Browsing by Subject "Quality Indicators, Health Care"

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Open Access
A predictive model and nomogram for predicting return to work at 3 months after cervical spine surgery: an analysis from the Quality Outcomes Database.
(Neurosurgical focus, 2018-11) Devin, Clinton J; Bydon, Mohamad; Alvi, Mohammed Ali; Kerezoudis, Panagiotis; Khan, Inamullah; Sivaganesan, Ahilan; McGirt, Matthew J; Archer, Kristin R; Foley, Kevin T; Mummaneni, Praveen V; Bisson, Erica F; Knightly, John J; Shaffrey, Christopher I; Asher, Anthony L
OBJECTIVEBack pain and neck pain are two of the most common causes of work loss due to disability, which poses an economic burden on society. Due to recent changes in healthcare policies, patient-centered outcomes including return to work have been increasingly prioritized by physicians and hospitals to optimize healthcare delivery. In this study, the authors used a national spine registry to identify clinical factors associated with return to work at 3 months among patients undergoing a cervical spine surgery.METHODSThe authors queried the Quality Outcomes Database registry for information collected from April 2013 through March 2017 for preoperatively employed patients undergoing cervical spine surgery for degenerative spine disease. Covariates included demographic, clinical, and operative variables, and baseline patient-reported outcomes. Multiple imputations were used for missing values and multivariable logistic regression analysis was used to identify factors associated with higher odds of returning to work. Bootstrap resampling (200 iterations) was used to assess the validity of the model. A nomogram was constructed using the results of the multivariable model.RESULTSA total of 4689 patients were analyzed, of whom 82.2% (n = 3854) returned to work at 3 months postoperatively. Among previously employed and working patients, 89.3% (n = 3443) returned to work compared to 52.3% (n = 411) among those who were employed but not working (e.g., were on a leave) at the time of surgery (p < 0.001). On multivariable logistic regression the authors found that patients who were less likely to return to work were older (age > 56-65 years: OR 0.69, 95% CI 0.57-0.85, p < 0.001; age > 65 years: OR 0.65, 95% CI 0.43-0.97, p = 0.02); were employed but not working (OR 0.24, 95% CI 0.20-0.29, p < 0.001); were employed part time (OR 0.56, 95% CI 0.42-0.76, p < 0.001); had a heavy-intensity (OR 0.42, 95% CI 0.32-0.54, p < 0.001) or medium-intensity (OR 0.59, 95% CI 0.46-0.76, p < 0.001) occupation compared to a sedentary occupation type; had workers' compensation (OR 0.38, 95% CI 0.28-0.53, p < 0.001); had a higher Neck Disability Index score at baseline (OR 0.60, 95% CI 0.51-0.70, p = 0.017); were more likely to present with myelopathy (OR 0.52, 95% CI 0.42-0.63, p < 0.001); and had more levels fused (3-5 levels: OR 0.46, 95% CI 0.35-0.61, p < 0.001). Using the multivariable analysis, the authors then constructed a nomogram to predict return to work, which was found to have an area under the curve of 0.812 and good validity.CONCLUSIONSReturn to work is a crucial outcome that is being increasingly prioritized for employed patients undergoing spine surgery. The results from this study could help surgeons identify at-risk patients so that preoperative expectations could be discussed more comprehensively.
Open Access
Absence of July Phenomenon in Acute Ischemic Stroke Care Quality and Outcomes.
(Journal of the American Heart Association, 2018-01-31) Gonzalez-Castellon, Marco; Ju, Christine; Xian, Ying; Hernandez, Adrian; Fonarow, Gregg C; Schwamm, Lee; Smith, Eric E; Bhatt, Deepak L; Reeves, Matthew; Willey, Joshua Z
BACKGROUND:Lower care quality and an increase in adverse outcomes as a result of new medical trainees is a concept well rooted in popular belief, termed the "July phenomenon." Whether this phenomenon occurs in acute ischemic stroke has not been well studied. METHODS AND RESULTS:We analyzed data from patients admitted with ischemic stroke in 1625 hospitals participating in the Get With The Guidelines-Stroke program for the 5-year period between January 2009 and December 2013. We compared acute stroke treatment processes and in-hospitals outcomes among the 4 quarters (first quarter: July-September, last quarter: April-June) of the academic year. Multivariable logistic regression models were used to evaluate the relationship between academic year transition and processes measures. A total of 967 891 patients were included in the study. There was a statistically significant, but modest (<4 minutes or 5 percentage points) difference in distribution of or quality and clinical metrics including door-to-computerized tomography time, door-to-needle time, the proportion of patients with symptomatic intracranial hemorrhage within 36 hours of admission, and the proportion of patients who received defect-free care in stroke performance measures among academic year quarters (P<0.0001). In multivariable analyses, there was no evidence that quarter 1 of the academic year was associated with lower quality of care or worse in-hospital outcomes in teaching and nonteaching hospitals. CONCLUSIONS:We found no evidence of the "July phenomenon" in patients with acute ischemic stroke among hospitals participating in the Get With The Guidelines-Stroke program.
