, leading to stiff painful feet as young adults. Now comprehensive releases are rarely used. Owing to advances in posterior spinal instrumentation as well as studies showing some decline in pulmonary function after thoracotomy and anterior spinal fusion, the treatment of adolescent scoliosis is predominantly done through the posterior approach. Advances in screening have led to a dramatic decrease in the surgical treatment of hip dysplasia. Medical treatment, such as corticosteroids for Duchenne muscular dystrophy, has prolonged length of life and improved quality of life as well as decreased the number of spinal fusions performed. Recombinant factor replacement for hemophilia has almost eliminated the horrible morbidity associated with hemophilic arthropathy and the need for synovectomy, arthrodesis, and arthroplasty, as well as the infectious issues, such as human immunodeficiency virus (HIV) and hepatitis, associated with the use of pooled blood products. The use of growth-friendly spinal implants, such as the Vertical Expandable Prosthetic Titanium Rib (VEPTR; DePuy Synthes), magnetically driven growing rods (MAGEC; Ellipse), and spinal tethers have improved pulmonary outcomes and presumably life expectancy in young patients with early-onset scoliosis who a decade ago may have had an in situ spinal fusion. These are just a few examples, and there are many more.

The articles in this issue highlight some of these changes. Tibial osteotomy and deformity correction, as described in the article by Burton and Hennrikus (pages 16-18), are classic techniques used by pediatric orthopedists over the past decades and will continue to be useful. The article by Hosseinzadeh and Talwalkar (pages 19-22) reviews unique aspects of pediatric compartment syndrome. While the basic concepts of compartment syndrome have not changed, the signs of compartment syndrome, the 5 Ps we all learned a decade ago (pain, paresthesia, paralysis, pallor, and pulselessness) have now been replaced in children with the 3 As (increasing analgesia, anxiety, and agitation). Finally, the article by Sferopoulos (pages 38-41) describing a case of a giant bone island in a child reminds us that we have a lot more to learn as pediatric orthopedists regarding the molecular nature and cause of disease.

The next few years will continue to be an exciting and dynamic time in the field of pediatric orthopedics. Not only is the workforce itself changing and growing, but so are the definitions of what a pediatric orthopedic surgeon is and does. While subspecialization is the trend in most aspects of medicine, it will be important to continue to monitor<hl name="1"/> this trend to ensure that pediatric orthopedics does not become too highly specialized. With the tremendous inflow of new talent, ideas, and technology, the future for pediatric orthopedics has never looked brighter.

References

In my 16 years of practice, there has been tremendous change in the field of pediatric orthopedics in both demographics and scope of practice. Because of scientific and technological advances, efforts of the Pediatric Orthopaedic Society of North America (POSNA), and a changing workforce, the nature of pediatric orthopedics is changing dramatically and will continue to do so.

In the late 1990s, a “typical” pediatric orthopedic surgeon was treating fractures, developmental dysplasia of the hip, clubfeet, and other congenital deformities. Surgery for adolescent idiopathic scoliosis was moving toward anterior instrumentation and correction of the spine. The concepts of early-onset scoliosis and thoracic insufficiency syndrome were in their infancy. Children with anterior cruciate ligament tears were treated with braces until skeletal maturity, often leading to life-altering meniscal pathology. Essential medical treatments for genetic conditions, including bisphosphonates for osteogenesis imperfecta and corticosteroids for Duchenne muscular dystrophy, were considered experimental.

The field itself also was at a crossroads. In 1993, there were 410 active members in POSNA (vs 653 in 2014), and the vast majority were male.¹ In the late 1990s, there were approximately 30 pediatric fellowship spots and 10 fellows being trained per year. Simultaneously, approximately 20 to 30 active POSNA members were retiring annually, leading to a projected shortage of pediatric orthopedic surgeons.¹ A 2007 American Orthopaedic Association survey found that 59% of members believed that pediatric orthopedics was the most underserved specialty for a variety of reasons, including perceived lower reimbursement, higher volume of nonoperative treatment, and lifestyle issues (such as on-call burden).²

Owing in part to efforts of POSNA in resident/fellow education and mentorship, the practice of pediatric orthopedics in 2016 is dramatically different from a decade ago. The number of fellowship programs has increased to 44 programs, offering a total of 71 fellowship spots, of which 60 were filled by US applicants in 2014. Interestingly, the current active membership of POSNA is 19% female, and the 2014 fellowship class was 34% female. This is in contrast to the 4.4% of all AAOS members who are female. If current trends continue, POSNA could be 40% female by 2025 as senior, predominantly male members retire.¹

Pediatric orthopedic practice in 2016 is also dramatically different owing to the development of subspecialization in areas of pediatric sports medicine, hand surgery, trauma, and the treatment of adolescent hip pathology. In fact, a recent survey of fellowship graduates showed that 30% of graduating fellows were going to do a second fellowship.³

While technological advances have driven the care of many pediatric orthopedic conditions such as spinal deformity and sports injuries, there also has been a resurgence of interest in the nonoperative treatment of clubfeet using the Ponseti method and of early-onset scoliosis using Mehta casting. Children with clubfeet even a decade ago were being treated with wide comprehensive releases and capsulotomies, leading to stiff painful feet as young adults. Now comprehensive releases are rarely used. Owing to advances in posterior spinal instrumentation as well as studies showing some decline in pulmonary function after thoracotomy and anterior spinal fusion, the treatment of adolescent scoliosis is predominantly done through the posterior approach. Advances in screening have led to a dramatic decrease in the surgical treatment of hip dysplasia. Medical treatment, such as corticosteroids for Duchenne muscular dystrophy, has prolonged length of life and improved quality of life as well as decreased the number of spinal fusions performed. Recombinant factor replacement for hemophilia has almost eliminated the horrible morbidity associated with hemophilic arthropathy and the need for synovectomy, arthrodesis, and arthroplasty, as well as the infectious issues, such as human immunodeficiency virus (HIV) and hepatitis, associated with the use of pooled blood products. The use of growth-friendly spinal implants, such as the Vertical Expandable Prosthetic Titanium Rib (VEPTR; DePuy Synthes), magnetically driven growing rods (MAGEC; Ellipse), and spinal tethers have improved pulmonary outcomes and presumably life expectancy in young patients with early-onset scoliosis who a decade ago may have had an in situ spinal fusion. These are just a few examples, and there are many more.

