NP and PA Scope of Practice

Article Type
Article
Changed
Sun, 05/21/2017 - 13:55
Display Headline
Nurse practitioner and physician assistant scope of practice in 118 acute care hospitals
Author(s)
Anand Kartha, MD, MS
Joseph D. Restuccia, DrPH
James F. Burgess, PhD
Justin Benzer, PhD
Justin Glasgow, MD, PhD
Jason Hockenberry, PhD
David C. Mohr, PhD
Peter J. Kaboli, MD, MS

Nurse practitioners (NPs) and physician assistants (PAs) provide healthcare in numerous environments internationally and in the United States.[1, 2] However, their role in the inpatient medicine setting is not well described.[2] In the United States, there are more than 157,000 NPs and 85,000 PAs with projected increases.[3, 4] Although both professions provide direct medical care, there are key differences.[1, 3, 4, 5] NPs typically complete a master's or doctoral degree with advanced clinical training beyond nursing. PAs complete at least 2 years of college courses similar to premedical school requirements. PA programs use a medical school‐based curriculum and train for about 2 years before awarding a master's degree. NPs are regulated through state nursing boards, whereas PAs are regulated through state licensing or medical boards. NPs and PAs have different, yet overlapping scopes of practice. A key difference is that PAs can only practice collaborating with a physician.[5, 6] Overall, both have been shown to provide healthcare that is similar in quality to physicians in specific primary care and surgical settings.[2]

NPs and PAs, often referred to as advanced practice providers (APPs), are employed primarily in outpatient clinic settings providing direct patient care. Most APP studies have focused on the outpatient setting, despite nearly a third of US healthcare expenditure for hospital care.[2, 7] Little is known about APP involvement, specific roles, or impact on outcomes in inpatient medicine settings where they are often referred to as NP or PA hospitalists.[2, 8, 9, 10]

The Veterans Health Administration (VHA) is 1 of the largest employers of APPs, with 3.6% of all NPs and 2.1% of all PAs reported to practice in the VHA.[11, 12, 13] As the largest fully integrated healthcare system in the US, the VHA had 8.8 million veterans enrolled and 703,500 inpatient admissions in 2012.[14] Although this makes the VHA an ideal environment to study the role of APPs, few studies have done so.[13, 15, 16, 17, 18, 19] Although studies have compared NPs and PAs to physicians, very little is known about how NPs differ from PAs when practicing in the same environment.

Our objective was to describe the scope of practice, defined as activities that an individual healthcare practitioner is licensed to perform, of NPs and PAs in the inpatient medicine setting and in the VHA. A secondary objective was to explore important outcomes that could potentially be affected by the presence of NPs and PAs on inpatient medicine.

METHODS

The Organizational Factors and Inpatient Medical Care Quality and Efficiency (OFIM) study provides a basis for this study with detail published elsewhere.[20] The OFIM study was conducted between 2010 and 2011 to evaluate quality of care in VHA inpatient medicine surveying chiefs of medicine (COM), inpatient medicine nurse managers (NM), attending physicians, and extant VHA survey data. The COM is the senior attending physician in charge of departments of medicine that include most medical subspecialties within the VHA medical centers. We used the subset of questions specific to NPs and PAs from the COM and NM surveys. Both COMs and NMs answered identical questions for NPs and PAs in 2 separate sections to avoid overlap of responses. NM survey responses were only used for the coordination of care regression model. Surveys were conducted by e‐mail with up to 4 reminders and a subsequent paper mailing. The inpatient medicine service included adult general internal medicine, medical subspecialties, and critical care. The study was approved by the institutional review boards of the VA Boston Healthcare System, the University of Iowa, and the Iowa City VA Healthcare System.

Measurements

To create our primary variable of interestNP and PA employmentwe used the COM survey. Respondents indicated the number and full‐time employee equivalent (FTEE) values for APPs on inpatient medicine. Based on responses, we created a categorical variable with 4 options: (1) facilities with NPs only, (2) facilities with PAs only, (3) facilities with both NPs and PAs, and (4) facilities with neither NPs nor PAs. We selected 3 outcomes that could potentially be affected by the presence of NPs and PAs on inpatient medicine: patient satisfaction, registered nurse (RN) satisfaction, and coordination of care. Patient satisfaction has been shown to improve with NPs and PAs in prior studies, and improving coordination of care has been a stated goal of medical centers in hiring NPs and PAs.[2, 9] Based on our personal experience and previous studies that have shown that nurses report better communication with NPs than physicians,[21] and that NPs retain a visible nursing component in their NP role,[22] we hypothesized that nurse satisfaction on inpatient medicine would improve with the presence of NPs and PAs.

Patient satisfaction was obtained from the 2010 VHA Survey of Healthcare Experiences of Patients (SHEP).[23] The average response rate was 45%. Approximately half the questions on the SHEP are identical to the Hospital Consumer Assessment of Healthcare Providers and Systems survey (HCAHPS).[24] We examined 2 items: an overall rating and willingness to recommend the facility. For the overall rating, patients rated their hospitalization on a scale from 0 (worst hospital possible) to 10 (best hospital possible). Following HCAHPS guidelines, responses of either 9 or 10 were coded as positive and all other nonmissing responses were coded 0. For willingness to recommend, patients were asked Would you recommend this hospital to your friends and family? using a 4‐point response scale. Responses of definitely and probably no were coded as 0, and probably and definitely yes were coded as 1.

Nurse satisfaction was obtained from the 2011 Veterans Administration Nursing Outcomes Database, an annual survey of VHA nurses that includes demographic, work environment and satisfaction data.[25] The survey, a modified version of the Practice Environment Scale,[26] had a response rate of 52.9% (out of 51,870). For this analysis, we selected only inpatient medicine RNs. We used 2 measures: overall job satisfaction and collegial RN/MD (physician) relations. The former was assessed using the item Compared to what you think it should be, what is your current overall level of satisfaction with your job? The RN/MD relations scale had 3 items, including Physicians and nurses have good working relationships. Both items were evaluated on a similar 5‐point response scale.

Coordination of care was assessed from COM and NM surveys. Overall coordination was evaluated from the COM survey using 1 of 8 items in a question about care coordination, In the past month, how would you rate the following aspects of coordination of patient care inpatient coordination overall. Overall coordination was also evaluated from the NM survey using a similar item. Discharge coordination was evaluated only from the NM survey using 1 of 8 items, Thinking about your experiences during the past month, how would you rate the following aspects of the coordination of patient care related to the discharge process on your inpatient medicine unit discharge coordination overall. When a service had more than 1 response from the NM survey, we took an average of responses to represent the mean score. Responses for all questions ranged from 1 for poor to 5 for excellent (for all of the questions see Supporting Information, Appendix 1, in the online version of this article).

Last, we modeled for several contextual features that could influence outcomes: geographic region as a 4‐item categorical variable; teaching affiliation as a dichotomous variable based on whether the hospital was a member of the Council of Teaching Hospitals, urban or rural status, and facility size as a continuous variable using the number of inpatient medicine service beds.

Statistical Analysis

Descriptive bivariate analyses used t tests, 2, or 2‐tailed Fisher tests when appropriate to compare NP and PA autonomy, tasks, location of care, work schedule, clinical workload, organizational characteristics (ie, academic, urban, facility complexity, inpatient medicine team structure), and performance evaluations.

Next, we examined whether any of the contextual characteristics were associated with use of NPs or PAs using inferential statistics. For patient satisfaction, we developed a hierarchical linear model (HLM) that nested patients within facilities. We controlled for patient age, sex, health status, and length of stay. For nurse satisfaction, individual responses of RNs also were analyzed using the HLM. We controlled for whether the nurse had a leadership position, worked during the daily shift, and job tenure. Ordinary least squares regression was used to examine the 3 measures of coordination from the COM and NM surveys. All analyses were performed using Stata version 12 (StataCorp, College Station, TX) and SAS version 9.2 (SAS Institute Inc., Cary, NC).

RESULTS

Of 123 inpatient medicine services that we surveyed, we included responses from the COMs of 118 services (response rate 95.2%); 5 responses were incomplete. Across 123 inpatient medicine services, we surveyed 264 nurse managers and received 198 responses (75.0%) from 114 inpatient medicine services. In the only model using NM responsesthe care coordination model104 inpatient medicine services had responses from both COM and NM surveys.

Of 118 VHA inpatient medicine services, 56 (47.5%) had APPs, of which 27 (48.2%) had NPs only, 15 (26.8%) had PAs only, and 14 (25.0%) had both NPs and PAs. FTEEs for NPs ranged from 0.5 to 7 (mean=2.22) and for PAs from 1 to 9 (mean=2.23) on the inpatient medicine service per hospital.

There were no significant differences on use of NPs and PAs by teaching affiliation, urban or rural setting, and geography. A significant difference was observed based on bed size (F[3,109]=5.13, P<0.001); facilities with both NPs and PAs had, on average, a larger number of inpatient beds (mean=79.0, standard deviation [SD]=32.3) compared to those without NPs or PAs (mean=50.1, SD=29.4) or with PAs only (mean=44.2, SD=20.5) using Tukey post hoc analysis.

The most common staffing model used staff (attending) physicians only working directly with APPs (N=29, 24.6%). Next most common was an academic model with staff physicians, housestaff, and APPs working together in teams (N=16, 13.4%). For performance evaluations, COMs contributed for both NPs (60.2%) and PAs (56.4%); in fewer cases, COMs completed evaluations of NPs (12.9%) and of PAs (29.0%) without input from other service managers (P=0.02).

Table 1 shows the differences reported by COMs between NPs and PAs scope of practice. Overall, 58.9% of NPs and 65.4% of PAs functioned somewhat or completely autonomously; 23.1% of NPs and 30.8% of PAs worked in a role closer to a ward assistant (eg, work directly with a physician, cowriting orders, and making care decisions with physician oversight). Tasks frequently performed by the majority of NPs and PAs included writing orders (87.9%), coordinating discharge plans (86.7%), communicating with consultants (83.1%), performing history and physicals (82.5%), writing daily progress notes (80.7%), communicating with primary care providers (73.5%), and working directly with hospitalists (72.8%). Less common tasks included serving on committees (46.4%), championing quality improvement activities (40.6%), and research (2.9%). There were no statistically significant differences between tasks, except for a higher proportion of services reporting PAs rather than NPs performing procedures (50.0% vs 22.0%, P=0.02) and teaching nonphysicians (50.0% vs 24.4%, P=0.04).

Nurse Practitioner and Physician Assistant Hospital‐Based Scopes of Practice
 Services With NPs,Services With PAs,P Value

  • NOTE: Abbreviations: NPs, nurse practitioners; PAs, physician assistants.

  • *Of 41 services with NPs, 14 had PAs too. Of 29 services with PAs, 14 had NPs too.

  • Numbers may vary between items because all respondents may not have answered all items on survey questions. Percentages do not add up to 100% because respondents may have more than 1 response to multiple response questions.

How do NPs and PAs function in conjunction with inpatient medicine staff (attending) physicians in the day‐to‐day care of patients (ie, scope of practice)?N=39 (%)*N=26 (%)* 
Autonomously, in a manner similar to physicians10 (25.6%)5 (19.2%)0.77
Somewhat autonomously, but with limitations13 (33.3%)12 (46.2%)0.31
In a role closer to a ward assistant9 (23.1%)8 (30.8%)0.57
Administrative2 (5.1%)0 (0.0%)0.51
Other6 (15.4%)1 (3.8%)0.23
What types of tasks do NPs and PAs perform?N=41 (%)*N=28 (%)* 
Write orders34 (82.9%)26 (92.9%)0.29
Coordinate discharge plans33 (80.5%)26 (92.9%)0.18
Communicate with consultants33 (80.5%)24 (85.7%)0.75
History and physicals31 (75.6%)25 (89.3%)0.22
Daily progress notes31 (75.6%)24 (85.7%)0.37
Communicate with primary care providers31 (75.6%)20 (71.4%0.78
Work directly with hospitalists26 (63.4%)23 (82.1%)0.18
Committees16 (39.0%)16 (57.1%)0.15
Champion quality improvement activities14 (34.1%)14 (50.0%)0.22
Teach nonphysician students10 (24.4%)14 (50.0%)0.04
Perform procedures9 (22.0%)14 (50.0%)0.02
Research1 (2.4%)1 (3.6%)1.00
Other6 (14.6%)0 (0.0%)0.04

Table 2 reports location of practice in the hospital and workload. There were no significant differences in locations where NPs and PAs provided care. Overall, 81.9% of APPs worked in inpatient wards, 23.1% in step‐down units, 18.6% in intensive care units, 13.8% in skilled care units, and 4.9% in other locations. In addition, 97.4% of NPs and 89.3% of PAs worked weekdays, whereas only 7.9% of NPs and 17.9% of PAs worked nights. More PAs than NPs worked federal holidays (32.1% vs 7.9%, P=0.02) and weekends (32.1% vs 13.2%, P=0.08). Most NPs and PAs handled a caseload of 4 to 10 patients with a mean of 6.5, with no difference between the 2. The minority, 27.0% of NPs and 23.1% of PAs, were not assigned specific patients.

Nurse Practitioner and Physician Assistant Hospital Location of Care and Workload
 Services With NPsServices With PAsP Value

  • NOTE: Abbreviations: N/A, not assigned specific patients; NPs, nurse practitioners; PAs, physician assistants.

  • *Of 41 services with NPs, 14 had PAs too. Of 29 services with PAs, 14 had NPs too.

  • Numbers may vary between items because all respondents may not have answered all items on survey questions. Percentages do not add up to 100% because respondents may have more than 1 response to multiple response questions.

Where do NPs and PAs provide care?N=38 (%)*N=28 (%)* 
Wards31 (81.6%)23 (82.1%)1.00
Step‐down unit8 (21.1%)7 (25.0%)0.77
Intensive care unit6 (15.8%)6 (21.4%)0.75
Skilled care units5 (13.2%)4 (14.3%)1.00
Other1 (2.6%)2 (7.1%)0.57
What are NPs and PAs tours of duty?N=38 (%)*N=28 (%)* 
Weekdays37 (97.4%)25 (89.3%)0.30
Weekends5 (13.2%)9 (32.1%)0.08
Nights3 (7.9%)5 (17.9%)0.27
Federal holidays3 (7.9%)9 (32.1%)0.02
Other2 (5.3%)1 (3.6%)1.00
What is the average clinical workload for NPs and PAs?N=37 (%)*N=26 (%)* 
Mean no. of patients6.816.180.45
N/A10 (27.0%)6 (23.1%)0.56
Other1 (2.7%)0 (0.0%) 

In multivariable adjusted analyses evaluating the association between patient satisfaction and use of APPs (Table 3), no significant differences were observed for patients' rating of the hospital (F[3,95]=0.19; P=0.90) or willingness to recommend the hospital (F[3,95]=0.54; P=0.65). Similarly, no significant differences were observed based on use of APPs for nurse overall job satisfaction (F[3,101]=1.85; P=0.14) or collegial relations with physicians (F[3,101]=0.96; P=0.41).

Adjusted Regression Model Examining Nurse Practitioner and Physician Assistant Association with Patient Satisfaction, Nurse Satisfaction, and Coordination of Care
 Patient SatisfactionNurse SatisfactionCoordination of Care
Overall RatingWillingness to RecommendRN Overall Job SatisfactionRN/MD RelationsChief of Medicine: Inpatient CoordinationNurse Manager: Inpatient CoordinationNurse Manager: Discharge Coordination

  • NOTE: Model shows parameter estimates (standard error). All models adjust for geographic region, teaching hospital affiliation, urban or rural hospital‐based setting, and inpatient medicine operating beds. Models for patient satisfaction adjust for patient age, health status, length of stay, and sex. Models for nurse satisfaction adjust for leadership position, working regular schedule, and job tenure. Abbreviations: MD, physician; NPs, nurse practitioners; PAs, physician assistants; RN, registered nurse. *P<0.05.

Intercept0.67 (0.14)10.20 (0.15)30.41 (0.13)20.89 (0.07)30.78 (0.26)30.67 (0.24)30.23 (0.26)
Facilities with NPs only0.06 (0.10)0.12 (0.09)0.14 (0.09)0.02 (0.05)10.63 (0.91)0.00 (0.19)0.42 (0.20)*
Facilities with PAs only0.06 (0.09)0.10 (0.11)0.10 (0.10)0.06 (0.05)10.08 (0.87)0.41 (0.22)0.36 (0.25)
Facilities with both NPs and PAs0.02 (0.12)0.11 (0.1300.17 (0.11)0.00 (0.00)0.31 (0.92)0.03 (0.27)0.21 (0.30)
Facilities with neither NPs nor PAs       

COM ratings of overall inpatient coordination were also nonsignificant (F[3, 100]=2.01; P=0.12), but their ratings of coordination were higher in facilities with NPs only than in those without either NPs or PAs (=1.63, P=0.08). Nurse manager ratings of overall inpatient coordination were not associated with APP use (F[3,91]=1.24; P=0.30), but were marginally lower with facilities using only PAs (=1.48; P=0.06). Nurse manager ratings of discharge coordination showed a significant effect for APP use (F[3,90]=3.30; P=0.02) with facilities having NPs only significantly higher than places without either NPs or PAs (=1.84, P=0.04).

DISCUSSION

Little evidence exists regarding the role of APPs in the inpatient medicine setting,[2] and important deficit concerns in medical knowledge, technical skills, and clinical experience have been raised.[27, 28] These concerns have called into question the appropriateness of involving APPs in the care of medical inpatients with extensive differential diagnoses and complex care requirements.[27, 28] In spite of these concerns, we found widespread use of APPs with almost half of the VHA inpatient medicine services reporting use, which stands in contrast to prior research.[9, 10, 22, 29, 30, 31, 32, 33, 34, 35] APPs practice in a variety of acute and subacute inpatient medicine settings including academic, community, rural, and urban settings without many discernable differences. The spectrum of activities performed by APPs in the VHA is similar to those reported in these inpatient medicine studies, although their scope of practice appears to be much broader than in these few small single academic center studies.[10, 22, 29, 30, 31, 32, 33, 34, 35, 36] For example, only 11% of hospitalist PAs did procedures in a 2006 Society of Hospital Medicine survey, whereas 50% did in our study.[36]

Interestingly, we found that VHA NPs and PAs perform very similar tasks with similar caseloads despite differences in their background, training, regulation, reimbursement, and the longstanding observation that nurse practitioners are not physician assistants.[1, 3, 4, 5] These findings may reflect that APP scope can be more extensive in the VHA. For example, PAs in the VHA practice under federal jurisdiction and can bypass state legislation of scope of practice.[13] It also may reflect ongoing expansion of the role of APPs in the healthcare system since prior studies.[33, 36]

We did, however, note a few significant differences in NP and PA scope. PAs are twice as likely to perform procedures as NPs in inpatient medicine. It is unclear why PAs may do more procedures, as acute care NPs also are commonly taught and perform similar procedures.[33] We also found that PAs teach nonphysician students twice as often as NPs. This may reflect the deep commitment shown by the VHA to PA education dating back to the 1960s.[13] Finally, we found that PAs were significantly more likely to work weekends and federal holidays, a finding that may have implications for inpatient medicine services hiring APPs. Although not statistically significant, PAs, in general, performed more clinically oriented tasks like history and physicals and more often worked directly with hospitalists.