Open Access
Association between hospital volume and network membership and an analgesia, sedation and delirium order set quality score: a cohort study.
(Critical care (London, England), 2012-06) Dale, Christopher R; Hayden, Shailaja J; Treggiari, Miriam M; Curtis, J Randall; Seymour, Christopher W; Yanez, N David; Fan, Vincent S
Introduction
Protocols for the delivery of analgesia, sedation and delirium care of the critically ill, mechanically ventilated patient have been shown to improve outcomes but are not uniformly used. The extent to which elements of analgesia, sedation and delirium guidelines are incorporated into order sets at hospitals across a geographic area is not known. We hypothesized that both greater hospital volume and membership in a hospital network are associated with greater adherence of order sets to sedation guidelines.
Methods
Sedation order sets from all nonfederal hospitals without pediatric designation in Washington State that provided ongoing care to mechanically ventilated patients were collected and their content systematically abstracted. Hospital data were collected from Washington State sources and interviews with ICU leadership in each hospital. An expert-validated score of order set quality was created based on the 2002 four-society guidelines. Clustered multivariable linear regression was used to assess the relationship between hospital characteristics and the order set quality score.
Results
Fifty-one Washington State hospitals met the inclusion criteria and all provided order sets. Based on expert consensus, 21 elements were included in the analgesia, sedation and delirium order set quality score. Each element was equally weighted and contributed one point to the score. Hospital order set quality scores ranged from 0 to 19 (median = 8, interquartile range 6 to 14). In multivariable analysis, a greater number of acute care days (P = 0.01) and membership in a larger hospital network (P = 0.01) were independently associated with a greater quality score.
Conclusions
Hospital volume and membership in a larger hospital network were independently associated with a higher quality score for ICU analgesia, sedation and delirium order sets. Further research is needed to determine whether greater order-set quality is associated with improved outcomes in the critically ill. The development of critical care networks might be one strategy to improve order set quality scores.
Open Access
Development and implementation of a proficiency testing program for Luminex bead-based cytokine assays.
(Journal of Immunological Methods, 2014-07) Lynch, Heather E; Sanchez, Ana M; D'Souza, M Patricia; Rountree, Wes; Denny, Thomas N; Kalos, Michael; Sempowski, Gregory D
Luminex bead array assays are widely used for rapid biomarker quantification due to the ability to measure up to 100 unique analytes in a single well of a 96-well plate. There has been, however, no comprehensive analysis of variables impacting assay performance, nor development of a standardized proficiency testing program for laboratories performing these assays. To meet this need, the NIH/NIAID and the Cancer Immunotherapy Consortium of the Cancer Research Institute collaborated to develop and implement a Luminex assay proficiency testing program as part of the NIH/NIAID-sponsored External Quality Assurance Program Oversight Laboratory (EQAPOL) at Duke University. The program currently monitors 25 domestic and international sites with two external proficiency panels per year. Each panel includes a de-identified commercial Luminex assay kit with standards to quantify human IFNγ, TNFα, IL-6, IL-10 and IL-2, and a series of recombinant cytokine-spiked human serum samples. All aspects of panel development, testing and shipping are performed under GCLP by EQAPOL support teams. Following development testing, a comprehensive site proficiency scoring system comprised of timeliness, protocol adherence, accuracy and precision was implemented. The overall mean proficiency score across three rounds of testing has remained stable (EP3: 76%, EP4: 75%, EP5: 77%); however, a more detailed analysis of site reported results indicates a significant improvement of intra- (within) and inter- (between) site variation, suggesting that training and remediation for poor performing sites may be having a positive impact on proficiency. Through continued proficiency testing, identification of variables affecting Luminex assay outcomes will strengthen efforts to bring standardization to the field.