The articles in this issue highlight some of these changes. Tibial osteotomy and deformity correction, as described in the article by Burton and Hennrikus (pages 16-18), are classic techniques used by pediatric orthopedists over the past decades and will continue to be useful. The article by Hosseinzadeh and Talwalkar (pages 19-22) reviews unique aspects of pediatric compartment syndrome. While the basic concepts of compartment syndrome have not changed, the signs of compartment syndrome, the 5 Ps we all learned a decade ago (pain, paresthesia, paralysis, pallor, and pulselessness) have now been replaced in children with the 3 As (increasing analgesia, anxiety, and agitation). Finally, the article by Sferopoulos (pages 38-41) describing a case of a giant bone island in a child reminds us that we have a lot more to learn as pediatric orthopedists regarding the molecular nature and cause of disease.

The next few years will continue to be an exciting and dynamic time in the field of pediatric orthopedics. Not only is the workforce itself changing and growing, but so are the definitions of what a pediatric orthopedic surgeon is and does. While subspecialization is the trend in most aspects of medicine, it will be important to continue to monitor<hl name="1"/> this trend to ensure that pediatric orthopedics does not become too highly specialized. With the tremendous inflow of new talent, ideas, and technology, the future for pediatric orthopedics has never looked brighter.

References

In my 16 years of practice, there has been tremendous change in the field of pediatric orthopedics in both demographics and scope of practice. Because of scientific and technological advances, efforts of the Pediatric Orthopaedic Society of North America (POSNA), and a changing workforce, the nature of pediatric orthopedics is changing dramatically and will continue to do so.

In the late 1990s, a “typical” pediatric orthopedic surgeon was treating fractures, developmental dysplasia of the hip, clubfeet, and other congenital deformities. Surgery for adolescent idiopathic scoliosis was moving toward anterior instrumentation and correction of the spine. The concepts of early-onset scoliosis and thoracic insufficiency syndrome were in their infancy. Children with anterior cruciate ligament tears were treated with braces until skeletal maturity, often leading to life-altering meniscal pathology. Essential medical treatments for genetic conditions, including bisphosphonates for osteogenesis imperfecta and corticosteroids for Duchenne muscular dystrophy, were considered experimental.

The field itself also was at a crossroads. In 1993, there were 410 active members in POSNA (vs 653 in 2014), and the vast majority were male.¹ In the late 1990s, there were approximately 30 pediatric fellowship spots and 10 fellows being trained per year. Simultaneously, approximately 20 to 30 active POSNA members were retiring annually, leading to a projected shortage of pediatric orthopedic surgeons.¹ A 2007 American Orthopaedic Association survey found that 59% of members believed that pediatric orthopedics was the most underserved specialty for a variety of reasons, including perceived lower reimbursement, higher volume of nonoperative treatment, and lifestyle issues (such as on-call burden).²

Owing in part to efforts of POSNA in resident/fellow education and mentorship, the practice of pediatric orthopedics in 2016 is dramatically different from a decade ago. The number of fellowship programs has increased to 44 programs, offering a total of 71 fellowship spots, of which 60 were filled by US applicants in 2014. Interestingly, the current active membership of POSNA is 19% female, and the 2014 fellowship class was 34% female. This is in contrast to the 4.4% of all AAOS members who are female. If current trends continue, POSNA could be 40% female by 2025 as senior, predominantly male members retire.¹

Pediatric orthopedic practice in 2016 is also dramatically different owing to the development of subspecialization in areas of pediatric sports medicine, hand surgery, trauma, and the treatment of adolescent hip pathology. In fact, a recent survey of fellowship graduates showed that 30% of graduating fellows were going to do a second fellowship.³

While technological advances have driven the care of many pediatric orthopedic conditions such as spinal deformity and sports injuries, there also has been a resurgence of interest in the nonoperative treatment of clubfeet using the Ponseti method and of early-onset scoliosis using Mehta casting. Children with clubfeet even a decade ago were being treated with wide comprehensive releases and capsulotomies, leading to stiff painful feet as young adults. Now comprehensive releases are rarely used. Owing to advances in posterior spinal instrumentation as well as studies showing some decline in pulmonary function after thoracotomy and anterior spinal fusion, the treatment of adolescent scoliosis is predominantly done through the posterior approach. Advances in screening have led to a dramatic decrease in the surgical treatment of hip dysplasia. Medical treatment, such as corticosteroids for Duchenne muscular dystrophy, has prolonged length of life and improved quality of life as well as decreased the number of spinal fusions performed. Recombinant factor replacement for hemophilia has almost eliminated the horrible morbidity associated with hemophilic arthropathy and the need for synovectomy, arthrodesis, and arthroplasty, as well as the infectious issues, such as human immunodeficiency virus (HIV) and hepatitis, associated with the use of pooled blood products. The use of growth-friendly spinal implants, such as the Vertical Expandable Prosthetic Titanium Rib (VEPTR; DePuy Synthes), magnetically driven growing rods (MAGEC; Ellipse), and spinal tethers have improved pulmonary outcomes and presumably life expectancy in young patients with early-onset scoliosis who a decade ago may have had an in situ spinal fusion. These are just a few examples, and there are many more.

The articles in this issue highlight some of these changes. Tibial osteotomy and deformity correction, as described in the article by Burton and Hennrikus (pages 16-18), are classic techniques used by pediatric orthopedists over the past decades and will continue to be useful. The article by Hosseinzadeh and Talwalkar (pages 19-22) reviews unique aspects of pediatric compartment syndrome. While the basic concepts of compartment syndrome have not changed, the signs of compartment syndrome, the 5 Ps we all learned a decade ago (pain, paresthesia, paralysis, pallor, and pulselessness) have now been replaced in children with the 3 As (increasing analgesia, anxiety, and agitation). Finally, the article by Sferopoulos (pages 38-41) describing a case of a giant bone island in a child reminds us that we have a lot more to learn as pediatric orthopedists regarding the molecular nature and cause of disease.