We found no difference in patient satisfaction or nurse satisfaction related to the presence of APPs, consistent with prior studies, where higher levels of satisfaction with APPs are observed in primary care but not hospital settings.[2, 10] However, it is surprising that no differences were observed for nurse satisfaction. NPs traditionally have a nursing focus, which might foster better relationships with nurses.[22] Expecting changes in either patient or nurse satisfaction with just the addition of APPs in the inpatient medicine setting without addressing other factors may be unrealistic. Patient satisfaction is a complex amalgam of various factors including patient expectations, sociodemographics, emotional and physical state, quality of care, and physician communication.[24] Similarly, nurse satisfaction depends on many factors including job stress, nursephysician collaboration, autonomy, staffing, and support.[37]

Finally, we found higher perception of both overall coordination of inpatient care and discharge coordination on services with NPs. A primary reason stated by medical centers to hire APPs is to improve continuity of care.[9] Prior research has shown better communication and collaboration between nurses, physicians, and NPs on inpatient medicine services.[21] NPs may feel that coordination of care is a major focus for their profession and may spend more time than physicians on care coordination activities.[38] Moreover, their background in both nursing and medicine may better lend itself to coordinating care between disciplines.[39] However, we were surprised to find that services with PAs had lower ratings of overall coordination by nurse managers given that care coordination also is a core competency of PA practice and a primary reason for medical centers to employ them.[9] The lack of a nursing background for PAs and potentially less overall medical experience than NPs possibly may contribute to this finding. However, our study does not suggest a direct explanation for this finding, and we had no measure of prior clinical experience, and thus it should be an area for further research.

There are a number of limitations to our study. First, findings from the VHA may not be generalizable to other healthcare systems.[39] However, VHA inpatient medicine services are, in general, structured similarly to non‐VHA settings and are often affiliated with academic medical centers. Further, this is the largest study to our knowledge to look at the specific roles and perceptions of care provided by both NPs and PAs in inpatient medicine. Second, we did not measure other outcomes of care that may be affected by the use of APPs, such as clinical outcomes, process of care measures, or cost‐effectiveness, some of which have been shown in small studies to be impacted by APPs in inpatient medicine.[10, 22, 29, 30, 31, 32, 33, 34, 35] Third, we are unable to attribute causality to our findings and may not have accounted for all the differences between services. Ideally, a randomized controlled trial of APPs in inpatient medicine would be helpful to address these concerns, but no such trials have been conducted. Finally, we did not survey APPs directly, but surveyed the chiefs of their service instead. The chiefs, however, are directly responsible for the scope of practice of all providers on their service and were directly involved in performance evaluations of most of these practitioners.

In conclusion, we found that NPs and PAs, functioning as APP hospitalists are more widely used and have a broader scope of practice on inpatient medicine than previously known or appreciated, at least in the VHA. In spite of their different backgrounds, training, regulations, and reimbursements, they appear to have a similar scope of practice with few differences in roles or perceived impact. Their impact on inpatient healthcare should be a subject of future research. In the meantime, inpatient medicine services should factor these findings into their decision making as they rapidly expand the use of APPs to provide better care to their patients and to address challenges in healthcare reform.[3, 27, 28, 40]

Acknowledgments

Disclosures: The work reported here was supported by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (IIR 08067) and the Comprehensive Access & Delivery Research and Evaluation (CADRE) Center at the Iowa City VAMC (CIN 13412), and the Center for Healthcare Organization and Implementation Research (CHOIR) at the Boston VA Healthcare System (HFP 04145). The funders did not play any role in the design and conduct of the study; in the collection, analysis, and interpretation of data; and in preparation, review, and approval of the manuscript. The authors do not have any conflicts of interest or financial relationships related to the content of this manuscript. The authors had full access to and take full responsibility for the integrity of the data and the accuracy of the data analysis. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.

Files
Supplementary Information Appendix 1. (1)
Supplementary Information (2)
References
  1. Cox CL. Advanced nurse practitioners and physician assistants: what is the difference? Comparing the USA and UK. Hosp Med. 2001;62:169–171.
  2. Laurant M, Harmsen M, Wollersheim H, Grol R, Faber M, Sibbald B. The impact of nonphysician clinicians: do they improve the quality and cost‐effectiveness of health care services? Med Care Res Rev. 2009;66(6 suppl):36S–89S.
  3. Auerbach DI. Will the NP workforce grow in the future? New forecasts and implications for healthcare delivery. Med Care. 2012;50(7):606–610.
  4. Danielsen RD, Lathrop J, Arbet S. The certified physician assistant iin the United States: a 2011 snapshot. JAAPA. 2012;25(4):58.
  5. Gershengorn HB, Johnson MP, Factor P. The use of nonphysician providers in adult intensive care units. Am J Respir Crit Care Med. 2012;185(6):600–605.
  6. American Academy of Physician Assistants. State law issues: supervision of PAs: access and excellence in patient care. October 2011. Available at: http://www.aapa.org/WorkArea/DownloadAsset.aspx?id=632. Accessed on June 22, 2014.
  7. Centers for Medicare 5(2):99–102.
  8. Moote M, Krsek C, Kleinpell R, Todd B. Physician assistant and nurse practitioner utilization in academic medical centers. Am J Med Qual. 2011;26(6):452–460.
  9. Roy CL, Liang CL, Lund M, et al. Implementation of a physician assistant/hospitalist service in an academic medical center: impact on efficiency and patient outcomes. J Hosp Med. 2008;3(5):361–368.
  10. American Academy of Physician Assistants. 2010 AAPA Physician Assistant Census. Alexandria, VA, 2011. Available at: http://www.aapa.org/WorkArea/DownloadAsset.aspx?id=838. Accessed on June 22, 2014.
  11. Goolsby MJ. 2009–2010 AANP national nurse practitioner sample survey: an overview. J Am Acad Nurse Pract. 2011;23(5):266–268.
  12. Woodmansee DJ, Hooker RS. Physician assistants working in the Department of Veterans Affairs. JAAPA 2010;23(11):41–44.
  13. National Center for Veterans Analysis and Statistics. Selected Veterans Health Administration Characteristics: FY2002 to FY2012. 2013; http://www.va.gov/vetdata/docs/Utilization/VHAStats.xls. Accessed January 7, 2014.
  14. Brock DM, Wick KH, Evans TC, Gianola FJ. The physician assistant profession and military veterans. Mil Med. 2011;176(2):197–203.
  15. Budzi D, Lurie S, Singh K, Hooker R. Veterans' perceptions of care by nurse practitioners, physician assistants, and physicians: a comparison from satisfaction surveys. J Am Acad Nurse Pract. 2010;22(3):170–176.
  16. Fletcher CE, Copeland LA, Lowery JC, Reeves PJ. Nurse practitioners as primary care providers within the VA. Mil Med. 2011;176(7):791–797.
  17. Hooker RS. Federally employed physician assistants. Mil Med. 2008;173(9):895–899.
  18. Huang PY, Yano EM, Lee ML, Chang BL, Rubenstein LV. Variations in nurse practitioner use in Veterans Affairs primary care practices. Health Serv Res. 2004;39(4 pt 1):887–904.
  19. Restuccia J, Mohr D, Meterko M, Stolzmann K, Kaboli P. The association of hospital characteristics and quality improvement activities in inpatient medical services. J Gen Intern Med. 2014;29(5):715–722.
  20. Vazirani S, Hays RD, Shapiro MF, Cowan M. Effect of a multidisciplinary intervention on communication and collaboration among physicians and nurses. Am J Crit Care. 2005;14(1):71–77.
  21. Stetler CB, Effken J, Frigon L, Tiernan C, Zwingman‐Bagley C. Utilization‐focused evaluation of acute care nurse practitioner role. Outcomes Manag Nurs Pract. 1998;2(4):152–160; quiz 160–151.
  22. Davies EA, Meterko MM, Charns MP, Seibert ME, Cleary PD. Factors affecting the use of patient survey data for quality improvement in the Veterans Health Administration. BMC Health Serv Res. 2011;11:334.
  23. Jha AK, Orav EJ, Zheng J, Epstein AM. Patients' perception of hospital care in the United States. N Engl J Med. 2008;359(18):1921–1931.
  24. Sales AE, Sharp ND, Li YF, et al. Nurse staffing and patient outcomes in Veterans Affairs hospitals. J Nurs Adm. 2005;35(10):459–466.
  25. Lake ET. Development of the practice environment scale of the Nursing Work Index. Res Nurs Health. 2002;25(3):176–188.
  26. Fairman JA, Rowe JW, Hassmiller S, Shalala DE. Broadening the scope of nursing practice. N Engl J Med. 2011;364(3):193–196.
  27. Iglehart JK. Expanding the role of advanced nurse practitioners—risks and rewards. N Engl J Med. 2013;368(20):1935–1941.
  28. Cowan MJ, Shapiro M, Hays RD, et al. The effect of a multidisciplinary hospitalist/physician and advanced practice nurse collaboration on hospital costs. J Nurs Adm. 2006;36(2):79–85.
  29. Goksel D, Harrison CJ, Morrison RE, Miller ST. Description of a nurse practitioner inpatient service in a public teaching hospital. J Gen Intern Med. 1993;8(1):29–30.
  30. Howie JN, Erickson M. Acute care nurse practitioners: creating and implementing a model of care for an inpatient general medical service. Am J Crit Care. 2002;11(5):448–458.
  31. Myers JS, Bellini LM, Rohrbach J, Shofer FS, Hollander JE. Improving resource utilization in a teaching hospital: development of a nonteaching service for chest pain admissions. Acad Med. 2006;81(5):432–435.
  32. Rudy EB, Davidson LJ, Daly B, et al. Care activities and outcomes of patients cared for by acute care nurse practitioners, physician assistants, and resident physicians: a comparison. Am J Crit Care. 1998;7(4):267–281.
  33. Singh S, Tarima S, Rana V, et al. Impact of localizing general medical teams to a single nursing unit. J Hosp Med. 2012;7(7):551–556.
  34. Rhee J, Ritchie J, Eward AM. Resource use by physician assistant services versus teaching services. JAAPA 2002;15(1):33–38, 40, 42.
  35. MaHaffy HW. Physician assistants in hospital medicine. In: Ballweg R, Sullivan EM, Brown D, Vetrosky D, eds. Physician Assistant: A Guide to Clinical Practice. 5th ed. Philadelphia, PA: W.B. Saunders; 2013:450–455.
  36. Hayes B, Bonner A, Pryor J. Factors contributing to nurse job satisfaction in the acute hospital setting: a review of recent literature. J Nurs Manage. 2010;18(7):804–814.
  37. Hoffman LA, Tasota FJ, Zullo TG, Scharfenberg C, Donahoe MP. Outcomes of care managed by an acute care nurse practitioner/attending physician team in a subacute medical intensive care unit. Am J Crit Care. 2005;14(2):121–130; quiz 131–132.
  38. Offenbeek MA, Knip M. The organizational and performance effects of nurse practitioner roles. J Adv Nurs. 2004;47(6):672–681.
  39. Sargen M, Hooker RS, Cooper RA. Gaps in the supply of physicians, advance practice nurses, and physician assistants. J Am Coll Surg. 2011;212(6):991–999.
Article PDF
jhm2231.pdf
Issue
Journal of Hospital Medicine - 9(10)
Page Number
615-620
Sections
Original Research
Author(s)
Anand Kartha, MD, MS
Joseph D. Restuccia, DrPH
James F. Burgess, PhD
Justin Benzer, PhD
Justin Glasgow, MD, PhD
Jason Hockenberry, PhD
David C. Mohr, PhD
Peter J. Kaboli, MD, MS
Author(s)
Anand Kartha, MD, MS
Joseph D. Restuccia, DrPH
James F. Burgess, PhD
Justin Benzer, PhD
Justin Glasgow, MD, PhD
Jason Hockenberry, PhD
David C. Mohr, PhD
Peter J. Kaboli, MD, MS
Files
Supplementary Information Appendix 1. (1)
Supplementary Information (2)
Files
Supplementary Information Appendix 1. (1)
Supplementary Information (2)
Article PDF
jhm2231.pdf
Article PDF
jhm2231.pdf

Nurse practitioners (NPs) and physician assistants (PAs) provide healthcare in numerous environments internationally and in the United States.[1, 2] However, their role in the inpatient medicine setting is not well described.[2] In the United States, there are more than 157,000 NPs and 85,000 PAs with projected increases.[3, 4] Although both professions provide direct medical care, there are key differences.[1, 3, 4, 5] NPs typically complete a master's or doctoral degree with advanced clinical training beyond nursing. PAs complete at least 2 years of college courses similar to premedical school requirements. PA programs use a medical school‐based curriculum and train for about 2 years before awarding a master's degree. NPs are regulated through state nursing boards, whereas PAs are regulated through state licensing or medical boards. NPs and PAs have different, yet overlapping scopes of practice. A key difference is that PAs can only practice collaborating with a physician.[5, 6] Overall, both have been shown to provide healthcare that is similar in quality to physicians in specific primary care and surgical settings.[2]

NPs and PAs, often referred to as advanced practice providers (APPs), are employed primarily in outpatient clinic settings providing direct patient care. Most APP studies have focused on the outpatient setting, despite nearly a third of US healthcare expenditure for hospital care.[2, 7] Little is known about APP involvement, specific roles, or impact on outcomes in inpatient medicine settings where they are often referred to as NP or PA hospitalists.[2, 8, 9, 10]

The Veterans Health Administration (VHA) is 1 of the largest employers of APPs, with 3.6% of all NPs and 2.1% of all PAs reported to practice in the VHA.[11, 12, 13] As the largest fully integrated healthcare system in the US, the VHA had 8.8 million veterans enrolled and 703,500 inpatient admissions in 2012.[14] Although this makes the VHA an ideal environment to study the role of APPs, few studies have done so.[13, 15, 16, 17, 18, 19] Although studies have compared NPs and PAs to physicians, very little is known about how NPs differ from PAs when practicing in the same environment.

Our objective was to describe the scope of practice, defined as activities that an individual healthcare practitioner is licensed to perform, of NPs and PAs in the inpatient medicine setting and in the VHA. A secondary objective was to explore important outcomes that could potentially be affected by the presence of NPs and PAs on inpatient medicine.

METHODS

The Organizational Factors and Inpatient Medical Care Quality and Efficiency (OFIM) study provides a basis for this study with detail published elsewhere.[20] The OFIM study was conducted between 2010 and 2011 to evaluate quality of care in VHA inpatient medicine surveying chiefs of medicine (COM), inpatient medicine nurse managers (NM), attending physicians, and extant VHA survey data. The COM is the senior attending physician in charge of departments of medicine that include most medical subspecialties within the VHA medical centers. We used the subset of questions specific to NPs and PAs from the COM and NM surveys. Both COMs and NMs answered identical questions for NPs and PAs in 2 separate sections to avoid overlap of responses. NM survey responses were only used for the coordination of care regression model. Surveys were conducted by e‐mail with up to 4 reminders and a subsequent paper mailing. The inpatient medicine service included adult general internal medicine, medical subspecialties, and critical care. The study was approved by the institutional review boards of the VA Boston Healthcare System, the University of Iowa, and the Iowa City VA Healthcare System.

Measurements

To create our primary variable of interestNP and PA employmentwe used the COM survey. Respondents indicated the number and full‐time employee equivalent (FTEE) values for APPs on inpatient medicine. Based on responses, we created a categorical variable with 4 options: (1) facilities with NPs only, (2) facilities with PAs only, (3) facilities with both NPs and PAs, and (4) facilities with neither NPs nor PAs. We selected 3 outcomes that could potentially be affected by the presence of NPs and PAs on inpatient medicine: patient satisfaction, registered nurse (RN) satisfaction, and coordination of care. Patient satisfaction has been shown to improve with NPs and PAs in prior studies, and improving coordination of care has been a stated goal of medical centers in hiring NPs and PAs.[2, 9] Based on our personal experience and previous studies that have shown that nurses report better communication with NPs than physicians,[21] and that NPs retain a visible nursing component in their NP role,[22] we hypothesized that nurse satisfaction on inpatient medicine would improve with the presence of NPs and PAs.

Patient satisfaction was obtained from the 2010 VHA Survey of Healthcare Experiences of Patients (SHEP).[23] The average response rate was 45%. Approximately half the questions on the SHEP are identical to the Hospital Consumer Assessment of Healthcare Providers and Systems survey (HCAHPS).[24] We examined 2 items: an overall rating and willingness to recommend the facility. For the overall rating, patients rated their hospitalization on a scale from 0 (worst hospital possible) to 10 (best hospital possible). Following HCAHPS guidelines, responses of either 9 or 10 were coded as positive and all other nonmissing responses were coded 0. For willingness to recommend, patients were asked Would you recommend this hospital to your friends and family? using a 4‐point response scale. Responses of definitely and probably no were coded as 0, and probably and definitely yes were coded as 1.

Nurse satisfaction was obtained from the 2011 Veterans Administration Nursing Outcomes Database, an annual survey of VHA nurses that includes demographic, work environment and satisfaction data.[25] The survey, a modified version of the Practice Environment Scale,[26] had a response rate of 52.9% (out of 51,870). For this analysis, we selected only inpatient medicine RNs. We used 2 measures: overall job satisfaction and collegial RN/MD (physician) relations. The former was assessed using the item Compared to what you think it should be, what is your current overall level of satisfaction with your job? The RN/MD relations scale had 3 items, including Physicians and nurses have good working relationships. Both items were evaluated on a similar 5‐point response scale.

Coordination of care was assessed from COM and NM surveys. Overall coordination was evaluated from the COM survey using 1 of 8 items in a question about care coordination, In the past month, how would you rate the following aspects of coordination of patient care inpatient coordination overall. Overall coordination was also evaluated from the NM survey using a similar item. Discharge coordination was evaluated only from the NM survey using 1 of 8 items, Thinking about your experiences during the past month, how would you rate the following aspects of the coordination of patient care related to the discharge process on your inpatient medicine unit discharge coordination overall. When a service had more than 1 response from the NM survey, we took an average of responses to represent the mean score. Responses for all questions ranged from 1 for poor to 5 for excellent (for all of the questions see Supporting Information, Appendix 1, in the online version of this article).

Last, we modeled for several contextual features that could influence outcomes: geographic region as a 4‐item categorical variable; teaching affiliation as a dichotomous variable based on whether the hospital was a member of the Council of Teaching Hospitals, urban or rural status, and facility size as a continuous variable using the number of inpatient medicine service beds.

Statistical Analysis

Descriptive bivariate analyses used t tests, 2, or 2‐tailed Fisher tests when appropriate to compare NP and PA autonomy, tasks, location of care, work schedule, clinical workload, organizational characteristics (ie, academic, urban, facility complexity, inpatient medicine team structure), and performance evaluations.

Next, we examined whether any of the contextual characteristics were associated with use of NPs or PAs using inferential statistics. For patient satisfaction, we developed a hierarchical linear model (HLM) that nested patients within facilities. We controlled for patient age, sex, health status, and length of stay. For nurse satisfaction, individual responses of RNs also were analyzed using the HLM. We controlled for whether the nurse had a leadership position, worked during the daily shift, and job tenure. Ordinary least squares regression was used to examine the 3 measures of coordination from the COM and NM surveys. All analyses were performed using Stata version 12 (StataCorp, College Station, TX) and SAS version 9.2 (SAS Institute Inc., Cary, NC).

