JC Compliance in NJ Stroke Centers

Article Type
Changed
Display Headline
Compliance with joint commission measures in state‐designated stroke centers

Stroke is the fourth leading cause of death in the United States.[1] Though actual stroke‐related death has declined nationally by 19.4%, stroke‐related morbidity is still a significant burden.[2, 3] Hospital certification programs have been developed to improve the quality of stroke care on state and national levels. The Brain Attack Coalition (BAC) proposed 2 levels of stroke hospitals: primary stroke centers (PSCs) and comprehensive stroke centers (CSCs).[3, 4] Although most stroke patients can be cared for at PSCs, CSCs are able to care for more complex stroke patients.[4, 5] Using BAC recommendations the Joint Commission (JC) and American Heart Association/American Stroke Association created a certification program for PSCs. Eight evidence‐based performance measures are currently required for JC PSC certification.[6]

At the state level, New Jersey and Florida began designating PSCs and CSCs.[7, 8] New Jersey PSC and CSC designation criteria incorporate the elements of JC PSC certification, despite preceding them by several years.[6, 9] New Jersey CSC certification consists of more comprehensive requirements (Table 1). All New Jersey‐designated stroke centers submit data in the New Jersey Acute Stroke Registry (NJASR),[7] which closely matches the Centers for Disease Control and Prevention's Paul Coverdell National Acute Stroke Registry and includes the JC‐required core measures.

New Jersey State Stroke Center Designation Criteria
Primary Stroke Center (N=53)Comprehensive Stroke Center (N=12)
  • NOTE: Abbreviations: CTA, computed tomography angiography; MRI, magnetic resonance imaging.

Must have acute stroke teams in place at all times that can respond to the bedside within 15 minutes of patient arrival or identificationMust meet all criteria for primary stroke centers
Must maintain neurology and emergency department personnel trained in the treatment of acute strokeMust maintain a neurosurgical team capable of assessing and treating complex stroke
Must maintain telemetry or critical care beds staffed by physicians and nurses trained in caring for acute stroke patientsMust maintain on staff a neuroradiologist (boarded) and a neurointerventionalist
Must provide for neurosurgical services within 2 hours either at the hospital or under agreement with a comprehensive stroke centerMust provide comprehensive rehabilitation services either on site or by transfer agreement
Must provide acute care rehabilitation servicesMust provide MRI, CTA, and digital subtraction angiography
Must enter into a written transfer agreement with a comprehensive stroke centerMust develop and maintain sophisticated outcomes assessment and performance improvement capability
Must provide graduate medical education in stroke and carry out research in stroke

There is a paucity of data comparing state‐designated CSCs and PSCs, largely because few states have state designation programs. Although a recent observational study from Finland showed better outcomes in patients treated at CSCs, measures in that study were limited to mortality and institutionalization at 1 year.[10] In this study, we examined adherence of all New Jersey state‐designated stroke centers to the JC PSC measures and compared CSCs to PSCs in this regard. We posited that better compliance with these evidence‐based measures might translate into better quality of stroke care in the state and may lend support to future, larger studies that may be conducted because of the recent certification of CSCs by the JC.

METHODS

Components of the NJASR, key components of PSCs and CSCs in the BAC report, and the 8 JC's core stroke measures for PSC certification were assessed.[3, 4, 6]

First responders in New Jersey are required to bring suspected stroke patients to the nearest stroke‐designated hospital, regardless of whether it is a PSC or CSC, unless the patient is too medically unstable and needs to be taken to the nearest hospital. From there, decisions can be made to transfer a patient to a higher level hospital (CSC) depending on the complexity of the patient's condition.

New Jersey state‐designated PSCs and CSCs are required to abstract patient‐level data, evaluate outcomes, and initiate quality improvement activities on all patients evaluated for ischemic stroke, hemorrhagic stroke, transient ischemic attack (TIA), and those who undergo acute interventional therapy. Data are submitted quarterly to the New Jersey Department of Health and Senior Services (NJDHSS).[7] Hospital data are imported into the Acute Stroke Registry Database. The NJASR statewide dataset used for this analysis included all stroke admissions for the calendar years 2010 and 2011 and contains patient demographic information, health history, clinical investigations performed, treatments provided, and outcome measures that allow for risk‐adjusted assessment of outcomes.

The JC core stroke measures (STK‐1 thru 10 [except STK‐7 and 9]: venous thromboembolism [VTE] prophylaxis, discharged on antithrombotic therapy, anticoagulation therapy for atrial fibrillation/flutter, thrombolytic therapy, antithrombotic therapy by the end of hospital day 2, discharged on statin medication, stroke education, and assessment for rehabilitation) (except STK‐7 [dysphagia screening] and STK‐9 [smoking cessation/advice counseling]) apply only to acute ischemic and/or hemorrhagic stroke patients.

In our analysis, transferred patients and patients with a diagnosis of TIA, stroke not otherwise specified, and nonstroke‐related diagnoses were excluded. Hospital identity was kept anonymous through assignment of random numeric codes by the NJDHSS. Hospitals were categorized as CSC or PSC based on NJDHSS designation. Stroke severity on admission was assessed by categorizing National Institutes of Health Stroke Scale (NIHSS) scores into: no stroke when NIHSS=0, mild stroke when NIHSS=14, and moderate to severe stroke when NIHSS>5. Median door‐to‐thrombolytic drug times were assessed for both patients who arrived to the hospital within 2 hours of stroke symptom onset and received thrombolytic therapy within 3 hours, as well as patients who arrived within 3.5 hours (210 minutes) and received treatment within 4.5 hours (270 minutes).

Inclusion and Exclusion Criteria for JC Performance Measures

Excluded from all measures are patients who were discharged to hospice, left against medical advice (AMA), expired, were transferred to another short‐term care facility, had an unknown discharge location, comfort measures only (CMO), or enrolled in clinical trials. Other exclusions are listed below each measure. VTE prophylaxis included nonambulatory ischemic and hemorrhagic stroke patients who received VTE prophylaxis by end of hospital day 2 and excluded patients discharged prior to hospital day 2 and with length of stay >120 days. Antithrombotics at discharge included ischemic stroke patients discharged on antithrombotics and excluded those with documented reason for not receiving antithrombotics. Anticoagulation for atrial fibrillation included ischemic stroke patients with documented atrial fibrillation/flutter who received anticoagulation therapy and excluded those with documented reason for not receiving anticoagulation. Thrombolytic therapy included acute ischemic stroke patients who arrived at the hospital within 2 hours from time last known well and for whom intravenous (IV) tissue plasminogen activator (tPA) was initiated at that hospital within 1hour of hospital arrival. Excluded were patients with valid reason for not getting tPA, length of stay >120 days, and time last known well >2 hours. We also looked at thrombolytic therapy for patients who arrived by 3.5 hours from time last known well and received IV‐tPA within 1 hour.

Antithrombotics by the end of hospital day 2 included ischemic stroke patients who received antithrombotic medication by the end of hospital day 2 and excluded patients who were discharged before hospital day 2, had a documented reason for not receiving antithrombotic medication, had a length of stay greater >120 days, were CMO by day 2, and patients who received IV or intra‐arterial tPA. Statin therapy included ischemic stroke patients with low‐density lipoprotein exceeding 100 mg/dL or not measured, or on cholesterol‐reducing medication prior to admission. Excluded were those with length of stay >120 days and a documented reason for not receiving medication. Stroke education on discharge included all stroke patients being discharged home who received education during the hospitalization addressing the following: patient's stroke‐specific risk factors, warning signs and symptoms, emergency medical services activation, follow‐up, and discharge medications. Those with length of stay >120 days were excluded. Assessment for rehabilitation included ischemic and hemorrhagic patients assessed for rehabilitation services.

Statistical Analysis

Patient characteristics were summarized using frequencies and percentages for categorical variables as well as median and interquartile range for continuous variables. 2 tests and median 2‐sample tests were used to compare patient characteristics between the 2 hospital levels. The likelihood that a patient received a particular JC core measure service in relation to hospital level (PSC vs CSC) was estimated using a multiple logistic regression analysis for both the crude/unadjusted and adjusted odds ratios, and their 95% confidence intervals were estimated. Gender, age, race, stroke type, medical history (hypertension, atrial fibrillation, diabetes mellitus, and history of smoking), and severity of stroke as measured by NIHSS were included in the model. Institutional review board approval to evaluate the data for this analysis was obtained from John F. Kennedy Medical Center in Edison, New Jersey. All analyses were performed using SAS software package version 9.3 (SAS Institute, Cary, NC).

RESULTS

There were 36,892 acute stroke cases treated at the 53 New Jersey PSCs and 12 CSCs in the calendar year 2010 and 2011 (Table 2). Sixty percent were treated at PSCs and 40% at CSCs. There were significant differences in the distribution of patients' characteristics (race, age, and gender) between the 2 hospital levels. At both PSCs and CSCs, the majority of patients were white, distantly followed by blacks. Patients at PSCs were statistically significantly older than CSCs. The most prevalent comorbid conditions in both PSCs and CSCs were hypertension, diabetes mellitus, and dyslipidemia. Based on our categorization, we found that 45% of patients admitted to CSCs had moderate‐to‐severe stroke (NIHSS>5). The median door‐to‐thrombolytic drug times were significantly shorter at CSCs than PSCs for both the 3‐hour (65 vs 74 minutes, P<0.0001) and 4.5 hour (65 vs 76 minutes, P<0.0001) IV tPA time windows.

Descriptive Statistics of Acute Stroke Patients by Hospital Levels (PSCs vs CSCs)
VariablesPSCs, N=22,305CSCs, N=14,587P Valuea
  • NOTE: Abbreviations: CSCs, comprehensive stroke centers; IQR, interquartile range; NIHSS, National Institutes of Health Stroke Scale; PCSs, primary stroke centers; TIA, transient ischemic attack; tPA, tissue plasminogen activator; VBI, vertebral‐basilar insufficiency.

  • 2 P values.

  • All others race category includes: Native American/Alaska Native, Hawaiian/Other Pacific Islander and Other.

  • Median 2‐sample test.

Race, n (%)  <0.0001
White16,586 (74.4)10,419 (71.4) 
Black3,930 (17.6)2,875 (19.7)
Asian511 (2.3)519 (3.6)
All othersb1,278 (5.7)774 (5.3)
Age, y, median (IQR)75.0 (22.0)73.0 (23.0)<0.0001c
Gender, female, n (%)12,552 (56.3)7,757 (53.2)<0.0001
Comorbidities   
Hypertension, n (%)17,405 (78.1)10,535 (72.2)<0.0001
Atrial fibrillation/flutter, n (%)3,762 (16.9)2,237 (15.3)0.0001
Diabetes mellitus, n (%)7,219 (32.4)4,220 (28.9)<0.0001
History of smoking, n (%)2,924 (13.1)1,706 (11.7)<0.0001
Heart failure, n (%)1,733 (7.8)749 (5.1)<0.0001
Myocardial infarction, n (%)6,138 (27.5)2,945 (20.3)<0.0001
Dyslipidemia, n (%)10,106 (45.6)5,161 (35.4)<0.0001
Prior stroke/TIA/VBI, n (%)7,085 (31.8)3,874 (26.6)<0.0001
NIHSS on admission, n (%)  <0.0001
No stroke (NIHSS=0)2,747 (27.4)913 (18.3) 
Mild stroke (NIHSS=14)4,010 (40.0)1,811 (33.3) 
Moderatesevere (NIHSS >5)3,272 (32.6)2,271 (45.4) 
Door‐to‐tPA time, min, median (IQR)  
Arrived within 120 minutes74.0 (35.0)65.0 (33.0)<0.0001c
Arrived within 210 minutes76.0 (37.0)65.0 (34.0)<0.0001c
Stroke diagnosis, distribution  <0.0001
Ischemic11,145 (50.0)8,235 (56.5) 
Hemorrhagic1,587 (7.1)3,270 (13.3) 
Subarachnoid219 (13.8)397 (20.4) 
Intracerebral1,368 (86.2)1,545 (79.6) 
Transient ischemic attack8,116 (36.4)4,162 (28.5) 
Stroke not otherwise specified1,145 (5.1)130 (0.9) 
No stroke‐related diagnosis293 (1.3)118 (0.8) 

The incidences of stroke diagnosis types are also detailed in Table 2. Seventy percent of patients at CSCs had either an ischemic or hemorrhagic stroke diagnosis versus 57.1% of patients admitted at PSCs. Hemorrhagic stroke patients were twice as likely to be admitted at CSCs compared to PSCs.

After excluding 13,964 patients with a diagnosis of TIA, stroke not otherwise specified, and those with nonstroke‐related diagnosis, the likelihood of stroke patients' receiving the JC's performance measure services at either of these hospital levels was assessed (Table 3). In general, the adjusted odds ratio estimates of patients receiving a JC core performance measure at PSCs were lower than CSCs, indicating better compliance with the measures at CSCs. For example, 19.5% of eligible patients received thrombolytic therapy at CSCs compared to 9.6% at PSCs. CSCs also were more likely to provide VTE prophylaxis, anticoagulation for atrial fibrillation, and assessment for rehabilitation. Stroke education and antithrombotic therapy by the end of hospital day 2 were more likely to be provided at PSCs, but the results were not statistically significant.

Frequencies and Odds Ratio for the Likelihood of Eligible Stroke Patients Receiving Joint Commission's Performance Measure Services in PSCs vs CSCs
VariablesHospital LevelsaOdds Ratio (95% CI)
PSCs, N (%)CSCs, N (%)UnadjustedAdjustedb
  • NOTE: Abbreviations: CI, confidence intervals; CSCs, comprehensive stroke centers; EMS, emergency medical services; PCSs, primary stroke centers; VTE, venous thromboembolism.

  • Performance measurements are based on the Joint Commission Stroke Performance Measures.

  • Adjusted for sex, age, race, and type of stroke (as appropriate).

VTE prophylaxis4,745 (92.1)5,455 (94.2)0.72 (0.610.83)0.47 (0.330.67)
Discharged on antithrombotic therapy8,835 (98.1)6,873 (99.2)0.42 (0.310.56)0.46 (0.270.78)
Anticoagulation therapy for atrial fibrillation/flutter1,464 (95.1)1,144 (97.6)0.48 (0.310.74)0.38 (0.170.86)
Thrombolytic therapy    
Time window=3.0 hours484 (9.6)666 (19.5)0.44 (0.390.50)0.28 (0.240.34)
Time window=4.5 hours564 (11.0)792 (22.4)0.43 (0.380.48)0.28 (0.230.33)
Antithrombotic therapy by end of hospital day 27,575 (97.4)5,396 (98.2)0.69 (0.540.88)1.01 (0.601.68)
Discharged on statin medication6,035 (97.9)4,261 (98.7)0.59 (0.430.80)0.69 (0.421.13)
Stroke education, for home discharge (overall)3,823 (97.7)3,072 (95.7)1.93 (1.472.53)1.78 (0.923.45)
Risk factors for stroke3,480 (88.9)3,026 (94.4)0.49 (0.410.59)0.43 (0.280.66)
Warning sign and symptoms3,514 (89.8)3,019 (94.1)0.56 (0.460.67)0.52 (0.340.79)
Activation of EMS3,539 (90.5)3,023 (94.2)0.59 (0.490.70)0.44 (0.280.69)
Followup after discharge3,807 (97.3)3,064 (95.5)1.73 (1.342.23)1.18 (0.652.20)
Medications prescribed at discharge3,788 (96.8)3,067 (95.5)1.42 (1.111.82)0.44 (0.280.70)
Assessed for rehabilitation9,725 (95.2)8,199 (97.5)0.51 (0.430.61)0.37 (0.260.53)

DISCUSSION

In New Jersey, CSCs were more likely to adhere better to JC core performance measures than PSCs. Median door‐to‐thrombolytic drug times were also significantly lower at CSCs. Such differences may be due to several factors including the fact that CSCs have generally been state designated for a longer period of time than PSCs. CSCs are likely to have higher volumes of stroke admissions, are more likely to be JC certified, provide more staff education, and have more staff and resources. The New Jersey stroke designation program began in 2006, and 11 of the 12 CSCs were designated by the end of 2007. However, the PSC designation process has been more gradual, with several of them designated in 2010 and 2011 as the data for this study were being collected.

The New York State Stroke Center Designation Project prospectively showed that stroke center designation improved the quality of acute stroke patient care and administration of thrombolytic therapy; however, differing levels of hospital designation were not present in New York at that time.[11] Participation in a data measurement program such as Get With The Guidelines has also been examined. It is evident that the amount of time in a program is predictive of process measure compliance.[12] JC certification as a PSC is also associated with increased thrombolytic rates for acute stroke over time.[13] New Jersey does not require that stroke‐designated hospitals have JC stroke certification. Although 11 New Jersey CSCs have been certified as JC PSCs since 2009, only 21 of the 53 state‐designated PSCs are JC certified. It may be that the highest performing sites pursue state CSC designation and JC PSC certification/recertification repeatedly. CSCs in New Jersey may also have a greater focus on quality measures by virtue of having been in quality programs such as Get With The Guidelines or by having been state designated and JC certified for a longer period of time.

The New Jersey requirements for CSCs, like those of the JC, include a large number of highly trained stroke experts, which ensures more continuous coverage. Although a disparity in mortality on weekends versus weekdays has been reported,[14] such a difference in mortality has not been seen at CSCs in New Jersey.[15] This lack of a weekend effect is felt to be related to the 24/7 availability of stroke specialists, advanced neuroimaging, ongoing training, and surveillance of specialized nursing care available at CSCs.[4, 16]

In our study, New Jersey CSCs overall had significantly higher rates of thrombolysis compared to PSCs (19.5% vs 9.6%) when looking at the 3‐hour window. This is higher overall than the national rate of 3.4% to 5.2%.[17] The number of patients treated in the expanded thrombolytic window were also significantly higher at CSCs, increasing thrombolysis rates to 22.4% at CSCs versus the 11% at PSCs. Door‐to‐drug times were also shorter at CSCs than PSCs in the 3‐ and 4.5‐hour windows (65 vs 74 minutes and 65 minutes vs 76 minutes, respectively). After we excluded transferred patients and those with a diagnosis of TIA, stroke not otherwise specified, and those with nonstroke‐related diagnoses, the total number of ischemic and hemorrhagic stroke patients seen at each of the 12 CSCs (n=11,505) was on average 4 times higher than the number seen at each of the 53 PSCs (n=12,732). High annual hospital stroke volume has been shown to be associated with higher rates of thrombolysis and lower stroke mortality.[14] A study of US academic centers found that although the same percentage of patients presented within 2 hours of stroke symptom onset in 2001 and 2004, the use of IV tPA more than doubled over this time period.[18] Improved system organization at the prehospital and hospital levels as well as greater comfort and experience with use of thrombolytic therapy likely contribute to all of these findings.[11]

CSCs did not outperform PSCs with regard to stroke education and antithrombotics by end of hospital day 2, but these results were not statistically significant. The former measure includes only stroke patients who are discharged home and is considered complete when all 5 of the following are addressed: risk factors for stroke, warning signs and symptoms for stroke, activation of emergency medical systems, follow‐up after discharge, and medications prescribed at discharge. CSCs were more likely to provide education for the first 3 and last component but less likely for the fourth element. These findings should be considered in the context of CSCs having higher volumes of more ill and complex patients who are more likely to be discharged to a rehabilitation hospital, nursing home, or other facility than to home. In our registry, CSCs discharged 46% of patients' to home versus 54% at PSCs. We speculate that CSCs may be less likely to habitually address follow‐up care and discharge medications as compared to PSCs. As far as provision of antithrombotics by hospital day 2, it is possible again that because CSCs have a higher number of complicated stroke patients, many may have had contraindications to use of antithrombotics in that time period.

Limitations of this study include the fact that this was a retrospective analysis of a database. Although the 2010 and 2011 NJASR dataset was sizeable, it was not possible to capture all potentially confounding variables that may have affected our point estimates. We were not able to perform a hierarchical analysis to account for clustering at the hospital level because of limited data available in the registry. Errors in recording data, coding, and documentation cannot be excluded. The fact that not all PSCs were necessarily JC certified may have contributed to the observed differences. Also, because pursuing PSC or CSC status is voluntary, it is not clear if the hospitals that chose CSC status were different in other unmeasured factors than those that chose PSC status, and the difference may have existed even in the absence of the designation program. Over the years, there have been changes in the criteria required by the state and the JC for PSC designation, although the larger differences between hospital levels remained intact. This may have limited our findings as well. The goal for hospitals is to continue strict adherence to policies and measures and thus improve quality of care for stroke patients. Future prospective studies should be conducted to ascertain validity and generalizability of our findings. Association of stroke measure adherence and functional outcomes would also be of interest. We were not able to measure this consistently in our study because not all patients at PSCs had admission and/or discharge NIHSS or modified Rankin Score. Although some studies have not shown an association between improved outcomes and higher performance on quality measures, we would like to look at this more closely in the stroke population.[19] As our database gets larger, we would like to reexamine our findings after correcting for more specific characteristics of each hospital. In the future, if additional states designate centers by level of stroke care, it will be important to compare how such designations compare to nonprofit organization certifications in terms of impacting performance on a larger scale.

CONCLUSION

This study shows better compliance of New Jersey state‐designated CSCs with the JC PSC core stroke measures and better mean door‐to‐thrombolytic drug times. Because these measures are evidence based, these results may translate into better stroke care and outcomes for patients treated at state‐designated CSCs.

ACKNOWLEDGEMENTS

Disclosures: Jawad Kirmani, MD: Consultant to Joint Commission on Performance Measure Development (modest). Martin Gizzi, MD, PhD: Consultant to Joint Commission on Performance Measure Development (modest), New Jersey Department of Health and Senior Services as chair of the Stroke Advisory Panel (significant). No other potential conflicts to report.