The next few years will continue to be an exciting and dynamic time in the field of pediatric orthopedics. Not only is the workforce itself changing and growing, but so are the definitions of what a pediatric orthopedic surgeon is and does. While subspecialization is the trend in most aspects of medicine, it will be important to continue to monitor<hl name="1"/> this trend to ensure that pediatric orthopedics does not become too highly specialized. With the tremendous inflow of new talent, ideas, and technology, the future for pediatric orthopedics has never looked brighter.

References

Generic drugs have long carried a stigma for at least some people. Patients sometimes feel scared and shortchanged when prescribed them, and some physicians have been wary of their safety and efficacy, compared with brand-name counterparts.

This fall, results appeared from a trio of prospective, randomized studies that compared several generic forms of the antiepileptic drug lamotrigine against the brand-name compound, Lamictal, in patients with epilepsy. As reported earlier this month in a special session at the annual meeting of the American Epilepsy Society, and as I wrote up in a news article, the findings from all three studies consistently and clearly showed that the generic lamotrigine products tested in these three studies all performed identically to Lamictal by both their pharmacokinetic profiles and in their clinical safety and efficacy.

Giorgiogp2/Wikimedia Commons/CC BY-SA 3.0

A critic could quibble that the three studies involved relatively small numbers of patients (they included 34-48 subjects), that the treatment times were relatively brief (a matter of a few weeks), and the investigations were limited to just lamotrigine. But the neurologists who reported these findings, a pair of Food and Drug Administration staffers who deal with generics and spoke at the session, and two pharmacy researchers who also participated in the panel all agreed that these groundbreaking studies establish an unprecedented level of confidence in not just the generic products tested but for generic drugs in general.

As Dr. Michael Privitera, director of the Epilepsy Center at the University of Cincinnati and a lead investigator for two of the three studies, told me, controlling seizures in epilepsy patients is a stringent test of drug efficacy and similarity. If generic forms of lamotrigine behave indistinguishably from Lamictal, then it’s very reasonable to expect that virtually any generic form of any brand-name drug used in medicine is also a good mimic if it recently passed FDA muster. His only caveat was selected drugs with very unusual pharmacokinetic properties, such as phenytoin – another antiepileptic drug, which has saturation kinetics making it a special case that requires additional, customized testing to prove equivalence between the generic and brand-name form.

But as he and others at the session highlighted, equivalent pharmacologic properties of generic and brand-name forms of a drug tell just part of the story. They may act the same once inside patients’ bodies, but what’s also important is how patients regard these drugs from the neck up. Psychological factors play a role in how patients perceive and use different forms of chemically identical products. Differences in pill size, shape, and color can confuse patients, and just knowing that a drug is a generic could possibly trigger anxiety in a patient that might perhaps produce a seizure or disrupt their pill-taking behavior. Several clinicians at the session spoke of certain patients who have begged them to specify the brand-name drug on their prescriptions. On the other hand, a generic’s lower price often encourages more conscientious use, a phenomenon documented in a database review reported at the session by pharmacoepidemiologist Joshua J. Gagne, Pharm.D.

Madison Avenue has known for years that function and utility tell just part of the story when it comes to consumer goods. A Kia may be just as durable and effective for transporting someone as a Mercedes or BMW, but cheap isn’t always what a consumer wants or feels comfortable with. Generics that work indistinguishably from brand drugs are certainly attractive for the U.S. health care system and the majority of the American public, but the concept that generic is best will be tough to sell to everyone.

[email protected]

On Twitter @mitchelzoler

Generic drugs have long carried a stigma for at least some people. Patients sometimes feel scared and shortchanged when prescribed them, and some physicians have been wary of their safety and efficacy, compared with brand-name counterparts.

This fall, results appeared from a trio of prospective, randomized studies that compared several generic forms of the antiepileptic drug lamotrigine against the brand-name compound, Lamictal, in patients with epilepsy. As reported earlier this month in a special session at the annual meeting of the American Epilepsy Society, and as I wrote up in a news article, the findings from all three studies consistently and clearly showed that the generic lamotrigine products tested in these three studies all performed identically to Lamictal by both their pharmacokinetic profiles and in their clinical safety and efficacy.

Giorgiogp2/Wikimedia Commons/CC BY-SA 3.0

A critic could quibble that the three studies involved relatively small numbers of patients (they included 34-48 subjects), that the treatment times were relatively brief (a matter of a few weeks), and the investigations were limited to just lamotrigine. But the neurologists who reported these findings, a pair of Food and Drug Administration staffers who deal with generics and spoke at the session, and two pharmacy researchers who also participated in the panel all agreed that these groundbreaking studies establish an unprecedented level of confidence in not just the generic products tested but for generic drugs in general.

As Dr. Michael Privitera, director of the Epilepsy Center at the University of Cincinnati and a lead investigator for two of the three studies, told me, controlling seizures in epilepsy patients is a stringent test of drug efficacy and similarity. If generic forms of lamotrigine behave indistinguishably from Lamictal, then it’s very reasonable to expect that virtually any generic form of any brand-name drug used in medicine is also a good mimic if it recently passed FDA muster. His only caveat was selected drugs with very unusual pharmacokinetic properties, such as phenytoin – another antiepileptic drug, which has saturation kinetics making it a special case that requires additional, customized testing to prove equivalence between the generic and brand-name form.

But as he and others at the session highlighted, equivalent pharmacologic properties of generic and brand-name forms of a drug tell just part of the story. They may act the same once inside patients’ bodies, but what’s also important is how patients regard these drugs from the neck up. Psychological factors play a role in how patients perceive and use different forms of chemically identical products. Differences in pill size, shape, and color can confuse patients, and just knowing that a drug is a generic could possibly trigger anxiety in a patient that might perhaps produce a seizure or disrupt their pill-taking behavior. Several clinicians at the session spoke of certain patients who have begged them to specify the brand-name drug on their prescriptions. On the other hand, a generic’s lower price often encourages more conscientious use, a phenomenon documented in a database review reported at the session by pharmacoepidemiologist Joshua J. Gagne, Pharm.D.

Madison Avenue has known for years that function and utility tell just part of the story when it comes to consumer goods. A Kia may be just as durable and effective for transporting someone as a Mercedes or BMW, but cheap isn’t always what a consumer wants or feels comfortable with. Generics that work indistinguishably from brand drugs are certainly attractive for the U.S. health care system and the majority of the American public, but the concept that generic is best will be tough to sell to everyone.