Open Access
Development of a contemporary globally diverse HIV viral panel by the EQAPOL program.
(J Immunol Methods, 2014-07) Sanchez, Ana M; DeMarco, C Todd; Hora, Bhavna; Keinonen, Sarah; Chen, Yue; Brinkley, Christie; Stone, Mars; Tobler, Leslie; Keating, Sheila; Schito, Marco; Busch, Michael P; Gao, Feng; Denny, Thomas N
The significant diversity among HIV-1 variants poses serious challenges for vaccine development and for developing sensitive assays for screening, surveillance, diagnosis, and clinical management. Recognizing a need to develop a panel of HIV representing the current genetic and geographic diversity NIH/NIAID contracted the External Quality Assurance Program Oversight Laboratory (EQAPOL) to isolate, characterize and establish panels of HIV-1 strains representing global diverse subtypes and circulating recombinant forms (CRFs), and to make them available to the research community. HIV-positive plasma specimens and previously established isolates were collected through a variety of collaborations with a preference for samples from acutely/recently infected persons. Source specimens were cultured to high-titer/high-volume using well-characterized cryopreserved PBMCs from National y donors. Panel samples were stored as neat culture supernatant or diluted into defibrinated plasma. Characterization for the final expanded virus stocks included viral load, p24 antigen, infectivity (TCID), sterility, coreceptor usage, and near full-length genome sequencing. Viruses are made available to approved, interested laboratories using an online ordering application. The current EQAPOL Viral Diversity panel includes 100 viral specimens representing 6 subtypes (A, B, C, D, F, and G), 2 sub-subtypes (F1 and F2), 7 CRFs (01, 02, 04, 14, 22, 24, and 47), 19 URFs and 3 group O viruses from 22 countries. The EQAPOL Viral Diversity panel is an invaluable collection of well-characterized reagents that are available to the scientific community, including researchers, epidemiologists, and commercial manufacturers of diagnostics and pharmaceuticals to support HIV research, as well as diagnostic and vaccine development.
Open Access
Effect of a Multifaceted Quality Improvement Intervention on Hospital Personnel Adherence to Performance Measures in Patients With Acute Ischemic Stroke in China: A Randomized Clinical Trial.
(JAMA, 2018-07) Wang, Yilong; Li, Zixiao; Zhao, Xingquan; Wang, Chunjuan; Wang, Xianwei; Wang, David; Liang, Li; Liu, Liping; Wang, Chunxue; Li, Hao; Shen, Haipeng; Bettger, Janet; Pan, Yuesong; Jiang, Yong; Yang, Xiaomeng; Zhang, Changqing; Han, Xiujie; Meng, Xia; Yang, Xin; Kang, Hong; Yuan, Weiqiang; Fonarow, Gregg C; Peterson, Eric D; Schwamm, Lee H; Xian, Ying; Wang, Yongjun; GOLDEN BRIDGE—AIS Investigators
In China and other parts of the world, hospital personnel adherence to evidence-based stroke care is limited.To determine whether a multifaceted quality improvement intervention can improve hospital personnel adherence to evidence-based performance measures in patients with acute ischemic stroke (AIS) in China.A multicenter, cluster-randomized clinical trial among 40 public hospitals in China that enrolled 4800 patients hospitalized with AIS from August 10, 2014, through June 20, 2015, with 12-month follow-up through July 30, 2016.Twenty hospitals received a multifaceted quality improvement intervention (intervention group; 2400 patients), including a clinical pathway, care protocols, quality coordinator oversight, and performance measure monitoring and feedback. Twenty hospitals participated in the stroke registry with usual care (control group; 2400 patients).The primary outcome was hospital personnel adherence to 9 AIS performance measures, with co-primary outcomes of a composite of percentage of performance measures adhered to, and as all-or-none. Secondary outcomes included in-hospital mortality and long-term outcomes (a new vascular event, disability [modified Rankin Scale score, 3-5], and all-cause mortality) at 3, 6, and 12 months.Among 4800 patients with AIS enrolled from 40 hospitals and randomized (mean age, 65 years; women, 1757 [36.6%]), 3980 patients (82.9%) completed the 12-month follow-up of the trial. Patients in intervention group were more likely to receive performance measures than those in the control groups (composite measure, 88.2% vs 