Files
References
  1. Centers for Disease Control and Prevention. Interactive atlas of heart disease and stroke. Available at: http://apps.Nccd.Cdc.Gov/dhdspatlas/reports.Aspx. Accessed May 5, 2012.
  2. Roger VL, Go AS, Lloyd‐Jones DM, et al.; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2012 update: a report from the American Heart Association. Circulation. 2012;125:e2e220.
  3. Alberts MJ, Hademenos G, Latchaw RE, et al. Recommendations for the establishment of primary stroke centers. JAMA. 2000;283:31023109.
  4. Alberts MJ, Latchaw RE, Selman WR, et al.; Brain Attack Coalition. Recommendations for comprehensive stroke centers: a consensus statement from the Brain Attack Coalition. Stroke. 2005;36:15971616.
  5. Schwamm LH, Pancioli A, Acker JE, et al. Recommendations for the establishment of stroke systems of care. Stroke. 2005;36:690703.
  6. The Joint Commission. Advanced Certification Comprehensive Stroke Centers. Available at: http://www.jointcommission.org/certification/advanced_certification_comprehensive_stroke_centers.aspx. Accessed July 25, 2012.
  7. New Jersey Department of Health and Senior Services: The New Jersey Acute Stroke Registry. Available at: http://www.state.nj.us/health/healthcarequality/stroke/documents/njacute_stroke_data_dictionary.pdf. Accessed July 8, 2012.
  8. Florida Agency for Health Care Administration. Primary stroke center and comprehensive stroke center designation. Available at: http://ahca.myflorida.com/mchq/Health_Facility_Regulation/Hospital_Outpatient/forms/59A3_2085_FAC_Rule_text.pdf. Accessed July 25, 2012.
  9. New Jersey Department of Health and Senior Services. Stroke Center Act (2004). Available at: http://www.njleg.state.nj.us/2004/bills/pl04/136_.pdf. Accessed September 25, 2013.
  10. Meretoja A, Roine RO, Kaste M, et al. Effectiveness of primary and comprehensive stroke centers. Stroke. 2010;41:11021107.
  11. Gropen TI, Gagliano PJ, Blake CA, et al.; NYSDOH Stroke Center Designation Project Workgroup. Quality improvement in acute stroke: The New York State Stroke Center Designation Project. Neurology. 2006;67(1):8893.
  12. Fonarow GC, Reeves MJ, Smith EE, et al. Characteristics, performance measures, and in‐hospital outcomes of the first one million stroke and transient ischemic attack admissions in get with the guidelines‐stroke. Circ Cardiovasc Qual Outcomes. 2010;3(3):291302.
  13. Prabhakaran S, McNulty M, O'Neill K, et al. Intravenous thrombolysis for stroke increases over time at primary stroke centers. Stroke. 2012;43:875877.
  14. Saposnik G, Baibergenova A, Bayer N, et al. Weekends: a dangerous time for having a stroke? Stroke. 2007;38:12111215.
  15. McKinney JS, Deng Y, Kasner SE, et al.; Myocardial Infarction Data Acquisition System (MIDAS 15) Study Group. Comprehensive stroke centers overcome the weekend versus weekday gap in stroke treatment and mortality. Stroke. 2011;42:24032409.
  16. Albright KC, Raman R, Ernstrom K, et al. Can comprehensive stroke centers erase the “weekend effect”? Cerebrovasc Dis. 2009;27:107113.
  17. Adeoye O, Hornung R, Khatri P, et al. Recombinant tissue‐type plasminogen activator use for ischemic stroke in the United States. Stroke. 2011;42:19521955.
  18. Lichtman JH, Watanabe E, Allen NB, et al. Hospital arrival time and intravenous t‐PA use in US academic medical centers, 2001–2004. Stroke. 2009;40:38453850.
  19. Ingraham AM, Cohen ME, Bilimoria KY, et al. Association of surgical care improvement project infection‐related process measure compliance with risk‐adjusted outcomes: implications for quality measurement. J Am Coll Surg. 2010;211(6):705714.
Article PDF
Issue
Journal of Hospital Medicine - 9(2)
Page Number
88-93
Sections
Files
Files
Article PDF
Article PDF

Stroke is the fourth leading cause of death in the United States.[1] Though actual stroke‐related death has declined nationally by 19.4%, stroke‐related morbidity is still a significant burden.[2, 3] Hospital certification programs have been developed to improve the quality of stroke care on state and national levels. The Brain Attack Coalition (BAC) proposed 2 levels of stroke hospitals: primary stroke centers (PSCs) and comprehensive stroke centers (CSCs).[3, 4] Although most stroke patients can be cared for at PSCs, CSCs are able to care for more complex stroke patients.[4, 5] Using BAC recommendations the Joint Commission (JC) and American Heart Association/American Stroke Association created a certification program for PSCs. Eight evidence‐based performance measures are currently required for JC PSC certification.[6]

At the state level, New Jersey and Florida began designating PSCs and CSCs.[7, 8] New Jersey PSC and CSC designation criteria incorporate the elements of JC PSC certification, despite preceding them by several years.[6, 9] New Jersey CSC certification consists of more comprehensive requirements (Table 1). All New Jersey‐designated stroke centers submit data in the New Jersey Acute Stroke Registry (NJASR),[7] which closely matches the Centers for Disease Control and Prevention's Paul Coverdell National Acute Stroke Registry and includes the JC‐required core measures.

New Jersey State Stroke Center Designation Criteria
Primary Stroke Center (N=53)Comprehensive Stroke Center (N=12)
  • NOTE: Abbreviations: CTA, computed tomography angiography; MRI, magnetic resonance imaging.

Must have acute stroke teams in place at all times that can respond to the bedside within 15 minutes of patient arrival or identificationMust meet all criteria for primary stroke centers
Must maintain neurology and emergency department personnel trained in the treatment of acute strokeMust maintain a neurosurgical team capable of assessing and treating complex stroke
Must maintain telemetry or critical care beds staffed by physicians and nurses trained in caring for acute stroke patientsMust maintain on staff a neuroradiologist (boarded) and a neurointerventionalist
Must provide for neurosurgical services within 2 hours either at the hospital or under agreement with a comprehensive stroke centerMust provide comprehensive rehabilitation services either on site or by transfer agreement
Must provide acute care rehabilitation servicesMust provide MRI, CTA, and digital subtraction angiography
Must enter into a written transfer agreement with a comprehensive stroke centerMust develop and maintain sophisticated outcomes assessment and performance improvement capability
Must provide graduate medical education in stroke and carry out research in stroke

There is a paucity of data comparing state‐designated CSCs and PSCs, largely because few states have state designation programs. Although a recent observational study from Finland showed better outcomes in patients treated at CSCs, measures in that study were limited to mortality and institutionalization at 1 year.[10] In this study, we examined adherence of all New Jersey state‐designated stroke centers to the JC PSC measures and compared CSCs to PSCs in this regard. We posited that better compliance with these evidence‐based measures might translate into better quality of stroke care in the state and may lend support to future, larger studies that may be conducted because of the recent certification of CSCs by the JC.

METHODS

Components of the NJASR, key components of PSCs and CSCs in the BAC report, and the 8 JC's core stroke measures for PSC certification were assessed.[3, 4, 6]

First responders in New Jersey are required to bring suspected stroke patients to the nearest stroke‐designated hospital, regardless of whether it is a PSC or CSC, unless the patient is too medically unstable and needs to be taken to the nearest hospital. From there, decisions can be made to transfer a patient to a higher level hospital (CSC) depending on the complexity of the patient's condition.

New Jersey state‐designated PSCs and CSCs are required to abstract patient‐level data, evaluate outcomes, and initiate quality improvement activities on all patients evaluated for ischemic stroke, hemorrhagic stroke, transient ischemic attack (TIA), and those who undergo acute interventional therapy. Data are submitted quarterly to the New Jersey Department of Health and Senior Services (NJDHSS).[7] Hospital data are imported into the Acute Stroke Registry Database. The NJASR statewide dataset used for this analysis included all stroke admissions for the calendar years 2010 and 2011 and contains patient demographic information, health history, clinical investigations performed, treatments provided, and outcome measures that allow for risk‐adjusted assessment of outcomes.

The JC core stroke measures (STK‐1 thru 10 [except STK‐7 and 9]: venous thromboembolism [VTE] prophylaxis, discharged on antithrombotic therapy, anticoagulation therapy for atrial fibrillation/flutter, thrombolytic therapy, antithrombotic therapy by the end of hospital day 2, discharged on statin medication, stroke education, and assessment for rehabilitation) (except STK‐7 [dysphagia screening] and STK‐9 [smoking cessation/advice counseling]) apply only to acute ischemic and/or hemorrhagic stroke patients.

In our analysis, transferred patients and patients with a diagnosis of TIA, stroke not otherwise specified, and nonstroke‐related diagnoses were excluded. Hospital identity was kept anonymous through assignment of random numeric codes by the NJDHSS. Hospitals were categorized as CSC or PSC based on NJDHSS designation. Stroke severity on admission was assessed by categorizing National Institutes of Health Stroke Scale (NIHSS) scores into: no stroke when NIHSS=0, mild stroke when NIHSS=14, and moderate to severe stroke when NIHSS>5. Median door‐to‐thrombolytic drug times were assessed for both patients who arrived to the hospital within 2 hours of stroke symptom onset and received thrombolytic therapy within 3 hours, as well as patients who arrived within 3.5 hours (210 minutes) and received treatment within 4.5 hours (270 minutes).

Inclusion and Exclusion Criteria for JC Performance Measures

Excluded from all measures are patients who were discharged to hospice, left against medical advice (AMA), expired, were transferred to another short‐term care facility, had an unknown discharge location, comfort measures only (CMO), or enrolled in clinical trials. Other exclusions are listed below each measure. VTE prophylaxis included nonambulatory ischemic and hemorrhagic stroke patients who received VTE prophylaxis by end of hospital day 2 and excluded patients discharged prior to hospital day 2 and with length of stay >120 days. Antithrombotics at discharge included ischemic stroke patients discharged on antithrombotics and excluded those with documented reason for not receiving antithrombotics. Anticoagulation for atrial fibrillation included ischemic stroke patients with documented atrial fibrillation/flutter who received anticoagulation therapy and excluded those with documented reason for not receiving anticoagulation. Thrombolytic therapy included acute ischemic stroke patients who arrived at the hospital within 2 hours from time last known well and for whom intravenous (IV) tissue plasminogen activator (tPA) was initiated at that hospital within 1hour of hospital arrival. Excluded were patients with valid reason for not getting tPA, length of stay >120 days, and time last known well >2 hours. We also looked at thrombolytic therapy for patients who arrived by 3.5 hours from time last known well and received IV‐tPA within 1 hour.

Antithrombotics by the end of hospital day 2 included ischemic stroke patients who received antithrombotic medication by the end of hospital day 2 and excluded patients who were discharged before hospital day 2, had a documented reason for not receiving antithrombotic medication, had a length of stay greater >120 days, were CMO by day 2, and patients who received IV or intra‐arterial tPA. Statin therapy included ischemic stroke patients with low‐density lipoprotein exceeding 100 mg/dL or not measured, or on cholesterol‐reducing medication prior to admission. Excluded were those with length of stay >120 days and a documented reason for not receiving medication. Stroke education on discharge included all stroke patients being discharged home who received education during the hospitalization addressing the following: patient's stroke‐specific risk factors, warning signs and symptoms, emergency medical services activation, follow‐up, and discharge medications. Those with length of stay >120 days were excluded. Assessment for rehabilitation included ischemic and hemorrhagic patients assessed for rehabilitation services.

Statistical Analysis

Patient characteristics were summarized using frequencies and percentages for categorical variables as well as median and interquartile range for continuous variables. 2 tests and median 2‐sample tests were used to compare patient characteristics between the 2 hospital levels. The likelihood that a patient received a particular JC core measure service in relation to hospital level (PSC vs CSC) was estimated using a multiple logistic regression analysis for both the crude/unadjusted and adjusted odds ratios, and their 95% confidence intervals were estimated. Gender, age, race, stroke type, medical history (hypertension, atrial fibrillation, diabetes mellitus, and history of smoking), and severity of stroke as measured by NIHSS were included in the model. Institutional review board approval to evaluate the data for this analysis was obtained from John F. Kennedy Medical Center in Edison, New Jersey. All analyses were performed using SAS software package version 9.3 (SAS Institute, Cary, NC).

RESULTS

There were 36,892 acute stroke cases treated at the 53 New Jersey PSCs and 12 CSCs in the calendar year 2010 and 2011 (Table 2). Sixty percent were treated at PSCs and 40% at CSCs. There were significant differences in the distribution of patients' characteristics (race, age, and gender) between the 2 hospital levels. At both PSCs and CSCs, the majority of patients were white, distantly followed by blacks. Patients at PSCs were statistically significantly older than CSCs. The most prevalent comorbid conditions in both PSCs and CSCs were hypertension, diabetes mellitus, and dyslipidemia. Based on our categorization, we found that 45% of patients admitted to CSCs had moderate‐to‐severe stroke (NIHSS>5). The median door‐to‐thrombolytic drug times were significantly shorter at CSCs than PSCs for both the 3‐hour (65 vs 74 minutes, P<0.0001) and 4.5 hour (65 vs 76 minutes, P<0.0001) IV tPA time windows.

Descriptive Statistics of Acute Stroke Patients by Hospital Levels (PSCs vs CSCs)
VariablesPSCs, N=22,305CSCs, N=14,587P Valuea
  • NOTE: Abbreviations: CSCs, comprehensive stroke centers; IQR, interquartile range; NIHSS, National Institutes of Health Stroke Scale; PCSs, primary stroke centers; TIA, transient ischemic attack; tPA, tissue plasminogen activator; VBI, vertebral‐basilar insufficiency.

  • 2 P values.

  • All others race category includes: Native American/Alaska Native, Hawaiian/Other Pacific Islander and Other.

  • Median 2‐sample test.

Race, n (%)  <0.0001
White16,586 (74.4)10,419 (71.4) 
Black3,930 (17.6)2,875 (19.7)
Asian511 (2.3)519 (3.6)
All othersb1,278 (5.7)774 (5.3)
Age, y, median (IQR)75.0 (22.0)73.0 (23.0)<0.0001c
Gender, female, n (%)12,552 (56.3)7,757 (53.2)<0.0001
Comorbidities   
Hypertension, n (%)17,405 (78.1)10,535 (72.2)<0.0001
Atrial fibrillation/flutter, n (%)3,762 (16.9)2,237 (15.3)0.0001
Diabetes mellitus, n (%)7,219 (32.4)4,220 (28.9)<0.0001
History of smoking, n (%)2,924 (13.1)1,706 (11.7)<0.0001
Heart failure, n (%)1,733 (7.8)749 (5.1)<0.0001
Myocardial infarction, n (%)6,138 (27.5)2,945 (20.3)<0.0001
Dyslipidemia, n (%)10,106 (45.6)5,161 (35.4)<0.0001
Prior stroke/TIA/VBI, n (%)7,085 (31.8)3,874 (26.6)<0.0001
NIHSS on admission, n (%)  <0.0001
No stroke (NIHSS=0)2,747 (27.4)913 (18.3) 
Mild stroke (NIHSS=14)4,010 (40.0)1,811 (33.3) 
Moderatesevere (NIHSS >5)3,272 (32.6)2,271 (45.4) 
Door‐to‐tPA time, min, median (IQR)  
Arrived within 120 minutes74.0 (35.0)65.0 (33.0)<0.0001c
Arrived within 210 minutes76.0 (37.0)65.0 (34.0)<0.0001c
Stroke diagnosis, distribution  <0.0001
Ischemic11,145 (50.0)8,235 (56.5) 
Hemorrhagic1,587 (7.1)3,270 (13.3) 
Subarachnoid219 (13.8)397 (20.4) 
Intracerebral1,368 (86.2)1,545 (79.6) 
Transient ischemic attack8,116 (36.4)4,162 (28.5) 
Stroke not otherwise specified1,145 (5.1)130 (0.9) 
No stroke‐related diagnosis293 (1.3)118 (0.8) 

The incidences of stroke diagnosis types are also detailed in Table 2. Seventy percent of patients at CSCs had either an ischemic or hemorrhagic stroke diagnosis versus 57.1% of patients admitted at PSCs. Hemorrhagic stroke patients were twice as likely to be admitted at CSCs compared to PSCs.

After excluding 13,964 patients with a diagnosis of TIA, stroke not otherwise specified, and those with nonstroke‐related diagnosis, the likelihood of stroke patients' receiving the JC's performance measure services at either of these hospital levels was assessed (Table 3). In general, the adjusted odds ratio estimates of patients receiving a JC core performance measure at PSCs were lower than CSCs, indicating better compliance with the measures at CSCs. For example, 19.5% of eligible patients received thrombolytic therapy at CSCs compared to 9.6% at PSCs. CSCs also were more likely to provide VTE prophylaxis, anticoagulation for atrial fibrillation, and assessment for rehabilitation. Stroke education and antithrombotic therapy by the end of hospital day 2 were more likely to be provided at PSCs, but the results were not statistically significant.

Frequencies and Odds Ratio for the Likelihood of Eligible Stroke Patients Receiving Joint Commission's Performance Measure Services in PSCs vs CSCs
VariablesHospital LevelsaOdds Ratio (95% CI)
PSCs, N (%)CSCs, N (%)UnadjustedAdjustedb
  • NOTE: Abbreviations: CI, confidence intervals; CSCs, comprehensive stroke centers; EMS, emergency medical services; PCSs, primary stroke centers; VTE, venous thromboembolism.

  • Performance measurements are based on the Joint Commission Stroke Performance Measures.

  • Adjusted for sex, age, race, and type of stroke (as appropriate).

VTE prophylaxis4,745 (92.1)5,455 (94.2)0.72 (0.610.83)0.47 (0.330.67)
Discharged on antithrombotic therapy8,835 (98.1)6,873 (99.2)0.42 (0.310.56)0.46 (0.270.78)
Anticoagulation therapy for atrial fibrillation/flutter1,464 (95.1)1,144 (97.6)0.48 (0.310.74)0.38 (0.170.86)
Thrombolytic therapy    
Time window=3.0 hours484 (9.6)666 (19.5)0.44 (0.390.50)0.28 (0.240.34)
Time window=4.5 hours564 (11.0)792 (22.4)0.43 (0.380.48)0.28 (0.230.33)
Antithrombotic therapy by end of hospital day 27,575 (97.4)5,396 (98.2)0.69 (0.540.88)1.01 (0.601.68)
Discharged on statin medication6,035 (97.9)4,261 (98.7)0.59 (0.430.80)0.69 (0.421.13)
Stroke education, for home discharge (overall)3,823 (97.7)3,072 (95.7)1.93 (1.472.53)1.78 (0.923.45)
Risk factors for stroke3,480 (88.9)3,026 (94.4)0.49 (0.410.59)0.43 (0.280.66)
Warning sign and symptoms3,514 (89.8)3,019 (94.1)0.56 (0.460.67)0.52 (0.340.79)
Activation of EMS3,539 (90.5)3,023 (94.2)0.59 (0.490.70)0.44 (0.280.69)
Followup after discharge3,807 (97.3)3,064 (95.5)1.73 (1.342.23)1.18 (0.652.20)
Medications prescribed at discharge3,788 (96.8)3,067 (95.5)1.42 (1.111.82)0.44 (0.280.70)
Assessed for rehabilitation9,725 (95.2)8,199 (97.5)0.51 (0.430.61)0.37 (0.260.53)

DISCUSSION

In New Jersey, CSCs were more likely to adhere better to JC core performance measures than PSCs. Median door‐to‐thrombolytic drug times were also significantly lower at CSCs. Such differences may be due to several factors including the fact that CSCs have generally been state designated for a longer period of time than PSCs. CSCs are likely to have higher volumes of stroke admissions, are more likely to be JC certified, provide more staff education, and have more staff and resources. The New Jersey stroke designation program began in 2006, and 11 of the 12 CSCs were designated by the end of 2007. However, the PSC designation process has been more gradual, with several of them designated in 2010 and 2011 as the data for this study were being collected.

The New York State Stroke Center Designation Project prospectively showed that stroke center designation improved the quality of acute stroke patient care and administration of thrombolytic therapy; however, differing levels of hospital designation were not present in New York at that time.[11] Participation in a data measurement program such as Get With The Guidelines has also been examined. It is evident that the amount of time in a program is predictive of process measure compliance.[12] JC certification as a PSC is also associated with increased thrombolytic rates for acute stroke over time.[13] New Jersey does not require that stroke‐designated hospitals have JC stroke certification. Although 11 New Jersey CSCs have been certified as JC PSCs since 2009, only 21 of the 53 state‐designated PSCs are JC certified. It may be that the highest performing sites pursue state CSC designation and JC PSC certification/recertification repeatedly. CSCs in New Jersey may also have a greater focus on quality measures by virtue of having been in quality programs such as Get With The Guidelines or by having been state designated and JC certified for a longer period of time.

The New Jersey requirements for CSCs, like those of the JC, include a large number of highly trained stroke experts, which ensures more continuous coverage. Although a disparity in mortality on weekends versus weekdays has been reported,[14] such a difference in mortality has not been seen at CSCs in New Jersey.[15] This lack of a weekend effect is felt to be related to the 24/7 availability of stroke specialists, advanced neuroimaging, ongoing training, and surveillance of specialized nursing care available at CSCs.[4, 16]

In our study, New Jersey CSCs overall had significantly higher rates of thrombolysis compared to PSCs (19.5% vs 9.6%) when looking at the 3‐hour window. This is higher overall than the national rate of 3.4% to 5.2%.[17] The number of patients treated in the expanded thrombolytic window were also significantly higher at CSCs, increasing thrombolysis rates to 22.4% at CSCs versus the 11% at PSCs. Door‐to‐drug times were also shorter at CSCs than PSCs in the 3‐ and 4.5‐hour windows (65 vs 74 minutes and 65 minutes vs 76 minutes, respectively). After we excluded transferred patients and those with a diagnosis of TIA, stroke not otherwise specified, and those with nonstroke‐related diagnoses, the total number of ischemic and hemorrhagic stroke patients seen at each of the 12 CSCs (n=11,505) was on average 4 times higher than the number seen at each of the 53 PSCs (n=12,732). High annual hospital stroke volume has been shown to be associated with higher rates of thrombolysis and lower stroke mortality.[14] A study of US academic centers found that although the same percentage of patients presented within 2 hours of stroke symptom onset in 2001 and 2004, the use of IV tPA more than doubled over this time period.[18] Improved system organization at the prehospital and hospital levels as well as greater comfort and experience with use of thrombolytic therapy likely contribute to all of these findings.[11]

CSCs did not outperform PSCs with regard to stroke education and antithrombotics by end of hospital day 2, but these results were not statistically significant. The former measure includes only stroke patients who are discharged home and is considered complete when all 5 of the following are addressed: risk factors for stroke, warning signs and symptoms for stroke, activation of emergency medical systems, follow‐up after discharge, and medications prescribed at discharge. CSCs were more likely to provide education for the first 3 and last component but less likely for the fourth element. These findings should be considered in the context of CSCs having higher volumes of more ill and complex patients who are more likely to be discharged to a rehabilitation hospital, nursing home, or other facility than to home. In our registry, CSCs discharged 46% of patients' to home versus 54% at PSCs. We speculate that CSCs may be less likely to habitually address follow‐up care and discharge medications as compared to PSCs. As far as provision of antithrombotics by hospital day 2, it is possible again that because CSCs have a higher number of complicated stroke patients, many may have had contraindications to use of antithrombotics in that time period.

Limitations of this study include the fact that this was a retrospective analysis of a database. Although the 2010 and 2011 NJASR dataset was sizeable, it was not possible to capture all potentially confounding variables that may have affected our point estimates. We were not able to perform a hierarchical analysis to account for clustering at the hospital level because of limited data available in the registry. Errors in recording data, coding, and documentation cannot be excluded. The fact that not all PSCs were necessarily JC certified may have contributed to the observed differences. Also, because pursuing PSC or CSC status is voluntary, it is not clear if the hospitals that chose CSC status were different in other unmeasured factors than those that chose PSC status, and the difference may have existed even in the absence of the designation program. Over the years, there have been changes in the criteria required by the state and the JC for PSC designation, although the larger differences between hospital levels remained intact. This may have limited our findings as well. The goal for hospitals is to continue strict adherence to policies and measures and thus improve quality of care for stroke patients. Future prospective studies should be conducted to ascertain validity and generalizability of our findings. Association of stroke measure adherence and functional outcomes would also be of interest. We were not able to measure this consistently in our study because not all patients at PSCs had admission and/or discharge NIHSS or modified Rankin Score. Although some studies have not shown an association between improved outcomes and higher performance on quality measures, we would like to look at this more closely in the stroke population.[19] As our database gets larger, we would like to reexamine our findings after correcting for more specific characteristics of each hospital. In the future, if additional states designate centers by level of stroke care, it will be important to compare how such designations compare to nonprofit organization certifications in terms of impacting performance on a larger scale.