[email protected]

On Twitter @mitchelzoler

Generic drugs have long carried a stigma for at least some people. Patients sometimes feel scared and shortchanged when prescribed them, and some physicians have been wary of their safety and efficacy, compared with brand-name counterparts.

This fall, results appeared from a trio of prospective, randomized studies that compared several generic forms of the antiepileptic drug lamotrigine against the brand-name compound, Lamictal, in patients with epilepsy. As reported earlier this month in a special session at the annual meeting of the American Epilepsy Society, and as I wrote up in a news article, the findings from all three studies consistently and clearly showed that the generic lamotrigine products tested in these three studies all performed identically to Lamictal by both their pharmacokinetic profiles and in their clinical safety and efficacy.

Giorgiogp2/Wikimedia Commons/CC BY-SA 3.0

A critic could quibble that the three studies involved relatively small numbers of patients (they included 34-48 subjects), that the treatment times were relatively brief (a matter of a few weeks), and the investigations were limited to just lamotrigine. But the neurologists who reported these findings, a pair of Food and Drug Administration staffers who deal with generics and spoke at the session, and two pharmacy researchers who also participated in the panel all agreed that these groundbreaking studies establish an unprecedented level of confidence in not just the generic products tested but for generic drugs in general.

As Dr. Michael Privitera, director of the Epilepsy Center at the University of Cincinnati and a lead investigator for two of the three studies, told me, controlling seizures in epilepsy patients is a stringent test of drug efficacy and similarity. If generic forms of lamotrigine behave indistinguishably from Lamictal, then it’s very reasonable to expect that virtually any generic form of any brand-name drug used in medicine is also a good mimic if it recently passed FDA muster. His only caveat was selected drugs with very unusual pharmacokinetic properties, such as phenytoin – another antiepileptic drug, which has saturation kinetics making it a special case that requires additional, customized testing to prove equivalence between the generic and brand-name form.

But as he and others at the session highlighted, equivalent pharmacologic properties of generic and brand-name forms of a drug tell just part of the story. They may act the same once inside patients’ bodies, but what’s also important is how patients regard these drugs from the neck up. Psychological factors play a role in how patients perceive and use different forms of chemically identical products. Differences in pill size, shape, and color can confuse patients, and just knowing that a drug is a generic could possibly trigger anxiety in a patient that might perhaps produce a seizure or disrupt their pill-taking behavior. Several clinicians at the session spoke of certain patients who have begged them to specify the brand-name drug on their prescriptions. On the other hand, a generic’s lower price often encourages more conscientious use, a phenomenon documented in a database review reported at the session by pharmacoepidemiologist Joshua J. Gagne, Pharm.D.

Madison Avenue has known for years that function and utility tell just part of the story when it comes to consumer goods. A Kia may be just as durable and effective for transporting someone as a Mercedes or BMW, but cheap isn’t always what a consumer wants or feels comfortable with. Generics that work indistinguishably from brand drugs are certainly attractive for the U.S. health care system and the majority of the American public, but the concept that generic is best will be tough to sell to everyone.

[email protected]

On Twitter @mitchelzoler

There is a woman whose mischief is causing me a whole lot of problems. Now, I don’t want you to think that I’m a misogynist or some type of closet chauvinist, but Miss Information is really troublesome. Besides me, this wayward troublemaker has managed to entwine herself in multiple aspects of the daily lives of practicing physicians. The widespread introduction of electronic medical record keeping has opened Pandora’s Box for Miss Information to flit about, inserting a word or two here, and fiddling with macros there. Yet it is not only her delight in altering medical records, although that is where I first noticed her trickery.

There could be no other way to explain that a local cardiologist’s history and physical described his patient as having “3 plus ankle pulses” despite the patient’s being a double amputee. Further, another’s records claimed that a patient was “neurologically intact” although he had suffered a dense left hemiplegia following carotid stenting. When I questioned the patient I got the distinct impression that perhaps Miss Information had disguised herself as his cardiologist. She told him that he needed a carotid stent because he had a 60% stenosis which if not treated would result in a stroke … and now he actually had one. I asked him why he had not consulted with me; after all, I am relatively well respected in my town, or so I thought! He said my web reviews were not stellar. Impossible, I believed! But when I checked, I found that impudent rascal Miss Information had inserted derogatory reviews about the cleanliness and friendliness of my office staff. I knew it was her doing because she had actually made a mistake in my favor. She had erroneously claimed that the wait time in my office was better than average and I know for a fact I am tardy in that respect.

Coincidentally, I had just Googled “indications for carotid surgery and stenting” since I had to give a talk on asymptomatic carotid stenosis at the VEITH symposium. To my consternation, I discovered evidence that Miss Information had also infiltrated the Internet. The mischievous imp has jumbled the data, causing researchers to write contrary articles demonstrating stents to be less dangerous than endarterectomy, but equally that they are more hazardous. She also has inserted articles suggesting that patients with greater than 70% blockages need invasive treatment whereas other references adamantly proclaim that no one should have CEA or CAS unless they are symptomatic.

I don’t want to insinuate that Miss Information is necessarily unethical, but I am concerned by how she has altered the credentials of some of the doctors in my area. For example, I read an ad in the newspaper that a general surgeon who does vein therapy claimed to be a “Board Certified Vascular Surgeon,” whereas he had never taken a fellowship, nor ever passed the boards in vascular surgery. Surely, such a mistaken advertisement could only have resulted from that playful wordsmith, Miss Information. The same doctor’s records had also been manipulated by this little devil. She altered the note of one of his patients to falsely claim that the patient had severe pain despite having complied with insurance regulations that required exercising and wearing stockings for 3 months. The patient had no pain and had not worn stockings at all. Further, the duplex scan described an incompetent saphenous vein that had previously been removed for his cardiac bypass.

And, lo and behold, even our patients can succumb to her advances. A 30-year-old fitness instructor informed me that he suffered from such severe pain from an ugly calf varicose vein that he was reduced to consuming large quantities of analgesics. He did not want phlebectomy even though scars would be minimal. Rather, he requested that I prescribe oxycodone!