84.8%, respectively; absolute difference, 3.54% [95% CI, 0.68% to 6.40%], P = .02). The all-or-none measure did not significantly differ between the intervention and control groups (53.8% vs 47.8%, respectively; absolute difference, 6.69% [95% CI, -0.41% to 13.79%], P = .06). New clinical vascular events were significantly reduced in the intervention group compared with the control group at 3 months (3.9% vs 5.3%, respectively; difference, -2.03% [95% CI, -3.51% to -0.55%]; P = .007), 6 months (6.3% vs 7.8%, respectively; difference, -2.18% [95% CI, -4.0% to -0.35%]; P = .02) and 12 months (9.1% vs 11.8%, respectively; difference, -3.13% [95% CI, -5.28% to -0.97%]; P = .005).Among 40 hospitals in China, a multifaceted quality improvement intervention compared with usual care resulted in a statistically significant but small improvement in hospital personnel adherence to evidence-based performance measures in patients with acute ischemic stroke when assessed as a composite measure, but not as an all-or-none measure. Further research is needed to understand the generalizability of these findings.ClinicalTrials.gov Identifier: NCT02212912.
Open Access
Establishment and maintenance of a PBMC repository for functional cellular studies in support of clinical vaccine trials.
(J Immunol Methods, 2014-07) Sambor, Anna; Garcia, Ambrosia; Berrong, Mark; Pickeral, Joy; Brown, Sara; Rountree, Wes; Sanchez, Ana; Pollara, Justin; Frahm, Nicole; Keinonen, Sarah; Kijak, Gustavo H; Roederer, Mario; Levine, Gail; D'Souza, M Patricia; Jaimes, Maria; Koup, Richard; Denny, Thomas; Cox, Josephine; Ferrari, Guido
A large repository of cryopreserved peripheral blood mononuclear cells (PBMCs) samples was created to provide laboratories testing the specimens from human immunodeficiency virus-1 (HIV-1) vaccine clinical trials the material for assay development, optimization, and validation. One hundred thirty-one PBMC samples were collected using leukapheresis procedure between 2007 and 2013 by the Comprehensive T cell Vaccine Immune Monitoring Consortium core repository. The donors included 83 human immunodeficiency virus-1 (HIV-1) seronegative and 32 HIV-1 seropositive subjects. The samples were extensively characterized for the ability of T cell subsets to respond to recall viral antigens including cytomegalovirus, Epstein-Barr virus, influenza virus, and HIV-1 using Interferon-gamma (IFN-γ) enzyme linked immunospot (ELISpot) and IFN-γ/interleukin 2 (IL-2) intracellular cytokine staining (ICS) assays. A subset of samples was evaluated over time to determine the integrity of the cryopreserved samples in relation to recovery, viability, and functionality. The principal results of our study demonstrate that viable and functional cells were consistently recovered from the cryopreserved samples. Therefore, we determined that this repository of large size cryopreserved cellular samples constitutes a unique resource for laboratories that are involved in optimization and validation of assays to evaluate T, B, and NK cellular functions in the context of clinical trials.
Open Access
Home blood pressure management and improved blood pressure control: results from a randomized controlled trial.
(Archives of internal medicine, 2011-07) Bosworth, Hayden B; Powers, Benjamin J; Olsen, Maren K; McCant, Felicia; Grubber, Janet; Smith, Valerie; Gentry, Pamela W; Rose, Cynthia; Van Houtven, Courtney; Wang, Virginia; Goldstein, Mary K; Oddone, Eugene Z
Background
To determine which of 3 interventions was most effective in improving blood pressure (BP) control, we performed a 4-arm randomized trial with 18-month follow-up at the primary care clinics at a Veterans Affairs Medical Center.
Methods
Eligible patients were randomized to either usual care or 1 of 3 telephone-based intervention groups: (1) nurse-administered behavioral management, (2) nurse- and physician-administered medication management, or (3) a combination of both. Of the 1551 eligible patients, 593 individuals were randomized; 48% were African American. The intervention telephone calls were triggered based on home BP values transmitted via telemonitoring devices. Behavioral management involved promotion of health behaviors. Medication management involved adjustment of medications by a study physician and nurse based on hypertension treatment guidelines.