CONCLUSION

This study shows better compliance of New Jersey state‐designated CSCs with the JC PSC core stroke measures and better mean door‐to‐thrombolytic drug times. Because these measures are evidence based, these results may translate into better stroke care and outcomes for patients treated at state‐designated CSCs.

ACKNOWLEDGEMENTS

Disclosures: Jawad Kirmani, MD: Consultant to Joint Commission on Performance Measure Development (modest). Martin Gizzi, MD, PhD: Consultant to Joint Commission on Performance Measure Development (modest), New Jersey Department of Health and Senior Services as chair of the Stroke Advisory Panel (significant). No other potential conflicts to report.

Stroke is the fourth leading cause of death in the United States.[1] Though actual stroke‐related death has declined nationally by 19.4%, stroke‐related morbidity is still a significant burden.[2, 3] Hospital certification programs have been developed to improve the quality of stroke care on state and national levels. The Brain Attack Coalition (BAC) proposed 2 levels of stroke hospitals: primary stroke centers (PSCs) and comprehensive stroke centers (CSCs).[3, 4] Although most stroke patients can be cared for at PSCs, CSCs are able to care for more complex stroke patients.[4, 5] Using BAC recommendations the Joint Commission (JC) and American Heart Association/American Stroke Association created a certification program for PSCs. Eight evidence‐based performance measures are currently required for JC PSC certification.[6]

At the state level, New Jersey and Florida began designating PSCs and CSCs.[7, 8] New Jersey PSC and CSC designation criteria incorporate the elements of JC PSC certification, despite preceding them by several years.[6, 9] New Jersey CSC certification consists of more comprehensive requirements (Table 1). All New Jersey‐designated stroke centers submit data in the New Jersey Acute Stroke Registry (NJASR),[7] which closely matches the Centers for Disease Control and Prevention's Paul Coverdell National Acute Stroke Registry and includes the JC‐required core measures.

New Jersey State Stroke Center Designation Criteria
Primary Stroke Center (N=53)Comprehensive Stroke Center (N=12)
  • NOTE: Abbreviations: CTA, computed tomography angiography; MRI, magnetic resonance imaging.

Must have acute stroke teams in place at all times that can respond to the bedside within 15 minutes of patient arrival or identificationMust meet all criteria for primary stroke centers
Must maintain neurology and emergency department personnel trained in the treatment of acute strokeMust maintain a neurosurgical team capable of assessing and treating complex stroke
Must maintain telemetry or critical care beds staffed by physicians and nurses trained in caring for acute stroke patientsMust maintain on staff a neuroradiologist (boarded) and a neurointerventionalist
Must provide for neurosurgical services within 2 hours either at the hospital or under agreement with a comprehensive stroke centerMust provide comprehensive rehabilitation services either on site or by transfer agreement
Must provide acute care rehabilitation servicesMust provide MRI, CTA, and digital subtraction angiography
Must enter into a written transfer agreement with a comprehensive stroke centerMust develop and maintain sophisticated outcomes assessment and performance improvement capability
Must provide graduate medical education in stroke and carry out research in stroke

There is a paucity of data comparing state‐designated CSCs and PSCs, largely because few states have state designation programs. Although a recent observational study from Finland showed better outcomes in patients treated at CSCs, measures in that study were limited to mortality and institutionalization at 1 year.[10] In this study, we examined adherence of all New Jersey state‐designated stroke centers to the JC PSC measures and compared CSCs to PSCs in this regard. We posited that better compliance with these evidence‐based measures might translate into better quality of stroke care in the state and may lend support to future, larger studies that may be conducted because of the recent certification of CSCs by the JC.

METHODS

Components of the NJASR, key components of PSCs and CSCs in the BAC report, and the 8 JC's core stroke measures for PSC certification were assessed.[3, 4, 6]

First responders in New Jersey are required to bring suspected stroke patients to the nearest stroke‐designated hospital, regardless of whether it is a PSC or CSC, unless the patient is too medically unstable and needs to be taken to the nearest hospital. From there, decisions can be made to transfer a patient to a higher level hospital (CSC) depending on the complexity of the patient's condition.

New Jersey state‐designated PSCs and CSCs are required to abstract patient‐level data, evaluate outcomes, and initiate quality improvement activities on all patients evaluated for ischemic stroke, hemorrhagic stroke, transient ischemic attack (TIA), and those who undergo acute interventional therapy. Data are submitted quarterly to the New Jersey Department of Health and Senior Services (NJDHSS).[7] Hospital data are imported into the Acute Stroke Registry Database. The NJASR statewide dataset used for this analysis included all stroke admissions for the calendar years 2010 and 2011 and contains patient demographic information, health history, clinical investigations performed, treatments provided, and outcome measures that allow for risk‐adjusted assessment of outcomes.

The JC core stroke measures (STK‐1 thru 10 [except STK‐7 and 9]: venous thromboembolism [VTE] prophylaxis, discharged on antithrombotic therapy, anticoagulation therapy for atrial fibrillation/flutter, thrombolytic therapy, antithrombotic therapy by the end of hospital day 2, discharged on statin medication, stroke education, and assessment for rehabilitation) (except STK‐7 [dysphagia screening] and STK‐9 [smoking cessation/advice counseling]) apply only to acute ischemic and/or hemorrhagic stroke patients.

In our analysis, transferred patients and patients with a diagnosis of TIA, stroke not otherwise specified, and nonstroke‐related diagnoses were excluded. Hospital identity was kept anonymous through assignment of random numeric codes by the NJDHSS. Hospitals were categorized as CSC or PSC based on NJDHSS designation. Stroke severity on admission was assessed by categorizing National Institutes of Health Stroke Scale (NIHSS) scores into: no stroke when NIHSS=0, mild stroke when NIHSS=14, and moderate to severe stroke when NIHSS>5. Median door‐to‐thrombolytic drug times were assessed for both patients who arrived to the hospital within 2 hours of stroke symptom onset and received thrombolytic therapy within 3 hours, as well as patients who arrived within 3.5 hours (210 minutes) and received treatment within 4.5 hours (270 minutes).

Inclusion and Exclusion Criteria for JC Performance Measures

Excluded from all measures are patients who were discharged to hospice, left against medical advice (AMA), expired, were transferred to another short‐term care facility, had an unknown discharge location, comfort measures only (CMO), or enrolled in clinical trials. Other exclusions are listed below each measure. VTE prophylaxis included nonambulatory ischemic and hemorrhagic stroke patients who received VTE prophylaxis by end of hospital day 2 and excluded patients discharged prior to hospital day 2 and with length of stay >120 days. Antithrombotics at discharge included ischemic stroke patients discharged on antithrombotics and excluded those with documented reason for not receiving antithrombotics. Anticoagulation for atrial fibrillation included ischemic stroke patients with documented atrial fibrillation/flutter who received anticoagulation therapy and excluded those with documented reason for not receiving anticoagulation. Thrombolytic therapy included acute ischemic stroke patients who arrived at the hospital within 2 hours from time last known well and for whom intravenous (IV) tissue plasminogen activator (tPA) was initiated at that hospital within 1hour of hospital arrival. Excluded were patients with valid reason for not getting tPA, length of stay >120 days, and time last known well >2 hours. We also looked at thrombolytic therapy for patients who arrived by 3.5 hours from time last known well and received IV‐tPA within 1 hour.

Antithrombotics by the end of hospital day 2 included ischemic stroke patients who received antithrombotic medication by the end of hospital day 2 and excluded patients who were discharged before hospital day 2, had a documented reason for not receiving antithrombotic medication, had a length of stay greater >120 days, were CMO by day 2, and patients who received IV or intra‐arterial tPA. Statin therapy included ischemic stroke patients with low‐density lipoprotein exceeding 100 mg/dL or not measured, or on cholesterol‐reducing medication prior to admission. Excluded were those with length of stay >120 days and a documented reason for not receiving medication. Stroke education on discharge included all stroke patients being discharged home who received education during the hospitalization addressing the following: patient's stroke‐specific risk factors, warning signs and symptoms, emergency medical services activation, follow‐up, and discharge medications. Those with length of stay >120 days were excluded. Assessment for rehabilitation included ischemic and hemorrhagic patients assessed for rehabilitation services.

Statistical Analysis

Patient characteristics were summarized using frequencies and percentages for categorical variables as well as median and interquartile range for continuous variables. 2 tests and median 2‐sample tests were used to compare patient characteristics between the 2 hospital levels. The likelihood that a patient received a particular JC core measure service in relation to hospital level (PSC vs CSC) was estimated using a multiple logistic regression analysis for both the crude/unadjusted and adjusted odds ratios, and their 95% confidence intervals were estimated. Gender, age, race, stroke type, medical history (hypertension, atrial fibrillation, diabetes mellitus, and history of smoking), and severity of stroke as measured by NIHSS were included in the model. Institutional review board approval to evaluate the data for this analysis was obtained from John F. Kennedy Medical Center in Edison, New Jersey. All analyses were performed using SAS software package version 9.3 (SAS Institute, Cary, NC).

RESULTS

There were 36,892 acute stroke cases treated at the 53 New Jersey PSCs and 12 CSCs in the calendar year 2010 and 2011 (Table 2). Sixty percent were treated at PSCs and 40% at CSCs. There were significant differences in the distribution of patients' characteristics (race, age, and gender) between the 2 hospital levels. At both PSCs and CSCs, the majority of patients were white, distantly followed by blacks. Patients at PSCs were statistically significantly older than CSCs. The most prevalent comorbid conditions in both PSCs and CSCs were hypertension, diabetes mellitus, and dyslipidemia. Based on our categorization, we found that 45% of patients admitted to CSCs had moderate‐to‐severe stroke (NIHSS>5). The median door‐to‐thrombolytic drug times were significantly shorter at CSCs than PSCs for both the 3‐hour (65 vs 74 minutes, P<0.0001) and 4.5 hour (65 vs 76 minutes, P<0.0001) IV tPA time windows.

Descriptive Statistics of Acute Stroke Patients by Hospital Levels (PSCs vs CSCs)
VariablesPSCs, N=22,305CSCs, N=14,587P Valuea
  • NOTE: Abbreviations: CSCs, comprehensive stroke centers; IQR, interquartile range; NIHSS, National Institutes of Health Stroke Scale; PCSs, primary stroke centers; TIA, transient ischemic attack; tPA, tissue plasminogen activator; VBI, vertebral‐basilar insufficiency.

  • 2 P values.

  • All others race category includes: Native American/Alaska Native, Hawaiian/Other Pacific Islander and Other.

  • Median 2‐sample test.

Race, n (%)  <0.0001
White16,586 (74.4)10,419 (71.4) 
Black3,930 (17.6)2,875 (19.7)
Asian511 (2.3)519 (3.6)
All othersb1,278 (5.7)774 (5.3)
Age, y, median (IQR)75.0 (22.0)73.0 (23.0)<0.0001c
Gender, female, n (%)12,552 (56.3)7,757 (53.2)<0.0001
Comorbidities   
Hypertension, n (%)17,405 (78.1)10,535 (72.2)<0.0001
Atrial fibrillation/flutter, n (%)3,762 (16.9)2,237 (15.3)0.0001
Diabetes mellitus, n (%)7,219 (32.4)4,220 (28.9)<0.0001
History of smoking, n (%)2,924 (13.1)1,706 (11.7)<0.0001
Heart failure, n (%)1,733 (7.8)749 (5.1)<0.0001
Myocardial infarction, n (%)6,138 (27.5)2,945 (20.3)<0.0001
Dyslipidemia, n (%)10,106 (45.6)5,161 (35.4)<0.0001
Prior stroke/TIA/VBI, n (%)7,085 (31.8)3,874 (26.6)<0.0001
NIHSS on admission, n (%)  <0.0001
No stroke (NIHSS=0)2,747 (27.4)913 (18.3) 
Mild stroke (NIHSS=14)4,010 (40.0)1,811 (33.3) 
Moderatesevere (NIHSS >5)3,272 (32.6)2,271 (45.4) 
Door‐to‐tPA time, min, median (IQR)  
Arrived within 120 minutes74.0 (35.0)65.0 (33.0)<0.0001c
Arrived within 210 minutes76.0 (37.0)65.0 (34.0)<0.0001c
Stroke diagnosis, distribution  <0.0001
Ischemic11,145 (50.0)8,235 (56.5) 
Hemorrhagic1,587 (7.1)3,270 (13.3) 
Subarachnoid219 (13.8)397 (20.4) 
Intracerebral1,368 (86.2)1,545 (79.6) 
Transient ischemic attack8,116 (36.4)4,162 (28.5) 
Stroke not otherwise specified1,145 (5.1)130 (0.9) 
No stroke‐related diagnosis293 (1.3)118 (0.8) 

The incidences of stroke diagnosis types are also detailed in Table 2. Seventy percent of patients at CSCs had either an ischemic or hemorrhagic stroke diagnosis versus 57.1% of patients admitted at PSCs. Hemorrhagic stroke patients were twice as likely to be admitted at CSCs compared to PSCs.

After excluding 13,964 patients with a diagnosis of TIA, stroke not otherwise specified, and those with nonstroke‐related diagnosis, the likelihood of stroke patients' receiving the JC's performance measure services at either of these hospital levels was assessed (Table 3). In general, the adjusted odds ratio estimates of patients receiving a JC core performance measure at PSCs were lower than CSCs, indicating better compliance with the measures at CSCs. For example, 19.5% of eligible patients received thrombolytic therapy at CSCs compared to 9.6% at PSCs. CSCs also were more likely to provide VTE prophylaxis, anticoagulation for atrial fibrillation, and assessment for rehabilitation. Stroke education and antithrombotic therapy by the end of hospital day 2 were more likely to be provided at PSCs, but the results were not statistically significant.

Frequencies and Odds Ratio for the Likelihood of Eligible Stroke Patients Receiving Joint Commission's Performance Measure Services in PSCs vs CSCs
VariablesHospital LevelsaOdds Ratio (95% CI)
PSCs, N (%)CSCs, N (%)UnadjustedAdjustedb
  • NOTE: Abbreviations: CI, confidence intervals; CSCs, comprehensive stroke centers; EMS, emergency medical services; PCSs, primary stroke centers; VTE, venous thromboembolism.

  • Performance measurements are based on the Joint Commission Stroke Performance Measures.

  • Adjusted for sex, age, race, and type of stroke (as appropriate).

VTE prophylaxis4,745 (92.1)5,455 (94.2)0.72 (0.610.83)0.47 (0.330.67)
Discharged on antithrombotic therapy8,835 (98.1)6,873 (99.2)0.42 (0.310.56)0.46 (0.270.78)
Anticoagulation therapy for atrial fibrillation/flutter1,464 (95.1)1,144 (97.6)0.48 (0.310.74)0.38 (0.170.86)
Thrombolytic therapy    
Time window=3.0 hours484 (9.6)666 (19.5)0.44 (0.390.50)0.28 (0.240.34)
Time window=4.5 hours564 (11.0)792 (22.4)0.43 (0.380.48)0.28 (0.230.33)
Antithrombotic therapy by end of hospital day 27,575 (97.4)5,396 (98.2)0.69 (0.540.88)1.01 (0.601.68)
Discharged on statin medication6,035 (97.9)4,261 (98.7)0.59 (0.430.80)0.69 (0.421.13)
Stroke education, for home discharge (overall)3,823 (97.7)3,072 (95.7)1.93 (1.472.53)1.78 (0.923.45)
Risk factors for stroke3,480 (88.9)3,026 (94.4)0.49 (0.410.59)0.43 (0.280.66)
Warning sign and symptoms3,514 (89.8)3,019 (94.1)0.56 (0.460.67)0.52 (0.340.79)
Activation of EMS3,539 (90.5)3,023 (94.2)0.59 (0.490.70)0.44 (0.280.69)
Followup after discharge3,807 (97.3)3,064 (95.5)1.73 (1.342.23)1.18 (0.652.20)
Medications prescribed at discharge3,788 (96.8)3,067 (95.5)1.42 (1.111.82)0.44 (0.280.70)
Assessed for rehabilitation9,725 (95.2)8,199 (97.5)0.51 (0.430.61)0.37 (0.260.53)

DISCUSSION

In New Jersey, CSCs were more likely to adhere better to JC core performance measures than PSCs. Median door‐to‐thrombolytic drug times were also significantly lower at CSCs. Such differences may be due to several factors including the fact that CSCs have generally been state designated for a longer period of time than PSCs. CSCs are likely to have higher volumes of stroke admissions, are more likely to be JC certified, provide more staff education, and have more staff and resources. The New Jersey stroke designation program began in 2006, and 11 of the 12 CSCs were designated by the end of 2007. However, the PSC designation process has been more gradual, with several of them designated in 2010 and 2011 as the data for this study were being collected.

The New York State Stroke Center Designation Project prospectively showed that stroke center designation improved the quality of acute stroke patient care and administration of thrombolytic therapy; however, differing levels of hospital designation were not present in New York at that time.[11] Participation in a data measurement program such as Get With The Guidelines has also been examined. It is evident that the amount of time in a program is predictive of process measure compliance.[12] JC certification as a PSC is also associated with increased thrombolytic rates for acute stroke over time.[13] New Jersey does not require that stroke‐designated hospitals have JC stroke certification. Although 11 New Jersey CSCs have been certified as JC PSCs since 2009, only 21 of the 53 state‐designated PSCs are JC certified. It may be that the highest performing sites pursue state CSC designation and JC PSC certification/recertification repeatedly. CSCs in New Jersey may also have a greater focus on quality measures by virtue of having been in quality programs such as Get With The Guidelines or by having been state designated and JC certified for a longer period of time.

The New Jersey requirements for CSCs, like those of the JC, include a large number of highly trained stroke experts, which ensures more continuous coverage. Although a disparity in mortality on weekends versus weekdays has been reported,[14] such a difference in mortality has not been seen at CSCs in New Jersey.[15] This lack of a weekend effect is felt to be related to the 24/7 availability of stroke specialists, advanced neuroimaging, ongoing training, and surveillance of specialized nursing care available at CSCs.[4, 16]

In our study, New Jersey CSCs overall had significantly higher rates of thrombolysis compared to PSCs (19.5% vs 9.6%) when looking at the 3‐hour window. This is higher overall than the national rate of 3.4% to 5.2%.[17] The number of patients treated in the expanded thrombolytic window were also significantly higher at CSCs, increasing thrombolysis rates to 22.4% at CSCs versus the 11% at PSCs. Door‐to‐drug times were also shorter at CSCs than PSCs in the 3‐ and 4.5‐hour windows (65 vs 74 minutes and 65 minutes vs 76 minutes, respectively). After we excluded transferred patients and those with a diagnosis of TIA, stroke not otherwise specified, and those with nonstroke‐related diagnoses, the total number of ischemic and hemorrhagic stroke patients seen at each of the 12 CSCs (n=11,505) was on average 4 times higher than the number seen at each of the 53 PSCs (n=12,732). High annual hospital stroke volume has been shown to be associated with higher rates of thrombolysis and lower stroke mortality.[14] A study of US academic centers found that although the same percentage of patients presented within 2 hours of stroke symptom onset in 2001 and 2004, the use of IV tPA more than doubled over this time period.[18] Improved system organization at the prehospital and hospital levels as well as greater comfort and experience with use of thrombolytic therapy likely contribute to all of these findings.[11]

CSCs did not outperform PSCs with regard to stroke education and antithrombotics by end of hospital day 2, but these results were not statistically significant. The former measure includes only stroke patients who are discharged home and is considered complete when all 5 of the following are addressed: risk factors for stroke, warning signs and symptoms for stroke, activation of emergency medical systems, follow‐up after discharge, and medications prescribed at discharge. CSCs were more likely to provide education for the first 3 and last component but less likely for the fourth element. These findings should be considered in the context of CSCs having higher volumes of more ill and complex patients who are more likely to be discharged to a rehabilitation hospital, nursing home, or other facility than to home. In our registry, CSCs discharged 46% of patients' to home versus 54% at PSCs. We speculate that CSCs may be less likely to habitually address follow‐up care and discharge medications as compared to PSCs. As far as provision of antithrombotics by hospital day 2, it is possible again that because CSCs have a higher number of complicated stroke patients, many may have had contraindications to use of antithrombotics in that time period.

Limitations of this study include the fact that this was a retrospective analysis of a database. Although the 2010 and 2011 NJASR dataset was sizeable, it was not possible to capture all potentially confounding variables that may have affected our point estimates. We were not able to perform a hierarchical analysis to account for clustering at the hospital level because of limited data available in the registry. Errors in recording data, coding, and documentation cannot be excluded. The fact that not all PSCs were necessarily JC certified may have contributed to the observed differences. Also, because pursuing PSC or CSC status is voluntary, it is not clear if the hospitals that chose CSC status were different in other unmeasured factors than those that chose PSC status, and the difference may have existed even in the absence of the designation program. Over the years, there have been changes in the criteria required by the state and the JC for PSC designation, although the larger differences between hospital levels remained intact. This may have limited our findings as well. The goal for hospitals is to continue strict adherence to policies and measures and thus improve quality of care for stroke patients. Future prospective studies should be conducted to ascertain validity and generalizability of our findings. Association of stroke measure adherence and functional outcomes would also be of interest. We were not able to measure this consistently in our study because not all patients at PSCs had admission and/or discharge NIHSS or modified Rankin Score. Although some studies have not shown an association between improved outcomes and higher performance on quality measures, we would like to look at this more closely in the stroke population.[19] As our database gets larger, we would like to reexamine our findings after correcting for more specific characteristics of each hospital. In the future, if additional states designate centers by level of stroke care, it will be important to compare how such designations compare to nonprofit organization certifications in terms of impacting performance on a larger scale.

CONCLUSION

This study shows better compliance of New Jersey state‐designated CSCs with the JC PSC core stroke measures and better mean door‐to‐thrombolytic drug times. Because these measures are evidence based, these results may translate into better stroke care and outcomes for patients treated at state‐designated CSCs.

ACKNOWLEDGEMENTS

Disclosures: Jawad Kirmani, MD: Consultant to Joint Commission on Performance Measure Development (modest). Martin Gizzi, MD, PhD: Consultant to Joint Commission on Performance Measure Development (modest), New Jersey Department of Health and Senior Services as chair of the Stroke Advisory Panel (significant). No other potential conflicts to report.