RESULTS

Of 123 inpatient medicine services that we surveyed, we included responses from the COMs of 118 services (response rate 95.2%); 5 responses were incomplete. Across 123 inpatient medicine services, we surveyed 264 nurse managers and received 198 responses (75.0%) from 114 inpatient medicine services. In the only model using NM responsesthe care coordination model104 inpatient medicine services had responses from both COM and NM surveys.

Of 118 VHA inpatient medicine services, 56 (47.5%) had APPs, of which 27 (48.2%) had NPs only, 15 (26.8%) had PAs only, and 14 (25.0%) had both NPs and PAs. FTEEs for NPs ranged from 0.5 to 7 (mean=2.22) and for PAs from 1 to 9 (mean=2.23) on the inpatient medicine service per hospital.

There were no significant differences on use of NPs and PAs by teaching affiliation, urban or rural setting, and geography. A significant difference was observed based on bed size (F[3,109]=5.13, P<0.001); facilities with both NPs and PAs had, on average, a larger number of inpatient beds (mean=79.0, standard deviation [SD]=32.3) compared to those without NPs or PAs (mean=50.1, SD=29.4) or with PAs only (mean=44.2, SD=20.5) using Tukey post hoc analysis.

The most common staffing model used staff (attending) physicians only working directly with APPs (N=29, 24.6%). Next most common was an academic model with staff physicians, housestaff, and APPs working together in teams (N=16, 13.4%). For performance evaluations, COMs contributed for both NPs (60.2%) and PAs (56.4%); in fewer cases, COMs completed evaluations of NPs (12.9%) and of PAs (29.0%) without input from other service managers (P=0.02).

Table 1 shows the differences reported by COMs between NPs and PAs scope of practice. Overall, 58.9% of NPs and 65.4% of PAs functioned somewhat or completely autonomously; 23.1% of NPs and 30.8% of PAs worked in a role closer to a ward assistant (eg, work directly with a physician, cowriting orders, and making care decisions with physician oversight). Tasks frequently performed by the majority of NPs and PAs included writing orders (87.9%), coordinating discharge plans (86.7%), communicating with consultants (83.1%), performing history and physicals (82.5%), writing daily progress notes (80.7%), communicating with primary care providers (73.5%), and working directly with hospitalists (72.8%). Less common tasks included serving on committees (46.4%), championing quality improvement activities (40.6%), and research (2.9%). There were no statistically significant differences between tasks, except for a higher proportion of services reporting PAs rather than NPs performing procedures (50.0% vs 22.0%, P=0.02) and teaching nonphysicians (50.0% vs 24.4%, P=0.04).

Nurse Practitioner and Physician Assistant Hospital‐Based Scopes of Practice
 Services With NPs,Services With PAs,P Value

  • NOTE: Abbreviations: NPs, nurse practitioners; PAs, physician assistants.

  • *Of 41 services with NPs, 14 had PAs too. Of 29 services with PAs, 14 had NPs too.

  • Numbers may vary between items because all respondents may not have answered all items on survey questions. Percentages do not add up to 100% because respondents may have more than 1 response to multiple response questions.

How do NPs and PAs function in conjunction with inpatient medicine staff (attending) physicians in the day‐to‐day care of patients (ie, scope of practice)?N=39 (%)*N=26 (%)* 
Autonomously, in a manner similar to physicians10 (25.6%)5 (19.2%)0.77
Somewhat autonomously, but with limitations13 (33.3%)12 (46.2%)0.31
In a role closer to a ward assistant9 (23.1%)8 (30.8%)0.57
Administrative2 (5.1%)0 (0.0%)0.51
Other6 (15.4%)1 (3.8%)0.23
What types of tasks do NPs and PAs perform?N=41 (%)*N=28 (%)* 
Write orders34 (82.9%)26 (92.9%)0.29
Coordinate discharge plans33 (80.5%)26 (92.9%)0.18
Communicate with consultants33 (80.5%)24 (85.7%)0.75
History and physicals31 (75.6%)25 (89.3%)0.22
Daily progress notes31 (75.6%)24 (85.7%)0.37
Communicate with primary care providers31 (75.6%)20 (71.4%0.78
Work directly with hospitalists26 (63.4%)23 (82.1%)0.18
Committees16 (39.0%)16 (57.1%)0.15
Champion quality improvement activities14 (34.1%)14 (50.0%)0.22
Teach nonphysician students10 (24.4%)14 (50.0%)0.04
Perform procedures9 (22.0%)14 (50.0%)0.02
Research1 (2.4%)1 (3.6%)1.00
Other6 (14.6%)0 (0.0%)0.04

Table 2 reports location of practice in the hospital and workload. There were no significant differences in locations where NPs and PAs provided care. Overall, 81.9% of APPs worked in inpatient wards, 23.1% in step‐down units, 18.6% in intensive care units, 13.8% in skilled care units, and 4.9% in other locations. In addition, 97.4% of NPs and 89.3% of PAs worked weekdays, whereas only 7.9% of NPs and 17.9% of PAs worked nights. More PAs than NPs worked federal holidays (32.1% vs 7.9%, P=0.02) and weekends (32.1% vs 13.2%, P=0.08). Most NPs and PAs handled a caseload of 4 to 10 patients with a mean of 6.5, with no difference between the 2. The minority, 27.0% of NPs and 23.1% of PAs, were not assigned specific patients.

Nurse Practitioner and Physician Assistant Hospital Location of Care and Workload
 Services With NPsServices With PAsP Value

  • NOTE: Abbreviations: N/A, not assigned specific patients; NPs, nurse practitioners; PAs, physician assistants.

  • *Of 41 services with NPs, 14 had PAs too. Of 29 services with PAs, 14 had NPs too.

  • Numbers may vary between items because all respondents may not have answered all items on survey questions. Percentages do not add up to 100% because respondents may have more than 1 response to multiple response questions.

Where do NPs and PAs provide care?N=38 (%)*N=28 (%)* 
Wards31 (81.6%)23 (82.1%)1.00
Step‐down unit8 (21.1%)7 (25.0%)0.77
Intensive care unit6 (15.8%)6 (21.4%)0.75
Skilled care units5 (13.2%)4 (14.3%)1.00
Other1 (2.6%)2 (7.1%)0.57
What are NPs and PAs tours of duty?N=38 (%)*N=28 (%)* 
Weekdays37 (97.4%)25 (89.3%)0.30
Weekends5 (13.2%)9 (32.1%)0.08
Nights3 (7.9%)5 (17.9%)0.27
Federal holidays3 (7.9%)9 (32.1%)0.02
Other2 (5.3%)1 (3.6%)1.00
What is the average clinical workload for NPs and PAs?N=37 (%)*N=26 (%)* 
Mean no. of patients6.816.180.45
N/A10 (27.0%)6 (23.1%)0.56
Other1 (2.7%)0 (0.0%) 

In multivariable adjusted analyses evaluating the association between patient satisfaction and use of APPs (Table 3), no significant differences were observed for patients' rating of the hospital (F[3,95]=0.19; P=0.90) or willingness to recommend the hospital (F[3,95]=0.54; P=0.65). Similarly, no significant differences were observed based on use of APPs for nurse overall job satisfaction (F[3,101]=1.85; P=0.14) or collegial relations with physicians (F[3,101]=0.96; P=0.41).

Adjusted Regression Model Examining Nurse Practitioner and Physician Assistant Association with Patient Satisfaction, Nurse Satisfaction, and Coordination of Care
 Patient SatisfactionNurse SatisfactionCoordination of Care
Overall RatingWillingness to RecommendRN Overall Job SatisfactionRN/MD RelationsChief of Medicine: Inpatient CoordinationNurse Manager: Inpatient CoordinationNurse Manager: Discharge Coordination

  • NOTE: Model shows parameter estimates (standard error). All models adjust for geographic region, teaching hospital affiliation, urban or rural hospital‐based setting, and inpatient medicine operating beds. Models for patient satisfaction adjust for patient age, health status, length of stay, and sex. Models for nurse satisfaction adjust for leadership position, working regular schedule, and job tenure. Abbreviations: MD, physician; NPs, nurse practitioners; PAs, physician assistants; RN, registered nurse. *P<0.05.

Intercept0.67 (0.14)10.20 (0.15)30.41 (0.13)20.89 (0.07)30.78 (0.26)30.67 (0.24)30.23 (0.26)
Facilities with NPs only0.06 (0.10)0.12 (0.09)0.14 (0.09)0.02 (0.05)10.63 (0.91)0.00 (0.19)0.42 (0.20)*
Facilities with PAs only0.06 (0.09)0.10 (0.11)0.10 (0.10)0.06 (0.05)10.08 (0.87)0.41 (0.22)0.36 (0.25)
Facilities with both NPs and PAs0.02 (0.12)0.11 (0.1300.17 (0.11)0.00 (0.00)0.31 (0.92)0.03 (0.27)0.21 (0.30)
Facilities with neither NPs nor PAs       

COM ratings of overall inpatient coordination were also nonsignificant (F[3, 100]=2.01; P=0.12), but their ratings of coordination were higher in facilities with NPs only than in those without either NPs or PAs (=1.63, P=0.08). Nurse manager ratings of overall inpatient coordination were not associated with APP use (F[3,91]=1.24; P=0.30), but were marginally lower with facilities using only PAs (=1.48; P=0.06). Nurse manager ratings of discharge coordination showed a significant effect for APP use (F[3,90]=3.30; P=0.02) with facilities having NPs only significantly higher than places without either NPs or PAs (=1.84, P=0.04).

DISCUSSION

Little evidence exists regarding the role of APPs in the inpatient medicine setting,[2] and important deficit concerns in medical knowledge, technical skills, and clinical experience have been raised.[27, 28] These concerns have called into question the appropriateness of involving APPs in the care of medical inpatients with extensive differential diagnoses and complex care requirements.[27, 28] In spite of these concerns, we found widespread use of APPs with almost half of the VHA inpatient medicine services reporting use, which stands in contrast to prior research.[9, 10, 22, 29, 30, 31, 32, 33, 34, 35] APPs practice in a variety of acute and subacute inpatient medicine settings including academic, community, rural, and urban settings without many discernable differences. The spectrum of activities performed by APPs in the VHA is similar to those reported in these inpatient medicine studies, although their scope of practice appears to be much broader than in these few small single academic center studies.[10, 22, 29, 30, 31, 32, 33, 34, 35, 36] For example, only 11% of hospitalist PAs did procedures in a 2006 Society of Hospital Medicine survey, whereas 50% did in our study.[36]

Interestingly, we found that VHA NPs and PAs perform very similar tasks with similar caseloads despite differences in their background, training, regulation, reimbursement, and the longstanding observation that nurse practitioners are not physician assistants.[1, 3, 4, 5] These findings may reflect that APP scope can be more extensive in the VHA. For example, PAs in the VHA practice under federal jurisdiction and can bypass state legislation of scope of practice.[13] It also may reflect ongoing expansion of the role of APPs in the healthcare system since prior studies.[33, 36]

We did, however, note a few significant differences in NP and PA scope. PAs are twice as likely to perform procedures as NPs in inpatient medicine. It is unclear why PAs may do more procedures, as acute care NPs also are commonly taught and perform similar procedures.[33] We also found that PAs teach nonphysician students twice as often as NPs. This may reflect the deep commitment shown by the VHA to PA education dating back to the 1960s.[13] Finally, we found that PAs were significantly more likely to work weekends and federal holidays, a finding that may have implications for inpatient medicine services hiring APPs. Although not statistically significant, PAs, in general, performed more clinically oriented tasks like history and physicals and more often worked directly with hospitalists.

We found no difference in patient satisfaction or nurse satisfaction related to the presence of APPs, consistent with prior studies, where higher levels of satisfaction with APPs are observed in primary care but not hospital settings.[2, 10] However, it is surprising that no differences were observed for nurse satisfaction. NPs traditionally have a nursing focus, which might foster better relationships with nurses.[22] Expecting changes in either patient or nurse satisfaction with just the addition of APPs in the inpatient medicine setting without addressing other factors may be unrealistic. Patient satisfaction is a complex amalgam of various factors including patient expectations, sociodemographics, emotional and physical state, quality of care, and physician communication.[24] Similarly, nurse satisfaction depends on many factors including job stress, nursephysician collaboration, autonomy, staffing, and support.[37]

Finally, we found higher perception of both overall coordination of inpatient care and discharge coordination on services with NPs. A primary reason stated by medical centers to hire APPs is to improve continuity of care.[9] Prior research has shown better communication and collaboration between nurses, physicians, and NPs on inpatient medicine services.[21] NPs may feel that coordination of care is a major focus for their profession and may spend more time than physicians on care coordination activities.[38] Moreover, their background in both nursing and medicine may better lend itself to coordinating care between disciplines.[39] However, we were surprised to find that services with PAs had lower ratings of overall coordination by nurse managers given that care coordination also is a core competency of PA practice and a primary reason for medical centers to employ them.[9] The lack of a nursing background for PAs and potentially less overall medical experience than NPs possibly may contribute to this finding. However, our study does not suggest a direct explanation for this finding, and we had no measure of prior clinical experience, and thus it should be an area for further research.

There are a number of limitations to our study. First, findings from the VHA may not be generalizable to other healthcare systems.[39] However, VHA inpatient medicine services are, in general, structured similarly to non‐VHA settings and are often affiliated with academic medical centers. Further, this is the largest study to our knowledge to look at the specific roles and perceptions of care provided by both NPs and PAs in inpatient medicine. Second, we did not measure other outcomes of care that may be affected by the use of APPs, such as clinical outcomes, process of care measures, or cost‐effectiveness, some of which have been shown in small studies to be impacted by APPs in inpatient medicine.[10, 22, 29, 30, 31, 32, 33, 34, 35] Third, we are unable to attribute causality to our findings and may not have accounted for all the differences between services. Ideally, a randomized controlled trial of APPs in inpatient medicine would be helpful to address these concerns, but no such trials have been conducted. Finally, we did not survey APPs directly, but surveyed the chiefs of their service instead. The chiefs, however, are directly responsible for the scope of practice of all providers on their service and were directly involved in performance evaluations of most of these practitioners.

In conclusion, we found that NPs and PAs, functioning as APP hospitalists are more widely used and have a broader scope of practice on inpatient medicine than previously known or appreciated, at least in the VHA. In spite of their different backgrounds, training, regulations, and reimbursements, they appear to have a similar scope of practice with few differences in roles or perceived impact. Their impact on inpatient healthcare should be a subject of future research. In the meantime, inpatient medicine services should factor these findings into their decision making as they rapidly expand the use of APPs to provide better care to their patients and to address challenges in healthcare reform.[3, 27, 28, 40]

Acknowledgments

Disclosures: The work reported here was supported by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (IIR 08067) and the Comprehensive Access & Delivery Research and Evaluation (CADRE) Center at the Iowa City VAMC (CIN 13412), and the Center for Healthcare Organization and Implementation Research (CHOIR) at the Boston VA Healthcare System (HFP 04145). The funders did not play any role in the design and conduct of the study; in the collection, analysis, and interpretation of data; and in preparation, review, and approval of the manuscript. The authors do not have any conflicts of interest or financial relationships related to the content of this manuscript. The authors had full access to and take full responsibility for the integrity of the data and the accuracy of the data analysis. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.

Nurse practitioners (NPs) and physician assistants (PAs) provide healthcare in numerous environments internationally and in the United States.[1, 2] However, their role in the inpatient medicine setting is not well described.[2] In the United States, there are more than 157,000 NPs and 85,000 PAs with projected increases.[3, 4] Although both professions provide direct medical care, there are key differences.[1, 3, 4, 5] NPs typically complete a master's or doctoral degree with advanced clinical training beyond nursing. PAs complete at least 2 years of college courses similar to premedical school requirements. PA programs use a medical school‐based curriculum and train for about 2 years before awarding a master's degree. NPs are regulated through state nursing boards, whereas PAs are regulated through state licensing or medical boards. NPs and PAs have different, yet overlapping scopes of practice. A key difference is that PAs can only practice collaborating with a physician.[5, 6] Overall, both have been shown to provide healthcare that is similar in quality to physicians in specific primary care and surgical settings.[2]

NPs and PAs, often referred to as advanced practice providers (APPs), are employed primarily in outpatient clinic settings providing direct patient care. Most APP studies have focused on the outpatient setting, despite nearly a third of US healthcare expenditure for hospital care.[2, 7] Little is known about APP involvement, specific roles, or impact on outcomes in inpatient medicine settings where they are often referred to as NP or PA hospitalists.[2, 8, 9, 10]

The Veterans Health Administration (VHA) is 1 of the largest employers of APPs, with 3.6% of all NPs and 2.1% of all PAs reported to practice in the VHA.[11, 12, 13] As the largest fully integrated healthcare system in the US, the VHA had 8.8 million veterans enrolled and 703,500 inpatient admissions in 2012.[14] Although this makes the VHA an ideal environment to study the role of APPs, few studies have done so.[13, 15, 16, 17, 18, 19] Although studies have compared NPs and PAs to physicians, very little is known about how NPs differ from PAs when practicing in the same environment.

Our objective was to describe the scope of practice, defined as activities that an individual healthcare practitioner is licensed to perform, of NPs and PAs in the inpatient medicine setting and in the VHA. A secondary objective was to explore important outcomes that could potentially be affected by the presence of NPs and PAs on inpatient medicine.

METHODS

The Organizational Factors and Inpatient Medical Care Quality and Efficiency (OFIM) study provides a basis for this study with detail published elsewhere.[20] The OFIM study was conducted between 2010 and 2011 to evaluate quality of care in VHA inpatient medicine surveying chiefs of medicine (COM), inpatient medicine nurse managers (NM), attending physicians, and extant VHA survey data. The COM is the senior attending physician in charge of departments of medicine that include most medical subspecialties within the VHA medical centers. We used the subset of questions specific to NPs and PAs from the COM and NM surveys. Both COMs and NMs answered identical questions for NPs and PAs in 2 separate sections to avoid overlap of responses. NM survey responses were only used for the coordination of care regression model. Surveys were conducted by e‐mail with up to 4 reminders and a subsequent paper mailing. The inpatient medicine service included adult general internal medicine, medical subspecialties, and critical care. The study was approved by the institutional review boards of the VA Boston Healthcare System, the University of Iowa, and the Iowa City VA Healthcare System.

Measurements

To create our primary variable of interestNP and PA employmentwe used the COM survey. Respondents indicated the number and full‐time employee equivalent (FTEE) values for APPs on inpatient medicine. Based on responses, we created a categorical variable with 4 options: (1) facilities with NPs only, (2) facilities with PAs only, (3) facilities with both NPs and PAs, and (4) facilities with neither NPs nor PAs. We selected 3 outcomes that could potentially be affected by the presence of NPs and PAs on inpatient medicine: patient satisfaction, registered nurse (RN) satisfaction, and coordination of care. Patient satisfaction has been shown to improve with NPs and PAs in prior studies, and improving coordination of care has been a stated goal of medical centers in hiring NPs and PAs.[2, 9] Based on our personal experience and previous studies that have shown that nurses report better communication with NPs than physicians,[21] and that NPs retain a visible nursing component in their NP role,[22] we hypothesized that nurse satisfaction on inpatient medicine would improve with the presence of NPs and PAs.