Results
The primary outcome was change in BP control measured at 6-month intervals over 18 months. Both the behavioral management and medication management alone showed significant improvements at 12 months-12.8% (95% confidence interval [CI], 1.6%-24.1%) and 12.5% (95% CI, 1.3%-23.6%), respectively-but not at 18 months. In subgroup analyses, among those with poor baseline BP control, systolic BP decreased in the combined intervention group by 14.8 mm Hg (95% CI, -21.8 to -7.8 mm Hg) at 12 months and 8.0 mm Hg (95% CI, -15.5 to -0.5 mm Hg) at 18 months, relative to usual care.
Conclusions
Overall intervention effects were moderate, but among individuals with poor BP control at baseline, the effects were larger. This study indicates the importance of identifying individuals most likely to benefit from potentially resource intensive programs.
Trial registration
clinicaltrials.gov Identifier: NCT00237692.
Open Access
Implementing a Continuous Quality Improvement Program in a High-Volume Clinical Echocardiography Laboratory: Improving Care for Patients With Aortic Stenosis.
(Circ Cardiovasc Imaging, 2016-03) Samad, Zainab; Minter, Stephanie; Armour, Alicia; Tinnemore, Amanda; Sivak, Joseph A; Sedberry, Brenda; Strub, Karen; Horan, Seanna M; Harrison, J Kevin; Kisslo, Joseph; Douglas, Pamela S; Velazquez, Eric J
BACKGROUND: The management of aortic stenosis rests on accurate echocardiographic diagnosis. Hence, it was chosen as a test case to examine the utility of continuous quality improvement (CQI) approaches to increase echocardiographic data accuracy and reliability. A novel, multistep CQI program was designed and prospectively used to investigate whether it could minimize the difference in aortic valve mean gradients reported by echocardiography when compared with cardiac catheterization. METHODS AND RESULTS: The Duke Echo Laboratory compiled a multidisciplinary CQI team including 4 senior sonographers and MD faculty to develop a mapped CQI process that incorporated Intersocietal Accreditation Commission standards. Quarterly, the CQI team reviewed all moderate- or greater-severity aortic stenosis echocardiography studies with concomitant catheterization data, and deidentified individual and group results were shared at meetings attended by cardiologists and sonographers. After review of 2011 data, the CQI team proposed specific amendments implemented over 2012: the use of nontraditional imaging and Doppler windows as well as evaluation of aortic gradients by a second sonographer. The primary outcome measure was agreement between catheterization- and echocardiography-derived mean gradients calculated by using the coverage probability index with a prespecified acceptable echocardiography-catheterization difference of <10 mm Hg in mean gradient. Between January 2011 and January 2014, 2093 echocardiograms reported moderate or greater aortic stenosis. Among cases with available catheterization data pre- and post-CQI, the coverage probability index increased from 54% to 70% (P=0.03; 98 cases, year 2011; 70 cases, year 2013). The proportion of patients referred for invasive valve hemodynamics decreased from 47% pre-CQI to 19% post-CQI (P<0.001). CONCLUSIONS: A laboratory practice pattern that was amenable to reform was identified, and a multistep modification was designed and implemented that produced clinically valuable performance improvements. The new protocol improved aortic stenosis mean gradient agreement between echocardiography and catheterization and was associated with a measurable decrease in referrals of patients for invasive studies.
Open Access
Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs.
(Journal of Immunological Methods, 2014-07) Garcia, Ambrosia; Keinonen, Sarah; Sanchez, Ana M; Ferrari, Guido; Denny, Thomas N; Moody, M Anthony
External proficiency testing programs designed to evaluate the performance of end-point laboratories involved in vaccine and therapeutic clinical trials form an important part of clinical trial quality assurance. Good clinical laboratory practice (GCLP) guidelines recommend both assay validation and proficiency testing for assays being used in clinical trials, and such testing is facilitated by the availability of large numbers of well-characterized test samples. These samples can be distributed to laboratories participating in these programs and allow monitoring of laboratory performance over time and among participating sites when results are obtained with samples derived from a large master set. The leukapheresis procedure provides an ideal way to collect samples from participants that can meet the required number of cells to support these activities. The collection and processing of leukapheresis samples require tight coordination between the clinical and laboratory teams to collect, process, and cryopreserve large number of samples within the established ideal time of ≤8 hours. Here, we describe our experience with a leukapheresis cryopreseration program that has been able to preserve the functionality of cellular subsets and that provides the sample numbers necessary to run an external proficiency testing program.