References
  1. Centers for Disease Control and Prevention. Interactive atlas of heart disease and stroke. Available at: http://apps.Nccd.Cdc.Gov/dhdspatlas/reports.Aspx. Accessed May 5, 2012.
  2. Roger VL, Go AS, Lloyd‐Jones DM, et al.; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2012 update: a report from the American Heart Association. Circulation. 2012;125:e2e220.
  3. Alberts MJ, Hademenos G, Latchaw RE, et al. Recommendations for the establishment of primary stroke centers. JAMA. 2000;283:31023109.
  4. Alberts MJ, Latchaw RE, Selman WR, et al.; Brain Attack Coalition. Recommendations for comprehensive stroke centers: a consensus statement from the Brain Attack Coalition. Stroke. 2005;36:15971616.
  5. Schwamm LH, Pancioli A, Acker JE, et al. Recommendations for the establishment of stroke systems of care. Stroke. 2005;36:690703.
  6. The Joint Commission. Advanced Certification Comprehensive Stroke Centers. Available at: http://www.jointcommission.org/certification/advanced_certification_comprehensive_stroke_centers.aspx. Accessed July 25, 2012.
  7. New Jersey Department of Health and Senior Services: The New Jersey Acute Stroke Registry. Available at: http://www.state.nj.us/health/healthcarequality/stroke/documents/njacute_stroke_data_dictionary.pdf. Accessed July 8, 2012.
  8. Florida Agency for Health Care Administration. Primary stroke center and comprehensive stroke center designation. Available at: http://ahca.myflorida.com/mchq/Health_Facility_Regulation/Hospital_Outpatient/forms/59A3_2085_FAC_Rule_text.pdf. Accessed July 25, 2012.
  9. New Jersey Department of Health and Senior Services. Stroke Center Act (2004). Available at: http://www.njleg.state.nj.us/2004/bills/pl04/136_.pdf. Accessed September 25, 2013.
  10. Meretoja A, Roine RO, Kaste M, et al. Effectiveness of primary and comprehensive stroke centers. Stroke. 2010;41:11021107.
  11. Gropen TI, Gagliano PJ, Blake CA, et al.; NYSDOH Stroke Center Designation Project Workgroup. Quality improvement in acute stroke: The New York State Stroke Center Designation Project. Neurology. 2006;67(1):8893.
  12. Fonarow GC, Reeves MJ, Smith EE, et al. Characteristics, performance measures, and in‐hospital outcomes of the first one million stroke and transient ischemic attack admissions in get with the guidelines‐stroke. Circ Cardiovasc Qual Outcomes. 2010;3(3):291302.
  13. Prabhakaran S, McNulty M, O'Neill K, et al. Intravenous thrombolysis for stroke increases over time at primary stroke centers. Stroke. 2012;43:875877.
  14. Saposnik G, Baibergenova A, Bayer N, et al. Weekends: a dangerous time for having a stroke? Stroke. 2007;38:12111215.
  15. McKinney JS, Deng Y, Kasner SE, et al.; Myocardial Infarction Data Acquisition System (MIDAS 15) Study Group. Comprehensive stroke centers overcome the weekend versus weekday gap in stroke treatment and mortality. Stroke. 2011;42:24032409.
  16. Albright KC, Raman R, Ernstrom K, et al. Can comprehensive stroke centers erase the “weekend effect”? Cerebrovasc Dis. 2009;27:107113.
  17. Adeoye O, Hornung R, Khatri P, et al. Recombinant tissue‐type plasminogen activator use for ischemic stroke in the United States. Stroke. 2011;42:19521955.
  18. Lichtman JH, Watanabe E, Allen NB, et al. Hospital arrival time and intravenous t‐PA use in US academic medical centers, 2001–2004. Stroke. 2009;40:38453850.
  19. Ingraham AM, Cohen ME, Bilimoria KY, et al. Association of surgical care improvement project infection‐related process measure compliance with risk‐adjusted outcomes: implications for quality measurement. J Am Coll Surg. 2010;211(6):705714.
References
  1. Centers for Disease Control and Prevention. Interactive atlas of heart disease and stroke. Available at: http://apps.Nccd.Cdc.Gov/dhdspatlas/reports.Aspx. Accessed May 5, 2012.
  2. Roger VL, Go AS, Lloyd‐Jones DM, et al.; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2012 update: a report from the American Heart Association. Circulation. 2012;125:e2e220.
  3. Alberts MJ, Hademenos G, Latchaw RE, et al. Recommendations for the establishment of primary stroke centers. JAMA. 2000;283:31023109.
  4. Alberts MJ, Latchaw RE, Selman WR, et al.; Brain Attack Coalition. Recommendations for comprehensive stroke centers: a consensus statement from the Brain Attack Coalition. Stroke. 2005;36:15971616.
  5. Schwamm LH, Pancioli A, Acker JE, et al. Recommendations for the establishment of stroke systems of care. Stroke. 2005;36:690703.
  6. The Joint Commission. Advanced Certification Comprehensive Stroke Centers. Available at: http://www.jointcommission.org/certification/advanced_certification_comprehensive_stroke_centers.aspx. Accessed July 25, 2012.
  7. New Jersey Department of Health and Senior Services: The New Jersey Acute Stroke Registry. Available at: http://www.state.nj.us/health/healthcarequality/stroke/documents/njacute_stroke_data_dictionary.pdf. Accessed July 8, 2012.
  8. Florida Agency for Health Care Administration. Primary stroke center and comprehensive stroke center designation. Available at: http://ahca.myflorida.com/mchq/Health_Facility_Regulation/Hospital_Outpatient/forms/59A3_2085_FAC_Rule_text.pdf. Accessed July 25, 2012.
  9. New Jersey Department of Health and Senior Services. Stroke Center Act (2004). Available at: http://www.njleg.state.nj.us/2004/bills/pl04/136_.pdf. Accessed September 25, 2013.
  10. Meretoja A, Roine RO, Kaste M, et al. Effectiveness of primary and comprehensive stroke centers. Stroke. 2010;41:11021107.
  11. Gropen TI, Gagliano PJ, Blake CA, et al.; NYSDOH Stroke Center Designation Project Workgroup. Quality improvement in acute stroke: The New York State Stroke Center Designation Project. Neurology. 2006;67(1):8893.
  12. Fonarow GC, Reeves MJ, Smith EE, et al. Characteristics, performance measures, and in‐hospital outcomes of the first one million stroke and transient ischemic attack admissions in get with the guidelines‐stroke. Circ Cardiovasc Qual Outcomes. 2010;3(3):291302.
  13. Prabhakaran S, McNulty M, O'Neill K, et al. Intravenous thrombolysis for stroke increases over time at primary stroke centers. Stroke. 2012;43:875877.
  14. Saposnik G, Baibergenova A, Bayer N, et al. Weekends: a dangerous time for having a stroke? Stroke. 2007;38:12111215.
  15. McKinney JS, Deng Y, Kasner SE, et al.; Myocardial Infarction Data Acquisition System (MIDAS 15) Study Group. Comprehensive stroke centers overcome the weekend versus weekday gap in stroke treatment and mortality. Stroke. 2011;42:24032409.
  16. Albright KC, Raman R, Ernstrom K, et al. Can comprehensive stroke centers erase the “weekend effect”? Cerebrovasc Dis. 2009;27:107113.
  17. Adeoye O, Hornung R, Khatri P, et al. Recombinant tissue‐type plasminogen activator use for ischemic stroke in the United States. Stroke. 2011;42:19521955.
  18. Lichtman JH, Watanabe E, Allen NB, et al. Hospital arrival time and intravenous t‐PA use in US academic medical centers, 2001–2004. Stroke. 2009;40:38453850.
  19. Ingraham AM, Cohen ME, Bilimoria KY, et al. Association of surgical care improvement project infection‐related process measure compliance with risk‐adjusted outcomes: implications for quality measurement. J Am Coll Surg. 2010;211(6):705714.
Issue
Journal of Hospital Medicine - 9(2)
Issue
Journal of Hospital Medicine - 9(2)
Page Number
88-93
Page Number
88-93
Article Type
Display Headline
Compliance with joint commission measures in state‐designated stroke centers
Display Headline
Compliance with joint commission measures in state‐designated stroke centers
Sections
Article Source

© 2013 Society of Hospital Medicine

Disallow All Ads
Correspondence Location
Address for correspondence and reprint requests: Spozhmy Panezai, MD, New Jersey Neuroscience Institute, 65 James St., Edison, NJ 08818; Telephone: 631‐335‐1845; Fax: 732‐744‐5821; E‐mail: spanezai@jfkhealth.org
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Article PDF Media
Media Files

Diffuse large B-cell lymphoma of the lung in a 63-year-old man with left flank pain

Article Type
Changed
Display Headline
Diffuse large B-cell lymphoma of the lung in a 63-year-old man with left flank pain

Diffuse large B-cell lymphoma of the lung is a rare entity, and although the prognosis is favorable, its biological features, clinical presentation, prognostic markers, and treatment have not been well defined.1,2 It is the second most common primary pulmonary lymphoma after mucosa-associated lymphoid tissue. PPL itself is very rare; it represents 3%-4% of extranodal non-Hodgkin lymphoma, less than 1% of NHL, and 0.5%-1.0% of primary pulmonary malignancies.2,3 A review of the literature indicates a lack of data on pulmonary DLBCL. The objective of this case report is to highlight areas in which further research may be pursued to better understand this disease.
 

Click on the PDF icon at the top of this introduction to read the full article.

 

Article PDF
Author and Disclosure Information

 

 

Publications
Topics
Legacy Keywords
diffuse large B-cell lymphoma, DLBCL, primary pulmonary lymphoma, PPL
Sections
Author and Disclosure Information

 

 

Author and Disclosure Information

 

 

Article PDF
Article PDF

Diffuse large B-cell lymphoma of the lung is a rare entity, and although the prognosis is favorable, its biological features, clinical presentation, prognostic markers, and treatment have not been well defined.1,2 It is the second most common primary pulmonary lymphoma after mucosa-associated lymphoid tissue. PPL itself is very rare; it represents 3%-4% of extranodal non-Hodgkin lymphoma, less than 1% of NHL, and 0.5%-1.0% of primary pulmonary malignancies.2,3 A review of the literature indicates a lack of data on pulmonary DLBCL. The objective of this case report is to highlight areas in which further research may be pursued to better understand this disease.
 

Click on the PDF icon at the top of this introduction to read the full article.

 

Diffuse large B-cell lymphoma of the lung is a rare entity, and although the prognosis is favorable, its biological features, clinical presentation, prognostic markers, and treatment have not been well defined.1,2 It is the second most common primary pulmonary lymphoma after mucosa-associated lymphoid tissue. PPL itself is very rare; it represents 3%-4% of extranodal non-Hodgkin lymphoma, less than 1% of NHL, and 0.5%-1.0% of primary pulmonary malignancies.2,3 A review of the literature indicates a lack of data on pulmonary DLBCL. The objective of this case report is to highlight areas in which further research may be pursued to better understand this disease.
 

Click on the PDF icon at the top of this introduction to read the full article.

 

Publications
Publications
Topics
Article Type
Display Headline
Diffuse large B-cell lymphoma of the lung in a 63-year-old man with left flank pain
Display Headline
Diffuse large B-cell lymphoma of the lung in a 63-year-old man with left flank pain
Legacy Keywords
diffuse large B-cell lymphoma, DLBCL, primary pulmonary lymphoma, PPL
Legacy Keywords
diffuse large B-cell lymphoma, DLBCL, primary pulmonary lymphoma, PPL
Sections
Citation Override
Commun Oncol 2013;10:333-336
Disallow All Ads
Alternative CME
Use ProPublica
Article PDF Media

A planning and evaluation program for assessing telecommunications applications in community radiation oncology programs

Article Type
Changed
Display Headline
A planning and evaluation program for assessing telecommunications applications in community radiation oncology programs

Management-focused scientific evaluation is a useful administrative tool especially when hospitals implement a new technology. This paper describes the components of a scientific evaluation framework and then illustrates the application and the utility of the framework in a hospital-based community oncology setting. The clinical technology, Telesynergy, is an advanced telecommunications and remote medical consultation system which has been developed by the National Cancer Institute to support community hospital-based radiation oncology programs.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Article PDF
Author and Disclosure Information

 

 

Publications
Topics
Legacy Keywords
radiation oncology
Sections
Author and Disclosure Information

 

 

Author and Disclosure Information

 

 

Article PDF
Article PDF
Related Articles

Management-focused scientific evaluation is a useful administrative tool especially when hospitals implement a new technology. This paper describes the components of a scientific evaluation framework and then illustrates the application and the utility of the framework in a hospital-based community oncology setting. The clinical technology, Telesynergy, is an advanced telecommunications and remote medical consultation system which has been developed by the National Cancer Institute to support community hospital-based radiation oncology programs.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Management-focused scientific evaluation is a useful administrative tool especially when hospitals implement a new technology. This paper describes the components of a scientific evaluation framework and then illustrates the application and the utility of the framework in a hospital-based community oncology setting. The clinical technology, Telesynergy, is an advanced telecommunications and remote medical consultation system which has been developed by the National Cancer Institute to support community hospital-based radiation oncology programs.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Publications
Publications
Topics
Article Type
Display Headline
A planning and evaluation program for assessing telecommunications applications in community radiation oncology programs
Display Headline
A planning and evaluation program for assessing telecommunications applications in community radiation oncology programs
Legacy Keywords
radiation oncology
Legacy Keywords
radiation oncology
Sections
Citation Override
Commun Oncol 2013;10:325-332
Disallow All Ads
Alternative CME
Article PDF Media

Inexpensive solutions to enhance remote cancer care in community hospitals

Article Type
Changed
Display Headline
Inexpensive solutions to enhance remote cancer care in community hospitals

Rapidly increasing volume and complexity of information used for multidisciplinary cancer treatment requires carefully evolving communications with programmatic planning, detailed evaluation, and new methodologies and technical approaches to enhance the impact and efficacy of medical conferencing systems. We designed, implemented, and evaluated cost-effective and appropriate remote learning optimize oncology practice techniques in community hospitals. Our experience over the course of more than 7 years demonstrated simple and inexpensive communication solutions for both professional and lay education, satisfying information-dense needs of multimodality cancer care. We describe how potential complexities may be resolved with inexpensive devices and software programs. Staff teamwork and creativity are always required to implement constantly evolving technologies. We provide both quantitative and qualitative data describing activities and resulting staff responses resulting in 6,520 personnel with more than 391 aggregate credit hours of continuing medical education and continuing education credit activities with enhanced collegial participant satisfaction levels and heightened interactions/professionalism among regional oncology staff. We noted significant cost reductions for communications in all our three partnered hospitals. We demonstrated both increased satisfaction levels and heightened levels of behavioral changes (Impacts) in participants. Always, activities must be cost effective and responsive to changing medical needs. Community focused efforts with regional partners should be similar, assuring evolving successes.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Article PDF
Author and Disclosure Information

 

 

Publications
Topics
Legacy Keywords
remote cancer care, multimodality cancer care
Sections
Author and Disclosure Information

 

 

Author and Disclosure Information

 

 

Article PDF
Article PDF

Rapidly increasing volume and complexity of information used for multidisciplinary cancer treatment requires carefully evolving communications with programmatic planning, detailed evaluation, and new methodologies and technical approaches to enhance the impact and efficacy of medical conferencing systems. We designed, implemented, and evaluated cost-effective and appropriate remote learning optimize oncology practice techniques in community hospitals. Our experience over the course of more than 7 years demonstrated simple and inexpensive communication solutions for both professional and lay education, satisfying information-dense needs of multimodality cancer care. We describe how potential complexities may be resolved with inexpensive devices and software programs. Staff teamwork and creativity are always required to implement constantly evolving technologies. We provide both quantitative and qualitative data describing activities and resulting staff responses resulting in 6,520 personnel with more than 391 aggregate credit hours of continuing medical education and continuing education credit activities with enhanced collegial participant satisfaction levels and heightened interactions/professionalism among regional oncology staff. We noted significant cost reductions for communications in all our three partnered hospitals. We demonstrated both increased satisfaction levels and heightened levels of behavioral changes (Impacts) in participants. Always, activities must be cost effective and responsive to changing medical needs. Community focused efforts with regional partners should be similar, assuring evolving successes.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Rapidly increasing volume and complexity of information used for multidisciplinary cancer treatment requires carefully evolving communications with programmatic planning, detailed evaluation, and new methodologies and technical approaches to enhance the impact and efficacy of medical conferencing systems. We designed, implemented, and evaluated cost-effective and appropriate remote learning optimize oncology practice techniques in community hospitals. Our experience over the course of more than 7 years demonstrated simple and inexpensive communication solutions for both professional and lay education, satisfying information-dense needs of multimodality cancer care. We describe how potential complexities may be resolved with inexpensive devices and software programs. Staff teamwork and creativity are always required to implement constantly evolving technologies. We provide both quantitative and qualitative data describing activities and resulting staff responses resulting in 6,520 personnel with more than 391 aggregate credit hours of continuing medical education and continuing education credit activities with enhanced collegial participant satisfaction levels and heightened interactions/professionalism among regional oncology staff. We noted significant cost reductions for communications in all our three partnered hospitals. We demonstrated both increased satisfaction levels and heightened levels of behavioral changes (Impacts) in participants. Always, activities must be cost effective and responsive to changing medical needs. Community focused efforts with regional partners should be similar, assuring evolving successes.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Publications
Publications
Topics
Article Type
Display Headline
Inexpensive solutions to enhance remote cancer care in community hospitals
Display Headline
Inexpensive solutions to enhance remote cancer care in community hospitals
Legacy Keywords
remote cancer care, multimodality cancer care
Legacy Keywords
remote cancer care, multimodality cancer care
Sections
Citation Override
Commun Oncol 2013;10:316-324
Disallow All Ads
Alternative CME
Article PDF Media

Virtual tumor boards: community–university collaboration to improve quality of care

Article Type
Changed
Display Headline
Virtual tumor boards: community–university collaboration to improve quality of care

Objective To develop and implement virtual interactive multidisciplinary cancer tumor boards (VTBs), created throughtelemedicine links between the University of California, Davis Cancer Center and community-based cancer care providers. Thegoal of this project was to facilitate communication among community and academic cancer specialists.


Materials and methods Four geographically remote sites were selected to participate with established disease-specific tumorboards of the UC Davis Cancer Center. Telemedicine links were created using dedicated T1 lines, and PolyCom HDX 9000 was used by the center for teleconference hosting. Participants were then surveyed on their perception of the benefit of VTBs.


Results The results across disease-specific virtual tumor boards show that most of the participants reported that the right amountof clinical information on the cases was presented and that new information was discussed that helped providers manage thecare of the patients.


Conclusions Teleconferencing of disease-specific tumor boards allowed providers in a geographically remote group ofproviders to make prospective, case-based treatment decisions that increased their knowledge of treatment options and facilitatedtheir decision making. This transfer of knowledge and experience speeds up the dissemination of rapidly evolving cancer care,which could lead to higher quality patient outcomes.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Article PDF
Author and Disclosure Information

 

 

Publications
Topics
Legacy Keywords
virtual tumor boards, quality of care, teleconference, patient outcomes
Sections
Author and Disclosure Information

 

 

Author and Disclosure Information

 

 

Article PDF
Article PDF
Related Articles

Objective To develop and implement virtual interactive multidisciplinary cancer tumor boards (VTBs), created throughtelemedicine links between the University of California, Davis Cancer Center and community-based cancer care providers. Thegoal of this project was to facilitate communication among community and academic cancer specialists.


Materials and methods Four geographically remote sites were selected to participate with established disease-specific tumorboards of the UC Davis Cancer Center. Telemedicine links were created using dedicated T1 lines, and PolyCom HDX 9000 was used by the center for teleconference hosting. Participants were then surveyed on their perception of the benefit of VTBs.


Results The results across disease-specific virtual tumor boards show that most of the participants reported that the right amountof clinical information on the cases was presented and that new information was discussed that helped providers manage thecare of the patients.


Conclusions Teleconferencing of disease-specific tumor boards allowed providers in a geographically remote group ofproviders to make prospective, case-based treatment decisions that increased their knowledge of treatment options and facilitatedtheir decision making. This transfer of knowledge and experience speeds up the dissemination of rapidly evolving cancer care,which could lead to higher quality patient outcomes.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Objective To develop and implement virtual interactive multidisciplinary cancer tumor boards (VTBs), created throughtelemedicine links between the University of California, Davis Cancer Center and community-based cancer care providers. Thegoal of this project was to facilitate communication among community and academic cancer specialists.


Materials and methods Four geographically remote sites were selected to participate with established disease-specific tumorboards of the UC Davis Cancer Center. Telemedicine links were created using dedicated T1 lines, and PolyCom HDX 9000 was used by the center for teleconference hosting. Participants were then surveyed on their perception of the benefit of VTBs.


Results The results across disease-specific virtual tumor boards show that most of the participants reported that the right amountof clinical information on the cases was presented and that new information was discussed that helped providers manage thecare of the patients.


Conclusions Teleconferencing of disease-specific tumor boards allowed providers in a geographically remote group ofproviders to make prospective, case-based treatment decisions that increased their knowledge of treatment options and facilitatedtheir decision making. This transfer of knowledge and experience speeds up the dissemination of rapidly evolving cancer care,which could lead to higher quality patient outcomes.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Publications
Publications
Topics
Article Type
Display Headline
Virtual tumor boards: community–university collaboration to improve quality of care
Display Headline
Virtual tumor boards: community–university collaboration to improve quality of care
Legacy Keywords
virtual tumor boards, quality of care, teleconference, patient outcomes
Legacy Keywords
virtual tumor boards, quality of care, teleconference, patient outcomes
Sections
Citation Override
Commun Oncol 2013;10:310-315
Disallow All Ads
Alternative CME
Article PDF Media

Sickle cell crises curtailed with experimental cellular adhesion inhibitor

Article Type
Changed
Display Headline
Sickle cell crises curtailed with experimental cellular adhesion inhibitor

NEW ORLEANS – An experimental cellular adhesion inhibitor was successful at reducing the severity and duration of vaso-occlusive crises in patients with sickle cell disease.

In a phase II trial of 76 patients with sickle cell disease, patients randomized to receive the pan-selectin inhibitor GMI 1070 early in their hospitalization for a vaso-occlusive crisis (VOC) had shorter lengths of stay and needed significantly lower cumulative doses of narcotics for pain control than did patients randomized to placebo, reported Dr. Marilyn J. Telen, chief of the hematology division at Duke University, Durham, N.C.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

"We see somewhere between 75,000 and 90,000 admissions [annually] for acute painful vaso-occlusive crisis among this patient population. Indeed, these crises are the most common and essentially the archetypal presentation of sickle cell disease. Nevertheless, up till this time, treatment for these crises or VOC in sickle cell disease, remain only supportive, focusing largely on using narcotics for symptom relief, and then other measures, some of which are used to counteract the ill effects of narcotics," said Dr. Telen at the annual meeting of the American Society of Hematology.

GMI 1070 (being developed by GlycoMimetics, in partnership with Pfizer) is a synthetic molecule designed to inhibit the glycoprotein cellular-adhesion molecules involved in inflammation. In previous studies, the drug has been shown to be safe, and in a mouse model of VOC, was successful at restoring blood flow, Dr. Telen said. The drug has received both orphan drug and fast-track status from the Food and Drug Administration, according to GlycoMimetics.

Dr. Telen and her colleagues enrolled 76 patients aged 12-51 years with sickle cell disease and randomized them to receive a loading dose of GMI 1070 delivered intravenously (43 patients), followed by up to 14 subsequent doses delivered every 12 hours, or placebo (33 patients), with other treatment left to the discretion of the participating institutions. After an interim pharmacokinetic analysis showed that the drug did not reach target nadir levels, the dose was doubled.

All 76 patients reached the primary endpoint of VOC resolution, defined as a composite of decreased pain, termination of the need for intravenous opioids, patient and physician agreement on the ability to discharge the patient, and actual hospital discharge.

A total of 58 patients continued on the assigned drug until they either reached the primary endpoint criteria or received the maximum number of doses allowed. The remaining 18 patients discontinued the drug either for adverse events, no improvement by day 5 on the assigned drug, or other reasons.

In an analysis pooling all patients assigned to GMI 1070, including those who started out on the lower dose, there was a consistent reduction over placebo in the mean time to resolution of VOC: 103 hours vs. 144 hours for patients treated with placebo. This difference was not statistically significant, however.

A Kaplan-Meier analysis showed a median time to resolution of 69.6 hours for GMI 1070, compared with 139 hours with placebo, a difference that was not significant.