Miss Information even seems to be able to get herself on TV. I saw her in an ad masquerading as a vein doctor claiming that varicose veins can lead to life-threatening complications. Like the sorcerer that she is, she charms viewers by assuring them that most insurers will pay for treatment. Another of her tricks is to show spider veins vanishing in an instant with sclerotherapy, when we all know they may look even worse for a while. And, every morning and throughout the day, I see TV ads touting that a large legal firm specializing in malpractice asserts that it is “For the people”… Really?

Even a hospital with all its ability to keep out dangerous pathogens can be infected by this ill-behaved sprite. A hospital in a neighboring county claims to be a full service hospital, but has no vascular surgeon to cover the emergency department. Two other local hospitals claim to be in the “Top 100” of American hospitals. Yet one was cited by the state department of health services for unsanitary conditions. The other just paid $2 million to the U.S. Department of Justice to settle allegations of improperly implanted cardiac devices. Miss Information, acting as the spokesperson for the latter hospital, claimed that payment was made to avoid “costly and distracting litigation.”

Industry also is not immune to her conniving ways. I have already devoted an editorial to target lesion revascularization (TLR), a term she frequently uses to mislead us into believing one device is better than another.

With all the potential for Miss Information to negatively affect our professional judgment and outcomes, I question the government’s insistence that we all use electronic medical records. The premise for widespread use of an EMR is that if a surgeon has easy access to patient records from another state, he or she will not have to repeat costly tests or procedures. However, how do we know if Miss Information has rendered these tests unreliable? I was recently placed in a clinical quandary when an insurance company insisted that it would not pay for a confirmatory duplex scan on its client. I was aware that the patient had the scan performed at another lab where Miss Information would notoriously exaggerate the degree of stenosis to support unnecessary endarterectomies.

I have tried to make myself immune to Miss Information’s depravity since I know how insidious her efforts can be. However, it is possible that even some of my writings may be contaminated. Accordingly, I must sadly acknowledge that some of the “stories” I relayed above might not be completely factual. You will have to decide which, if any, Miss Information got hold of. Good luck!

Dr. Samson is clinical professor of surgery (vascular) at Florida State University Medical School, is president of Mote Vascular Foundation, and an attending vascular surgeon, Sarasota (Fla.) Vascular Specialists. Dr. Samson also considers himself a member of his proposed American College of Vascular Surgery.

There is a woman whose mischief is causing me a whole lot of problems. Now, I don’t want you to think that I’m a misogynist or some type of closet chauvinist, but Miss Information is really troublesome. Besides me, this wayward troublemaker has managed to entwine herself in multiple aspects of the daily lives of practicing physicians. The widespread introduction of electronic medical record keeping has opened Pandora’s Box for Miss Information to flit about, inserting a word or two here, and fiddling with macros there. Yet it is not only her delight in altering medical records, although that is where I first noticed her trickery.

There could be no other way to explain that a local cardiologist’s history and physical described his patient as having “3 plus ankle pulses” despite the patient’s being a double amputee. Further, another’s records claimed that a patient was “neurologically intact” although he had suffered a dense left hemiplegia following carotid stenting. When I questioned the patient I got the distinct impression that perhaps Miss Information had disguised herself as his cardiologist. She told him that he needed a carotid stent because he had a 60% stenosis which if not treated would result in a stroke … and now he actually had one. I asked him why he had not consulted with me; after all, I am relatively well respected in my town, or so I thought! He said my web reviews were not stellar. Impossible, I believed! But when I checked, I found that impudent rascal Miss Information had inserted derogatory reviews about the cleanliness and friendliness of my office staff. I knew it was her doing because she had actually made a mistake in my favor. She had erroneously claimed that the wait time in my office was better than average and I know for a fact I am tardy in that respect.

Coincidentally, I had just Googled “indications for carotid surgery and stenting” since I had to give a talk on asymptomatic carotid stenosis at the VEITH symposium. To my consternation, I discovered evidence that Miss Information had also infiltrated the Internet. The mischievous imp has jumbled the data, causing researchers to write contrary articles demonstrating stents to be less dangerous than endarterectomy, but equally that they are more hazardous. She also has inserted articles suggesting that patients with greater than 70% blockages need invasive treatment whereas other references adamantly proclaim that no one should have CEA or CAS unless they are symptomatic.

I don’t want to insinuate that Miss Information is necessarily unethical, but I am concerned by how she has altered the credentials of some of the doctors in my area. For example, I read an ad in the newspaper that a general surgeon who does vein therapy claimed to be a “Board Certified Vascular Surgeon,” whereas he had never taken a fellowship, nor ever passed the boards in vascular surgery. Surely, such a mistaken advertisement could only have resulted from that playful wordsmith, Miss Information. The same doctor’s records had also been manipulated by this little devil. She altered the note of one of his patients to falsely claim that the patient had severe pain despite having complied with insurance regulations that required exercising and wearing stockings for 3 months. The patient had no pain and had not worn stockings at all. Further, the duplex scan described an incompetent saphenous vein that had previously been removed for his cardiac bypass.

And, lo and behold, even our patients can succumb to her advances. A 30-year-old fitness instructor informed me that he suffered from such severe pain from an ugly calf varicose vein that he was reduced to consuming large quantities of analgesics. He did not want phlebectomy even though scars would be minimal. Rather, he requested that I prescribe oxycodone!

Miss Information even seems to be able to get herself on TV. I saw her in an ad masquerading as a vein doctor claiming that varicose veins can lead to life-threatening complications. Like the sorcerer that she is, she charms viewers by assuring them that most insurers will pay for treatment. Another of her tricks is to show spider veins vanishing in an instant with sclerotherapy, when we all know they may look even worse for a while. And, every morning and throughout the day, I see TV ads touting that a large legal firm specializing in malpractice asserts that it is “For the people”… Really?

Even a hospital with all its ability to keep out dangerous pathogens can be infected by this ill-behaved sprite. A hospital in a neighboring county claims to be a full service hospital, but has no vascular surgeon to cover the emergency department. Two other local hospitals claim to be in the “Top 100” of American hospitals. Yet one was cited by the state department of health services for unsanitary conditions. The other just paid $2 million to the U.S. Department of Justice to settle allegations of improperly implanted cardiac devices. Miss Information, acting as the spokesperson for the latter hospital, claimed that payment was made to avoid “costly and distracting litigation.”