Patient satisfaction was obtained from the 2010 VHA Survey of Healthcare Experiences of Patients (SHEP).[23] The average response rate was 45%. Approximately half the questions on the SHEP are identical to the Hospital Consumer Assessment of Healthcare Providers and Systems survey (HCAHPS).[24] We examined 2 items: an overall rating and willingness to recommend the facility. For the overall rating, patients rated their hospitalization on a scale from 0 (worst hospital possible) to 10 (best hospital possible). Following HCAHPS guidelines, responses of either 9 or 10 were coded as positive and all other nonmissing responses were coded 0. For willingness to recommend, patients were asked Would you recommend this hospital to your friends and family? using a 4‐point response scale. Responses of definitely and probably no were coded as 0, and probably and definitely yes were coded as 1.

Nurse satisfaction was obtained from the 2011 Veterans Administration Nursing Outcomes Database, an annual survey of VHA nurses that includes demographic, work environment and satisfaction data.[25] The survey, a modified version of the Practice Environment Scale,[26] had a response rate of 52.9% (out of 51,870). For this analysis, we selected only inpatient medicine RNs. We used 2 measures: overall job satisfaction and collegial RN/MD (physician) relations. The former was assessed using the item Compared to what you think it should be, what is your current overall level of satisfaction with your job? The RN/MD relations scale had 3 items, including Physicians and nurses have good working relationships. Both items were evaluated on a similar 5‐point response scale.

Coordination of care was assessed from COM and NM surveys. Overall coordination was evaluated from the COM survey using 1 of 8 items in a question about care coordination, In the past month, how would you rate the following aspects of coordination of patient care inpatient coordination overall. Overall coordination was also evaluated from the NM survey using a similar item. Discharge coordination was evaluated only from the NM survey using 1 of 8 items, Thinking about your experiences during the past month, how would you rate the following aspects of the coordination of patient care related to the discharge process on your inpatient medicine unit discharge coordination overall. When a service had more than 1 response from the NM survey, we took an average of responses to represent the mean score. Responses for all questions ranged from 1 for poor to 5 for excellent (for all of the questions see Supporting Information, Appendix 1, in the online version of this article).

Last, we modeled for several contextual features that could influence outcomes: geographic region as a 4‐item categorical variable; teaching affiliation as a dichotomous variable based on whether the hospital was a member of the Council of Teaching Hospitals, urban or rural status, and facility size as a continuous variable using the number of inpatient medicine service beds.

Statistical Analysis

Descriptive bivariate analyses used t tests, 2, or 2‐tailed Fisher tests when appropriate to compare NP and PA autonomy, tasks, location of care, work schedule, clinical workload, organizational characteristics (ie, academic, urban, facility complexity, inpatient medicine team structure), and performance evaluations.

Next, we examined whether any of the contextual characteristics were associated with use of NPs or PAs using inferential statistics. For patient satisfaction, we developed a hierarchical linear model (HLM) that nested patients within facilities. We controlled for patient age, sex, health status, and length of stay. For nurse satisfaction, individual responses of RNs also were analyzed using the HLM. We controlled for whether the nurse had a leadership position, worked during the daily shift, and job tenure. Ordinary least squares regression was used to examine the 3 measures of coordination from the COM and NM surveys. All analyses were performed using Stata version 12 (StataCorp, College Station, TX) and SAS version 9.2 (SAS Institute Inc., Cary, NC).

RESULTS

Of 123 inpatient medicine services that we surveyed, we included responses from the COMs of 118 services (response rate 95.2%); 5 responses were incomplete. Across 123 inpatient medicine services, we surveyed 264 nurse managers and received 198 responses (75.0%) from 114 inpatient medicine services. In the only model using NM responsesthe care coordination model104 inpatient medicine services had responses from both COM and NM surveys.

Of 118 VHA inpatient medicine services, 56 (47.5%) had APPs, of which 27 (48.2%) had NPs only, 15 (26.8%) had PAs only, and 14 (25.0%) had both NPs and PAs. FTEEs for NPs ranged from 0.5 to 7 (mean=2.22) and for PAs from 1 to 9 (mean=2.23) on the inpatient medicine service per hospital.

There were no significant differences on use of NPs and PAs by teaching affiliation, urban or rural setting, and geography. A significant difference was observed based on bed size (F[3,109]=5.13, P<0.001); facilities with both NPs and PAs had, on average, a larger number of inpatient beds (mean=79.0, standard deviation [SD]=32.3) compared to those without NPs or PAs (mean=50.1, SD=29.4) or with PAs only (mean=44.2, SD=20.5) using Tukey post hoc analysis.

The most common staffing model used staff (attending) physicians only working directly with APPs (N=29, 24.6%). Next most common was an academic model with staff physicians, housestaff, and APPs working together in teams (N=16, 13.4%). For performance evaluations, COMs contributed for both NPs (60.2%) and PAs (56.4%); in fewer cases, COMs completed evaluations of NPs (12.9%) and of PAs (29.0%) without input from other service managers (P=0.02).

Table 1 shows the differences reported by COMs between NPs and PAs scope of practice. Overall, 58.9% of NPs and 65.4% of PAs functioned somewhat or completely autonomously; 23.1% of NPs and 30.8% of PAs worked in a role closer to a ward assistant (eg, work directly with a physician, cowriting orders, and making care decisions with physician oversight). Tasks frequently performed by the majority of NPs and PAs included writing orders (87.9%), coordinating discharge plans (86.7%), communicating with consultants (83.1%), performing history and physicals (82.5%), writing daily progress notes (80.7%), communicating with primary care providers (73.5%), and working directly with hospitalists (72.8%). Less common tasks included serving on committees (46.4%), championing quality improvement activities (40.6%), and research (2.9%). There were no statistically significant differences between tasks, except for a higher proportion of services reporting PAs rather than NPs performing procedures (50.0% vs 22.0%, P=0.02) and teaching nonphysicians (50.0% vs 24.4%, P=0.04).

Nurse Practitioner and Physician Assistant Hospital‐Based Scopes of Practice
 Services With NPs,Services With PAs,P Value

  • NOTE: Abbreviations: NPs, nurse practitioners; PAs, physician assistants.

  • *Of 41 services with NPs, 14 had PAs too. Of 29 services with PAs, 14 had NPs too.

  • Numbers may vary between items because all respondents may not have answered all items on survey questions. Percentages do not add up to 100% because respondents may have more than 1 response to multiple response questions.

How do NPs and PAs function in conjunction with inpatient medicine staff (attending) physicians in the day‐to‐day care of patients (ie, scope of practice)?N=39 (%)*N=26 (%)* 
Autonomously, in a manner similar to physicians10 (25.6%)5 (19.2%)0.77
Somewhat autonomously, but with limitations13 (33.3%)12 (46.2%)0.31
In a role closer to a ward assistant9 (23.1%)8 (30.8%)0.57
Administrative2 (5.1%)0 (0.0%)0.51
Other6 (15.4%)1 (3.8%)0.23
What types of tasks do NPs and PAs perform?N=41 (%)*N=28 (%)* 
Write orders34 (82.9%)26 (92.9%)0.29
Coordinate discharge plans33 (80.5%)26 (92.9%)0.18
Communicate with consultants33 (80.5%)24 (85.7%)0.75
History and physicals31 (75.6%)25 (89.3%)0.22
Daily progress notes31 (75.6%)24 (85.7%)0.37
Communicate with primary care providers31 (75.6%)20 (71.4%0.78
Work directly with hospitalists26 (63.4%)23 (82.1%)0.18
Committees16 (39.0%)16 (57.1%)0.15
Champion quality improvement activities14 (34.1%)14 (50.0%)0.22
Teach nonphysician students10 (24.4%)14 (50.0%)0.04
Perform procedures9 (22.0%)14 (50.0%)0.02
Research1 (2.4%)1 (3.6%)1.00
Other6 (14.6%)0 (0.0%)0.04

Table 2 reports location of practice in the hospital and workload. There were no significant differences in locations where NPs and PAs provided care. Overall, 81.9% of APPs worked in inpatient wards, 23.1% in step‐down units, 18.6% in intensive care units, 13.8% in skilled care units, and 4.9% in other locations. In addition, 97.4% of NPs and 89.3% of PAs worked weekdays, whereas only 7.9% of NPs and 17.9% of PAs worked nights. More PAs than NPs worked federal holidays (32.1% vs 7.9%, P=0.02) and weekends (32.1% vs 13.2%, P=0.08). Most NPs and PAs handled a caseload of 4 to 10 patients with a mean of 6.5, with no difference between the 2. The minority, 27.0% of NPs and 23.1% of PAs, were not assigned specific patients.

Nurse Practitioner and Physician Assistant Hospital Location of Care and Workload
 Services With NPsServices With PAsP Value

  • NOTE: Abbreviations: N/A, not assigned specific patients; NPs, nurse practitioners; PAs, physician assistants.

  • *Of 41 services with NPs, 14 had PAs too. Of 29 services with PAs, 14 had NPs too.

  • Numbers may vary between items because all respondents may not have answered all items on survey questions. Percentages do not add up to 100% because respondents may have more than 1 response to multiple response questions.

Where do NPs and PAs provide care?N=38 (%)*N=28 (%)* 
Wards31 (81.6%)23 (82.1%)1.00
Step‐down unit8 (21.1%)7 (25.0%)0.77
Intensive care unit6 (15.8%)6 (21.4%)0.75
Skilled care units5 (13.2%)4 (14.3%)1.00
Other1 (2.6%)2 (7.1%)0.57
What are NPs and PAs tours of duty?N=38 (%)*N=28 (%)* 
Weekdays37 (97.4%)25 (89.3%)0.30
Weekends5 (13.2%)9 (32.1%)0.08
Nights3 (7.9%)5 (17.9%)0.27
Federal holidays3 (7.9%)9 (32.1%)0.02
Other2 (5.3%)1 (3.6%)1.00
What is the average clinical workload for NPs and PAs?N=37 (%)*N=26 (%)* 
Mean no. of patients6.816.180.45
N/A10 (27.0%)6 (23.1%)0.56
Other1 (2.7%)0 (0.0%) 

In multivariable adjusted analyses evaluating the association between patient satisfaction and use of APPs (Table 3), no significant differences were observed for patients' rating of the hospital (F[3,95]=0.19; P=0.90) or willingness to recommend the hospital (F[3,95]=0.54; P=0.65). Similarly, no significant differences were observed based on use of APPs for nurse overall job satisfaction (F[3,101]=1.85; P=0.14) or collegial relations with physicians (F[3,101]=0.96; P=0.41).

Adjusted Regression Model Examining Nurse Practitioner and Physician Assistant Association with Patient Satisfaction, Nurse Satisfaction, and Coordination of Care
 Patient SatisfactionNurse SatisfactionCoordination of Care
Overall RatingWillingness to RecommendRN Overall Job SatisfactionRN/MD RelationsChief of Medicine: Inpatient CoordinationNurse Manager: Inpatient CoordinationNurse Manager: Discharge Coordination

  • NOTE: Model shows parameter estimates (standard error). All models adjust for geographic region, teaching hospital affiliation, urban or rural hospital‐based setting, and inpatient medicine operating beds. Models for patient satisfaction adjust for patient age, health status, length of stay, and sex. Models for nurse satisfaction adjust for leadership position, working regular schedule, and job tenure. Abbreviations: MD, physician; NPs, nurse practitioners; PAs, physician assistants; RN, registered nurse. *P<0.05.

Intercept0.67 (0.14)10.20 (0.15)30.41 (0.13)20.89 (0.07)30.78 (0.26)30.67 (0.24)30.23 (0.26)
Facilities with NPs only0.06 (0.10)0.12 (0.09)0.14 (0.09)0.02 (0.05)10.63 (0.91)0.00 (0.19)0.42 (0.20)*
Facilities with PAs only0.06 (0.09)0.10 (0.11)0.10 (0.10)0.06 (0.05)10.08 (0.87)0.41 (0.22)0.36 (0.25)
Facilities with both NPs and PAs0.02 (0.12)0.11 (0.1300.17 (0.11)0.00 (0.00)0.31 (0.92)0.03 (0.27)0.21 (0.30)
Facilities with neither NPs nor PAs       

COM ratings of overall inpatient coordination were also nonsignificant (F[3, 100]=2.01; P=0.12), but their ratings of coordination were higher in facilities with NPs only than in those without either NPs or PAs (=1.63, P=0.08). Nurse manager ratings of overall inpatient coordination were not associated with APP use (F[3,91]=1.24; P=0.30), but were marginally lower with facilities using only PAs (=1.48; P=0.06). Nurse manager ratings of discharge coordination showed a significant effect for APP use (F[3,90]=3.30; P=0.02) with facilities having NPs only significantly higher than places without either NPs or PAs (=1.84, P=0.04).

DISCUSSION

Little evidence exists regarding the role of APPs in the inpatient medicine setting,[2] and important deficit concerns in medical knowledge, technical skills, and clinical experience have been raised.[27, 28] These concerns have called into question the appropriateness of involving APPs in the care of medical inpatients with extensive differential diagnoses and complex care requirements.[27, 28] In spite of these concerns, we found widespread use of APPs with almost half of the VHA inpatient medicine services reporting use, which stands in contrast to prior research.[9, 10, 22, 29, 30, 31, 32, 33, 34, 35] APPs practice in a variety of acute and subacute inpatient medicine settings including academic, community, rural, and urban settings without many discernable differences. The spectrum of activities performed by APPs in the VHA is similar to those reported in these inpatient medicine studies, although their scope of practice appears to be much broader than in these few small single academic center studies.[10, 22, 29, 30, 31, 32, 33, 34, 35, 36] For example, only 11% of hospitalist PAs did procedures in a 2006 Society of Hospital Medicine survey, whereas 50% did in our study.[36]

Interestingly, we found that VHA NPs and PAs perform very similar tasks with similar caseloads despite differences in their background, training, regulation, reimbursement, and the longstanding observation that nurse practitioners are not physician assistants.[1, 3, 4, 5] These findings may reflect that APP scope can be more extensive in the VHA. For example, PAs in the VHA practice under federal jurisdiction and can bypass state legislation of scope of practice.[13] It also may reflect ongoing expansion of the role of APPs in the healthcare system since prior studies.[33, 36]

We did, however, note a few significant differences in NP and PA scope. PAs are twice as likely to perform procedures as NPs in inpatient medicine. It is unclear why PAs may do more procedures, as acute care NPs also are commonly taught and perform similar procedures.[33] We also found that PAs teach nonphysician students twice as often as NPs. This may reflect the deep commitment shown by the VHA to PA education dating back to the 1960s.[13] Finally, we found that PAs were significantly more likely to work weekends and federal holidays, a finding that may have implications for inpatient medicine services hiring APPs. Although not statistically significant, PAs, in general, performed more clinically oriented tasks like history and physicals and more often worked directly with hospitalists.

We found no difference in patient satisfaction or nurse satisfaction related to the presence of APPs, consistent with prior studies, where higher levels of satisfaction with APPs are observed in primary care but not hospital settings.[2, 10] However, it is surprising that no differences were observed for nurse satisfaction. NPs traditionally have a nursing focus, which might foster better relationships with nurses.[22] Expecting changes in either patient or nurse satisfaction with just the addition of APPs in the inpatient medicine setting without addressing other factors may be unrealistic. Patient satisfaction is a complex amalgam of various factors including patient expectations, sociodemographics, emotional and physical state, quality of care, and physician communication.[24] Similarly, nurse satisfaction depends on many factors including job stress, nursephysician collaboration, autonomy, staffing, and support.[37]

Finally, we found higher perception of both overall coordination of inpatient care and discharge coordination on services with NPs. A primary reason stated by medical centers to hire APPs is to improve continuity of care.[9] Prior research has shown better communication and collaboration between nurses, physicians, and NPs on inpatient medicine services.[21] NPs may feel that coordination of care is a major focus for their profession and may spend more time than physicians on care coordination activities.[38] Moreover, their background in both nursing and medicine may better lend itself to coordinating care between disciplines.[39] However, we were surprised to find that services with PAs had lower ratings of overall coordination by nurse managers given that care coordination also is a core competency of PA practice and a primary reason for medical centers to employ them.[9] The lack of a nursing background for PAs and potentially less overall medical experience than NPs possibly may contribute to this finding. However, our study does not suggest a direct explanation for this finding, and we had no measure of prior clinical experience, and thus it should be an area for further research.

There are a number of limitations to our study. First, findings from the VHA may not be generalizable to other healthcare systems.[39] However, VHA inpatient medicine services are, in general, structured similarly to non‐VHA settings and are often affiliated with academic medical centers. Further, this is the largest study to our knowledge to look at the specific roles and perceptions of care provided by both NPs and PAs in inpatient medicine. Second, we did not measure other outcomes of care that may be affected by the use of APPs, such as clinical outcomes, process of care measures, or cost‐effectiveness, some of which have been shown in small studies to be impacted by APPs in inpatient medicine.[10, 22, 29, 30, 31, 32, 33, 34, 35] Third, we are unable to attribute causality to our findings and may not have accounted for all the differences between services. Ideally, a randomized controlled trial of APPs in inpatient medicine would be helpful to address these concerns, but no such trials have been conducted. Finally, we did not survey APPs directly, but surveyed the chiefs of their service instead. The chiefs, however, are directly responsible for the scope of practice of all providers on their service and were directly involved in performance evaluations of most of these practitioners.

In conclusion, we found that NPs and PAs, functioning as APP hospitalists are more widely used and have a broader scope of practice on inpatient medicine than previously known or appreciated, at least in the VHA. In spite of their different backgrounds, training, regulations, and reimbursements, they appear to have a similar scope of practice with few differences in roles or perceived impact. Their impact on inpatient healthcare should be a subject of future research. In the meantime, inpatient medicine services should factor these findings into their decision making as they rapidly expand the use of APPs to provide better care to their patients and to address challenges in healthcare reform.[3, 27, 28, 40]

Acknowledgments

Disclosures: The work reported here was supported by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (IIR 08067) and the Comprehensive Access & Delivery Research and Evaluation (CADRE) Center at the Iowa City VAMC (CIN 13412), and the Center for Healthcare Organization and Implementation Research (CHOIR) at the Boston VA Healthcare System (HFP 04145). The funders did not play any role in the design and conduct of the study; in the collection, analysis, and interpretation of data; and in preparation, review, and approval of the manuscript. The authors do not have any conflicts of interest or financial relationships related to the content of this manuscript. The authors had full access to and take full responsibility for the integrity of the data and the accuracy of the data analysis. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.