There was an 83% reduction in the secondary endpoint of cumulative opioid analgesics administered during hospitalization, a difference that was statistically significant (P =.010). There was also a reduction by 84 hours in the median time to discharge, and by 55 hours in the mean time to discharge, among patients treated with the active drug, compared with those on placebo. These differences, while large, were not significant, Dr. Telen said.

She noted that although most of the endpoints in this study failed to reach statistical significance, the separation of the curves between the placebo- and GMI 1070–treated patients began early, usually within 2 days of the start of treatment.

Total adverse event rates, including serious events and those deemed to be treatment related, were comparable between the two study arms for all subgroups.

Dr. Telen noted that because the population of patients enrolled was more clinically diverse than the available literature would suggest, the study was underpowered to detect differences, given the size of the sample. She predicted that given the size of the effects seen, statistical significance would emerge in a larger study.

GlycoMimetics is currently working with Pfizer to develop a phase III trial of GM 1070 for this indication.

The study was supported by GlycoMimetics. Dr. Telen is a consultant to the company, and several coauthors are employees of the company.

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
cellular adhesion inhibitor, vaso-occlusive crises, sickle cell disease, pan-selectin inhibitor, GMI 1070, VOC, narcotics, pain control, hematology
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

NEW ORLEANS – An experimental cellular adhesion inhibitor was successful at reducing the severity and duration of vaso-occlusive crises in patients with sickle cell disease.

In a phase II trial of 76 patients with sickle cell disease, patients randomized to receive the pan-selectin inhibitor GMI 1070 early in their hospitalization for a vaso-occlusive crisis (VOC) had shorter lengths of stay and needed significantly lower cumulative doses of narcotics for pain control than did patients randomized to placebo, reported Dr. Marilyn J. Telen, chief of the hematology division at Duke University, Durham, N.C.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

"We see somewhere between 75,000 and 90,000 admissions [annually] for acute painful vaso-occlusive crisis among this patient population. Indeed, these crises are the most common and essentially the archetypal presentation of sickle cell disease. Nevertheless, up till this time, treatment for these crises or VOC in sickle cell disease, remain only supportive, focusing largely on using narcotics for symptom relief, and then other measures, some of which are used to counteract the ill effects of narcotics," said Dr. Telen at the annual meeting of the American Society of Hematology.

GMI 1070 (being developed by GlycoMimetics, in partnership with Pfizer) is a synthetic molecule designed to inhibit the glycoprotein cellular-adhesion molecules involved in inflammation. In previous studies, the drug has been shown to be safe, and in a mouse model of VOC, was successful at restoring blood flow, Dr. Telen said. The drug has received both orphan drug and fast-track status from the Food and Drug Administration, according to GlycoMimetics.

Dr. Telen and her colleagues enrolled 76 patients aged 12-51 years with sickle cell disease and randomized them to receive a loading dose of GMI 1070 delivered intravenously (43 patients), followed by up to 14 subsequent doses delivered every 12 hours, or placebo (33 patients), with other treatment left to the discretion of the participating institutions. After an interim pharmacokinetic analysis showed that the drug did not reach target nadir levels, the dose was doubled.

All 76 patients reached the primary endpoint of VOC resolution, defined as a composite of decreased pain, termination of the need for intravenous opioids, patient and physician agreement on the ability to discharge the patient, and actual hospital discharge.

A total of 58 patients continued on the assigned drug until they either reached the primary endpoint criteria or received the maximum number of doses allowed. The remaining 18 patients discontinued the drug either for adverse events, no improvement by day 5 on the assigned drug, or other reasons.

In an analysis pooling all patients assigned to GMI 1070, including those who started out on the lower dose, there was a consistent reduction over placebo in the mean time to resolution of VOC: 103 hours vs. 144 hours for patients treated with placebo. This difference was not statistically significant, however.

A Kaplan-Meier analysis showed a median time to resolution of 69.6 hours for GMI 1070, compared with 139 hours with placebo, a difference that was not significant.

There was an 83% reduction in the secondary endpoint of cumulative opioid analgesics administered during hospitalization, a difference that was statistically significant (P =.010). There was also a reduction by 84 hours in the median time to discharge, and by 55 hours in the mean time to discharge, among patients treated with the active drug, compared with those on placebo. These differences, while large, were not significant, Dr. Telen said.

She noted that although most of the endpoints in this study failed to reach statistical significance, the separation of the curves between the placebo- and GMI 1070–treated patients began early, usually within 2 days of the start of treatment.

Total adverse event rates, including serious events and those deemed to be treatment related, were comparable between the two study arms for all subgroups.

Dr. Telen noted that because the population of patients enrolled was more clinically diverse than the available literature would suggest, the study was underpowered to detect differences, given the size of the sample. She predicted that given the size of the effects seen, statistical significance would emerge in a larger study.

GlycoMimetics is currently working with Pfizer to develop a phase III trial of GM 1070 for this indication.

The study was supported by GlycoMimetics. Dr. Telen is a consultant to the company, and several coauthors are employees of the company.

NEW ORLEANS – An experimental cellular adhesion inhibitor was successful at reducing the severity and duration of vaso-occlusive crises in patients with sickle cell disease.

In a phase II trial of 76 patients with sickle cell disease, patients randomized to receive the pan-selectin inhibitor GMI 1070 early in their hospitalization for a vaso-occlusive crisis (VOC) had shorter lengths of stay and needed significantly lower cumulative doses of narcotics for pain control than did patients randomized to placebo, reported Dr. Marilyn J. Telen, chief of the hematology division at Duke University, Durham, N.C.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

"We see somewhere between 75,000 and 90,000 admissions [annually] for acute painful vaso-occlusive crisis among this patient population. Indeed, these crises are the most common and essentially the archetypal presentation of sickle cell disease. Nevertheless, up till this time, treatment for these crises or VOC in sickle cell disease, remain only supportive, focusing largely on using narcotics for symptom relief, and then other measures, some of which are used to counteract the ill effects of narcotics," said Dr. Telen at the annual meeting of the American Society of Hematology.

GMI 1070 (being developed by GlycoMimetics, in partnership with Pfizer) is a synthetic molecule designed to inhibit the glycoprotein cellular-adhesion molecules involved in inflammation. In previous studies, the drug has been shown to be safe, and in a mouse model of VOC, was successful at restoring blood flow, Dr. Telen said. The drug has received both orphan drug and fast-track status from the Food and Drug Administration, according to GlycoMimetics.

Dr. Telen and her colleagues enrolled 76 patients aged 12-51 years with sickle cell disease and randomized them to receive a loading dose of GMI 1070 delivered intravenously (43 patients), followed by up to 14 subsequent doses delivered every 12 hours, or placebo (33 patients), with other treatment left to the discretion of the participating institutions. After an interim pharmacokinetic analysis showed that the drug did not reach target nadir levels, the dose was doubled.

All 76 patients reached the primary endpoint of VOC resolution, defined as a composite of decreased pain, termination of the need for intravenous opioids, patient and physician agreement on the ability to discharge the patient, and actual hospital discharge.

A total of 58 patients continued on the assigned drug until they either reached the primary endpoint criteria or received the maximum number of doses allowed. The remaining 18 patients discontinued the drug either for adverse events, no improvement by day 5 on the assigned drug, or other reasons.

In an analysis pooling all patients assigned to GMI 1070, including those who started out on the lower dose, there was a consistent reduction over placebo in the mean time to resolution of VOC: 103 hours vs. 144 hours for patients treated with placebo. This difference was not statistically significant, however.

A Kaplan-Meier analysis showed a median time to resolution of 69.6 hours for GMI 1070, compared with 139 hours with placebo, a difference that was not significant.

There was an 83% reduction in the secondary endpoint of cumulative opioid analgesics administered during hospitalization, a difference that was statistically significant (P =.010). There was also a reduction by 84 hours in the median time to discharge, and by 55 hours in the mean time to discharge, among patients treated with the active drug, compared with those on placebo. These differences, while large, were not significant, Dr. Telen said.

She noted that although most of the endpoints in this study failed to reach statistical significance, the separation of the curves between the placebo- and GMI 1070–treated patients began early, usually within 2 days of the start of treatment.

Total adverse event rates, including serious events and those deemed to be treatment related, were comparable between the two study arms for all subgroups.

Dr. Telen noted that because the population of patients enrolled was more clinically diverse than the available literature would suggest, the study was underpowered to detect differences, given the size of the sample. She predicted that given the size of the effects seen, statistical significance would emerge in a larger study.

GlycoMimetics is currently working with Pfizer to develop a phase III trial of GM 1070 for this indication.

The study was supported by GlycoMimetics. Dr. Telen is a consultant to the company, and several coauthors are employees of the company.

Publications
Publications
Topics
Article Type
Display Headline
Sickle cell crises curtailed with experimental cellular adhesion inhibitor
Display Headline
Sickle cell crises curtailed with experimental cellular adhesion inhibitor
Legacy Keywords
cellular adhesion inhibitor, vaso-occlusive crises, sickle cell disease, pan-selectin inhibitor, GMI 1070, VOC, narcotics, pain control, hematology
Legacy Keywords
cellular adhesion inhibitor, vaso-occlusive crises, sickle cell disease, pan-selectin inhibitor, GMI 1070, VOC, narcotics, pain control, hematology
Sections
Article Source

AT ASH 2013

PURLs Copyright

Inside the Article

Vitals

Major finding: The mean time to resolution of vaso-occlusive crisis in patients with sickle cell disease was 103 hours for patients treated with GMI 1070 vs. 144 for those treated with placebo.

Data source: A randomized, double blind multicenter study of 76 patients aged 12-51.

Disclosures: The study was supported by GlycoMimetics. Dr. Telen is a consultant to the company, and several coauthors are employees of the company.

VIDEO: Idelalisib shows promise in refractory non-Hodgkin lymphoma

Article Type
Changed
Display Headline
VIDEO: Idelalisib shows promise in refractory non-Hodgkin lymphoma

NEW ORLEANS – When indolent B-cell non-Hodgkin lymphoma becomes refractory to rituximab and alkylating agents, few therapeutic options remain. But the PI3kd inhibitor idelalisib may someday offer a new treatment choice. Dr. Ajay Gopal discusses the promising findings from a phase II trial of idelalisib, including a 57% response rate.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Author and Disclosure Information

Publications
Topics
Sections
Author and Disclosure Information

Author and Disclosure Information

NEW ORLEANS – When indolent B-cell non-Hodgkin lymphoma becomes refractory to rituximab and alkylating agents, few therapeutic options remain. But the PI3kd inhibitor idelalisib may someday offer a new treatment choice. Dr. Ajay Gopal discusses the promising findings from a phase II trial of idelalisib, including a 57% response rate.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

NEW ORLEANS – When indolent B-cell non-Hodgkin lymphoma becomes refractory to rituximab and alkylating agents, few therapeutic options remain. But the PI3kd inhibitor idelalisib may someday offer a new treatment choice. Dr. Ajay Gopal discusses the promising findings from a phase II trial of idelalisib, including a 57% response rate.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Publications
Publications
Topics
Article Type
Display Headline
VIDEO: Idelalisib shows promise in refractory non-Hodgkin lymphoma
Display Headline
VIDEO: Idelalisib shows promise in refractory non-Hodgkin lymphoma
Sections
Article Source

PURLs Copyright

Inside the Article

Gene therapy for SCID-X1 may successfully reset immune system

Article Type
Changed
Display Headline
Gene therapy for SCID-X1 may successfully reset immune system

NEW ORLEANS – Tweaking experimental gene therapy for X-linked severe combined immunodeficiency may help to restore patient immune function while reducing the risk for subsequent leukemias.

In a small, multinational phase I/II trial, seven of nine children with SCID-X1 showed evidence of T-cell recovery and function, as well as a lower risk for promoting growth of leukemic cells, when a self-inactivating gamma-retroviral vector (SCID-2) was used to promote reconstitution of the child’s immune system without insertional oncogenesis, reported Dr. Sung-Yun Pai at the annual meeting of the American Society of Hematology.

"Outcomes for boys who do not have well-matched donors are suboptimal, and it’s particularly for these boys that we are targeting gene therapy," said Dr. Pai, of Boston Children’s Hospital and the Dana-Farber Cancer Institute, Boston.

In previous gene therapy trials, investigators used the Moloney leukemia virus (MLV)-based gamma-retroviral vector (SCID-1) with strong promoters and enhancers to express an IL-2 receptor that reconstituted the immune system successfully in 18 of 20 boys.

However, 5 of the 20 boys developed T-cell acute lymphoblastic leukemia; 1 of the children died, and the remaining 4 were successfully treated.

The investigators found that in the patients with leukemia, the SCID-1 vector had inserted into a chromosomal region close to proto-oncogenes such as LMO2, and the enhancers were driving expression of the neighboring oncogene, promoting expression of aberrant T cells. The vector was subsequently modified with the goal of improved safety but similar efficacy to the original, said Dr. Pai. The strong viral enhancers were removed to prevent accident enhancement should the inserted genes manage to find their way into oncogenes.

The phase I/II study is being conducted in London, Paris, Boston, Cincinnati, and Los Angeles, and to date has enrolled 9 male children of a planned 20.

Of the 9, one child died from a preexisting adenoviral infection before immune recovery was complete, and one child did not have engraftment of the gene-marked cells and went on to transplant.

"The other patients have 9 months to 36 months of follow-up, they have evidence of T-cell recovery, of T-cell function, have cleared SCID-related infections, and are all out of hospital, healthy at home, [and] leading essentially normal lives."

When the investigators looked at the comparative efficacy of the SCID-1 and SCID-2 vectors, they saw that 6 months after gene therapy, there was no significant difference in the median number of T cells generated.

"It’s far too early to comment on whether this vector will truly be safer in terms of leukemia," Dr. Pai said, noting that in the SCID-1 trial the leukemias developed 3-5 years after gene therapy, and the longest follow-up in the SCID-2 study is only 3 years.

The investigators are, however, conducting molecular surrogate safety analyses looking at gene insertion sites from the blood of patients treated with SCID-1 and are comparing those sites with the vector-insertion sites in cells from patients in SCID-2.

Looking at a global genomewide map of integrations, they found no significant differences between SCID-1 and SCID-2. However, when they focused on 38 genes that are to be proto-oncogenes in lymphoid cancer, they found that significantly more integration of the modified genes occurred in proximity to the oncogenes in SCID-1 than in SCID-2 (P = .003).

"We hope that these data suggest that the modified SCID vector will show less capacity to drive aberrant cell growth and lead to less leukemogenesis," said Dr. Pai.

SCID-X1 is caused by inherited mutations in the gamma subunit of the interleukin (IL)-2 receptor. As a result, males are born without T lymphocytes or natural killer cells. Without a bone marrow or stem cell transplantation, children with the disease die early from opportunistic or community-acquired infections.

"These are really paradigm-changing results for mortally wounded children," said Dr. Laurence James Neil Cooper of the University of Texas M.D. Anderson Cancer Center in Houston, who moderated the briefing but was not involved in the study.

The trial is being sponsored by Children’s Hospital Boston, Cincinnati Children’s Hospital Medical Center, and the University of California, Los Angeles. Dr. Pai and Dr. Cooper reported having no relevant conflicts of interest.

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
experimental gene therapy, X-linked severe combined immunodeficiency, immune function, leukemias, children, SCID-X1, T-cell recovery, leukemic cells, self-inactivating gamma-retroviral vector, SCID-2, insertional oncogenesis, Dr. Sung-Yun Pai, American Society of Hematology, Boston Children’s Hospital, the Dana-Farber Cancer Institute, Boston, gene therapy, Moloney leukemia virus (MLV)-based gamma-retroviral vector (SCID-1),
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

NEW ORLEANS – Tweaking experimental gene therapy for X-linked severe combined immunodeficiency may help to restore patient immune function while reducing the risk for subsequent leukemias.

In a small, multinational phase I/II trial, seven of nine children with SCID-X1 showed evidence of T-cell recovery and function, as well as a lower risk for promoting growth of leukemic cells, when a self-inactivating gamma-retroviral vector (SCID-2) was used to promote reconstitution of the child’s immune system without insertional oncogenesis, reported Dr. Sung-Yun Pai at the annual meeting of the American Society of Hematology.

"Outcomes for boys who do not have well-matched donors are suboptimal, and it’s particularly for these boys that we are targeting gene therapy," said Dr. Pai, of Boston Children’s Hospital and the Dana-Farber Cancer Institute, Boston.

In previous gene therapy trials, investigators used the Moloney leukemia virus (MLV)-based gamma-retroviral vector (SCID-1) with strong promoters and enhancers to express an IL-2 receptor that reconstituted the immune system successfully in 18 of 20 boys.

However, 5 of the 20 boys developed T-cell acute lymphoblastic leukemia; 1 of the children died, and the remaining 4 were successfully treated.

The investigators found that in the patients with leukemia, the SCID-1 vector had inserted into a chromosomal region close to proto-oncogenes such as LMO2, and the enhancers were driving expression of the neighboring oncogene, promoting expression of aberrant T cells. The vector was subsequently modified with the goal of improved safety but similar efficacy to the original, said Dr. Pai. The strong viral enhancers were removed to prevent accident enhancement should the inserted genes manage to find their way into oncogenes.

The phase I/II study is being conducted in London, Paris, Boston, Cincinnati, and Los Angeles, and to date has enrolled 9 male children of a planned 20.

Of the 9, one child died from a preexisting adenoviral infection before immune recovery was complete, and one child did not have engraftment of the gene-marked cells and went on to transplant.

"The other patients have 9 months to 36 months of follow-up, they have evidence of T-cell recovery, of T-cell function, have cleared SCID-related infections, and are all out of hospital, healthy at home, [and] leading essentially normal lives."

When the investigators looked at the comparative efficacy of the SCID-1 and SCID-2 vectors, they saw that 6 months after gene therapy, there was no significant difference in the median number of T cells generated.

"It’s far too early to comment on whether this vector will truly be safer in terms of leukemia," Dr. Pai said, noting that in the SCID-1 trial the leukemias developed 3-5 years after gene therapy, and the longest follow-up in the SCID-2 study is only 3 years.

The investigators are, however, conducting molecular surrogate safety analyses looking at gene insertion sites from the blood of patients treated with SCID-1 and are comparing those sites with the vector-insertion sites in cells from patients in SCID-2.

Looking at a global genomewide map of integrations, they found no significant differences between SCID-1 and SCID-2. However, when they focused on 38 genes that are to be proto-oncogenes in lymphoid cancer, they found that significantly more integration of the modified genes occurred in proximity to the oncogenes in SCID-1 than in SCID-2 (P = .003).

"We hope that these data suggest that the modified SCID vector will show less capacity to drive aberrant cell growth and lead to less leukemogenesis," said Dr. Pai.

SCID-X1 is caused by inherited mutations in the gamma subunit of the interleukin (IL)-2 receptor. As a result, males are born without T lymphocytes or natural killer cells. Without a bone marrow or stem cell transplantation, children with the disease die early from opportunistic or community-acquired infections.

"These are really paradigm-changing results for mortally wounded children," said Dr. Laurence James Neil Cooper of the University of Texas M.D. Anderson Cancer Center in Houston, who moderated the briefing but was not involved in the study.

The trial is being sponsored by Children’s Hospital Boston, Cincinnati Children’s Hospital Medical Center, and the University of California, Los Angeles. Dr. Pai and Dr. Cooper reported having no relevant conflicts of interest.

NEW ORLEANS – Tweaking experimental gene therapy for X-linked severe combined immunodeficiency may help to restore patient immune function while reducing the risk for subsequent leukemias.

In a small, multinational phase I/II trial, seven of nine children with SCID-X1 showed evidence of T-cell recovery and function, as well as a lower risk for promoting growth of leukemic cells, when a self-inactivating gamma-retroviral vector (SCID-2) was used to promote reconstitution of the child’s immune system without insertional oncogenesis, reported Dr. Sung-Yun Pai at the annual meeting of the American Society of Hematology.

"Outcomes for boys who do not have well-matched donors are suboptimal, and it’s particularly for these boys that we are targeting gene therapy," said Dr. Pai, of Boston Children’s Hospital and the Dana-Farber Cancer Institute, Boston.

In previous gene therapy trials, investigators used the Moloney leukemia virus (MLV)-based gamma-retroviral vector (SCID-1) with strong promoters and enhancers to express an IL-2 receptor that reconstituted the immune system successfully in 18 of 20 boys.

However, 5 of the 20 boys developed T-cell acute lymphoblastic leukemia; 1 of the children died, and the remaining 4 were successfully treated.

The investigators found that in the patients with leukemia, the SCID-1 vector had inserted into a chromosomal region close to proto-oncogenes such as LMO2, and the enhancers were driving expression of the neighboring oncogene, promoting expression of aberrant T cells. The vector was subsequently modified with the goal of improved safety but similar efficacy to the original, said Dr. Pai. The strong viral enhancers were removed to prevent accident enhancement should the inserted genes manage to find their way into oncogenes.

The phase I/II study is being conducted in London, Paris, Boston, Cincinnati, and Los Angeles, and to date has enrolled 9 male children of a planned 20.

Of the 9, one child died from a preexisting adenoviral infection before immune recovery was complete, and one child did not have engraftment of the gene-marked cells and went on to transplant.

"The other patients have 9 months to 36 months of follow-up, they have evidence of T-cell recovery, of T-cell function, have cleared SCID-related infections, and are all out of hospital, healthy at home, [and] leading essentially normal lives."

When the investigators looked at the comparative efficacy of the SCID-1 and SCID-2 vectors, they saw that 6 months after gene therapy, there was no significant difference in the median number of T cells generated.

"It’s far too early to comment on whether this vector will truly be safer in terms of leukemia," Dr. Pai said, noting that in the SCID-1 trial the leukemias developed 3-5 years after gene therapy, and the longest follow-up in the SCID-2 study is only 3 years.

The investigators are, however, conducting molecular surrogate safety analyses looking at gene insertion sites from the blood of patients treated with SCID-1 and are comparing those sites with the vector-insertion sites in cells from patients in SCID-2.

Looking at a global genomewide map of integrations, they found no significant differences between SCID-1 and SCID-2. However, when they focused on 38 genes that are to be proto-oncogenes in lymphoid cancer, they found that significantly more integration of the modified genes occurred in proximity to the oncogenes in SCID-1 than in SCID-2 (P = .003).

"We hope that these data suggest that the modified SCID vector will show less capacity to drive aberrant cell growth and lead to less leukemogenesis," said Dr. Pai.

SCID-X1 is caused by inherited mutations in the gamma subunit of the interleukin (IL)-2 receptor. As a result, males are born without T lymphocytes or natural killer cells. Without a bone marrow or stem cell transplantation, children with the disease die early from opportunistic or community-acquired infections.

"These are really paradigm-changing results for mortally wounded children," said Dr. Laurence James Neil Cooper of the University of Texas M.D. Anderson Cancer Center in Houston, who moderated the briefing but was not involved in the study.

The trial is being sponsored by Children’s Hospital Boston, Cincinnati Children’s Hospital Medical Center, and the University of California, Los Angeles. Dr. Pai and Dr. Cooper reported having no relevant conflicts of interest.