Industry also is not immune to her conniving ways. I have already devoted an editorial to target lesion revascularization (TLR), a term she frequently uses to mislead us into believing one device is better than another.

With all the potential for Miss Information to negatively affect our professional judgment and outcomes, I question the government’s insistence that we all use electronic medical records. The premise for widespread use of an EMR is that if a surgeon has easy access to patient records from another state, he or she will not have to repeat costly tests or procedures. However, how do we know if Miss Information has rendered these tests unreliable? I was recently placed in a clinical quandary when an insurance company insisted that it would not pay for a confirmatory duplex scan on its client. I was aware that the patient had the scan performed at another lab where Miss Information would notoriously exaggerate the degree of stenosis to support unnecessary endarterectomies.

I have tried to make myself immune to Miss Information’s depravity since I know how insidious her efforts can be. However, it is possible that even some of my writings may be contaminated. Accordingly, I must sadly acknowledge that some of the “stories” I relayed above might not be completely factual. You will have to decide which, if any, Miss Information got hold of. Good luck!

Dr. Samson is clinical professor of surgery (vascular) at Florida State University Medical School, is president of Mote Vascular Foundation, and an attending vascular surgeon, Sarasota (Fla.) Vascular Specialists. Dr. Samson also considers himself a member of his proposed American College of Vascular Surgery.

There is a woman whose mischief is causing me a whole lot of problems. Now, I don’t want you to think that I’m a misogynist or some type of closet chauvinist, but Miss Information is really troublesome. Besides me, this wayward troublemaker has managed to entwine herself in multiple aspects of the daily lives of practicing physicians. The widespread introduction of electronic medical record keeping has opened Pandora’s Box for Miss Information to flit about, inserting a word or two here, and fiddling with macros there. Yet it is not only her delight in altering medical records, although that is where I first noticed her trickery.

There could be no other way to explain that a local cardiologist’s history and physical described his patient as having “3 plus ankle pulses” despite the patient’s being a double amputee. Further, another’s records claimed that a patient was “neurologically intact” although he had suffered a dense left hemiplegia following carotid stenting. When I questioned the patient I got the distinct impression that perhaps Miss Information had disguised herself as his cardiologist. She told him that he needed a carotid stent because he had a 60% stenosis which if not treated would result in a stroke … and now he actually had one. I asked him why he had not consulted with me; after all, I am relatively well respected in my town, or so I thought! He said my web reviews were not stellar. Impossible, I believed! But when I checked, I found that impudent rascal Miss Information had inserted derogatory reviews about the cleanliness and friendliness of my office staff. I knew it was her doing because she had actually made a mistake in my favor. She had erroneously claimed that the wait time in my office was better than average and I know for a fact I am tardy in that respect.

Coincidentally, I had just Googled “indications for carotid surgery and stenting” since I had to give a talk on asymptomatic carotid stenosis at the VEITH symposium. To my consternation, I discovered evidence that Miss Information had also infiltrated the Internet. The mischievous imp has jumbled the data, causing researchers to write contrary articles demonstrating stents to be less dangerous than endarterectomy, but equally that they are more hazardous. She also has inserted articles suggesting that patients with greater than 70% blockages need invasive treatment whereas other references adamantly proclaim that no one should have CEA or CAS unless they are symptomatic.

I don’t want to insinuate that Miss Information is necessarily unethical, but I am concerned by how she has altered the credentials of some of the doctors in my area. For example, I read an ad in the newspaper that a general surgeon who does vein therapy claimed to be a “Board Certified Vascular Surgeon,” whereas he had never taken a fellowship, nor ever passed the boards in vascular surgery. Surely, such a mistaken advertisement could only have resulted from that playful wordsmith, Miss Information. The same doctor’s records had also been manipulated by this little devil. She altered the note of one of his patients to falsely claim that the patient had severe pain despite having complied with insurance regulations that required exercising and wearing stockings for 3 months. The patient had no pain and had not worn stockings at all. Further, the duplex scan described an incompetent saphenous vein that had previously been removed for his cardiac bypass.

And, lo and behold, even our patients can succumb to her advances. A 30-year-old fitness instructor informed me that he suffered from such severe pain from an ugly calf varicose vein that he was reduced to consuming large quantities of analgesics. He did not want phlebectomy even though scars would be minimal. Rather, he requested that I prescribe oxycodone!

Miss Information even seems to be able to get herself on TV. I saw her in an ad masquerading as a vein doctor claiming that varicose veins can lead to life-threatening complications. Like the sorcerer that she is, she charms viewers by assuring them that most insurers will pay for treatment. Another of her tricks is to show spider veins vanishing in an instant with sclerotherapy, when we all know they may look even worse for a while. And, every morning and throughout the day, I see TV ads touting that a large legal firm specializing in malpractice asserts that it is “For the people”… Really?

Even a hospital with all its ability to keep out dangerous pathogens can be infected by this ill-behaved sprite. A hospital in a neighboring county claims to be a full service hospital, but has no vascular surgeon to cover the emergency department. Two other local hospitals claim to be in the “Top 100” of American hospitals. Yet one was cited by the state department of health services for unsanitary conditions. The other just paid $2 million to the U.S. Department of Justice to settle allegations of improperly implanted cardiac devices. Miss Information, acting as the spokesperson for the latter hospital, claimed that payment was made to avoid “costly and distracting litigation.”

Industry also is not immune to her conniving ways. I have already devoted an editorial to target lesion revascularization (TLR), a term she frequently uses to mislead us into believing one device is better than another.

With all the potential for Miss Information to negatively affect our professional judgment and outcomes, I question the government’s insistence that we all use electronic medical records. The premise for widespread use of an EMR is that if a surgeon has easy access to patient records from another state, he or she will not have to repeat costly tests or procedures. However, how do we know if Miss Information has rendered these tests unreliable? I was recently placed in a clinical quandary when an insurance company insisted that it would not pay for a confirmatory duplex scan on its client. I was aware that the patient had the scan performed at another lab where Miss Information would notoriously exaggerate the degree of stenosis to support unnecessary endarterectomies.