References
  1. Cox CL. Advanced nurse practitioners and physician assistants: what is the difference? Comparing the USA and UK. Hosp Med. 2001;62:169–171.
  2. Laurant M, Harmsen M, Wollersheim H, Grol R, Faber M, Sibbald B. The impact of nonphysician clinicians: do they improve the quality and cost‐effectiveness of health care services? Med Care Res Rev. 2009;66(6 suppl):36S–89S.
  3. Auerbach DI. Will the NP workforce grow in the future? New forecasts and implications for healthcare delivery. Med Care. 2012;50(7):606–610.
  4. Danielsen RD, Lathrop J, Arbet S. The certified physician assistant iin the United States: a 2011 snapshot. JAAPA. 2012;25(4):58.
  5. Gershengorn HB, Johnson MP, Factor P. The use of nonphysician providers in adult intensive care units. Am J Respir Crit Care Med. 2012;185(6):600–605.
  6. American Academy of Physician Assistants. State law issues: supervision of PAs: access and excellence in patient care. October 2011. Available at: http://www.aapa.org/WorkArea/DownloadAsset.aspx?id=632. Accessed on June 22, 2014.
  7. Centers for Medicare 5(2):99–102.
  8. Moote M, Krsek C, Kleinpell R, Todd B. Physician assistant and nurse practitioner utilization in academic medical centers. Am J Med Qual. 2011;26(6):452–460.
  9. Roy CL, Liang CL, Lund M, et al. Implementation of a physician assistant/hospitalist service in an academic medical center: impact on efficiency and patient outcomes. J Hosp Med. 2008;3(5):361–368.
  10. American Academy of Physician Assistants. 2010 AAPA Physician Assistant Census. Alexandria, VA, 2011. Available at: http://www.aapa.org/WorkArea/DownloadAsset.aspx?id=838. Accessed on June 22, 2014.
  11. Goolsby MJ. 2009–2010 AANP national nurse practitioner sample survey: an overview. J Am Acad Nurse Pract. 2011;23(5):266–268.
  12. Woodmansee DJ, Hooker RS. Physician assistants working in the Department of Veterans Affairs. JAAPA 2010;23(11):41–44.
  13. National Center for Veterans Analysis and Statistics. Selected Veterans Health Administration Characteristics: FY2002 to FY2012. 2013; http://www.va.gov/vetdata/docs/Utilization/VHAStats.xls. Accessed January 7, 2014.
  14. Brock DM, Wick KH, Evans TC, Gianola FJ. The physician assistant profession and military veterans. Mil Med. 2011;176(2):197–203.
  15. Budzi D, Lurie S, Singh K, Hooker R. Veterans' perceptions of care by nurse practitioners, physician assistants, and physicians: a comparison from satisfaction surveys. J Am Acad Nurse Pract. 2010;22(3):170–176.
  16. Fletcher CE, Copeland LA, Lowery JC, Reeves PJ. Nurse practitioners as primary care providers within the VA. Mil Med. 2011;176(7):791–797.
  17. Hooker RS. Federally employed physician assistants. Mil Med. 2008;173(9):895–899.
  18. Huang PY, Yano EM, Lee ML, Chang BL, Rubenstein LV. Variations in nurse practitioner use in Veterans Affairs primary care practices. Health Serv Res. 2004;39(4 pt 1):887–904.
  19. Restuccia J, Mohr D, Meterko M, Stolzmann K, Kaboli P. The association of hospital characteristics and quality improvement activities in inpatient medical services. J Gen Intern Med. 2014;29(5):715–722.
  20. Vazirani S, Hays RD, Shapiro MF, Cowan M. Effect of a multidisciplinary intervention on communication and collaboration among physicians and nurses. Am J Crit Care. 2005;14(1):71–77.
  21. Stetler CB, Effken J, Frigon L, Tiernan C, Zwingman‐Bagley C. Utilization‐focused evaluation of acute care nurse practitioner role. Outcomes Manag Nurs Pract. 1998;2(4):152–160; quiz 160–151.
  22. Davies EA, Meterko MM, Charns MP, Seibert ME, Cleary PD. Factors affecting the use of patient survey data for quality improvement in the Veterans Health Administration. BMC Health Serv Res. 2011;11:334.
  23. Jha AK, Orav EJ, Zheng J, Epstein AM. Patients' perception of hospital care in the United States. N Engl J Med. 2008;359(18):1921–1931.
  24. Sales AE, Sharp ND, Li YF, et al. Nurse staffing and patient outcomes in Veterans Affairs hospitals. J Nurs Adm. 2005;35(10):459–466.
  25. Lake ET. Development of the practice environment scale of the Nursing Work Index. Res Nurs Health. 2002;25(3):176–188.
  26. Fairman JA, Rowe JW, Hassmiller S, Shalala DE. Broadening the scope of nursing practice. N Engl J Med. 2011;364(3):193–196.
  27. Iglehart JK. Expanding the role of advanced nurse practitioners—risks and rewards. N Engl J Med. 2013;368(20):1935–1941.
  28. Cowan MJ, Shapiro M, Hays RD, et al. The effect of a multidisciplinary hospitalist/physician and advanced practice nurse collaboration on hospital costs. J Nurs Adm. 2006;36(2):79–85.
  29. Goksel D, Harrison CJ, Morrison RE, Miller ST. Description of a nurse practitioner inpatient service in a public teaching hospital. J Gen Intern Med. 1993;8(1):29–30.
  30. Howie JN, Erickson M. Acute care nurse practitioners: creating and implementing a model of care for an inpatient general medical service. Am J Crit Care. 2002;11(5):448–458.
  31. Myers JS, Bellini LM, Rohrbach J, Shofer FS, Hollander JE. Improving resource utilization in a teaching hospital: development of a nonteaching service for chest pain admissions. Acad Med. 2006;81(5):432–435.
  32. Rudy EB, Davidson LJ, Daly B, et al. Care activities and outcomes of patients cared for by acute care nurse practitioners, physician assistants, and resident physicians: a comparison. Am J Crit Care. 1998;7(4):267–281.
  33. Singh S, Tarima S, Rana V, et al. Impact of localizing general medical teams to a single nursing unit. J Hosp Med. 2012;7(7):551–556.
  34. Rhee J, Ritchie J, Eward AM. Resource use by physician assistant services versus teaching services. JAAPA 2002;15(1):33–38, 40, 42.
  35. MaHaffy HW. Physician assistants in hospital medicine. In: Ballweg R, Sullivan EM, Brown D, Vetrosky D, eds. Physician Assistant: A Guide to Clinical Practice. 5th ed. Philadelphia, PA: W.B. Saunders; 2013:450–455.
  36. Hayes B, Bonner A, Pryor J. Factors contributing to nurse job satisfaction in the acute hospital setting: a review of recent literature. J Nurs Manage. 2010;18(7):804–814.
  37. Hoffman LA, Tasota FJ, Zullo TG, Scharfenberg C, Donahoe MP. Outcomes of care managed by an acute care nurse practitioner/attending physician team in a subacute medical intensive care unit. Am J Crit Care. 2005;14(2):121–130; quiz 131–132.
  38. Offenbeek MA, Knip M. The organizational and performance effects of nurse practitioner roles. J Adv Nurs. 2004;47(6):672–681.
  39. Sargen M, Hooker RS, Cooper RA. Gaps in the supply of physicians, advance practice nurses, and physician assistants. J Am Coll Surg. 2011;212(6):991–999.
References
  1. Cox CL. Advanced nurse practitioners and physician assistants: what is the difference? Comparing the USA and UK. Hosp Med. 2001;62:169–171.
  2. Laurant M, Harmsen M, Wollersheim H, Grol R, Faber M, Sibbald B. The impact of nonphysician clinicians: do they improve the quality and cost‐effectiveness of health care services? Med Care Res Rev. 2009;66(6 suppl):36S–89S.
  3. Auerbach DI. Will the NP workforce grow in the future? New forecasts and implications for healthcare delivery. Med Care. 2012;50(7):606–610.
  4. Danielsen RD, Lathrop J, Arbet S. The certified physician assistant iin the United States: a 2011 snapshot. JAAPA. 2012;25(4):58.
  5. Gershengorn HB, Johnson MP, Factor P. The use of nonphysician providers in adult intensive care units. Am J Respir Crit Care Med. 2012;185(6):600–605.
  6. American Academy of Physician Assistants. State law issues: supervision of PAs: access and excellence in patient care. October 2011. Available at: http://www.aapa.org/WorkArea/DownloadAsset.aspx?id=632. Accessed on June 22, 2014.
  7. Centers for Medicare 5(2):99–102.
  8. Moote M, Krsek C, Kleinpell R, Todd B. Physician assistant and nurse practitioner utilization in academic medical centers. Am J Med Qual. 2011;26(6):452–460.
  9. Roy CL, Liang CL, Lund M, et al. Implementation of a physician assistant/hospitalist service in an academic medical center: impact on efficiency and patient outcomes. J Hosp Med. 2008;3(5):361–368.
  10. American Academy of Physician Assistants. 2010 AAPA Physician Assistant Census. Alexandria, VA, 2011. Available at: http://www.aapa.org/WorkArea/DownloadAsset.aspx?id=838. Accessed on June 22, 2014.
  11. Goolsby MJ. 2009–2010 AANP national nurse practitioner sample survey: an overview. J Am Acad Nurse Pract. 2011;23(5):266–268.
  12. Woodmansee DJ, Hooker RS. Physician assistants working in the Department of Veterans Affairs. JAAPA 2010;23(11):41–44.
  13. National Center for Veterans Analysis and Statistics. Selected Veterans Health Administration Characteristics: FY2002 to FY2012. 2013; http://www.va.gov/vetdata/docs/Utilization/VHAStats.xls. Accessed January 7, 2014.
  14. Brock DM, Wick KH, Evans TC, Gianola FJ. The physician assistant profession and military veterans. Mil Med. 2011;176(2):197–203.
  15. Budzi D, Lurie S, Singh K, Hooker R. Veterans' perceptions of care by nurse practitioners, physician assistants, and physicians: a comparison from satisfaction surveys. J Am Acad Nurse Pract. 2010;22(3):170–176.
  16. Fletcher CE, Copeland LA, Lowery JC, Reeves PJ. Nurse practitioners as primary care providers within the VA. Mil Med. 2011;176(7):791–797.
  17. Hooker RS. Federally employed physician assistants. Mil Med. 2008;173(9):895–899.
  18. Huang PY, Yano EM, Lee ML, Chang BL, Rubenstein LV. Variations in nurse practitioner use in Veterans Affairs primary care practices. Health Serv Res. 2004;39(4 pt 1):887–904.
  19. Restuccia J, Mohr D, Meterko M, Stolzmann K, Kaboli P. The association of hospital characteristics and quality improvement activities in inpatient medical services. J Gen Intern Med. 2014;29(5):715–722.
  20. Vazirani S, Hays RD, Shapiro MF, Cowan M. Effect of a multidisciplinary intervention on communication and collaboration among physicians and nurses. Am J Crit Care. 2005;14(1):71–77.
  21. Stetler CB, Effken J, Frigon L, Tiernan C, Zwingman‐Bagley C. Utilization‐focused evaluation of acute care nurse practitioner role. Outcomes Manag Nurs Pract. 1998;2(4):152–160; quiz 160–151.
  22. Davies EA, Meterko MM, Charns MP, Seibert ME, Cleary PD. Factors affecting the use of patient survey data for quality improvement in the Veterans Health Administration. BMC Health Serv Res. 2011;11:334.
  23. Jha AK, Orav EJ, Zheng J, Epstein AM. Patients' perception of hospital care in the United States. N Engl J Med. 2008;359(18):1921–1931.
  24. Sales AE, Sharp ND, Li YF, et al. Nurse staffing and patient outcomes in Veterans Affairs hospitals. J Nurs Adm. 2005;35(10):459–466.
  25. Lake ET. Development of the practice environment scale of the Nursing Work Index. Res Nurs Health. 2002;25(3):176–188.
  26. Fairman JA, Rowe JW, Hassmiller S, Shalala DE. Broadening the scope of nursing practice. N Engl J Med. 2011;364(3):193–196.
  27. Iglehart JK. Expanding the role of advanced nurse practitioners—risks and rewards. N Engl J Med. 2013;368(20):1935–1941.
  28. Cowan MJ, Shapiro M, Hays RD, et al. The effect of a multidisciplinary hospitalist/physician and advanced practice nurse collaboration on hospital costs. J Nurs Adm. 2006;36(2):79–85.
  29. Goksel D, Harrison CJ, Morrison RE, Miller ST. Description of a nurse practitioner inpatient service in a public teaching hospital. J Gen Intern Med. 1993;8(1):29–30.
  30. Howie JN, Erickson M. Acute care nurse practitioners: creating and implementing a model of care for an inpatient general medical service. Am J Crit Care. 2002;11(5):448–458.
  31. Myers JS, Bellini LM, Rohrbach J, Shofer FS, Hollander JE. Improving resource utilization in a teaching hospital: development of a nonteaching service for chest pain admissions. Acad Med. 2006;81(5):432–435.
  32. Rudy EB, Davidson LJ, Daly B, et al. Care activities and outcomes of patients cared for by acute care nurse practitioners, physician assistants, and resident physicians: a comparison. Am J Crit Care. 1998;7(4):267–281.
  33. Singh S, Tarima S, Rana V, et al. Impact of localizing general medical teams to a single nursing unit. J Hosp Med. 2012;7(7):551–556.
  34. Rhee J, Ritchie J, Eward AM. Resource use by physician assistant services versus teaching services. JAAPA 2002;15(1):33–38, 40, 42.
  35. MaHaffy HW. Physician assistants in hospital medicine. In: Ballweg R, Sullivan EM, Brown D, Vetrosky D, eds. Physician Assistant: A Guide to Clinical Practice. 5th ed. Philadelphia, PA: W.B. Saunders; 2013:450–455.
  36. Hayes B, Bonner A, Pryor J. Factors contributing to nurse job satisfaction in the acute hospital setting: a review of recent literature. J Nurs Manage. 2010;18(7):804–814.
  37. Hoffman LA, Tasota FJ, Zullo TG, Scharfenberg C, Donahoe MP. Outcomes of care managed by an acute care nurse practitioner/attending physician team in a subacute medical intensive care unit. Am J Crit Care. 2005;14(2):121–130; quiz 131–132.
  38. Offenbeek MA, Knip M. The organizational and performance effects of nurse practitioner roles. J Adv Nurs. 2004;47(6):672–681.
  39. Sargen M, Hooker RS, Cooper RA. Gaps in the supply of physicians, advance practice nurses, and physician assistants. J Am Coll Surg. 2011;212(6):991–999.
Issue
Journal of Hospital Medicine - 9(10)
Issue
Journal of Hospital Medicine - 9(10)
Page Number
615-620
Page Number
615-620
Article Type
Article
Display Headline
Nurse practitioner and physician assistant scope of practice in 118 acute care hospitals
Display Headline
Nurse practitioner and physician assistant scope of practice in 118 acute care hospitals
Sections
Original Research
Article Source

© 2014 Society of Hospital Medicine

Disallow All Ads
Corresponding Author
Anand Kartha, MD, MS
Correspondence Location
Address for correspondence and reprint requests: Anand Kartha, MD, Veterans Administration Boston Healthcare System, 1400 VFW Parkway, Mail Stop 111, West Roxbury, MA 02132; Telephone: 857‐203‐6361; Fax: 857‐203‐5549; E‐mail: [email protected]
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Article PDF Media
Media Files

Spleen-like device could solve problems in treating sepsis

Article Type
News
Changed
Mon, 09/15/2014 - 06:00
Display Headline
Spleen-like device could solve problems in treating sepsis
Author(s)
HT Staff

Biospleen device

Credit: Wyss Institute

A device inspired by the human spleen could change the way we treat sepsis, researchers say.

This “biospleen” was able to cleanse human blood in lab tests and increase survival in animals with infected blood.

Experiments showed that, in a matter of hours, the biospleen can filter live and dead pathogens from the blood, as well as dangerous toxins released from the pathogens.

The researchers detailed these experiments in Nature Medicine.

“Sepsis is a major medical threat, which is increasing because of antibiotic resistance,” said study author Donald Ingber, MD, PhD, of the Wyss Institute for Biologically Inspired Engineering in Boston, Massachusetts.

“We’re excited by the biospleen because it potentially provides a way to treat patients quickly without having to wait days to identify the source of infection, and it works equally well with antibiotic-resistant organisms. We hope to move this toward human testing [by] advancing to large animal studies as quickly as possible.”

The biospleen is a microfluidic device that works outside the body like a dialysis machine and removes living and dead microbes of all varieties, as well as toxins.

It consists of 2 adjacent, hollow channels that are connected to each other by a series of slits. One channel contains flowing blood, and the other has a saline solution that collects and removes the pathogens that travel through the slits.

Key to the success of the device are nanometer-sized magnetic beads coated with a genetically engineered version of the protein mannose binding lectin (MBL).

In its innate state, MBL has a branch-like “head” and a stick-like “tail.” The head binds to specific sugars on the surfaces of all sorts of bacteria, fungi, viruses, protozoa, and toxins, and the tail cues the immune system to destroy them.

However, other immune system proteins sometimes bind to the MBL tail and activate clotting and organ damage. So Dr Ingber and his colleagues used genetic engineering tools to lop off the tail and graft on a similar one from an antibody protein that does not cause these problems.

The team then attached the hybrid proteins to magnetic beads measuring 128 nanometers in diameter. These novel beads could be added to infected blood to bind to the pathogens and toxins without having to first identify the type of infectious agent.

The biospleen has a magnet that pulls the pathogen-coated magnetic beads through the channels to cleanse the blood flowing through the device, which can then be returned to the patient.

The researchers first tested the biospleen using human blood spiked with pathogens. They were able to filter blood faster than ever before, and the magnets efficiently pulled the beads—coated with pathogens—out of the blood.

More than 90% of key sepsis pathogens were bound and removed when the blood flowed through a single device at a rate of about 0.5 L to 1 L per hour. Many devices can be linked together to obtain levels required for human blood cleansing at dialysis-like rates.

Next, the researchers tested the device using rats infected with E coli, S aureus, and toxins—mimicking many of the bloodstream infections human sepsis patients experience. After 5 hours of filtering, about 90% of the bacteria and toxins were removed from the rats’ bloodstreams.

“We didn’t have to kill the pathogens,” said Michael Super, PhD, also of the Wyss Institute. “We just captured and removed them.”

What’s more, 90% of the treated animals survived, compared to 14% of the controls. And the modified MBL prevented the activation of complement factors and coagulation.

Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Related Issues
Author(s)
HT Staff
Author(s)
HT Staff

Biospleen device

Credit: Wyss Institute

A device inspired by the human spleen could change the way we treat sepsis, researchers say.

This “biospleen” was able to cleanse human blood in lab tests and increase survival in animals with infected blood.

Experiments showed that, in a matter of hours, the biospleen can filter live and dead pathogens from the blood, as well as dangerous toxins released from the pathogens.

The researchers detailed these experiments in Nature Medicine.

“Sepsis is a major medical threat, which is increasing because of antibiotic resistance,” said study author Donald Ingber, MD, PhD, of the Wyss Institute for Biologically Inspired Engineering in Boston, Massachusetts.

“We’re excited by the biospleen because it potentially provides a way to treat patients quickly without having to wait days to identify the source of infection, and it works equally well with antibiotic-resistant organisms. We hope to move this toward human testing [by] advancing to large animal studies as quickly as possible.”

The biospleen is a microfluidic device that works outside the body like a dialysis machine and removes living and dead microbes of all varieties, as well as toxins.

It consists of 2 adjacent, hollow channels that are connected to each other by a series of slits. One channel contains flowing blood, and the other has a saline solution that collects and removes the pathogens that travel through the slits.

Key to the success of the device are nanometer-sized magnetic beads coated with a genetically engineered version of the protein mannose binding lectin (MBL).