Open Access
Perception Versus Actual Performance in Timely Tissue Plasminogen Activation Administration in the Management of Acute Ischemic Stroke.
(J Am Heart Assoc, 2015-07-22) Lin, Cheryl B; Cox, Margueritte; Olson, DaiWai M; Britz, Gavin W; Constable, Mark; Fonarow, Gregg C; Schwamm, Lee; Peterson, Eric D; Shah, Bimal R
BACKGROUND: Timely thrombolytic therapy can improve stroke outcomes. Nevertheless, the ability of US hospitals to meet guidelines for intravenous tissue plasminogen activator (tPA) remains suboptimal. What is unclear is whether hospitals accurately perceive their rate of tPA "door-to-needle" (DTN) time within 60 minutes and how DTN rates compare across different hospitals. METHODS AND RESULTS: DTN performance was defined by the percentage of treated patients who received tPA within 60 minutes of arrival. Telephone surveys were obtained from staff at 141 Get With The Guidelines hospitals, representing top, middle, and low DTN performance. Less than one-third (29.1%) of staff accurately identified their DTN performance. Among middle- and low-performing hospitals (n=92), 56 sites (60.9%) overestimated their performance; 42% of middle performers and 85% of low performers overestimated their performance. Sites that overestimated tended to have lower annual volumes of tPA administration (median 8.4 patients [25th to 75th percentile 5.9 to 11.8] versus 10.2 patients [25th to 75th percentile 8.2 to 17.3], P=0.047), smaller percentages of eligible patients receiving tPA (84.7% versus 89.8%, P=0.008), and smaller percentages of DTN ≤60 minutes among treated patients (10.6% versus 16.6%, P=0.002). CONCLUSIONS: Hospitals often overestimate their ability to deliver timely tPA to treated patients. Our findings indicate the need to routinely provide comparative provider performance rates as a key step to improving the quality of acute stroke care.
Open Access
Practice-Level Variation in Outpatient Cardiac Care and Association With Outcomes.
(J Am Heart Assoc, 2016-02-23) Clough, Jeffrey D; Rajkumar, Rahul; Crim, Matthew T; Ott, Lesli S; Desai, Nihar R; Conway, Patrick H; Maresh, Sha; Kahvecioglu, Daver C; Krumholz, Harlan M
BACKGROUND: Utilization of cardiac services varies across regions and hospitals, yet little is known regarding variation in the intensity of outpatient cardiac care across cardiology physician practices or the association with clinical endpoints, an area of potential importance to promote efficient care. METHODS AND RESULTS: We included 7 160 732 Medicare beneficiaries who received services from 5635 cardiology practices in 2012. Beneficiaries were assigned to practices providing the plurality of office visits, and practices were ranked and assigned to quartiles using the ratio of observed to predicted annual payments per beneficiary for common cardiac services (outpatient intensity index). The median (interquartile range) outpatient intensity index was 1.00 (0.81-1.24). Mean payments for beneficiaries attributed to practices in the highest (Q4) and lowest (Q1) quartile of outpatient intensity were: all cardiac payments (Q4 $1272 vs Q1 $581; ratio, 2.2); cardiac catheterization (Q4 $215 vs Q1 $64; ratio, 3.4); myocardial perfusion imaging (Q4 $253 vs Q1 $83; ratio, 3.0); and electrophysiology device procedures (Q4 $353 vs Q1 $142; ratio, 2.5). The adjusted odds ratios (95% CI) for 1 incremental quartile of outpatient intensity for each outcome was: cardiac surgical/procedural hospitalization (1.09 [1.09, 1.10]); cardiac medical hospitalization (1.00 [0.99, 1.00]); noncardiac hospitalization (0.99 [0.99, 0.99]); and death at 1 year (1.00 [0.99, 1.00]). CONCLUSION: Substantial variation in the intensity of outpatient care exists at the cardiology practice level, and higher intensity is not associated with reduced mortality or hospitalizations. Outpatient cardiac care is a potentially important target for efforts to improve efficiency in the Medicare population.