Publications
Publications
Topics
Article Type
Display Headline
Gene therapy for SCID-X1 may successfully reset immune system
Display Headline
Gene therapy for SCID-X1 may successfully reset immune system
Legacy Keywords
experimental gene therapy, X-linked severe combined immunodeficiency, immune function, leukemias, children, SCID-X1, T-cell recovery, leukemic cells, self-inactivating gamma-retroviral vector, SCID-2, insertional oncogenesis, Dr. Sung-Yun Pai, American Society of Hematology, Boston Children’s Hospital, the Dana-Farber Cancer Institute, Boston, gene therapy, Moloney leukemia virus (MLV)-based gamma-retroviral vector (SCID-1),
Legacy Keywords
experimental gene therapy, X-linked severe combined immunodeficiency, immune function, leukemias, children, SCID-X1, T-cell recovery, leukemic cells, self-inactivating gamma-retroviral vector, SCID-2, insertional oncogenesis, Dr. Sung-Yun Pai, American Society of Hematology, Boston Children’s Hospital, the Dana-Farber Cancer Institute, Boston, gene therapy, Moloney leukemia virus (MLV)-based gamma-retroviral vector (SCID-1),
Sections
Article Source

AT ASH 2013

PURLs Copyright

Inside the Article

Vitals

Major finding: Of nine boys with X-linked severe combined immunodeficiency who were treated with gene therapy, seven patients have evidence of T-cell function, have cleared SCID-related infections, and are out of hospital.

Data source: Preliminary results of a prospective phase I/II clinical trial of nine children.

Disclosures: The trial is being sponsored by Children’s Hospital Boston, Cincinnati Children’s Hospital Medical Center, and the University of California, Los Angeles. Dr. Pai and Dr. Cooper reported having no relevant conflicts of interest.

Receptor may play key role in sepsis

Article Type
Changed
Display Headline
Receptor may play key role in sepsis

Red blood cell culture showing
Staphylococcus infection
Credit: Bill Branson

Researchers have identified a receptor that may be instrumental in the body’s response to sepsis. And they believe this discovery could be the key to unlocking new treatments for the disease.

The nociceptin receptor activates the chemical nociceptin. Previous research revealed that nociceptin is involved in inflammation; it is known to affect white blood cell function.

This suggests nociceptin has an important role in the body’s response to inflammation and sepsis, according to David Lambert, PhD, of the University of Leicester in the UK, and his colleagues.

The group’s theory, which they have explored in 2 papers published in PLOS ONE, is that nociceptin makes inflammation or sepsis worse. And by blocking the nociceptin system, the symptoms of sepsis could be reduced, which could lead to new treatments.

“We have found that nociceptin, a chemical similar to endorphins produced in the body, is increased in inflammation and sepsis,” said study author Jonathan Thompson, MD, MB ChB, also of the University of Leicester.

“This suggests that drugs which block the nociceptin receptor could dampen the widespread inflammation that occurs in sepsis, and improve outcome. More work is needed, but these drugs are being developed. If they are effective, then we could potentially save many lives.”

In their first paper, the researchers described how they used fluorescent chemistry to find nociceptin receptors on blood vessels with no nerve supply. The team also showed, in a lab model of sepsis, that blocking these receptors has a protective effect.

In the second paper, the researchers recounted their discovery that bloodstream nociceptin levels are elevated in sepsis patients in intensive care. This suggests nociceptin activation might be important in critically ill patients suffering from sepsis.

Dr Lambert and his colleagues noted that sepsis remains a leading cause of admission to intensive care units, with high mortality, costs, and long-term morbidity in those who survive. The incidence of severe sepsis has increased in the last decade, making the discovery of new treatments highly desirable.

“Sepsis is a major health problem . . . that has often been under-recognized,” Dr Thompson said. “It can be rapidly fatal, especially if not diagnosed and treated early, because inflammation can spread and affect many different organs in the body.”

Dr Lambert added, “I am particularly excited by these findings, as they translate many years of laboratory work into a possible target for this disease.”

Publications
Topics

Red blood cell culture showing
Staphylococcus infection
Credit: Bill Branson

Researchers have identified a receptor that may be instrumental in the body’s response to sepsis. And they believe this discovery could be the key to unlocking new treatments for the disease.

The nociceptin receptor activates the chemical nociceptin. Previous research revealed that nociceptin is involved in inflammation; it is known to affect white blood cell function.

This suggests nociceptin has an important role in the body’s response to inflammation and sepsis, according to David Lambert, PhD, of the University of Leicester in the UK, and his colleagues.

The group’s theory, which they have explored in 2 papers published in PLOS ONE, is that nociceptin makes inflammation or sepsis worse. And by blocking the nociceptin system, the symptoms of sepsis could be reduced, which could lead to new treatments.

“We have found that nociceptin, a chemical similar to endorphins produced in the body, is increased in inflammation and sepsis,” said study author Jonathan Thompson, MD, MB ChB, also of the University of Leicester.

“This suggests that drugs which block the nociceptin receptor could dampen the widespread inflammation that occurs in sepsis, and improve outcome. More work is needed, but these drugs are being developed. If they are effective, then we could potentially save many lives.”

In their first paper, the researchers described how they used fluorescent chemistry to find nociceptin receptors on blood vessels with no nerve supply. The team also showed, in a lab model of sepsis, that blocking these receptors has a protective effect.

In the second paper, the researchers recounted their discovery that bloodstream nociceptin levels are elevated in sepsis patients in intensive care. This suggests nociceptin activation might be important in critically ill patients suffering from sepsis.

Dr Lambert and his colleagues noted that sepsis remains a leading cause of admission to intensive care units, with high mortality, costs, and long-term morbidity in those who survive. The incidence of severe sepsis has increased in the last decade, making the discovery of new treatments highly desirable.

“Sepsis is a major health problem . . . that has often been under-recognized,” Dr Thompson said. “It can be rapidly fatal, especially if not diagnosed and treated early, because inflammation can spread and affect many different organs in the body.”

Dr Lambert added, “I am particularly excited by these findings, as they translate many years of laboratory work into a possible target for this disease.”

Red blood cell culture showing
Staphylococcus infection
Credit: Bill Branson

Researchers have identified a receptor that may be instrumental in the body’s response to sepsis. And they believe this discovery could be the key to unlocking new treatments for the disease.

The nociceptin receptor activates the chemical nociceptin. Previous research revealed that nociceptin is involved in inflammation; it is known to affect white blood cell function.

This suggests nociceptin has an important role in the body’s response to inflammation and sepsis, according to David Lambert, PhD, of the University of Leicester in the UK, and his colleagues.

The group’s theory, which they have explored in 2 papers published in PLOS ONE, is that nociceptin makes inflammation or sepsis worse. And by blocking the nociceptin system, the symptoms of sepsis could be reduced, which could lead to new treatments.

“We have found that nociceptin, a chemical similar to endorphins produced in the body, is increased in inflammation and sepsis,” said study author Jonathan Thompson, MD, MB ChB, also of the University of Leicester.

“This suggests that drugs which block the nociceptin receptor could dampen the widespread inflammation that occurs in sepsis, and improve outcome. More work is needed, but these drugs are being developed. If they are effective, then we could potentially save many lives.”

In their first paper, the researchers described how they used fluorescent chemistry to find nociceptin receptors on blood vessels with no nerve supply. The team also showed, in a lab model of sepsis, that blocking these receptors has a protective effect.

In the second paper, the researchers recounted their discovery that bloodstream nociceptin levels are elevated in sepsis patients in intensive care. This suggests nociceptin activation might be important in critically ill patients suffering from sepsis.

Dr Lambert and his colleagues noted that sepsis remains a leading cause of admission to intensive care units, with high mortality, costs, and long-term morbidity in those who survive. The incidence of severe sepsis has increased in the last decade, making the discovery of new treatments highly desirable.

“Sepsis is a major health problem . . . that has often been under-recognized,” Dr Thompson said. “It can be rapidly fatal, especially if not diagnosed and treated early, because inflammation can spread and affect many different organs in the body.”

Dr Lambert added, “I am particularly excited by these findings, as they translate many years of laboratory work into a possible target for this disease.”

Publications
Publications
Topics
Article Type
Display Headline
Receptor may play key role in sepsis
Display Headline
Receptor may play key role in sepsis
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Quick Diagnosis Units

Article Type
Changed
Display Headline
Quick diagnosis units—an effective alternative to hospitalization for diagnostic workup: A systematic review

Inpatient admissions are a major component of healthcare costs in the United States,[1] where the number of annual inpatient hospital admissions has increased by 15% from 34.3 million in 1993 to 39.5 million in 2006.2 Studies performed predominantly in Europe have shown that inappropriate use of hospital beds exceeds 20% across various specialties.[3] A study by Campbell et al. showed that if given the choice, 60% of physicians would consider an alternative to admission for such patients, if such an option were available, and 70% of patients would prefer not to be admitted for workup.[4] Based on similar findings, various hospitals across the world have tried to make organizational changes to allocate healthcare resources more efficiently. The concept of quick and early diagnosis was first introduced in 1996 by Kendall et al., and it included a hospital unit in the United Kingdom managed by consultants receiving referrals from primary care doctors and led to early diagnostic workup without hospitalization.[5] A more refined version of this concept, a potentially cost‐saving and efficient alternative to inpatient hospitalization for diagnostic purposes, was described by Bosch et al., and named the quick diagnosis unit (QDU).[1]

The basic objectives of QDUs include early diagnosis of potentially severe diseases such as cancer, avoiding unnecessary hospitalization, minimizing hospital morbidity, reducing costs, and improving patient satisfaction. The first described QDU was managed by internists, where patients with specific symptoms such as undiagnosed lumps or masses, anemia, hematuria, or gastrointestinal symptoms could be referred for a diagnostic evaluation. Patients were required to be well enough to travel to the QDU on an outpatient basis, and patients unable to do so were thought to be better suited for hospitalization.[1]

In the present study, we conduct a systematic review, the first one on this subject to our knowledge, of studies that tested established QDUs or similar units in hospital settings. The majority of established units were tested and exist in Europe.[1, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14] They have been studied in Spain, from where much of these data have been obtained.[1]

METHODS

Study Selection

We searched MEDLINE (January 1946 to November 2012) via OVID and EMBASE (January 1974 to November 2012) via SCOPUS using keywords and Medical Subject Heading terms for quick diagnosis units and rapid diagnosis units. The detailed search strategy can be found in Table 1. A screening of titles and abstracts was done by 2 independent reviewers and followed by full‐text screening. We screened for additional articles by reviewing the bibliography of the articles selected for full‐text screening. We included in our review all studies that (1) were published in any language, (2) focused on the design and implementation of a quick diagnosis unit or a rapid diagnosis unit in a hospital setting, and (3) included at least 2 of the primary outcomes, as described below.

Search Strategy
No. Searches
1 Quick diagnosis units.mp.
2 Quick diagnosis unit.mp.
3 (Quick adj diagnosis adj units).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
4 (Quick adj diagnosis adj unit).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
5 (Quick adj diagnosis).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
6 (Diagnosis adj unit).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
7 (Diagnosis adj units).mp [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
8 Rapid diagnosis units.mp.
9 Rapid diagnosis unit.mp.
10 (Rapid adj diagnosis adj units).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
11 (Rapid adj diagnosis adj unit).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
12 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11

Outcome Measures

Our primary outcome measures were categories of final diagnosis, mean time to final diagnosis in an outpatient setting, inpatient bed‐days per patient saved, and costs saved per patient for QDUs versus in‐hospital stay. Secondary outcomes included disposition of patients after completion of this initial evaluation (whether admitted to the hospital or discharged to clinics) and the patients' care preferences, if available. For cost outcomes, currency exchange rates used for conversion were provided by Citibank National Bank Association, powered by Google online currency converter service (accessed June 16, 2013).

Data Extraction

We extracted data on the specifics of the early diagnostic unit setup including staffing and hours of operation, hospital setting, sources of referral, referring diagnosis, patient population, and the role of the diagnostic units in expediting workup and duration of study. For multiple studies done in the same institution by the same principal author, we used the study with the largest patient population to avoid duplication of data. The primary outcome measures for comparing costs were calculated by different methods and in different currencies by different investigators, which we have attempted to reconcile by using current currency conversion rates. We also evaluated patient preferences (if available) via patient surveys. The data were extracted by 2 independent reviewers, and disagreements were resolved by consensus.

RESULTS

Study Selection

Our literature search initially yielded 2047 publications, out of which 2034 were excluded after title and abstract screening. Thirteen studies were selected for full‐text review, out of which 5 were selected for detailed review based on our inclusion criteria (Figure 1). Three of the studies were in Spanish, and the results were analyzed with the help of a Spanish translator. The other 2 studies were in English.

Figure 1
Preferred Reporting Items for Systematic Reviews and Meta‐Analyses flow diagram for study selection.

Study Characteristics

Four studies that were included were descriptive longitudinal studies,[6, 7, 9, 10] and 1 was a retrospective study[8] (Table 2). There were a total of 8895 patients included in all of the studies. All of the studies except 1 described a similar organizational arrangement for the QDU, with 1 internist and 1 registered nurse, administrative support, and the ability to expedite the scheduling of diagnostic tests. The exception was a dedicated lung cancer rapid diagnostic unit (RDU) set up by Sanz‐Santos et al.[9] The study durations ranged from 6 months to 5 years. Patients were referred from local emergency rooms, primary care clinics, and specialty care clinics. The most common reasons for referral were anemia, adenopathy, visceromegaly, febrile syndromes, and incidentally detected masses or nodules on imaging. Two studies included some form of cost analysis,[6, 7] and 3 included patient surveys on satisfaction with patient care.[6, 7, 10]

Study Characteristics
Author Methods Setup of Rapid Diagnosis Units Sources of Referrals to the Unit Reasons for Referrals to the Unit Cases Duration Intervention
  • NOTE: Abbreviations: CT, computed tomography; FNAC, fine‐needle aspiration cytology; LC RDU, lung cancer rapid diagnosis unit; QDU, quick diagnostic unit; QEDU, quick and early diagnosis unit; RDU, rapid diagnosis unit; TB, tuberculosis; EBUS, endobronchial ultrasound; TBNA, transbronchial needle aspiration; FUO, fever of unknown origin.

Bosch et al., 2012 Prospective descriptive study in 4,170 patients evaluated by a dedicated QDU in a university hospital in Barcelona, Spain, between December 2007 to December 2009 and January 2010 to January 2012. QDU costs compared with costs for randomly selected, retrospectively reviewed hospital admissions for similar diagnosis. Care preferences studied with random surveys. Quick diagnostic unit consisting of an internist, and a registered nurse. Single consulting room with a family waiting room. Assisted by specialists from other specialties. Local primary health center (40%), emergency room (56%), other sources (4%). Anemia, anorexia‐cachexia syndrome, febrile syndrome, adenopathies, abdominal pain, chronic diarrhea, lung abnormalities. 4,170 4 years Outpatient workup with urgent first visit, preferential scheduling of diagnostic tests and follow‐up until diagnosis is made.
Capell et al., 2004 Prospective descriptive study with retrospective controls in 2,748 patients evaluated by a QEDU in a university hospital in Barcelona, Spain, between September 1996 and 2001. QEDU costs compared with costs for randomly selected, retrospectively reviewed hospital admissions for similar diagnosis. Care preferences studied with random surveys. UDR made up of an internist and a nurse, a consultation and waiting room. Referrals from emergency rooms (64%), primary care (28.6%), specialty clinics (6.4%). Abdominal pain (12%), focal neurological symptoms (11.5%), constitutional symptoms (11%), anemia (6%), abnormal chest radiology (5.8%), palpable tumors (5.3%), adenopathies (4.7%), rectal bleeding (4.6%), febrile syndrome (4.6%), hemoptysis (3.5%), others (30%). 2,748 5 years Preferential scheduling and urgent workup.
Rubio‐Rivas et al., 2008 Retrospective, descriptive study for 1,132 patients evaluated by a dedicated RDU in a university hospital in Barcelona, Spain from October 2005 to March 2007. RDU consisted of an internist, a radiologist, and a nurse. Local primary health centers (71%), emergency rooms (26%), and others (3%). FUO, adenopathies, visceromegalies, chronic diarrhea, rectal bleeding, dysphagia, jaundice, hypercalcemia. 1,132 11.5 years Prioritized scheduling and urgent workup.
Sanz‐Santos et al., 2010 Prospective observational study in 678 patients referred to an LC RDU, at a tertiary care center in Barcelona, Spain from October 2005 to September 2009. An LC‐RDU, with nursing staff, 3 pulmonologists, bronchoscopy suites with EBUS‐TBNA, facilities for mediastinoscopy, CT‐guided FNAC, thoracoscopy, and surgery. Referrals from specialty clinics (59.4%), primary care (20.2%), and local emergency rooms (20.4%). Cough, dyspnea, hemoptysis, weight loss, imaging evidence of lung masses. 678 4 years Specialized outpatient noninvasive and invasive workup.
Franco‐Hidalgo et al., 2012 Prospective descriptive study on 167 patients, evaluated by an RDU in a tertiary care hospital in Palencia, Spain between November 2008 and April 2009. Care preferences studied with random surveys. An RDU run by an internist and nursing staff with administrative support. Has a consulting room and a waiting room. Referrals from primary care (70.7%), emergency room (21.6%), specialty clinics (7.8%). Abdominal masses and visceromegalies, chronic diarrhea, dysphagia, ascites, icterus, transaminitis, heart failure, abnormal chest imaging, suspicion of pulmonary TB, or neoplasia, 167 6 months Early scheduling and urgent specialized workup.

Outcomes

The most common final diagnosis was malignancy in 18% to 30% of the cases[6, 7, 8, 10] and in 55% of the lung cancer RDU cases[9] (Table 3). The time from initial contact to final diagnosis ranged from 6 to 11 days. Only 3% to 10% of the patients were admitted to the hospital from the QDUs; most patients were discharged to specialty‐care clinics or to primary care centers. Capell et al.[7] estimated that such a unit could save 7 inpatient bed‐days per patient, whereas Rubio‐Rivas et al.[8] estimated that value to be 4.5 bed‐days per patient. Bosch et al.[6] calculated that they saved 8.76 bed‐days per patient.

Study Outcomes
Author Final Diagnosis Time to Diagnosis Final Disposition Benefit Analysis Care Preference Survey Duration Intervention
  • NOTE: Abbreviations: GI, gastrointestinal; QDU, quick diagnostic unit; QEDU, quick and early diagnosis unit; IDA, iron deficiency anemia.

Bosch et al., 2012 Malignancy (30%), IDA (19%), other benign GI disorders (12%), others (39%). Mean=8.9 days (cases) (3.13 QDU visits) Hospital for admission: 3%, primary health centers: 62%, outpatient follow‐up: 35%. Estimated hospital days saved: mean length of stay 8.76 days. Average cost saved per process (admission to discharge): 2,514.64. 88% preferred QDU care model over hospital stay. 4 years Outpatient workup with urgent first visit, preferential scheduling of diagnostic tests, and follow‐up until diagnosis is made.
Capell et al., 2004 Malignancy (15%), GI disorders (24%), neurological disorders (14%). Mean=5.7 days Hospital for admission: 7%, primary care: 51%, outpatient hospital follow‐up: 38%,specialty clinics: 4%. Estimated 7 inpatient bed/days per year during the period of study. Cost saved per encounter: 1,764. 95% reported high satisfaction with QEDU. 5 years Prioritized scheduling and urgent workup.
Rubio‐Rivas et al., 2008 Malignancy (18%). Mean=9 days Hospital for admission: 10%, outpatient follow‐up: 56%, discharged from follow‐up: 38%. Hospitalizations avoided: 4.5 bed/days over the study period. Cost analysis not available. None 11.5 years Prioritized scheduling and urgent workup.
Sanz‐Santos et al., 2010 Lung cancer (55%). Mean=11 days Not available. No available data on cost analysis or hospitalizations avoided. None 4 years Specialized outpatient noninvasive and invasive workup.
Franco‐Hidalgo et al., 2012 Neoplastic (19%), nonmalignant digestive diseases (23%,), infection 13%, and rheumatic (11%). Mean=8 days Not available. No available data on cost analysis or hospitalizations avoided. 97% reported high/very high satisfaction with the UDR. 6 months Early scheduling and urgent specialized workup.

Two studies included a cost comparison between a conventional inpatient evaluation and a QDU evaluation. Bosch et al.[6] and Capell et al.[7] found an average saving of $3304 (2514) and $2353 (1764) per patient, respectively. Bosch et al.[6] calculated these savings by comparing QDU patients to randomly selected control patients with similar referring complaints, who had reached their final diagnosis during a conventional inpatient evaluation. Capell et al.[7] compared their QDU patient costs to estimated in‐hospital costs for similar diagnoses.

Safety data were reported in detail only by Bosch et al.[6] who showed that 125 (3%) patients who initially were stable for QDU evaluation were referred to the emergency department. A total of 15 patients required admission and 12 died, with an overall mortality for the QDU cohort of 0.3%. Causes of death in this group included sudden unexplained death in 8 patients, pulmonary embolism in 2, aspiration pneumonia in 1, and shock of unknown origin in 1. Capell et al.[7] described a 7% admission rate, and Rubio‐Rivas et al.[8] noted that number to be 10%. No mortality was reported in these 2 studies.

In terms of preference for care, an overwhelming majority (88%) of patients in 1 study[6] preferred the QDU care model over hospitalization, and 95% to 97% of patients in 2 other studies[7, 10] reported very high satisfaction rates.

DISCUSSION

Our systematic review evaluated the effectiveness of QDUs for the diagnostic evaluation of patients with potentially severe disease and showed that such units, where established, are cost‐effective, prevent unnecessary hospitalizations, and diagnose potentially severe diseases, particularly malignant conditions, in a timely manner.

QDUs can evaluate medically stable patients with a variety of complaints such as anemia, lymphadenopathy, undiagnosed lumps and masses, and gastrointestinal symptoms and accelerate the diagnostic evaluation without requiring inpatient hospitalization. Many times patients are admitted to the hospital for a diagnostic evaluation without actual treatment.[12] These patients may not be sick enough to warrant hospitalization and may be able to return to the clinic for an outpatient workup. The QDU approach can complete the evaluation in such patients with the added advantages of saving money and higher patient satisfaction, due to diminished disruption of the patient's daily life.[1, 12] As most primary care physicians are unlikely to provide regular and frequent access for unscheduled care and EDs are more likely to admit patients for diagnostic workup,[2] a QDU approach seems a reasonable alternative for making a quick diagnosis and at the same time avoiding unnecessary hospitalization. Bosch et al. have also evaluated the impact of the QDUs in the diagnosis of specific diseases such as cancer in 169 patients diagnosed at the QDU, and compared them to 53 patients who were diagnosed with cancer during an inpatient evaluation.[11] They found that although QDU patients were significantly younger than hospitalized patients, there was no difference in diagnoses established and the time to diagnosis at the QDU and length of stay in the hospital.

There is a significant cost saving associated with QDUs. The cost savings calculated by Bosch et al. and Capell et al. were for each patient enrolled in this protocol from index encounter to final diagnosis.[6, 7] These 2 studies describe primarily fixed costs saved per patient treated in the QDU versus an inpatient admission. Fixed costs in hospital care include personnel cost, buildings, and equipment, whereas variable costs include medication, test reagents, and disposable supplies.[15] In comparison with the US healthcare system, fixed costs in Europe are considerably lower, and certain variable costs (like medications and procedures) are significantly higher in the United States.[16] This suggests a greater opportunity for healthcare savings for carefully selected patients in the United States, where costs related to inpatient admissions are significantly higher.[16]

Another limitation of our analysis is the paucity of studies on this topic. Many of the publications are from Bosch et al.,[1, 6, 11, 12, 13, 14] a single group in Spain, and these show considerable cost savings, patient satisfaction, and patient safety. However, most of their data are either retrospective or from nonrandomized, prospective cohort studies. The only report describing a similar approach in the United States was by Paschal in the city of New Orleans.[17] After Charity Hospital and the Veterans Affairs Hospital in New Orleans were lost to hurricane Katrina, an urgent care clinic was set up where potentially severe diseases such as cancer, leukemia, and autoimmune and endocrine disorders were diagnosed efficiently, although safety data were not reported.