In its innate state, MBL has a branch-like “head” and a stick-like “tail.” The head binds to specific sugars on the surfaces of all sorts of bacteria, fungi, viruses, protozoa, and toxins, and the tail cues the immune system to destroy them.

However, other immune system proteins sometimes bind to the MBL tail and activate clotting and organ damage. So Dr Ingber and his colleagues used genetic engineering tools to lop off the tail and graft on a similar one from an antibody protein that does not cause these problems.

The team then attached the hybrid proteins to magnetic beads measuring 128 nanometers in diameter. These novel beads could be added to infected blood to bind to the pathogens and toxins without having to first identify the type of infectious agent.

The biospleen has a magnet that pulls the pathogen-coated magnetic beads through the channels to cleanse the blood flowing through the device, which can then be returned to the patient.

The researchers first tested the biospleen using human blood spiked with pathogens. They were able to filter blood faster than ever before, and the magnets efficiently pulled the beads—coated with pathogens—out of the blood.

More than 90% of key sepsis pathogens were bound and removed when the blood flowed through a single device at a rate of about 0.5 L to 1 L per hour. Many devices can be linked together to obtain levels required for human blood cleansing at dialysis-like rates.

Next, the researchers tested the device using rats infected with E coli, S aureus, and toxins—mimicking many of the bloodstream infections human sepsis patients experience. After 5 hours of filtering, about 90% of the bacteria and toxins were removed from the rats’ bloodstreams.

“We didn’t have to kill the pathogens,” said Michael Super, PhD, also of the Wyss Institute. “We just captured and removed them.”

What’s more, 90% of the treated animals survived, compared to 14% of the controls. And the modified MBL prevented the activation of complement factors and coagulation.

Biospleen device

Credit: Wyss Institute

A device inspired by the human spleen could change the way we treat sepsis, researchers say.

This “biospleen” was able to cleanse human blood in lab tests and increase survival in animals with infected blood.

Experiments showed that, in a matter of hours, the biospleen can filter live and dead pathogens from the blood, as well as dangerous toxins released from the pathogens.

The researchers detailed these experiments in Nature Medicine.

“Sepsis is a major medical threat, which is increasing because of antibiotic resistance,” said study author Donald Ingber, MD, PhD, of the Wyss Institute for Biologically Inspired Engineering in Boston, Massachusetts.

“We’re excited by the biospleen because it potentially provides a way to treat patients quickly without having to wait days to identify the source of infection, and it works equally well with antibiotic-resistant organisms. We hope to move this toward human testing [by] advancing to large animal studies as quickly as possible.”

The biospleen is a microfluidic device that works outside the body like a dialysis machine and removes living and dead microbes of all varieties, as well as toxins.

It consists of 2 adjacent, hollow channels that are connected to each other by a series of slits. One channel contains flowing blood, and the other has a saline solution that collects and removes the pathogens that travel through the slits.

Key to the success of the device are nanometer-sized magnetic beads coated with a genetically engineered version of the protein mannose binding lectin (MBL).

In its innate state, MBL has a branch-like “head” and a stick-like “tail.” The head binds to specific sugars on the surfaces of all sorts of bacteria, fungi, viruses, protozoa, and toxins, and the tail cues the immune system to destroy them.

However, other immune system proteins sometimes bind to the MBL tail and activate clotting and organ damage. So Dr Ingber and his colleagues used genetic engineering tools to lop off the tail and graft on a similar one from an antibody protein that does not cause these problems.

The team then attached the hybrid proteins to magnetic beads measuring 128 nanometers in diameter. These novel beads could be added to infected blood to bind to the pathogens and toxins without having to first identify the type of infectious agent.

The biospleen has a magnet that pulls the pathogen-coated magnetic beads through the channels to cleanse the blood flowing through the device, which can then be returned to the patient.

The researchers first tested the biospleen using human blood spiked with pathogens. They were able to filter blood faster than ever before, and the magnets efficiently pulled the beads—coated with pathogens—out of the blood.

More than 90% of key sepsis pathogens were bound and removed when the blood flowed through a single device at a rate of about 0.5 L to 1 L per hour. Many devices can be linked together to obtain levels required for human blood cleansing at dialysis-like rates.

Next, the researchers tested the device using rats infected with E coli, S aureus, and toxins—mimicking many of the bloodstream infections human sepsis patients experience. After 5 hours of filtering, about 90% of the bacteria and toxins were removed from the rats’ bloodstreams.

“We didn’t have to kill the pathogens,” said Michael Super, PhD, also of the Wyss Institute. “We just captured and removed them.”

What’s more, 90% of the treated animals survived, compared to 14% of the controls. And the modified MBL prevented the activation of complement factors and coagulation.

Publications
Hematology Times
MDedge Hematology and Oncology
Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Related Issues
Article Type
News
Display Headline
Spleen-like device could solve problems in treating sepsis
Display Headline
Spleen-like device could solve problems in treating sepsis
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Teaser Media

FDA approves new treatment for PI

Article Type
News
Changed
Mon, 09/15/2014 - 05:00
Display Headline
FDA approves new treatment for PI
Author(s)
HT Staff

HyQvia

Credit: Baxter

The US Food and Drug Administration (FDA) has approved a subcutaneous immune globulin product for use in adults with primary immunodeficiency (PI).

The product, HyQvia, is an immune globulin with a recombinant human hyaluronidase. It requires a single infusion every 3 to 4 weeks and 1 injection site per infusion to deliver a full therapeutic dose of immune globulin.

Current therapies require weekly or bi-weekly treatment with multiple infusion sites per treatment.

Baxter International Inc. expects to launch HyQvia in the US in the coming weeks. The product has been FDA-approved with a black-box warning detailing the risk of thrombosis associated with immune globulin products.

The immune globulin component of HyQvia is a 10% solution prepared from large pools of human plasma consisting of at least 98% IgG. The recombinant human hyaluronidase increases the dispersion and absorption of the immune globulin.

In a phase 3 trial, HyQvia compared well with intravenous human immune globulin 10% (IVIG).

Researchers compared the treatments at different time periods in a cohort of PI patients with a median age of 35 (range, 4-78 years). All 87 patients studied received IVIG, and 83 of the patients received at least 1 dose of HyQvia.

Patients received HyQvia for a median of 366 days and IVIG for a median of 91 days. The median ratio (HyQvia:IVIG) for the IgG dosage administered was 1.088 (range, 0.986–1.382).

Trough IgG concentrations, the incidence of infection, and rates of adverse events were generally similar during the HyQvia treatment period and the IVIG treatment period.

For patients aged 12 years and older, the median IgG Ctrough values with HyQvia were approximately the same as with IVIG. The median trough ratio (HyQvia:IVIG) was 0.985.

For patients younger than 12 (n=11), the median IgG Ctrough values were 10.0 and 9.6 g/L after HyQvia and IVIG, respectively, with a median trough ratio of 1.038.

The overall infection rates were 2.97 per patient-year with HyQvia and 4.51 per patient-year with IVIG.

During the HyQvia treatment period, the rate of acute serious bacterial infection (SBI) was 0.025 per patient-year. The rate of acute SBIs occurring during IVIG treatment was not reported.

In patients age 18 and older (n=59), the rate of acute SBIs was 0.00 per patient-year, and the overall infection rate was 3.20 per patient-year.

For this same patient group, the local adverse reaction rate was 0.286 per infusion.

The rate of systemic adverse events temporally related to an infusion was 0.20 per infusion with HyQvia and 0.33 per infusion with IVIG. There were no serious adverse events reported in these patients with either treatment.

HyQvia was approved in Europe in 2013 for adults with PI syndromes and myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections.

For more details on HyQvia, see the prescribing information.

Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Anemia
Leukemia, Myelodysplasia, Transplantation
Pharmacy
Related Issues
Author(s)
HT Staff
Author(s)
HT Staff

HyQvia

Credit: Baxter

The US Food and Drug Administration (FDA) has approved a subcutaneous immune globulin product for use in adults with primary immunodeficiency (PI).

The product, HyQvia, is an immune globulin with a recombinant human hyaluronidase. It requires a single infusion every 3 to 4 weeks and 1 injection site per infusion to deliver a full therapeutic dose of immune globulin.

Current therapies require weekly or bi-weekly treatment with multiple infusion sites per treatment.

Baxter International Inc. expects to launch HyQvia in the US in the coming weeks. The product has been FDA-approved with a black-box warning detailing the risk of thrombosis associated with immune globulin products.

The immune globulin component of HyQvia is a 10% solution prepared from large pools of human plasma consisting of at least 98% IgG. The recombinant human hyaluronidase increases the dispersion and absorption of the immune globulin.

In a phase 3 trial, HyQvia compared well with intravenous human immune globulin 10% (IVIG).

Researchers compared the treatments at different time periods in a cohort of PI patients with a median age of 35 (range, 4-78 years). All 87 patients studied received IVIG, and 83 of the patients received at least 1 dose of HyQvia.

Patients received HyQvia for a median of 366 days and IVIG for a median of 91 days. The median ratio (HyQvia:IVIG) for the IgG dosage administered was 1.088 (range, 0.986–1.382).

Trough IgG concentrations, the incidence of infection, and rates of adverse events were generally similar during the HyQvia treatment period and the IVIG treatment period.

For patients aged 12 years and older, the median IgG Ctrough values with HyQvia were approximately the same as with IVIG. The median trough ratio (HyQvia:IVIG) was 0.985.

For patients younger than 12 (n=11), the median IgG Ctrough values were 10.0 and 9.6 g/L after HyQvia and IVIG, respectively, with a median trough ratio of 1.038.

The overall infection rates were 2.97 per patient-year with HyQvia and 4.51 per patient-year with IVIG.

During the HyQvia treatment period, the rate of acute serious bacterial infection (SBI) was 0.025 per patient-year. The rate of acute SBIs occurring during IVIG treatment was not reported.

In patients age 18 and older (n=59), the rate of acute SBIs was 0.00 per patient-year, and the overall infection rate was 3.20 per patient-year.

For this same patient group, the local adverse reaction rate was 0.286 per infusion.

The rate of systemic adverse events temporally related to an infusion was 0.20 per infusion with HyQvia and 0.33 per infusion with IVIG. There were no serious adverse events reported in these patients with either treatment.

HyQvia was approved in Europe in 2013 for adults with PI syndromes and myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections.

For more details on HyQvia, see the prescribing information.

HyQvia

Credit: Baxter

The US Food and Drug Administration (FDA) has approved a subcutaneous immune globulin product for use in adults with primary immunodeficiency (PI).

The product, HyQvia, is an immune globulin with a recombinant human hyaluronidase. It requires a single infusion every 3 to 4 weeks and 1 injection site per infusion to deliver a full therapeutic dose of immune globulin.

Current therapies require weekly or bi-weekly treatment with multiple infusion sites per treatment.

Baxter International Inc. expects to launch HyQvia in the US in the coming weeks. The product has been FDA-approved with a black-box warning detailing the risk of thrombosis associated with immune globulin products.

The immune globulin component of HyQvia is a 10% solution prepared from large pools of human plasma consisting of at least 98% IgG. The recombinant human hyaluronidase increases the dispersion and absorption of the immune globulin.

In a phase 3 trial, HyQvia compared well with intravenous human immune globulin 10% (IVIG).

Researchers compared the treatments at different time periods in a cohort of PI patients with a median age of 35 (range, 4-78 years). All 87 patients studied received IVIG, and 83 of the patients received at least 1 dose of HyQvia.

Patients received HyQvia for a median of 366 days and IVIG for a median of 91 days. The median ratio (HyQvia:IVIG) for the IgG dosage administered was 1.088 (range, 0.986–1.382).

Trough IgG concentrations, the incidence of infection, and rates of adverse events were generally similar during the HyQvia treatment period and the IVIG treatment period.

For patients aged 12 years and older, the median IgG Ctrough values with HyQvia were approximately the same as with IVIG. The median trough ratio (HyQvia:IVIG) was 0.985.

For patients younger than 12 (n=11), the median IgG Ctrough values were 10.0 and 9.6 g/L after HyQvia and IVIG, respectively, with a median trough ratio of 1.038.

The overall infection rates were 2.97 per patient-year with HyQvia and 4.51 per patient-year with IVIG.

During the HyQvia treatment period, the rate of acute serious bacterial infection (SBI) was 0.025 per patient-year. The rate of acute SBIs occurring during IVIG treatment was not reported.

In patients age 18 and older (n=59), the rate of acute SBIs was 0.00 per patient-year, and the overall infection rate was 3.20 per patient-year.

For this same patient group, the local adverse reaction rate was 0.286 per infusion.

The rate of systemic adverse events temporally related to an infusion was 0.20 per infusion with HyQvia and 0.33 per infusion with IVIG. There were no serious adverse events reported in these patients with either treatment.

HyQvia was approved in Europe in 2013 for adults with PI syndromes and myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections.

For more details on HyQvia, see the prescribing information.

Publications
Hematology Times
MDedge Hematology and Oncology
Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Anemia
Leukemia, Myelodysplasia, Transplantation
Pharmacy
Related Issues
Article Type
News
Display Headline
FDA approves new treatment for PI
Display Headline
FDA approves new treatment for PI
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Teaser Media

Palliative Care for Patients With Head and Neck Cancer

Article Type
Video
Changed
Tue, 12/13/2016 - 12:08
Display Headline
Palliative Care for Patients With Head and Neck Cancer
Dr. Mark Klein discusses his research and poster presentation from the 2014 AVAHO Meeting in Portland, Oregon.

Mark Klein, MD, and his team of fellow researchers came to the 2014 AVAHO Meeting to present their poster presentation, Incorporation of Palliative Care with Chemotherapy and Radiation in Patients Treated for Head and Neck Cancer.

To hear Dr. Klein discuss his research, watch the video below.

 

 

Publications
AVAHO
Topics
Head & Neck/Thyroid Cancers
Hospice & Palliative Medicine
Legacy Keywords
Oncology, hematology, head and neck cancer, cancer, AVAHO, veterans affairs, Minneapolis, Minnesota, VA
Sections
Conference Coverage
Dr. Mark Klein discusses his research and poster presentation from the 2014 AVAHO Meeting in Portland, Oregon.
Dr. Mark Klein discusses his research and poster presentation from the 2014 AVAHO Meeting in Portland, Oregon.

Mark Klein, MD, and his team of fellow researchers came to the 2014 AVAHO Meeting to present their poster presentation, Incorporation of Palliative Care with Chemotherapy and Radiation in Patients Treated for Head and Neck Cancer.

To hear Dr. Klein discuss his research, watch the video below.

 

 

Mark Klein, MD, and his team of fellow researchers came to the 2014 AVAHO Meeting to present their poster presentation, Incorporation of Palliative Care with Chemotherapy and Radiation in Patients Treated for Head and Neck Cancer.

To hear Dr. Klein discuss his research, watch the video below.

 

 

Publications
AVAHO
Publications
AVAHO
Topics
Head & Neck/Thyroid Cancers
Hospice & Palliative Medicine
Article Type
Video
Display Headline
Palliative Care for Patients With Head and Neck Cancer
Display Headline
Palliative Care for Patients With Head and Neck Cancer
Legacy Keywords
Oncology, hematology, head and neck cancer, cancer, AVAHO, veterans affairs, Minneapolis, Minnesota, VA
Legacy Keywords
Oncology, hematology, head and neck cancer, cancer, AVAHO, veterans affairs, Minneapolis, Minnesota, VA
Sections
Conference Coverage
Disallow All Ads
Teaser Media

Using Data to Improve Lung Cancer Screening

Article Type
News
Changed
Tue, 12/13/2016 - 12:08
Display Headline
Using Data to Improve Lung Cancer Screening
Dr. Michael Kelley discusses how the collection of data has the capability to reduce mortality associated with lung cancer among veterans.

Michael Kelley, MD, presented a session on how an improved understanding of lung cancer screening in the VA Health Care System can help physicians better identify the inherent biases associated with uncontrolled trials. According to Kelley—who works as the national program director of oncology for the Durham VAMC in North Carolina—patients with lung cancer can often face biases such as the healthy volunteer bias, the lead-time bias, and the overdiagnosis bias. These can often lead to a misidentification and failure to send the right candidates for screening.

Dr. Kelley’s presentation discussed a limited pilot study being conducted by the VA known as the National Lung Screening Trial. This aim of the trial is to collect data to help identify the right candidates for screening and to determine if additional tests, such as CT scans, can help identify barriers in lung cancer treatment. Dr. Kelley hopes that the inclusion of this data during lung cancer screening can reduce and eventually eliminate lung cancer-associated mortality in the VA.

Publications
AVAHO
Topics
Lung Cancer
Legacy Keywords
Lung cancer, 2014 AVAHO Meeting, Portland, Michael Kelley, Oregon, Oncology, Hematology, Durham VAMC, Veterans Affairs, VA
Sections
Conference Coverage
Dr. Michael Kelley discusses how the collection of data has the capability to reduce mortality associated with lung cancer among veterans.
Dr. Michael Kelley discusses how the collection of data has the capability to reduce mortality associated with lung cancer among veterans.

Michael Kelley, MD, presented a session on how an improved understanding of lung cancer screening in the VA Health Care System can help physicians better identify the inherent biases associated with uncontrolled trials. According to Kelley—who works as the national program director of oncology for the Durham VAMC in North Carolina—patients with lung cancer can often face biases such as the healthy volunteer bias, the lead-time bias, and the overdiagnosis bias. These can often lead to a misidentification and failure to send the right candidates for screening.

Dr. Kelley’s presentation discussed a limited pilot study being conducted by the VA known as the National Lung Screening Trial. This aim of the trial is to collect data to help identify the right candidates for screening and to determine if additional tests, such as CT scans, can help identify barriers in lung cancer treatment. Dr. Kelley hopes that the inclusion of this data during lung cancer screening can reduce and eventually eliminate lung cancer-associated mortality in the VA.

Michael Kelley, MD, presented a session on how an improved understanding of lung cancer screening in the VA Health Care System can help physicians better identify the inherent biases associated with uncontrolled trials. According to Kelley—who works as the national program director of oncology for the Durham VAMC in North Carolina—patients with lung cancer can often face biases such as the healthy volunteer bias, the lead-time bias, and the overdiagnosis bias. These can often lead to a misidentification and failure to send the right candidates for screening.

Dr. Kelley’s presentation discussed a limited pilot study being conducted by the VA known as the National Lung Screening Trial. This aim of the trial is to collect data to help identify the right candidates for screening and to determine if additional tests, such as CT scans, can help identify barriers in lung cancer treatment. Dr. Kelley hopes that the inclusion of this data during lung cancer screening can reduce and eventually eliminate lung cancer-associated mortality in the VA.

Publications
AVAHO
Publications
AVAHO
Topics
Lung Cancer
Article Type
News
Display Headline
Using Data to Improve Lung Cancer Screening
Display Headline
Using Data to Improve Lung Cancer Screening
Legacy Keywords
Lung cancer, 2014 AVAHO Meeting, Portland, Michael Kelley, Oregon, Oncology, Hematology, Durham VAMC, Veterans Affairs, VA
Legacy Keywords
Lung cancer, 2014 AVAHO Meeting, Portland, Michael Kelley, Oregon, Oncology, Hematology, Durham VAMC, Veterans Affairs, VA
Sections
Conference Coverage
Disallow All Ads

Test allows for rapid diagnosis of anemia

Article Type
News
Changed
Sun, 09/14/2014 - 05:00
Display Headline
Test allows for rapid diagnosis of anemia
Author(s)
HT Staff

Anemia testing device

Credit: Gary Meek

A simple device could provide more rapid diagnosis of anemia and allow for inexpensive at-home monitoring, according to a paper published in The Journal of Clinical Investigation.