I have tried to make myself immune to Miss Information’s depravity since I know how insidious her efforts can be. However, it is possible that even some of my writings may be contaminated. Accordingly, I must sadly acknowledge that some of the “stories” I relayed above might not be completely factual. You will have to decide which, if any, Miss Information got hold of. Good luck!

Dr. Samson is clinical professor of surgery (vascular) at Florida State University Medical School, is president of Mote Vascular Foundation, and an attending vascular surgeon, Sarasota (Fla.) Vascular Specialists. Dr. Samson also considers himself a member of his proposed American College of Vascular Surgery.

Decades ago, a baby born at just 28 weeks’ gestation and weighing less than 1,000 grams would not likely survive. Today, thanks to the latest advances in neonatal intensive care, the survival rates for these infants have significantly improved.

Survival is just the first hurdle on these patients’ journey. Despite numerous medical advancements, many of these “micro-preemies” still may be discharged with significant challenges, including neurodevelopmental delays and/or chronic medical problems.

Our goal at Children’s Hospital of Orange County (CHOC Children’s) is to ensure that extremely-low-birth-weight (ELBW) babies not only survive, but that they do so with fewer long-term complications.

Outcomes from our small baby unit (SBU) show we’re doing just that.

Unique environment, bonds

Established in 2010, the SBU consists of four individual patient rooms, two of which are surgical suites, and three four-bed pods. Different from a traditional neonatal intensive care unit (NICU), this smaller unit allows a darker, quieter environment that encourages developmentally supportive care.

In the SBU, patients lie inside covered incubators that keep light away from their underdeveloped eyes. Families and staff members speak in “library voices,” because even a whisper is too harsh for these babies’ ears in the early stages of care. The goal is to create an environment that respects and supports the physiologic needs of the baby to grow and develop after being born so prematurely. Grouping this population also provides parents an opportunity to form strong bonds with other families sharing similar experiences. Only another parent of an ELBW baby can truly understand the fear felt when delivering an infant 12-16 weeks early; the trial of a months-long hospital stay; and the elation on discharge day. Anecdotally, these bonds have sometimes lasted years after discharge.

Dedicated, coordinated care

An objective of the initiative was to cohort ELBW infants in a single location physically separated from the main NICU, and to recognize that progressive changes in unit culture were essential for successfully shifting the practice model.

Experienced multidisciplinary NICU staff with interest and expertise in caring for ELBW patients became the initiative’s core tore team members. They received education – both independent study as well as an 8-hour class – prior to opening the SBU, and continuing education and team building remain key components of program development.

Improved outcomes

By utilizing a dedicated team with expertise in the care of these patients, CHOC Children’s clinicians have determined that establishing a unit dedicated to the care of ELBW patients has led to improved quality and outcomes.

Reducing chronic lung disease was a top motivation for the creation of the unit, and rates of chronic lung disease dropped from 48% of babies 2 years prior to the unit’s 2010 opening to 36% after the first 4 years of the program. The percentage of babies discharged on oxygen decreased from 23% to 18%. Continued improvement over time showed as well in both areas.

Infants being discharged with growth restriction (combined weight and head circumference less than the 10th percentile) decreased from 62% to 37%, and continued improvement showed over time.

Rates of hospital-acquired infections decreased from 39% to 19%, which led to fewer days of antibiotic administration.

Coordinated care from a dedicated multidisciplinary team also led to the reduction of ordering unnecessary tests. For example, the mean number per patient of routine laboratory tests decreased from 224 to 82 and radiographs decreased from 45 to 22 during the infants’ hospitalization.

Eliminating practice variation

Because practice variation often complicates care, the SBU cares for patients through a standardized, evidence-based practice that incorporates guidelines and checklists.

Evidence and unit culture informed the development of guidelines, and input was sought from the whole team: nursing staff, neonatal nurse practitioners, neonatologists, respiratory therapists, developmental specialists, dietitians, lactation support, pharmacists, social services, transport services, and high-risk infant follow-up clinic staff.

Checklists helped standardize practices, reduce variation, and improve safety.

Culture, consistency are key

Our clinicians found that improved outcomes in ELBW infants can be achieved by changing the culture of the practice. The successful outcomes likely reflect the benefits of consistency in practice by a dedicated team that gained expertise in the care of this population in a separate developmentally appropriate location.

In addition, there was a reduction in complications among infants prior to leaving the SBU. Engaging the team on an ongoing basis can sustain improved outcomes, including improved staff satisfaction.

Mindy Morris is a neonatal nurse practitioner and coordinator of the extremely-low-birth-weight program at Children’s Hospital of Orange County in Southern California.

Decades ago, a baby born at just 28 weeks’ gestation and weighing less than 1,000 grams would not likely survive. Today, thanks to the latest advances in neonatal intensive care, the survival rates for these infants have significantly improved.

Survival is just the first hurdle on these patients’ journey. Despite numerous medical advancements, many of these “micro-preemies” still may be discharged with significant challenges, including neurodevelopmental delays and/or chronic medical problems.

Our goal at Children’s Hospital of Orange County (CHOC Children’s) is to ensure that extremely-low-birth-weight (ELBW) babies not only survive, but that they do so with fewer long-term complications.

Outcomes from our small baby unit (SBU) show we’re doing just that.

Unique environment, bonds

Established in 2010, the SBU consists of four individual patient rooms, two of which are surgical suites, and three four-bed pods. Different from a traditional neonatal intensive care unit (NICU), this smaller unit allows a darker, quieter environment that encourages developmentally supportive care.

In the SBU, patients lie inside covered incubators that keep light away from their underdeveloped eyes. Families and staff members speak in “library voices,” because even a whisper is too harsh for these babies’ ears in the early stages of care. The goal is to create an environment that respects and supports the physiologic needs of the baby to grow and develop after being born so prematurely. Grouping this population also provides parents an opportunity to form strong bonds with other families sharing similar experiences. Only another parent of an ELBW baby can truly understand the fear felt when delivering an infant 12-16 weeks early; the trial of a months-long hospital stay; and the elation on discharge day. Anecdotally, these bonds have sometimes lasted years after discharge.

Dedicated, coordinated care

An objective of the initiative was to cohort ELBW infants in a single location physically separated from the main NICU, and to recognize that progressive changes in unit culture were essential for successfully shifting the practice model.