The reported studies used different study designs and evaluated different primary outcomes. These limitations can be overcome with a well‐designed prospective trial, which could also evaluate the actual impact on patient care, safety, and healthcare savings in the United States.

Safety data were reported in detail only in 1 study,[6] and the rates of admissions were reported by 2 other studies.[7, 8] These suggest that QDUs may be safe for a selected group of patients. Patients evaluated in these units preferred this approach as shown by the overwhelming majority of the patients who chose QDU care over inpatient admissions when patient surveys were performed.

CONCLUSION

In this era of healthcare reform and emphasis on value‐based care, we must optimize the efficiency of our care delivery systems and challenge our preexisting resource‐intensive healthcare models. One source of potential savings is avoiding hospitalizations for purely diagnostic purposes, utilizing quick diagnostic units for patients who are able to return for outpatient evaluations. Such units are established, have been studied in Europe, and our systematic review shows that they are cost‐effective, time‐ and resource‐efficient, and preferred by patients. In our healthcare system, with the high cost of inpatient care, the QDU can yield large savings of healthcare dollars while expediting diagnostic workup, increasing patient satisfaction, and preventing lost productivity from hospital stays. Further exploration and study of alternative care delivery models, such as quick diagnostic units, is required to achieve the goal of cost‐effective high‐quality care for all.

Disclosure: Nothing to report.

Files
References
  1. Bosch X, Aibar J, Capell S, Coca A, Lopez‐Soto A. Quick diagnosis units: a potentially useful alternative to conventional hospitalization. Med J Aust. 2009;191:496498.
  2. Schuur J, Venkatesh A. The growing role of emergency departments in hospital admissions. N Engl J Med. 2012;5:391393.
  3. McDonagh MS, Smith DH, Goddard M. Measuring appropriate use of acute beds. A Systematic review of methods and results. Health Policy. 2000;3:157184.
  4. Campbell J. Inappropriate admissions: thoughts of patients and referring doctors. J R Soc Med. 2001;12:628631.
  5. Kendall MJ, Toescu , Wallace DMA. QED: quick and early diagnosis. Lancet. 1996;348:528529.
  6. Bosch X, Jordan A, Lopez‐Soto A. Quick diagnosis units: avoiding referrals from primary care to the ED and hospitalizations. Am J Emerg Med. 2013;31(1):114123.
  7. Capell S, Comas P, Piella T, et al. Quick and early diagnostic outpatient unit: an effective and efficient assistential model. Five years experience. Med Clin (Barc). 2004;123(7):247250.
  8. Rubio‐Rivas M, Vidaller A, Farriols RP, Mast R. Rapid diagnosis unit in a third level hospital. Descriptive study of the first year and a half. Rev Clin Esp. 2008;208(11):561563.
  9. Sanz‐Santos J, Andreo F, Sanchez D, et al. Usefulness of a lung cancer rapid diagnosis specialist clinic. Contribution of ultrasound bronchoscopy. Arch Bronconeumol. 2010;46(12):640645.
  10. Franco Hidalgo S, De Paula P, Serradilla M, Carbayo M. Rapid diagnosis units or immediate health care clinics in internal medicine. Analysis of the first six months of operation in Palencia (Spain). Semergen. 2012;38(2):126130.
  11. Bosch X, Moreno P, Ros M, Jordan A, Lopez‐Soto A. Comparison of quick diagnosis units and conventional hospitalization for the diagnosis of cancer in Spain: a descriptive cohort study. Oncology (Switzerland). 2012;83(5):283291.
  12. Bosch X, Jordan A, Coca A, Lopez‐Soto A. Quick diagnosis units versus hospitalization for the diagnosis of potentially severe diseases in Spain. J Hosp Med. 2012;7(1):4147.
  13. Bosch X, Foix A, Jordan A, Coca A, Lopez‐Soto A. Outpatient quick diagnosis units for the evaluation of suspected severe diseases: an observational study. Clinics. 2011;66(5):737741.
  14. Bosch X, Palacios F, Inclan‐Iribar G, et al. Quick diagnosis units or conventional hospitalization for the diagnostic evaluation of severe anemia: a paradigm shift in public health systems? Eur J Int Med. 2012;23(2):159164.
  15. Roberts RR, Frutos PW, Ciavarella GG, et al. Distribution of variable vs fixed costs of hospital care. JAMA. 1999;281(7):644649.
  16. Squires DA. Explaining high healthcare spending in the united states: an international comparison of supply, utilization, prices and quality. Issue Brief (Commonw Fund). 2012;10:114.
  17. Paschal D. Launching complex medical workups from an urgent care platform. Ann Int Med. 2012;156:232233.
Article PDF
Issue
Journal of Hospital Medicine - 9(1)
Page Number
54-59
Sections
Files
Files
Article PDF
Article PDF

Inpatient admissions are a major component of healthcare costs in the United States,[1] where the number of annual inpatient hospital admissions has increased by 15% from 34.3 million in 1993 to 39.5 million in 2006.2 Studies performed predominantly in Europe have shown that inappropriate use of hospital beds exceeds 20% across various specialties.[3] A study by Campbell et al. showed that if given the choice, 60% of physicians would consider an alternative to admission for such patients, if such an option were available, and 70% of patients would prefer not to be admitted for workup.[4] Based on similar findings, various hospitals across the world have tried to make organizational changes to allocate healthcare resources more efficiently. The concept of quick and early diagnosis was first introduced in 1996 by Kendall et al., and it included a hospital unit in the United Kingdom managed by consultants receiving referrals from primary care doctors and led to early diagnostic workup without hospitalization.[5] A more refined version of this concept, a potentially cost‐saving and efficient alternative to inpatient hospitalization for diagnostic purposes, was described by Bosch et al., and named the quick diagnosis unit (QDU).[1]

The basic objectives of QDUs include early diagnosis of potentially severe diseases such as cancer, avoiding unnecessary hospitalization, minimizing hospital morbidity, reducing costs, and improving patient satisfaction. The first described QDU was managed by internists, where patients with specific symptoms such as undiagnosed lumps or masses, anemia, hematuria, or gastrointestinal symptoms could be referred for a diagnostic evaluation. Patients were required to be well enough to travel to the QDU on an outpatient basis, and patients unable to do so were thought to be better suited for hospitalization.[1]

In the present study, we conduct a systematic review, the first one on this subject to our knowledge, of studies that tested established QDUs or similar units in hospital settings. The majority of established units were tested and exist in Europe.[1, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14] They have been studied in Spain, from where much of these data have been obtained.[1]

METHODS

Study Selection

We searched MEDLINE (January 1946 to November 2012) via OVID and EMBASE (January 1974 to November 2012) via SCOPUS using keywords and Medical Subject Heading terms for quick diagnosis units and rapid diagnosis units. The detailed search strategy can be found in Table 1. A screening of titles and abstracts was done by 2 independent reviewers and followed by full‐text screening. We screened for additional articles by reviewing the bibliography of the articles selected for full‐text screening. We included in our review all studies that (1) were published in any language, (2) focused on the design and implementation of a quick diagnosis unit or a rapid diagnosis unit in a hospital setting, and (3) included at least 2 of the primary outcomes, as described below.

Search Strategy
No. Searches
1 Quick diagnosis units.mp.
2 Quick diagnosis unit.mp.
3 (Quick adj diagnosis adj units).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
4 (Quick adj diagnosis adj unit).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
5 (Quick adj diagnosis).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
6 (Diagnosis adj unit).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
7 (Diagnosis adj units).mp [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
8 Rapid diagnosis units.mp.
9 Rapid diagnosis unit.mp.
10 (Rapid adj diagnosis adj units).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
11 (Rapid adj diagnosis adj unit).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
12 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11

Outcome Measures

Our primary outcome measures were categories of final diagnosis, mean time to final diagnosis in an outpatient setting, inpatient bed‐days per patient saved, and costs saved per patient for QDUs versus in‐hospital stay. Secondary outcomes included disposition of patients after completion of this initial evaluation (whether admitted to the hospital or discharged to clinics) and the patients' care preferences, if available. For cost outcomes, currency exchange rates used for conversion were provided by Citibank National Bank Association, powered by Google online currency converter service (accessed June 16, 2013).

Data Extraction

We extracted data on the specifics of the early diagnostic unit setup including staffing and hours of operation, hospital setting, sources of referral, referring diagnosis, patient population, and the role of the diagnostic units in expediting workup and duration of study. For multiple studies done in the same institution by the same principal author, we used the study with the largest patient population to avoid duplication of data. The primary outcome measures for comparing costs were calculated by different methods and in different currencies by different investigators, which we have attempted to reconcile by using current currency conversion rates. We also evaluated patient preferences (if available) via patient surveys. The data were extracted by 2 independent reviewers, and disagreements were resolved by consensus.

RESULTS

Study Selection

Our literature search initially yielded 2047 publications, out of which 2034 were excluded after title and abstract screening. Thirteen studies were selected for full‐text review, out of which 5 were selected for detailed review based on our inclusion criteria (Figure 1). Three of the studies were in Spanish, and the results were analyzed with the help of a Spanish translator. The other 2 studies were in English.

Figure 1
Preferred Reporting Items for Systematic Reviews and Meta‐Analyses flow diagram for study selection.

Study Characteristics

Four studies that were included were descriptive longitudinal studies,[6, 7, 9, 10] and 1 was a retrospective study[8] (Table 2). There were a total of 8895 patients included in all of the studies. All of the studies except 1 described a similar organizational arrangement for the QDU, with 1 internist and 1 registered nurse, administrative support, and the ability to expedite the scheduling of diagnostic tests. The exception was a dedicated lung cancer rapid diagnostic unit (RDU) set up by Sanz‐Santos et al.[9] The study durations ranged from 6 months to 5 years. Patients were referred from local emergency rooms, primary care clinics, and specialty care clinics. The most common reasons for referral were anemia, adenopathy, visceromegaly, febrile syndromes, and incidentally detected masses or nodules on imaging. Two studies included some form of cost analysis,[6, 7] and 3 included patient surveys on satisfaction with patient care.[6, 7, 10]

Study Characteristics
Author Methods Setup of Rapid Diagnosis Units Sources of Referrals to the Unit Reasons for Referrals to the Unit Cases Duration Intervention
  • NOTE: Abbreviations: CT, computed tomography; FNAC, fine‐needle aspiration cytology; LC RDU, lung cancer rapid diagnosis unit; QDU, quick diagnostic unit; QEDU, quick and early diagnosis unit; RDU, rapid diagnosis unit; TB, tuberculosis; EBUS, endobronchial ultrasound; TBNA, transbronchial needle aspiration; FUO, fever of unknown origin.

Bosch et al., 2012 Prospective descriptive study in 4,170 patients evaluated by a dedicated QDU in a university hospital in Barcelona, Spain, between December 2007 to December 2009 and January 2010 to January 2012. QDU costs compared with costs for randomly selected, retrospectively reviewed hospital admissions for similar diagnosis. Care preferences studied with random surveys. Quick diagnostic unit consisting of an internist, and a registered nurse. Single consulting room with a family waiting room. Assisted by specialists from other specialties. Local primary health center (40%), emergency room (56%), other sources (4%). Anemia, anorexia‐cachexia syndrome, febrile syndrome, adenopathies, abdominal pain, chronic diarrhea, lung abnormalities. 4,170 4 years Outpatient workup with urgent first visit, preferential scheduling of diagnostic tests and follow‐up until diagnosis is made.
Capell et al., 2004 Prospective descriptive study with retrospective controls in 2,748 patients evaluated by a QEDU in a university hospital in Barcelona, Spain, between September 1996 and 2001. QEDU costs compared with costs for randomly selected, retrospectively reviewed hospital admissions for similar diagnosis. Care preferences studied with random surveys. UDR made up of an internist and a nurse, a consultation and waiting room. Referrals from emergency rooms (64%), primary care (28.6%), specialty clinics (6.4%). Abdominal pain (12%), focal neurological symptoms (11.5%), constitutional symptoms (11%), anemia (6%), abnormal chest radiology (5.8%), palpable tumors (5.3%), adenopathies (4.7%), rectal bleeding (4.6%), febrile syndrome (4.6%), hemoptysis (3.5%), others (30%). 2,748 5 years Preferential scheduling and urgent workup.
Rubio‐Rivas et al., 2008 Retrospective, descriptive study for 1,132 patients evaluated by a dedicated RDU in a university hospital in Barcelona, Spain from October 2005 to March 2007. RDU consisted of an internist, a radiologist, and a nurse. Local primary health centers (71%), emergency rooms (26%), and others (3%). FUO, adenopathies, visceromegalies, chronic diarrhea, rectal bleeding, dysphagia, jaundice, hypercalcemia. 1,132 11.5 years Prioritized scheduling and urgent workup.
Sanz‐Santos et al., 2010 Prospective observational study in 678 patients referred to an LC RDU, at a tertiary care center in Barcelona, Spain from October 2005 to September 2009. An LC‐RDU, with nursing staff, 3 pulmonologists, bronchoscopy suites with EBUS‐TBNA, facilities for mediastinoscopy, CT‐guided FNAC, thoracoscopy, and surgery. Referrals from specialty clinics (59.4%), primary care (20.2%), and local emergency rooms (20.4%). Cough, dyspnea, hemoptysis, weight loss, imaging evidence of lung masses. 678 4 years Specialized outpatient noninvasive and invasive workup.
Franco‐Hidalgo et al., 2012 Prospective descriptive study on 167 patients, evaluated by an RDU in a tertiary care hospital in Palencia, Spain between November 2008 and April 2009. Care preferences studied with random surveys. An RDU run by an internist and nursing staff with administrative support. Has a consulting room and a waiting room. Referrals from primary care (70.7%), emergency room (21.6%), specialty clinics (7.8%). Abdominal masses and visceromegalies, chronic diarrhea, dysphagia, ascites, icterus, transaminitis, heart failure, abnormal chest imaging, suspicion of pulmonary TB, or neoplasia, 167 6 months Early scheduling and urgent specialized workup.

Outcomes

The most common final diagnosis was malignancy in 18% to 30% of the cases[6, 7, 8, 10] and in 55% of the lung cancer RDU cases[9] (Table 3). The time from initial contact to final diagnosis ranged from 6 to 11 days. Only 3% to 10% of the patients were admitted to the hospital from the QDUs; most patients were discharged to specialty‐care clinics or to primary care centers. Capell et al.[7] estimated that such a unit could save 7 inpatient bed‐days per patient, whereas Rubio‐Rivas et al.[8] estimated that value to be 4.5 bed‐days per patient. Bosch et al.[6] calculated that they saved 8.76 bed‐days per patient.

Study Outcomes
Author Final Diagnosis Time to Diagnosis Final Disposition Benefit Analysis Care Preference Survey Duration Intervention
  • NOTE: Abbreviations: GI, gastrointestinal; QDU, quick diagnostic unit; QEDU, quick and early diagnosis unit; IDA, iron deficiency anemia.

Bosch et al., 2012 Malignancy (30%), IDA (19%), other benign GI disorders (12%), others (39%). Mean=8.9 days (cases) (3.13 QDU visits) Hospital for admission: 3%, primary health centers: 62%, outpatient follow‐up: 35%. Estimated hospital days saved: mean length of stay 8.76 days. Average cost saved per process (admission to discharge): 2,514.64. 88% preferred QDU care model over hospital stay. 4 years Outpatient workup with urgent first visit, preferential scheduling of diagnostic tests, and follow‐up until diagnosis is made.
Capell et al., 2004 Malignancy (15%), GI disorders (24%), neurological disorders (14%). Mean=5.7 days Hospital for admission: 7%, primary care: 51%, outpatient hospital follow‐up: 38%,specialty clinics: 4%. Estimated 7 inpatient bed/days per year during the period of study. Cost saved per encounter: 1,764. 95% reported high satisfaction with QEDU. 5 years Prioritized scheduling and urgent workup.
Rubio‐Rivas et al., 2008 Malignancy (18%). Mean=9 days Hospital for admission: 10%, outpatient follow‐up: 56%, discharged from follow‐up: 38%. Hospitalizations avoided: 4.5 bed/days over the study period. Cost analysis not available. None 11.5 years Prioritized scheduling and urgent workup.
Sanz‐Santos et al., 2010 Lung cancer (55%). Mean=11 days Not available. No available data on cost analysis or hospitalizations avoided. None 4 years Specialized outpatient noninvasive and invasive workup.
Franco‐Hidalgo et al., 2012 Neoplastic (19%), nonmalignant digestive diseases (23%,), infection 13%, and rheumatic (11%). Mean=8 days Not available. No available data on cost analysis or hospitalizations avoided. 97% reported high/very high satisfaction with the UDR. 6 months Early scheduling and urgent specialized workup.

Two studies included a cost comparison between a conventional inpatient evaluation and a QDU evaluation. Bosch et al.[6] and Capell et al.[7] found an average saving of $3304 (2514) and $2353 (1764) per patient, respectively. Bosch et al.[6] calculated these savings by comparing QDU patients to randomly selected control patients with similar referring complaints, who had reached their final diagnosis during a conventional inpatient evaluation. Capell et al.[7] compared their QDU patient costs to estimated in‐hospital costs for similar diagnoses.

Safety data were reported in detail only by Bosch et al.[6] who showed that 125 (3%) patients who initially were stable for QDU evaluation were referred to the emergency department. A total of 15 patients required admission and 12 died, with an overall mortality for the QDU cohort of 0.3%. Causes of death in this group included sudden unexplained death in 8 patients, pulmonary embolism in 2, aspiration pneumonia in 1, and shock of unknown origin in 1. Capell et al.[7] described a 7% admission rate, and Rubio‐Rivas et al.[8] noted that number to be 10%. No mortality was reported in these 2 studies.

In terms of preference for care, an overwhelming majority (88%) of patients in 1 study[6] preferred the QDU care model over hospitalization, and 95% to 97% of patients in 2 other studies[7, 10] reported very high satisfaction rates.

DISCUSSION

Our systematic review evaluated the effectiveness of QDUs for the diagnostic evaluation of patients with potentially severe disease and showed that such units, where established, are cost‐effective, prevent unnecessary hospitalizations, and diagnose potentially severe diseases, particularly malignant conditions, in a timely manner.

QDUs can evaluate medically stable patients with a variety of complaints such as anemia, lymphadenopathy, undiagnosed lumps and masses, and gastrointestinal symptoms and accelerate the diagnostic evaluation without requiring inpatient hospitalization. Many times patients are admitted to the hospital for a diagnostic evaluation without actual treatment.[12] These patients may not be sick enough to warrant hospitalization and may be able to return to the clinic for an outpatient workup. The QDU approach can complete the evaluation in such patients with the added advantages of saving money and higher patient satisfaction, due to diminished disruption of the patient's daily life.[1, 12] As most primary care physicians are unlikely to provide regular and frequent access for unscheduled care and EDs are more likely to admit patients for diagnostic workup,[2] a QDU approach seems a reasonable alternative for making a quick diagnosis and at the same time avoiding unnecessary hospitalization. Bosch et al. have also evaluated the impact of the QDUs in the diagnosis of specific diseases such as cancer in 169 patients diagnosed at the QDU, and compared them to 53 patients who were diagnosed with cancer during an inpatient evaluation.[11] They found that although QDU patients were significantly younger than hospitalized patients, there was no difference in diagnoses established and the time to diagnosis at the QDU and length of stay in the hospital.

There is a significant cost saving associated with QDUs. The cost savings calculated by Bosch et al. and Capell et al. were for each patient enrolled in this protocol from index encounter to final diagnosis.[6, 7] These 2 studies describe primarily fixed costs saved per patient treated in the QDU versus an inpatient admission. Fixed costs in hospital care include personnel cost, buildings, and equipment, whereas variable costs include medication, test reagents, and disposable supplies.[15] In comparison with the US healthcare system, fixed costs in Europe are considerably lower, and certain variable costs (like medications and procedures) are significantly higher in the United States.[16] This suggests a greater opportunity for healthcare savings for carefully selected patients in the United States, where costs related to inpatient admissions are significantly higher.[16]

Another limitation of our analysis is the paucity of studies on this topic. Many of the publications are from Bosch et al.,[1, 6, 11, 12, 13, 14] a single group in Spain, and these show considerable cost savings, patient satisfaction, and patient safety. However, most of their data are either retrospective or from nonrandomized, prospective cohort studies. The only report describing a similar approach in the United States was by Paschal in the city of New Orleans.[17] After Charity Hospital and the Veterans Affairs Hospital in New Orleans were lost to hurricane Katrina, an urgent care clinic was set up where potentially severe diseases such as cancer, leukemia, and autoimmune and endocrine disorders were diagnosed efficiently, although safety data were not reported.

The reported studies used different study designs and evaluated different primary outcomes. These limitations can be overcome with a well‐designed prospective trial, which could also evaluate the actual impact on patient care, safety, and healthcare savings in the United States.

Safety data were reported in detail only in 1 study,[6] and the rates of admissions were reported by 2 other studies.[7, 8] These suggest that QDUs may be safe for a selected group of patients. Patients evaluated in these units preferred this approach as shown by the overwhelming majority of the patients who chose QDU care over inpatient admissions when patient surveys were performed.

CONCLUSION

In this era of healthcare reform and emphasis on value‐based care, we must optimize the efficiency of our care delivery systems and challenge our preexisting resource‐intensive healthcare models. One source of potential savings is avoiding hospitalizations for purely diagnostic purposes, utilizing quick diagnostic units for patients who are able to return for outpatient evaluations. Such units are established, have been studied in Europe, and our systematic review shows that they are cost‐effective, time‐ and resource‐efficient, and preferred by patients. In our healthcare system, with the high cost of inpatient care, the QDU can yield large savings of healthcare dollars while expediting diagnostic workup, increasing patient satisfaction, and preventing lost productivity from hospital stays. Further exploration and study of alternative care delivery models, such as quick diagnostic units, is required to achieve the goal of cost‐effective high‐quality care for all.

Disclosure: Nothing to report.