The disposable device analyzes a single droplet of blood using a chemical reagent that produces visible color changes corresponding to different levels of anemia.

The test produces results in about 60 seconds, and a smartphone application can correlate the visual results to specific hemoglobin levels.

“Our goal is to get this device into patients’ hands so they can diagnose and monitor anemia themselves,” said Wilbur Lam, MD, PhD, of the Georgia Institute of Technology and Emory University in Atlanta.

“Patients could use this device in a way that’s very similar to how diabetics use glucose-monitoring devices, but this will be even simpler because this is a visual-based test that doesn’t require an additional electrical device to analyze the results.”

The device was developed through a collaboration between Emory University, Children’s Healthcare of Atlanta, and Georgia Tech. It grew out of a 2011 undergraduate senior design project in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

Using a 2-piece prototype device, the test works this way: A patient sticks a finger with a lance to produce a droplet of blood. The device’s cap, a small vial, is touched to the droplet, drawing in a precise amount of blood using capillary action.

The cap containing the blood sample is then placed onto the body of the clear plastic test kit, which contains the chemical reagent. After the cap is closed, the device is briefly shaken to mix the blood and reagent.

“When the capillary is filled, we have a very precise volume of blood, about 5 microliters, which is less than a droplet—much less than what is required by other anemia tests,” explained Erika Tyburski, the paper’s first author and leader of the team that developed the device.

Hemoglobin then serves as a catalyst for a reduction-oxidation reaction that takes place in the device. After about 45 seconds, the reaction is complete, and the user sees a color ranging from green-blue to red, indicating the degree of anemia.

A label on the device helps with interpretation of the color, or patients could use a smartphone app that automatically correlates the color to a specific hemoglobin level.

To evaluate sensitivity and specificity of the device, Tyburski studied blood taken from 238 pediatric and adult patients. Each blood sample was tested 4 times using the device, and the results were compared to reports provided by conventional hematology analyzers.

The results of the 1-minute test were consistent with those of the conventional analyses. The smartphone app produced the best results for measuring severe anemia.

“The test doesn’t require a skilled technician or a draw of venous blood, and you see the results immediately,” Dr Lam said. “We think this is an empowering system, both for the general public and for our patients.”

Tyburski and Dr Lam have teamed up with 2 other partners to launch a startup company called Sanguina to commercialize the test, which will be known as AnemoCheck™.

The test will require approval from the US Food and Drug Administration, but the researchers believe the device could be on pharmacy shelves sometime in 2016.

The team also plans to study how the test may be applied to sickle cell anemia and other diseases.

Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Anemia
Author(s)
HT Staff
Author(s)
HT Staff

Anemia testing device

Credit: Gary Meek

A simple device could provide more rapid diagnosis of anemia and allow for inexpensive at-home monitoring, according to a paper published in The Journal of Clinical Investigation.

The disposable device analyzes a single droplet of blood using a chemical reagent that produces visible color changes corresponding to different levels of anemia.

The test produces results in about 60 seconds, and a smartphone application can correlate the visual results to specific hemoglobin levels.

“Our goal is to get this device into patients’ hands so they can diagnose and monitor anemia themselves,” said Wilbur Lam, MD, PhD, of the Georgia Institute of Technology and Emory University in Atlanta.

“Patients could use this device in a way that’s very similar to how diabetics use glucose-monitoring devices, but this will be even simpler because this is a visual-based test that doesn’t require an additional electrical device to analyze the results.”

The device was developed through a collaboration between Emory University, Children’s Healthcare of Atlanta, and Georgia Tech. It grew out of a 2011 undergraduate senior design project in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

Using a 2-piece prototype device, the test works this way: A patient sticks a finger with a lance to produce a droplet of blood. The device’s cap, a small vial, is touched to the droplet, drawing in a precise amount of blood using capillary action.

The cap containing the blood sample is then placed onto the body of the clear plastic test kit, which contains the chemical reagent. After the cap is closed, the device is briefly shaken to mix the blood and reagent.

“When the capillary is filled, we have a very precise volume of blood, about 5 microliters, which is less than a droplet—much less than what is required by other anemia tests,” explained Erika Tyburski, the paper’s first author and leader of the team that developed the device.

Hemoglobin then serves as a catalyst for a reduction-oxidation reaction that takes place in the device. After about 45 seconds, the reaction is complete, and the user sees a color ranging from green-blue to red, indicating the degree of anemia.

A label on the device helps with interpretation of the color, or patients could use a smartphone app that automatically correlates the color to a specific hemoglobin level.

To evaluate sensitivity and specificity of the device, Tyburski studied blood taken from 238 pediatric and adult patients. Each blood sample was tested 4 times using the device, and the results were compared to reports provided by conventional hematology analyzers.

The results of the 1-minute test were consistent with those of the conventional analyses. The smartphone app produced the best results for measuring severe anemia.

“The test doesn’t require a skilled technician or a draw of venous blood, and you see the results immediately,” Dr Lam said. “We think this is an empowering system, both for the general public and for our patients.”

Tyburski and Dr Lam have teamed up with 2 other partners to launch a startup company called Sanguina to commercialize the test, which will be known as AnemoCheck™.

The test will require approval from the US Food and Drug Administration, but the researchers believe the device could be on pharmacy shelves sometime in 2016.

The team also plans to study how the test may be applied to sickle cell anemia and other diseases.

Anemia testing device

Credit: Gary Meek

A simple device could provide more rapid diagnosis of anemia and allow for inexpensive at-home monitoring, according to a paper published in The Journal of Clinical Investigation.

The disposable device analyzes a single droplet of blood using a chemical reagent that produces visible color changes corresponding to different levels of anemia.

The test produces results in about 60 seconds, and a smartphone application can correlate the visual results to specific hemoglobin levels.

“Our goal is to get this device into patients’ hands so they can diagnose and monitor anemia themselves,” said Wilbur Lam, MD, PhD, of the Georgia Institute of Technology and Emory University in Atlanta.

“Patients could use this device in a way that’s very similar to how diabetics use glucose-monitoring devices, but this will be even simpler because this is a visual-based test that doesn’t require an additional electrical device to analyze the results.”

The device was developed through a collaboration between Emory University, Children’s Healthcare of Atlanta, and Georgia Tech. It grew out of a 2011 undergraduate senior design project in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

Using a 2-piece prototype device, the test works this way: A patient sticks a finger with a lance to produce a droplet of blood. The device’s cap, a small vial, is touched to the droplet, drawing in a precise amount of blood using capillary action.

The cap containing the blood sample is then placed onto the body of the clear plastic test kit, which contains the chemical reagent. After the cap is closed, the device is briefly shaken to mix the blood and reagent.

“When the capillary is filled, we have a very precise volume of blood, about 5 microliters, which is less than a droplet—much less than what is required by other anemia tests,” explained Erika Tyburski, the paper’s first author and leader of the team that developed the device.

Hemoglobin then serves as a catalyst for a reduction-oxidation reaction that takes place in the device. After about 45 seconds, the reaction is complete, and the user sees a color ranging from green-blue to red, indicating the degree of anemia.

A label on the device helps with interpretation of the color, or patients could use a smartphone app that automatically correlates the color to a specific hemoglobin level.

To evaluate sensitivity and specificity of the device, Tyburski studied blood taken from 238 pediatric and adult patients. Each blood sample was tested 4 times using the device, and the results were compared to reports provided by conventional hematology analyzers.

The results of the 1-minute test were consistent with those of the conventional analyses. The smartphone app produced the best results for measuring severe anemia.

“The test doesn’t require a skilled technician or a draw of venous blood, and you see the results immediately,” Dr Lam said. “We think this is an empowering system, both for the general public and for our patients.”

Tyburski and Dr Lam have teamed up with 2 other partners to launch a startup company called Sanguina to commercialize the test, which will be known as AnemoCheck™.

The test will require approval from the US Food and Drug Administration, but the researchers believe the device could be on pharmacy shelves sometime in 2016.

The team also plans to study how the test may be applied to sickle cell anemia and other diseases.

Publications
Hematology Times
MDedge Hematology and Oncology
Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Anemia
Article Type
News
Display Headline
Test allows for rapid diagnosis of anemia
Display Headline
Test allows for rapid diagnosis of anemia
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Teaser Media

Heparin lot recalled due to particulate

Article Type
News
Changed
Sat, 09/13/2014 - 05:00
Display Headline
Heparin lot recalled due to particulate
Author(s)
HT Staff

Vial of heparin

Hospira Inc. has initiated a US-wide recall of 1 lot of heparin sodium, following a customer report of particulate in a single unit.

The recall affects lot 41-046-JT of 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL (NDC 0409-7620-03; expiration date November 1, 2015).

The foreign particle found in a unit from this lot was a human hair sealed between the tube and the film at the round seal of the unused administrative port on the non-print side of the container.

To date, Hospira has not received reports of any adverse events associated with this issue. The root cause has not been determined and is under investigation.

Heparin sodium injection is indicated as an anticoagulant to maintain catheter patency. In the event that a particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.

Capillaries may become occluded. Patients with a pre-existing condition of trauma or another medical condition that adversely affects the microvascular blood supply are at an increased risk.

The lot of heparin affected by this recall was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals, and pharmacies.

Anyone with existing inventory should stop use and distribution and quarantine the product immediately. Customers should also inform potential users of this product about the recall.

Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for the impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-855-201-4337 between the hours of 8 am and 5pm ET, Monday through Friday.

For clinical inquiries, contact Hospira. To report adverse events or product complaints, call 1-800-441-4100 (8 am to 5 pm CT, Monday through Friday) or email [email protected].

For medical inquiries, call 1-800-615-0187 (available 24 hours a day, 7 days per week) or email [email protected].

Adverse reactions or quality problems associated with this product can be reported to the US Food and Drug Administration’s MedWatch Adverse Event Reporting Program.

Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Thrombosis
Pharmacy
Author(s)
HT Staff
Author(s)
HT Staff

Vial of heparin

Hospira Inc. has initiated a US-wide recall of 1 lot of heparin sodium, following a customer report of particulate in a single unit.

The recall affects lot 41-046-JT of 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL (NDC 0409-7620-03; expiration date November 1, 2015).

The foreign particle found in a unit from this lot was a human hair sealed between the tube and the film at the round seal of the unused administrative port on the non-print side of the container.

To date, Hospira has not received reports of any adverse events associated with this issue. The root cause has not been determined and is under investigation.

Heparin sodium injection is indicated as an anticoagulant to maintain catheter patency. In the event that a particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.

Capillaries may become occluded. Patients with a pre-existing condition of trauma or another medical condition that adversely affects the microvascular blood supply are at an increased risk.

The lot of heparin affected by this recall was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals, and pharmacies.

Anyone with existing inventory should stop use and distribution and quarantine the product immediately. Customers should also inform potential users of this product about the recall.

Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for the impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-855-201-4337 between the hours of 8 am and 5pm ET, Monday through Friday.

For clinical inquiries, contact Hospira. To report adverse events or product complaints, call 1-800-441-4100 (8 am to 5 pm CT, Monday through Friday) or email [email protected].

For medical inquiries, call 1-800-615-0187 (available 24 hours a day, 7 days per week) or email [email protected].

Adverse reactions or quality problems associated with this product can be reported to the US Food and Drug Administration’s MedWatch Adverse Event Reporting Program.

Vial of heparin

Hospira Inc. has initiated a US-wide recall of 1 lot of heparin sodium, following a customer report of particulate in a single unit.

The recall affects lot 41-046-JT of 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL (NDC 0409-7620-03; expiration date November 1, 2015).

The foreign particle found in a unit from this lot was a human hair sealed between the tube and the film at the round seal of the unused administrative port on the non-print side of the container.

To date, Hospira has not received reports of any adverse events associated with this issue. The root cause has not been determined and is under investigation.

Heparin sodium injection is indicated as an anticoagulant to maintain catheter patency. In the event that a particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.

Capillaries may become occluded. Patients with a pre-existing condition of trauma or another medical condition that adversely affects the microvascular blood supply are at an increased risk.

The lot of heparin affected by this recall was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals, and pharmacies.

Anyone with existing inventory should stop use and distribution and quarantine the product immediately. Customers should also inform potential users of this product about the recall.

Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for the impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-855-201-4337 between the hours of 8 am and 5pm ET, Monday through Friday.

For clinical inquiries, contact Hospira. To report adverse events or product complaints, call 1-800-441-4100 (8 am to 5 pm CT, Monday through Friday) or email [email protected].

For medical inquiries, call 1-800-615-0187 (available 24 hours a day, 7 days per week) or email [email protected].

Adverse reactions or quality problems associated with this product can be reported to the US Food and Drug Administration’s MedWatch Adverse Event Reporting Program.

Publications
Hematology Times
MDedge Hematology and Oncology
Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Thrombosis
Pharmacy
Article Type
News
Display Headline
Heparin lot recalled due to particulate
Display Headline
Heparin lot recalled due to particulate
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Teaser Media

Sunlight and suicide

Article Type
News
Changed
Mon, 04/16/2018 - 13:35
Display Headline
Sunlight and suicide
Author(s)
Dr. Annette Hanson

Ever since the 2001 attack on the World Trade Center, I have associated a bright, sunny day with disaster. I vividly remember what a beautiful morning that was -- a crystal blue cloudless sky, low humidity, and a cool, comfortable temperature. Who could be unhappy on such a marvelous day?

On the other hand, my experience living in a northern climate taught me that winter was another story. Getting up in the dark to go to school or work was a miserable experience, followed by coming home in the dark and endless hours of biting cold and bitter nights. I was not surprised to learn later in my residency training about seasonal affective disorder and about the effects of light on mood. With this background, I felt primed to write a column about a new study, "Direct Effect of Sunshine on Suicide" (JAMA Psychiatry 2014 Sept. 10 [doi:10.1001/jamapsychiatry.2014.1198]).

In this study, investigators looked at public records of confirmed suicides in Austria between January 1970 and May 2010.They gathered 40 years of daily sunlight data from 86 meteorological stations. The amount of sunlight was defined as the duration of time that light intensity was higher than 120 watts per square meter, which apparently is the amount of light typically seen just after sunrise or just before sunset. Using this information, they compared daily suicide rates with the average daily duration of sunshine. Since sunlight varies in both duration and intensity over the seasons, the researchers used statistical methods to compensate for this, which distinguished this work from previous similar suicide studies. The authors then compared suicide rates by gender and method.

There were 69,462 suicide deaths, the majority through violent means such as hanging, drowning, shooting, or jumping. Only a quarter of the deaths were through nonviolent means such as poisoning. A significant correlation was found between the daily suicide rate and the daily duration of sunshine, but the surprising result was that sunshine appeared to have both a provocative and a palliative effect. Suicide rates climbed with increasing sunshine during the 10 days leading up to a suicide for suicides as a whole, for suicide through violent means, and for women. Sunlight had no effect on suicides for nonviolent deaths.

As a group, there was a negative correlation with deaths for the 14-60 days prior to a given suicide. Violent suicides were less likely during this time. The effects of sunshine also were specific to gender. There was a negative correlation, or apparently a protective effect, for men but not for women in the preceding 14-60 days.

Many physiologic reasons explain why light can affect mood, such as disruption of circadian rhythms and altered melatonin levels, or disturbances in serotonin or monoamine systems. There have also been social explanations for why suicides show seasonal variation. The "winter blues" have been explained by the stress of holiday preparation and its associated high expectations, family conflict, and increased alcohol use around this time. The authors concluded that one reason sunlight may increase suicide rates is that sunlight may improve motivation before lifting mood, giving a person the impetus to act on self-destructive impulses.

How this relates to the use of light boxes to treat seasonal affective disorder remains to be seen. Traditionally, this intervention is favored because of the relatively few associated hazards and side effects compared to pharmacotherapy. This risk-benefit ratio may need to be reassessed as more studies address the sunlight-suicide connection. Still, given that these devices are not Food and Drug Administration‑regulated or approved, I doubt we will be seeing the equivalent of a “black box” warning anytime in the near future.

Dr. Hanson is a forensic psychiatrist and coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work.” The opinions expressed are those of the author only, and do not represent those of any of Dr. Hanson's employers or consultees, including the Maryland Department of Health and Mental Hygiene or the Maryland Division of Correction.

References

Author and Disclosure Information

Publications
MDedge Psychiatry
Clinical Psychiatry News
Legacy Keywords
suicide, shrink rap
Sections
Shrink Rap News
Author(s)
Dr. Annette Hanson
Author(s)
Dr. Annette Hanson
Author and Disclosure Information

Author and Disclosure Information

Ever since the 2001 attack on the World Trade Center, I have associated a bright, sunny day with disaster. I vividly remember what a beautiful morning that was -- a crystal blue cloudless sky, low humidity, and a cool, comfortable temperature. Who could be unhappy on such a marvelous day?

On the other hand, my experience living in a northern climate taught me that winter was another story. Getting up in the dark to go to school or work was a miserable experience, followed by coming home in the dark and endless hours of biting cold and bitter nights. I was not surprised to learn later in my residency training about seasonal affective disorder and about the effects of light on mood. With this background, I felt primed to write a column about a new study, "Direct Effect of Sunshine on Suicide" (JAMA Psychiatry 2014 Sept. 10 [doi:10.1001/jamapsychiatry.2014.1198]).

In this study, investigators looked at public records of confirmed suicides in Austria between January 1970 and May 2010.They gathered 40 years of daily sunlight data from 86 meteorological stations. The amount of sunlight was defined as the duration of time that light intensity was higher than 120 watts per square meter, which apparently is the amount of light typically seen just after sunrise or just before sunset. Using this information, they compared daily suicide rates with the average daily duration of sunshine. Since sunlight varies in both duration and intensity over the seasons, the researchers used statistical methods to compensate for this, which distinguished this work from previous similar suicide studies. The authors then compared suicide rates by gender and method.

There were 69,462 suicide deaths, the majority through violent means such as hanging, drowning, shooting, or jumping. Only a quarter of the deaths were through nonviolent means such as poisoning. A significant correlation was found between the daily suicide rate and the daily duration of sunshine, but the surprising result was that sunshine appeared to have both a provocative and a palliative effect. Suicide rates climbed with increasing sunshine during the 10 days leading up to a suicide for suicides as a whole, for suicide through violent means, and for women. Sunlight had no effect on suicides for nonviolent deaths.

As a group, there was a negative correlation with deaths for the 14-60 days prior to a given suicide. Violent suicides were less likely during this time. The effects of sunshine also were specific to gender. There was a negative correlation, or apparently a protective effect, for men but not for women in the preceding 14-60 days.

Many physiologic reasons explain why light can affect mood, such as disruption of circadian rhythms and altered melatonin levels, or disturbances in serotonin or monoamine systems. There have also been social explanations for why suicides show seasonal variation. The "winter blues" have been explained by the stress of holiday preparation and its associated high expectations, family conflict, and increased alcohol use around this time. The authors concluded that one reason sunlight may increase suicide rates is that sunlight may improve motivation before lifting mood, giving a person the impetus to act on self-destructive impulses.