Experienced multidisciplinary NICU staff with interest and expertise in caring for ELBW patients became the initiative’s core tore team members. They received education – both independent study as well as an 8-hour class – prior to opening the SBU, and continuing education and team building remain key components of program development.

Improved outcomes

By utilizing a dedicated team with expertise in the care of these patients, CHOC Children’s clinicians have determined that establishing a unit dedicated to the care of ELBW patients has led to improved quality and outcomes.

Reducing chronic lung disease was a top motivation for the creation of the unit, and rates of chronic lung disease dropped from 48% of babies 2 years prior to the unit’s 2010 opening to 36% after the first 4 years of the program. The percentage of babies discharged on oxygen decreased from 23% to 18%. Continued improvement over time showed as well in both areas.

Infants being discharged with growth restriction (combined weight and head circumference less than the 10th percentile) decreased from 62% to 37%, and continued improvement showed over time.

Rates of hospital-acquired infections decreased from 39% to 19%, which led to fewer days of antibiotic administration.

Coordinated care from a dedicated multidisciplinary team also led to the reduction of ordering unnecessary tests. For example, the mean number per patient of routine laboratory tests decreased from 224 to 82 and radiographs decreased from 45 to 22 during the infants’ hospitalization.

Eliminating practice variation

Because practice variation often complicates care, the SBU cares for patients through a standardized, evidence-based practice that incorporates guidelines and checklists.

Evidence and unit culture informed the development of guidelines, and input was sought from the whole team: nursing staff, neonatal nurse practitioners, neonatologists, respiratory therapists, developmental specialists, dietitians, lactation support, pharmacists, social services, transport services, and high-risk infant follow-up clinic staff.

Checklists helped standardize practices, reduce variation, and improve safety.

Culture, consistency are key

Our clinicians found that improved outcomes in ELBW infants can be achieved by changing the culture of the practice. The successful outcomes likely reflect the benefits of consistency in practice by a dedicated team that gained expertise in the care of this population in a separate developmentally appropriate location.

In addition, there was a reduction in complications among infants prior to leaving the SBU. Engaging the team on an ongoing basis can sustain improved outcomes, including improved staff satisfaction.

Mindy Morris is a neonatal nurse practitioner and coordinator of the extremely-low-birth-weight program at Children’s Hospital of Orange County in Southern California.

Decades ago, a baby born at just 28 weeks’ gestation and weighing less than 1,000 grams would not likely survive. Today, thanks to the latest advances in neonatal intensive care, the survival rates for these infants have significantly improved.

Survival is just the first hurdle on these patients’ journey. Despite numerous medical advancements, many of these “micro-preemies” still may be discharged with significant challenges, including neurodevelopmental delays and/or chronic medical problems.

Our goal at Children’s Hospital of Orange County (CHOC Children’s) is to ensure that extremely-low-birth-weight (ELBW) babies not only survive, but that they do so with fewer long-term complications.

Outcomes from our small baby unit (SBU) show we’re doing just that.

Unique environment, bonds

Established in 2010, the SBU consists of four individual patient rooms, two of which are surgical suites, and three four-bed pods. Different from a traditional neonatal intensive care unit (NICU), this smaller unit allows a darker, quieter environment that encourages developmentally supportive care.

In the SBU, patients lie inside covered incubators that keep light away from their underdeveloped eyes. Families and staff members speak in “library voices,” because even a whisper is too harsh for these babies’ ears in the early stages of care. The goal is to create an environment that respects and supports the physiologic needs of the baby to grow and develop after being born so prematurely. Grouping this population also provides parents an opportunity to form strong bonds with other families sharing similar experiences. Only another parent of an ELBW baby can truly understand the fear felt when delivering an infant 12-16 weeks early; the trial of a months-long hospital stay; and the elation on discharge day. Anecdotally, these bonds have sometimes lasted years after discharge.

Dedicated, coordinated care

An objective of the initiative was to cohort ELBW infants in a single location physically separated from the main NICU, and to recognize that progressive changes in unit culture were essential for successfully shifting the practice model.

Experienced multidisciplinary NICU staff with interest and expertise in caring for ELBW patients became the initiative’s core tore team members. They received education – both independent study as well as an 8-hour class – prior to opening the SBU, and continuing education and team building remain key components of program development.

Improved outcomes

By utilizing a dedicated team with expertise in the care of these patients, CHOC Children’s clinicians have determined that establishing a unit dedicated to the care of ELBW patients has led to improved quality and outcomes.

Reducing chronic lung disease was a top motivation for the creation of the unit, and rates of chronic lung disease dropped from 48% of babies 2 years prior to the unit’s 2010 opening to 36% after the first 4 years of the program. The percentage of babies discharged on oxygen decreased from 23% to 18%. Continued improvement over time showed as well in both areas.

Infants being discharged with growth restriction (combined weight and head circumference less than the 10th percentile) decreased from 62% to 37%, and continued improvement showed over time.

Rates of hospital-acquired infections decreased from 39% to 19%, which led to fewer days of antibiotic administration.

Coordinated care from a dedicated multidisciplinary team also led to the reduction of ordering unnecessary tests. For example, the mean number per patient of routine laboratory tests decreased from 224 to 82 and radiographs decreased from 45 to 22 during the infants’ hospitalization.

Eliminating practice variation

Because practice variation often complicates care, the SBU cares for patients through a standardized, evidence-based practice that incorporates guidelines and checklists.

Evidence and unit culture informed the development of guidelines, and input was sought from the whole team: nursing staff, neonatal nurse practitioners, neonatologists, respiratory therapists, developmental specialists, dietitians, lactation support, pharmacists, social services, transport services, and high-risk infant follow-up clinic staff.

Checklists helped standardize practices, reduce variation, and improve safety.

Culture, consistency are key

Our clinicians found that improved outcomes in ELBW infants can be achieved by changing the culture of the practice. The successful outcomes likely reflect the benefits of consistency in practice by a dedicated team that gained expertise in the care of this population in a separate developmentally appropriate location.

In addition, there was a reduction in complications among infants prior to leaving the SBU. Engaging the team on an ongoing basis can sustain improved outcomes, including improved staff satisfaction.

Mindy Morris is a neonatal nurse practitioner and coordinator of the extremely-low-birth-weight program at Children’s Hospital of Orange County in Southern California.