Inpatient admissions are a major component of healthcare costs in the United States,[1] where the number of annual inpatient hospital admissions has increased by 15% from 34.3 million in 1993 to 39.5 million in 2006.2 Studies performed predominantly in Europe have shown that inappropriate use of hospital beds exceeds 20% across various specialties.[3] A study by Campbell et al. showed that if given the choice, 60% of physicians would consider an alternative to admission for such patients, if such an option were available, and 70% of patients would prefer not to be admitted for workup.[4] Based on similar findings, various hospitals across the world have tried to make organizational changes to allocate healthcare resources more efficiently. The concept of quick and early diagnosis was first introduced in 1996 by Kendall et al., and it included a hospital unit in the United Kingdom managed by consultants receiving referrals from primary care doctors and led to early diagnostic workup without hospitalization.[5] A more refined version of this concept, a potentially cost‐saving and efficient alternative to inpatient hospitalization for diagnostic purposes, was described by Bosch et al., and named the quick diagnosis unit (QDU).[1]

The basic objectives of QDUs include early diagnosis of potentially severe diseases such as cancer, avoiding unnecessary hospitalization, minimizing hospital morbidity, reducing costs, and improving patient satisfaction. The first described QDU was managed by internists, where patients with specific symptoms such as undiagnosed lumps or masses, anemia, hematuria, or gastrointestinal symptoms could be referred for a diagnostic evaluation. Patients were required to be well enough to travel to the QDU on an outpatient basis, and patients unable to do so were thought to be better suited for hospitalization.[1]

In the present study, we conduct a systematic review, the first one on this subject to our knowledge, of studies that tested established QDUs or similar units in hospital settings. The majority of established units were tested and exist in Europe.[1, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14] They have been studied in Spain, from where much of these data have been obtained.[1]

METHODS

Study Selection

We searched MEDLINE (January 1946 to November 2012) via OVID and EMBASE (January 1974 to November 2012) via SCOPUS using keywords and Medical Subject Heading terms for quick diagnosis units and rapid diagnosis units. The detailed search strategy can be found in Table 1. A screening of titles and abstracts was done by 2 independent reviewers and followed by full‐text screening. We screened for additional articles by reviewing the bibliography of the articles selected for full‐text screening. We included in our review all studies that (1) were published in any language, (2) focused on the design and implementation of a quick diagnosis unit or a rapid diagnosis unit in a hospital setting, and (3) included at least 2 of the primary outcomes, as described below.

Search Strategy
No. Searches
1 Quick diagnosis units.mp.
2 Quick diagnosis unit.mp.
3 (Quick adj diagnosis adj units).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
4 (Quick adj diagnosis adj unit).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
5 (Quick adj diagnosis).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
6 (Diagnosis adj unit).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
7 (Diagnosis adj units).mp [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
8 Rapid diagnosis units.mp.
9 Rapid diagnosis unit.mp.
10 (Rapid adj diagnosis adj units).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
11 (Rapid adj diagnosis adj unit).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]
12 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11

Outcome Measures

Our primary outcome measures were categories of final diagnosis, mean time to final diagnosis in an outpatient setting, inpatient bed‐days per patient saved, and costs saved per patient for QDUs versus in‐hospital stay. Secondary outcomes included disposition of patients after completion of this initial evaluation (whether admitted to the hospital or discharged to clinics) and the patients' care preferences, if available. For cost outcomes, currency exchange rates used for conversion were provided by Citibank National Bank Association, powered by Google online currency converter service (accessed June 16, 2013).

Data Extraction

We extracted data on the specifics of the early diagnostic unit setup including staffing and hours of operation, hospital setting, sources of referral, referring diagnosis, patient population, and the role of the diagnostic units in expediting workup and duration of study. For multiple studies done in the same institution by the same principal author, we used the study with the largest patient population to avoid duplication of data. The primary outcome measures for comparing costs were calculated by different methods and in different currencies by different investigators, which we have attempted to reconcile by using current currency conversion rates. We also evaluated patient preferences (if available) via patient surveys. The data were extracted by 2 independent reviewers, and disagreements were resolved by consensus.

RESULTS

Study Selection

Our literature search initially yielded 2047 publications, out of which 2034 were excluded after title and abstract screening. Thirteen studies were selected for full‐text review, out of which 5 were selected for detailed review based on our inclusion criteria (Figure 1). Three of the studies were in Spanish, and the results were analyzed with the help of a Spanish translator. The other 2 studies were in English.

Figure 1
Preferred Reporting Items for Systematic Reviews and Meta‐Analyses flow diagram for study selection.

Study Characteristics

Four studies that were included were descriptive longitudinal studies,[6, 7, 9, 10] and 1 was a retrospective study[8] (Table 2). There were a total of 8895 patients included in all of the studies. All of the studies except 1 described a similar organizational arrangement for the QDU, with 1 internist and 1 registered nurse, administrative support, and the ability to expedite the scheduling of diagnostic tests. The exception was a dedicated lung cancer rapid diagnostic unit (RDU) set up by Sanz‐Santos et al.[9] The study durations ranged from 6 months to 5 years. Patients were referred from local emergency rooms, primary care clinics, and specialty care clinics. The most common reasons for referral were anemia, adenopathy, visceromegaly, febrile syndromes, and incidentally detected masses or nodules on imaging. Two studies included some form of cost analysis,[6, 7] and 3 included patient surveys on satisfaction with patient care.[6, 7, 10]

Study Characteristics
Author Methods Setup of Rapid Diagnosis Units Sources of Referrals to the Unit Reasons for Referrals to the Unit Cases Duration Intervention
  • NOTE: Abbreviations: CT, computed tomography; FNAC, fine‐needle aspiration cytology; LC RDU, lung cancer rapid diagnosis unit; QDU, quick diagnostic unit; QEDU, quick and early diagnosis unit; RDU, rapid diagnosis unit; TB, tuberculosis; EBUS, endobronchial ultrasound; TBNA, transbronchial needle aspiration; FUO, fever of unknown origin.

Bosch et al., 2012 Prospective descriptive study in 4,170 patients evaluated by a dedicated QDU in a university hospital in Barcelona, Spain, between December 2007 to December 2009 and January 2010 to January 2012. QDU costs compared with costs for randomly selected, retrospectively reviewed hospital admissions for similar diagnosis. Care preferences studied with random surveys. Quick diagnostic unit consisting of an internist, and a registered nurse. Single consulting room with a family waiting room. Assisted by specialists from other specialties. Local primary health center (40%), emergency room (56%), other sources (4%). Anemia, anorexia‐cachexia syndrome, febrile syndrome, adenopathies, abdominal pain, chronic diarrhea, lung abnormalities. 4,170 4 years Outpatient workup with urgent first visit, preferential scheduling of diagnostic tests and follow‐up until diagnosis is made.
Capell et al., 2004 Prospective descriptive study with retrospective controls in 2,748 patients evaluated by a QEDU in a university hospital in Barcelona, Spain, between September 1996 and 2001. QEDU costs compared with costs for randomly selected, retrospectively reviewed hospital admissions for similar diagnosis. Care preferences studied with random surveys. UDR made up of an internist and a nurse, a consultation and waiting room. Referrals from emergency rooms (64%), primary care (28.6%), specialty clinics (6.4%). Abdominal pain (12%), focal neurological symptoms (11.5%), constitutional symptoms (11%), anemia (6%), abnormal chest radiology (5.8%), palpable tumors (5.3%), adenopathies (4.7%), rectal bleeding (4.6%), febrile syndrome (4.6%), hemoptysis (3.5%), others (30%). 2,748 5 years Preferential scheduling and urgent workup.
Rubio‐Rivas et al., 2008 Retrospective, descriptive study for 1,132 patients evaluated by a dedicated RDU in a university hospital in Barcelona, Spain from October 2005 to March 2007. RDU consisted of an internist, a radiologist, and a nurse. Local primary health centers (71%), emergency rooms (26%), and others (3%). FUO, adenopathies, visceromegalies, chronic diarrhea, rectal bleeding, dysphagia, jaundice, hypercalcemia. 1,132 11.5 years Prioritized scheduling and urgent workup.
Sanz‐Santos et al., 2010 Prospective observational study in 678 patients referred to an LC RDU, at a tertiary care center in Barcelona, Spain from October 2005 to September 2009. An LC‐RDU, with nursing staff, 3 pulmonologists, bronchoscopy suites with EBUS‐TBNA, facilities for mediastinoscopy, CT‐guided FNAC, thoracoscopy, and surgery. Referrals from specialty clinics (59.4%), primary care (20.2%), and local emergency rooms (20.4%). Cough, dyspnea, hemoptysis, weight loss, imaging evidence of lung masses. 678 4 years Specialized outpatient noninvasive and invasive workup.
Franco‐Hidalgo et al., 2012 Prospective descriptive study on 167 patients, evaluated by an RDU in a tertiary care hospital in Palencia, Spain between November 2008 and April 2009. Care preferences studied with random surveys. An RDU run by an internist and nursing staff with administrative support. Has a consulting room and a waiting room. Referrals from primary care (70.7%), emergency room (21.6%), specialty clinics (7.8%). Abdominal masses and visceromegalies, chronic diarrhea, dysphagia, ascites, icterus, transaminitis, heart failure, abnormal chest imaging, suspicion of pulmonary TB, or neoplasia, 167 6 months Early scheduling and urgent specialized workup.

Outcomes

The most common final diagnosis was malignancy in 18% to 30% of the cases[6, 7, 8, 10] and in 55% of the lung cancer RDU cases[9] (Table 3). The time from initial contact to final diagnosis ranged from 6 to 11 days. Only 3% to 10% of the patients were admitted to the hospital from the QDUs; most patients were discharged to specialty‐care clinics or to primary care centers. Capell et al.[7] estimated that such a unit could save 7 inpatient bed‐days per patient, whereas Rubio‐Rivas et al.[8] estimated that value to be 4.5 bed‐days per patient. Bosch et al.[6] calculated that they saved 8.76 bed‐days per patient.

Study Outcomes
Author Final Diagnosis Time to Diagnosis Final Disposition Benefit Analysis Care Preference Survey Duration Intervention
  • NOTE: Abbreviations: GI, gastrointestinal; QDU, quick diagnostic unit; QEDU, quick and early diagnosis unit; IDA, iron deficiency anemia.

Bosch et al., 2012 Malignancy (30%), IDA (19%), other benign GI disorders (12%), others (39%). Mean=8.9 days (cases) (3.13 QDU visits) Hospital for admission: 3%, primary health centers: 62%, outpatient follow‐up: 35%. Estimated hospital days saved: mean length of stay 8.76 days. Average cost saved per process (admission to discharge): 2,514.64. 88% preferred QDU care model over hospital stay. 4 years Outpatient workup with urgent first visit, preferential scheduling of diagnostic tests, and follow‐up until diagnosis is made.
Capell et al., 2004 Malignancy (15%), GI disorders (24%), neurological disorders (14%). Mean=5.7 days Hospital for admission: 7%, primary care: 51%, outpatient hospital follow‐up: 38%,specialty clinics: 4%. Estimated 7 inpatient bed/days per year during the period of study. Cost saved per encounter: 1,764. 95% reported high satisfaction with QEDU. 5 years Prioritized scheduling and urgent workup.
Rubio‐Rivas et al., 2008 Malignancy (18%). Mean=9 days Hospital for admission: 10%, outpatient follow‐up: 56%, discharged from follow‐up: 38%. Hospitalizations avoided: 4.5 bed/days over the study period. Cost analysis not available. None 11.5 years Prioritized scheduling and urgent workup.
Sanz‐Santos et al., 2010 Lung cancer (55%). Mean=11 days Not available. No available data on cost analysis or hospitalizations avoided. None 4 years Specialized outpatient noninvasive and invasive workup.
Franco‐Hidalgo et al., 2012 Neoplastic (19%), nonmalignant digestive diseases (23%,), infection 13%, and rheumatic (11%). Mean=8 days Not available. No available data on cost analysis or hospitalizations avoided. 97% reported high/very high satisfaction with the UDR. 6 months Early scheduling and urgent specialized workup.

Two studies included a cost comparison between a conventional inpatient evaluation and a QDU evaluation. Bosch et al.[6] and Capell et al.[7] found an average saving of $3304 (2514) and $2353 (1764) per patient, respectively. Bosch et al.[6] calculated these savings by comparing QDU patients to randomly selected control patients with similar referring complaints, who had reached their final diagnosis during a conventional inpatient evaluation. Capell et al.[7] compared their QDU patient costs to estimated in‐hospital costs for similar diagnoses.

Safety data were reported in detail only by Bosch et al.[6] who showed that 125 (3%) patients who initially were stable for QDU evaluation were referred to the emergency department. A total of 15 patients required admission and 12 died, with an overall mortality for the QDU cohort of 0.3%. Causes of death in this group included sudden unexplained death in 8 patients, pulmonary embolism in 2, aspiration pneumonia in 1, and shock of unknown origin in 1. Capell et al.[7] described a 7% admission rate, and Rubio‐Rivas et al.[8] noted that number to be 10%. No mortality was reported in these 2 studies.

In terms of preference for care, an overwhelming majority (88%) of patients in 1 study[6] preferred the QDU care model over hospitalization, and 95% to 97% of patients in 2 other studies[7, 10] reported very high satisfaction rates.

DISCUSSION

Our systematic review evaluated the effectiveness of QDUs for the diagnostic evaluation of patients with potentially severe disease and showed that such units, where established, are cost‐effective, prevent unnecessary hospitalizations, and diagnose potentially severe diseases, particularly malignant conditions, in a timely manner.

QDUs can evaluate medically stable patients with a variety of complaints such as anemia, lymphadenopathy, undiagnosed lumps and masses, and gastrointestinal symptoms and accelerate the diagnostic evaluation without requiring inpatient hospitalization. Many times patients are admitted to the hospital for a diagnostic evaluation without actual treatment.[12] These patients may not be sick enough to warrant hospitalization and may be able to return to the clinic for an outpatient workup. The QDU approach can complete the evaluation in such patients with the added advantages of saving money and higher patient satisfaction, due to diminished disruption of the patient's daily life.[1, 12] As most primary care physicians are unlikely to provide regular and frequent access for unscheduled care and EDs are more likely to admit patients for diagnostic workup,[2] a QDU approach seems a reasonable alternative for making a quick diagnosis and at the same time avoiding unnecessary hospitalization. Bosch et al. have also evaluated the impact of the QDUs in the diagnosis of specific diseases such as cancer in 169 patients diagnosed at the QDU, and compared them to 53 patients who were diagnosed with cancer during an inpatient evaluation.[11] They found that although QDU patients were significantly younger than hospitalized patients, there was no difference in diagnoses established and the time to diagnosis at the QDU and length of stay in the hospital.

There is a significant cost saving associated with QDUs. The cost savings calculated by Bosch et al. and Capell et al. were for each patient enrolled in this protocol from index encounter to final diagnosis.[6, 7] These 2 studies describe primarily fixed costs saved per patient treated in the QDU versus an inpatient admission. Fixed costs in hospital care include personnel cost, buildings, and equipment, whereas variable costs include medication, test reagents, and disposable supplies.[15] In comparison with the US healthcare system, fixed costs in Europe are considerably lower, and certain variable costs (like medications and procedures) are significantly higher in the United States.[16] This suggests a greater opportunity for healthcare savings for carefully selected patients in the United States, where costs related to inpatient admissions are significantly higher.[16]

Another limitation of our analysis is the paucity of studies on this topic. Many of the publications are from Bosch et al.,[1, 6, 11, 12, 13, 14] a single group in Spain, and these show considerable cost savings, patient satisfaction, and patient safety. However, most of their data are either retrospective or from nonrandomized, prospective cohort studies. The only report describing a similar approach in the United States was by Paschal in the city of New Orleans.[17] After Charity Hospital and the Veterans Affairs Hospital in New Orleans were lost to hurricane Katrina, an urgent care clinic was set up where potentially severe diseases such as cancer, leukemia, and autoimmune and endocrine disorders were diagnosed efficiently, although safety data were not reported.

The reported studies used different study designs and evaluated different primary outcomes. These limitations can be overcome with a well‐designed prospective trial, which could also evaluate the actual impact on patient care, safety, and healthcare savings in the United States.

Safety data were reported in detail only in 1 study,[6] and the rates of admissions were reported by 2 other studies.[7, 8] These suggest that QDUs may be safe for a selected group of patients. Patients evaluated in these units preferred this approach as shown by the overwhelming majority of the patients who chose QDU care over inpatient admissions when patient surveys were performed.

CONCLUSION

In this era of healthcare reform and emphasis on value‐based care, we must optimize the efficiency of our care delivery systems and challenge our preexisting resource‐intensive healthcare models. One source of potential savings is avoiding hospitalizations for purely diagnostic purposes, utilizing quick diagnostic units for patients who are able to return for outpatient evaluations. Such units are established, have been studied in Europe, and our systematic review shows that they are cost‐effective, time‐ and resource‐efficient, and preferred by patients. In our healthcare system, with the high cost of inpatient care, the QDU can yield large savings of healthcare dollars while expediting diagnostic workup, increasing patient satisfaction, and preventing lost productivity from hospital stays. Further exploration and study of alternative care delivery models, such as quick diagnostic units, is required to achieve the goal of cost‐effective high‐quality care for all.

Disclosure: Nothing to report.

References
  1. Bosch X, Aibar J, Capell S, Coca A, Lopez‐Soto A. Quick diagnosis units: a potentially useful alternative to conventional hospitalization. Med J Aust. 2009;191:496498.
  2. Schuur J, Venkatesh A. The growing role of emergency departments in hospital admissions. N Engl J Med. 2012;5:391393.
  3. McDonagh MS, Smith DH, Goddard M. Measuring appropriate use of acute beds. A Systematic review of methods and results. Health Policy. 2000;3:157184.
  4. Campbell J. Inappropriate admissions: thoughts of patients and referring doctors. J R Soc Med. 2001;12:628631.
  5. Kendall MJ, Toescu , Wallace DMA. QED: quick and early diagnosis. Lancet. 1996;348:528529.
  6. Bosch X, Jordan A, Lopez‐Soto A. Quick diagnosis units: avoiding referrals from primary care to the ED and hospitalizations. Am J Emerg Med. 2013;31(1):114123.
  7. Capell S, Comas P, Piella T, et al. Quick and early diagnostic outpatient unit: an effective and efficient assistential model. Five years experience. Med Clin (Barc). 2004;123(7):247250.
  8. Rubio‐Rivas M, Vidaller A, Farriols RP, Mast R. Rapid diagnosis unit in a third level hospital. Descriptive study of the first year and a half. Rev Clin Esp. 2008;208(11):561563.
  9. Sanz‐Santos J, Andreo F, Sanchez D, et al. Usefulness of a lung cancer rapid diagnosis specialist clinic. Contribution of ultrasound bronchoscopy. Arch Bronconeumol. 2010;46(12):640645.
  10. Franco Hidalgo S, De Paula P, Serradilla M, Carbayo M. Rapid diagnosis units or immediate health care clinics in internal medicine. Analysis of the first six months of operation in Palencia (Spain). Semergen. 2012;38(2):126130.
  11. Bosch X, Moreno P, Ros M, Jordan A, Lopez‐Soto A. Comparison of quick diagnosis units and conventional hospitalization for the diagnosis of cancer in Spain: a descriptive cohort study. Oncology (Switzerland). 2012;83(5):283291.
  12. Bosch X, Jordan A, Coca A, Lopez‐Soto A. Quick diagnosis units versus hospitalization for the diagnosis of potentially severe diseases in Spain. J Hosp Med. 2012;7(1):4147.
  13. Bosch X, Foix A, Jordan A, Coca A, Lopez‐Soto A. Outpatient quick diagnosis units for the evaluation of suspected severe diseases: an observational study. Clinics. 2011;66(5):737741.
  14. Bosch X, Palacios F, Inclan‐Iribar G, et al. Quick diagnosis units or conventional hospitalization for the diagnostic evaluation of severe anemia: a paradigm shift in public health systems? Eur J Int Med. 2012;23(2):159164.
  15. Roberts RR, Frutos PW, Ciavarella GG, et al. Distribution of variable vs fixed costs of hospital care. JAMA. 1999;281(7):644649.
  16. Squires DA. Explaining high healthcare spending in the united states: an international comparison of supply, utilization, prices and quality. Issue Brief (Commonw Fund). 2012;10:114.
  17. Paschal D. Launching complex medical workups from an urgent care platform. Ann Int Med. 2012;156:232233.
References
  1. Bosch X, Aibar J, Capell S, Coca A, Lopez‐Soto A. Quick diagnosis units: a potentially useful alternative to conventional hospitalization. Med J Aust. 2009;191:496498.
  2. Schuur J, Venkatesh A. The growing role of emergency departments in hospital admissions. N Engl J Med. 2012;5:391393.
  3. McDonagh MS, Smith DH, Goddard M. Measuring appropriate use of acute beds. A Systematic review of methods and results. Health Policy. 2000;3:157184.
  4. Campbell J. Inappropriate admissions: thoughts of patients and referring doctors. J R Soc Med. 2001;12:628631.
  5. Kendall MJ, Toescu , Wallace DMA. QED: quick and early diagnosis. Lancet. 1996;348:528529.
  6. Bosch X, Jordan A, Lopez‐Soto A. Quick diagnosis units: avoiding referrals from primary care to the ED and hospitalizations. Am J Emerg Med. 2013;31(1):114123.
  7. Capell S, Comas P, Piella T, et al. Quick and early diagnostic outpatient unit: an effective and efficient assistential model. Five years experience. Med Clin (Barc). 2004;123(7):247250.
  8. Rubio‐Rivas M, Vidaller A, Farriols RP, Mast R. Rapid diagnosis unit in a third level hospital. Descriptive study of the first year and a half. Rev Clin Esp. 2008;208(11):561563.
  9. Sanz‐Santos J, Andreo F, Sanchez D, et al. Usefulness of a lung cancer rapid diagnosis specialist clinic. Contribution of ultrasound bronchoscopy. Arch Bronconeumol. 2010;46(12):640645.
  10. Franco Hidalgo S, De Paula P, Serradilla M, Carbayo M. Rapid diagnosis units or immediate health care clinics in internal medicine. Analysis of the first six months of operation in Palencia (Spain). Semergen. 2012;38(2):126130.
  11. Bosch X, Moreno P, Ros M, Jordan A, Lopez‐Soto A. Comparison of quick diagnosis units and conventional hospitalization for the diagnosis of cancer in Spain: a descriptive cohort study. Oncology (Switzerland). 2012;83(5):283291.
  12. Bosch X, Jordan A, Coca A, Lopez‐Soto A. Quick diagnosis units versus hospitalization for the diagnosis of potentially severe diseases in Spain. J Hosp Med. 2012;7(1):4147.
  13. Bosch X, Foix A, Jordan A, Coca A, Lopez‐Soto A. Outpatient quick diagnosis units for the evaluation of suspected severe diseases: an observational study. Clinics. 2011;66(5):737741.
  14. Bosch X, Palacios F, Inclan‐Iribar G, et al. Quick diagnosis units or conventional hospitalization for the diagnostic evaluation of severe anemia: a paradigm shift in public health systems? Eur J Int Med. 2012;23(2):159164.
  15. Roberts RR, Frutos PW, Ciavarella GG, et al. Distribution of variable vs fixed costs of hospital care. JAMA. 1999;281(7):644649.
  16. Squires DA. Explaining high healthcare spending in the united states: an international comparison of supply, utilization, prices and quality. Issue Brief (Commonw Fund). 2012;10:114.
  17. Paschal D. Launching complex medical workups from an urgent care platform. Ann Int Med. 2012;156:232233.
Issue
Journal of Hospital Medicine - 9(1)
Issue
Journal of Hospital Medicine - 9(1)
Page Number
54-59
Page Number
54-59
Article Type
Display Headline
Quick diagnosis units—an effective alternative to hospitalization for diagnostic workup: A systematic review
Display Headline
Quick diagnosis units—an effective alternative to hospitalization for diagnostic workup: A systematic review
Sections
Article Source
© 2013 Society of Hospital Medicine
Disallow All Ads
Correspondence Location
Address for correspondence and reprint requests: Shashvat Sukhal, MD, Department of Medicine, John H. Stroger Hospital of Cook County, Chicago, IL 60612; Telephone: 312‐333‐6174; Fax: 312‐864‐9177; E‐mail: ssukhal@cookcountyhhs.org
Content Gating
Gated (full article locked unless allowed per User)
Gating Strategy
First Peek Free
Article PDF Media
Media Files