How this relates to the use of light boxes to treat seasonal affective disorder remains to be seen. Traditionally, this intervention is favored because of the relatively few associated hazards and side effects compared to pharmacotherapy. This risk-benefit ratio may need to be reassessed as more studies address the sunlight-suicide connection. Still, given that these devices are not Food and Drug Administration‑regulated or approved, I doubt we will be seeing the equivalent of a “black box” warning anytime in the near future.

Dr. Hanson is a forensic psychiatrist and coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work.” The opinions expressed are those of the author only, and do not represent those of any of Dr. Hanson's employers or consultees, including the Maryland Department of Health and Mental Hygiene or the Maryland Division of Correction.

Ever since the 2001 attack on the World Trade Center, I have associated a bright, sunny day with disaster. I vividly remember what a beautiful morning that was -- a crystal blue cloudless sky, low humidity, and a cool, comfortable temperature. Who could be unhappy on such a marvelous day?

On the other hand, my experience living in a northern climate taught me that winter was another story. Getting up in the dark to go to school or work was a miserable experience, followed by coming home in the dark and endless hours of biting cold and bitter nights. I was not surprised to learn later in my residency training about seasonal affective disorder and about the effects of light on mood. With this background, I felt primed to write a column about a new study, "Direct Effect of Sunshine on Suicide" (JAMA Psychiatry 2014 Sept. 10 [doi:10.1001/jamapsychiatry.2014.1198]).

In this study, investigators looked at public records of confirmed suicides in Austria between January 1970 and May 2010.They gathered 40 years of daily sunlight data from 86 meteorological stations. The amount of sunlight was defined as the duration of time that light intensity was higher than 120 watts per square meter, which apparently is the amount of light typically seen just after sunrise or just before sunset. Using this information, they compared daily suicide rates with the average daily duration of sunshine. Since sunlight varies in both duration and intensity over the seasons, the researchers used statistical methods to compensate for this, which distinguished this work from previous similar suicide studies. The authors then compared suicide rates by gender and method.

There were 69,462 suicide deaths, the majority through violent means such as hanging, drowning, shooting, or jumping. Only a quarter of the deaths were through nonviolent means such as poisoning. A significant correlation was found between the daily suicide rate and the daily duration of sunshine, but the surprising result was that sunshine appeared to have both a provocative and a palliative effect. Suicide rates climbed with increasing sunshine during the 10 days leading up to a suicide for suicides as a whole, for suicide through violent means, and for women. Sunlight had no effect on suicides for nonviolent deaths.

As a group, there was a negative correlation with deaths for the 14-60 days prior to a given suicide. Violent suicides were less likely during this time. The effects of sunshine also were specific to gender. There was a negative correlation, or apparently a protective effect, for men but not for women in the preceding 14-60 days.

Many physiologic reasons explain why light can affect mood, such as disruption of circadian rhythms and altered melatonin levels, or disturbances in serotonin or monoamine systems. There have also been social explanations for why suicides show seasonal variation. The "winter blues" have been explained by the stress of holiday preparation and its associated high expectations, family conflict, and increased alcohol use around this time. The authors concluded that one reason sunlight may increase suicide rates is that sunlight may improve motivation before lifting mood, giving a person the impetus to act on self-destructive impulses.

How this relates to the use of light boxes to treat seasonal affective disorder remains to be seen. Traditionally, this intervention is favored because of the relatively few associated hazards and side effects compared to pharmacotherapy. This risk-benefit ratio may need to be reassessed as more studies address the sunlight-suicide connection. Still, given that these devices are not Food and Drug Administration‑regulated or approved, I doubt we will be seeing the equivalent of a “black box” warning anytime in the near future.

Dr. Hanson is a forensic psychiatrist and coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work.” The opinions expressed are those of the author only, and do not represent those of any of Dr. Hanson's employers or consultees, including the Maryland Department of Health and Mental Hygiene or the Maryland Division of Correction.

References

References

Publications
MDedge Psychiatry
Clinical Psychiatry News
Publications
MDedge Psychiatry
Clinical Psychiatry News
Article Type
News
Display Headline
Sunlight and suicide
Display Headline
Sunlight and suicide
Legacy Keywords
suicide, shrink rap
Legacy Keywords
suicide, shrink rap
Sections
Shrink Rap News
Article Source

PURLs Copyright

Inside the Article

Teaser Media

Patients with Ph-like ALL may benefit from TKIs

Article Type
News
Changed
Fri, 09/12/2014 - 06:00
Display Headline
Patients with Ph-like ALL may benefit from TKIs
Author(s)
HT Staff

Charles Mullighan, MD, MBBS

Credit: St Jude Children’s

Research Hospital

New research indicates that Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL) becomes more common with age and is associated with poor prognosis.

The study also showed that Ph-like ALL is characterized by genomic alterations that might make patients receptive to treatment with tyrosine kinase inhibitors (TKIs).

Initial tests in a small number of patients seem to support this theory, but trials are needed to verify and expand upon these results, according to researchers.

Charles Mullighan, MD, MBBS, of the St Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues reported the results in The New England Journal of Medicine.

Age and prognosis

The researchers performed genomic profiling of 1725 patients with precursor B-cell ALL, detailed genomic analyses of 154 patients with Ph-like ALL, and transcriptome sequencing for 160 patients with non-Ph-like ALL.

The team found the prevalence of Ph-like ALL increased significantly with age, from 10% among children with standard-risk B-ALL (ages 1 to 9) and 13% among those with high-risk ALL (ages 10 to 15) to 21% among adolescents (ages 16 to 20) and 27% among young adults with ALL (ages 21 to 39).

Regardless of their age, patients with Ph-like ALL were less likely than other B-ALL patients to be alive and leukemia-free 5 years after diagnosis.

Overall survival for children, adolescents, and young adults with Ph-like ALL was 62%, compared to 91% for other B-ALL patients of the same age. Leukemia-free survival was about 47% for patients with Ph-like ALL and about 83% for other patients.

Genomic alterations and TKI treatment

The researchers found that 91% of patients with Ph-like ALL had chromosomal rearrangements or other genetic alterations that activate cytokine receptor or kinase signaling.

“We identified several new subgroups of Ph-like ALL that were distinguished by the type of cytokine receptor or kinase gene alteration,” said Kathryn Roberts, PhD, also of St Jude Children’s Research Hospital.

Evidence suggests that several of these subtypes would be vulnerable to TKIs and other targeted therapies. For example, about 12% of patients had rearrangements involving the genes ABL1, ABL2, CSF1R, and PDGFRB, which are known to respond to dasatinib and related TKIs.

Other Ph-like ALL patients had gene rearrangements involving JAK2, EPOR, and other genes that can be targeted by the drug ruxolitinib.

To determine if TKIs are effective in these patients, the researchers administered TKIs to 12 patients with Ph-ALL. Follow-up is not sufficient for all of the patients, but 5 achieved remission following TKI treatment (alone, with chemotherapy, or followed by transplant), and 1 patient has been in remission for more than a year.

“We showed that Ph-like ALL is a common disease that spans the age spectrum, and we identified new genomic alterations that converge on a handful of signaling pathways that are vulnerable to treatment with tyrosine kinase inhibitors,” Dr Mullighan said. “The findings lead the way for clinical trials that could help to transform the outlook for patients, regardless of age.”

A study testing TKI therapy in children with Ph-like ALL is scheduled to begin later this year or early in 2015.

Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Leukemia, Myelodysplasia, Transplantation
Pediatrics
ALL
Author(s)
HT Staff
Author(s)
HT Staff

Charles Mullighan, MD, MBBS

Credit: St Jude Children’s

Research Hospital

New research indicates that Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL) becomes more common with age and is associated with poor prognosis.

The study also showed that Ph-like ALL is characterized by genomic alterations that might make patients receptive to treatment with tyrosine kinase inhibitors (TKIs).

Initial tests in a small number of patients seem to support this theory, but trials are needed to verify and expand upon these results, according to researchers.

Charles Mullighan, MD, MBBS, of the St Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues reported the results in The New England Journal of Medicine.

Age and prognosis

The researchers performed genomic profiling of 1725 patients with precursor B-cell ALL, detailed genomic analyses of 154 patients with Ph-like ALL, and transcriptome sequencing for 160 patients with non-Ph-like ALL.

The team found the prevalence of Ph-like ALL increased significantly with age, from 10% among children with standard-risk B-ALL (ages 1 to 9) and 13% among those with high-risk ALL (ages 10 to 15) to 21% among adolescents (ages 16 to 20) and 27% among young adults with ALL (ages 21 to 39).

Regardless of their age, patients with Ph-like ALL were less likely than other B-ALL patients to be alive and leukemia-free 5 years after diagnosis.

Overall survival for children, adolescents, and young adults with Ph-like ALL was 62%, compared to 91% for other B-ALL patients of the same age. Leukemia-free survival was about 47% for patients with Ph-like ALL and about 83% for other patients.

Genomic alterations and TKI treatment

The researchers found that 91% of patients with Ph-like ALL had chromosomal rearrangements or other genetic alterations that activate cytokine receptor or kinase signaling.

“We identified several new subgroups of Ph-like ALL that were distinguished by the type of cytokine receptor or kinase gene alteration,” said Kathryn Roberts, PhD, also of St Jude Children’s Research Hospital.

Evidence suggests that several of these subtypes would be vulnerable to TKIs and other targeted therapies. For example, about 12% of patients had rearrangements involving the genes ABL1, ABL2, CSF1R, and PDGFRB, which are known to respond to dasatinib and related TKIs.

Other Ph-like ALL patients had gene rearrangements involving JAK2, EPOR, and other genes that can be targeted by the drug ruxolitinib.

To determine if TKIs are effective in these patients, the researchers administered TKIs to 12 patients with Ph-ALL. Follow-up is not sufficient for all of the patients, but 5 achieved remission following TKI treatment (alone, with chemotherapy, or followed by transplant), and 1 patient has been in remission for more than a year.

“We showed that Ph-like ALL is a common disease that spans the age spectrum, and we identified new genomic alterations that converge on a handful of signaling pathways that are vulnerable to treatment with tyrosine kinase inhibitors,” Dr Mullighan said. “The findings lead the way for clinical trials that could help to transform the outlook for patients, regardless of age.”

A study testing TKI therapy in children with Ph-like ALL is scheduled to begin later this year or early in 2015.

Charles Mullighan, MD, MBBS

Credit: St Jude Children’s

Research Hospital

New research indicates that Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL) becomes more common with age and is associated with poor prognosis.

The study also showed that Ph-like ALL is characterized by genomic alterations that might make patients receptive to treatment with tyrosine kinase inhibitors (TKIs).

Initial tests in a small number of patients seem to support this theory, but trials are needed to verify and expand upon these results, according to researchers.

Charles Mullighan, MD, MBBS, of the St Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues reported the results in The New England Journal of Medicine.

Age and prognosis

The researchers performed genomic profiling of 1725 patients with precursor B-cell ALL, detailed genomic analyses of 154 patients with Ph-like ALL, and transcriptome sequencing for 160 patients with non-Ph-like ALL.

The team found the prevalence of Ph-like ALL increased significantly with age, from 10% among children with standard-risk B-ALL (ages 1 to 9) and 13% among those with high-risk ALL (ages 10 to 15) to 21% among adolescents (ages 16 to 20) and 27% among young adults with ALL (ages 21 to 39).

Regardless of their age, patients with Ph-like ALL were less likely than other B-ALL patients to be alive and leukemia-free 5 years after diagnosis.

Overall survival for children, adolescents, and young adults with Ph-like ALL was 62%, compared to 91% for other B-ALL patients of the same age. Leukemia-free survival was about 47% for patients with Ph-like ALL and about 83% for other patients.

Genomic alterations and TKI treatment

The researchers found that 91% of patients with Ph-like ALL had chromosomal rearrangements or other genetic alterations that activate cytokine receptor or kinase signaling.

“We identified several new subgroups of Ph-like ALL that were distinguished by the type of cytokine receptor or kinase gene alteration,” said Kathryn Roberts, PhD, also of St Jude Children’s Research Hospital.

Evidence suggests that several of these subtypes would be vulnerable to TKIs and other targeted therapies. For example, about 12% of patients had rearrangements involving the genes ABL1, ABL2, CSF1R, and PDGFRB, which are known to respond to dasatinib and related TKIs.

Other Ph-like ALL patients had gene rearrangements involving JAK2, EPOR, and other genes that can be targeted by the drug ruxolitinib.

To determine if TKIs are effective in these patients, the researchers administered TKIs to 12 patients with Ph-ALL. Follow-up is not sufficient for all of the patients, but 5 achieved remission following TKI treatment (alone, with chemotherapy, or followed by transplant), and 1 patient has been in remission for more than a year.

“We showed that Ph-like ALL is a common disease that spans the age spectrum, and we identified new genomic alterations that converge on a handful of signaling pathways that are vulnerable to treatment with tyrosine kinase inhibitors,” Dr Mullighan said. “The findings lead the way for clinical trials that could help to transform the outlook for patients, regardless of age.”

A study testing TKI therapy in children with Ph-like ALL is scheduled to begin later this year or early in 2015.

Publications
Hematology Times
MDedge Hematology and Oncology
Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Leukemia, Myelodysplasia, Transplantation
Pediatrics
ALL
Article Type
News
Display Headline
Patients with Ph-like ALL may benefit from TKIs
Display Headline
Patients with Ph-like ALL may benefit from TKIs
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Teaser Media

Malaria parasites react to mosquito presence

Article Type
News
Changed
Fri, 09/12/2014 - 05:00
Display Headline
Malaria parasites react to mosquito presence
Author(s)
HT Staff

Plasmodium oocysts

(blue) in mosquito gut

Credit: Antoine Nicot

and Jacques Denoyelle

Experiments in canaries have shown that Plasmodium parasites react when non-infected mosquitoes bite their hosts, and the parasite responses increase transmission to the mosquito.

Like many other parasites, Plasmodium goes through a phase of chronic infection during which most of the parasites are in a dormant stage, and parasite numbers in the blood are very low.

Every now and then, however, the parasites “relapse,” and numbers increase, but the cause of this is not well understood.

So researchers set out to determine whether bites from non-infected mosquitoes can trigger relapses in Plasmodium during chronic infections, and whether relapses are associated with higher rates of transmission to the vector, ie, infection of the mosquitoes.

Sylvain Gandon, PhD, of the Université de Montpellier in France, and his colleagues described this research in PLOS Pathogens.

Specifically, the researchers studied the interaction between Plasmodium relictum, the parasite responsible for most cases of bird malaria in European songbirds, and its natural vector, a mosquito called Culex pipiens.

The team infected domestic canaries with P relictum and tested whether bites from uninfected Culex mosquitoes could trigger malaria relapses during chronic infection.

Indeed, parasite numbers in the blood routinely increased after the canaries were bitten. Moreover, the higher parasite loads following mosquito bites translated into higher infection rates in the mosquitoes.

The researchers therefore concluded that P relictum has the ability to boost its own transmission during the chronic phase of the vertebrate infection after being exposed to mosquito bites.

Although it is unclear if this also occurs in humans, the team suggested that better understanding of this phenomenon could eventually improve malaria control.

They also pointed out that many other pathogens alternate between acute and dormant phases. So better understanding of the ecological determinants and evolutionary forces governing parasite relapses could have wide-ranging applications.

Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Related Issues
Author(s)
HT Staff
Author(s)
HT Staff

Plasmodium oocysts

(blue) in mosquito gut

Credit: Antoine Nicot

and Jacques Denoyelle

Experiments in canaries have shown that Plasmodium parasites react when non-infected mosquitoes bite their hosts, and the parasite responses increase transmission to the mosquito.

Like many other parasites, Plasmodium goes through a phase of chronic infection during which most of the parasites are in a dormant stage, and parasite numbers in the blood are very low.

Every now and then, however, the parasites “relapse,” and numbers increase, but the cause of this is not well understood.

So researchers set out to determine whether bites from non-infected mosquitoes can trigger relapses in Plasmodium during chronic infections, and whether relapses are associated with higher rates of transmission to the vector, ie, infection of the mosquitoes.

Sylvain Gandon, PhD, of the Université de Montpellier in France, and his colleagues described this research in PLOS Pathogens.

Specifically, the researchers studied the interaction between Plasmodium relictum, the parasite responsible for most cases of bird malaria in European songbirds, and its natural vector, a mosquito called Culex pipiens.

The team infected domestic canaries with P relictum and tested whether bites from uninfected Culex mosquitoes could trigger malaria relapses during chronic infection.

Indeed, parasite numbers in the blood routinely increased after the canaries were bitten. Moreover, the higher parasite loads following mosquito bites translated into higher infection rates in the mosquitoes.

The researchers therefore concluded that P relictum has the ability to boost its own transmission during the chronic phase of the vertebrate infection after being exposed to mosquito bites.

Although it is unclear if this also occurs in humans, the team suggested that better understanding of this phenomenon could eventually improve malaria control.

They also pointed out that many other pathogens alternate between acute and dormant phases. So better understanding of the ecological determinants and evolutionary forces governing parasite relapses could have wide-ranging applications.

Plasmodium oocysts

(blue) in mosquito gut

Credit: Antoine Nicot

and Jacques Denoyelle

Experiments in canaries have shown that Plasmodium parasites react when non-infected mosquitoes bite their hosts, and the parasite responses increase transmission to the mosquito.

Like many other parasites, Plasmodium goes through a phase of chronic infection during which most of the parasites are in a dormant stage, and parasite numbers in the blood are very low.

Every now and then, however, the parasites “relapse,” and numbers increase, but the cause of this is not well understood.

So researchers set out to determine whether bites from non-infected mosquitoes can trigger relapses in Plasmodium during chronic infections, and whether relapses are associated with higher rates of transmission to the vector, ie, infection of the mosquitoes.

Sylvain Gandon, PhD, of the Université de Montpellier in France, and his colleagues described this research in PLOS Pathogens.

Specifically, the researchers studied the interaction between Plasmodium relictum, the parasite responsible for most cases of bird malaria in European songbirds, and its natural vector, a mosquito called Culex pipiens.

The team infected domestic canaries with P relictum and tested whether bites from uninfected Culex mosquitoes could trigger malaria relapses during chronic infection.

Indeed, parasite numbers in the blood routinely increased after the canaries were bitten. Moreover, the higher parasite loads following mosquito bites translated into higher infection rates in the mosquitoes.

The researchers therefore concluded that P relictum has the ability to boost its own transmission during the chronic phase of the vertebrate infection after being exposed to mosquito bites.

Although it is unclear if this also occurs in humans, the team suggested that better understanding of this phenomenon could eventually improve malaria control.

They also pointed out that many other pathogens alternate between acute and dormant phases. So better understanding of the ecological determinants and evolutionary forces governing parasite relapses could have wide-ranging applications.

Publications
Hematology Times
MDedge Hematology and Oncology
Publications
Hematology Times
MDedge Hematology and Oncology
Topics
Related Issues
Article Type
News
Display Headline
Malaria parasites react to mosquito presence
Display Headline
Malaria parasites react to mosquito presence
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Teaser Media
Subscribe to