Open Access
Rates and causes of mortality associated with spine surgery based on 108,419 procedures: a review of the Scoliosis Research Society Morbidity and Mortality Database.
(Spine, 2012-11) Smith, Justin S; Saulle, Dwight; Chen, Ching-Jen; Lenke, Lawrence G; Polly, David W; Kasliwal, Manish K; Broadstone, Paul A; Glassman, Steven D; Vaccaro, Alexander R; Ames, Christopher P; Shaffrey, Christopher I
Study design
A retrospective review of a prospectively collected database.
Objective
To assess rates and causes of mortality associated with spine surgery.
Summary of background data
Despite the best of care, all surgical procedures have inherent risks of complications, including mortality. Defining these risks is important for patient counseling and quality improvement.
Methods
The Scoliosis Research Society Morbidity and Mortality database was queried for spinal surgery cases complicated by death from 2004 to 2007, including pediatric (younger than 21 yr) and adult (21 yr or older) patients. Deaths occurring within 60 days and complications within 60 days of surgery that resulted in death were assessed.
Results
A total of 197 mortalities were reported among 108,419 patients (1.8 deaths per 1000 patients). Based on age, rates of death per 1000 patients for adult and pediatric patients were 2.0 and 1.3, respectively. Based on primary diagnosis (available for 107,996 patients), rates of death per 1000 patients were as follows: 0.9 for degenerative (n = 47,393), 1.8 for scoliosis (n = 26,421), 0.9 for spondylolisthesis (n = 11,421), 5.7 for fracture (n = 6706), 4.4 for kyphosis (n = 3600), and 3.3 for other (n = 12,455). The most common causes of mortality included: respiratory/pulmonary causes (n = 83), cardiac causes (n = 41), sepsis (n = 35), stroke (n = 15), and intraoperative blood loss (n = 8). Death occurred prior to hospital discharge for 109 (79%) of 138 deaths for which this information was reported. The specific postoperative day (POD) of death was reported for 94 (48%) patients and included POD 0 (n = 23), POD 1-3 (n = 17), POD 4-14 (n = 30), and POD >14 (n = 24). Increased mortality rates were associated with higher American Society of Anesthesiologists score, spinal fusion, and implants (P < 0.001). Mortality rates increased with age, ranging from 0.9 per 1000 to 34.3 per 1000 for patients aged 20 to 39 years and 90 years or older, respectively.
Conclusion
This study provides rates and causes of mortality associated with spine surgery for a broad range of diagnoses and includes assessments for adult and pediatric patients. These findings may prove valuable for patient counseling and efforts to improve the safety of patient care.
Open Access
Relationship between hospital performance measures and outcomes in patients with acute ischaemic stroke: a prospective cohort study.
(BMJ open, 2018-08) Zhang, Xinmiao; Li, Zixiao; Zhao, Xingquan; Xian, Ying; Liu, Liping; Wang, Chunxue; Wang, Chunjuan; Li, Hao; Prvu Bettger, Janet; Yang, Qing; Wang, David; Jiang, Yong; Bao, Xiaolei; Yang, Xiaomeng; Wang, Yilong; Wang, Yongjun
OBJECTIVE:Evidence-based performance measures have been increasingly used to evaluate hospital quality of stroke care, but their impact on stroke outcomes has not been verified. We aimed to evaluate the correlations between hospital performance measures and outcomes among patients with acute ischaemic stroke in a Chinese population. METHODS:Data were derived from a prospective cohort, which included 120 hospitals participating in the China National Stroke Registry between September 2007 and August 2008. Adherence to nine evidence-based performance measures was examined, and the composite score of hospital performance measures was calculated. The primary stroke outcomes were hospital-level, 30-day and 1-year risk-standardised mortality (RSM). Associations of individual performance measures and composite score with stroke outcomes were assessed using Spearman correlation coefficients. RESULTS:One hundred and twenty hospitals that recruited 12 027 patients with ischaemic stroke were included in our analysis. Among 12 027 patients, 61.59% were men, and the median age was 67 years. The overall composite score of performance measures was 63.3%. The correlation coefficients between individual performance measures ranged widely from 0.01 to 0.66. No association was observed between the composite score and 30-day RSM. The composite score was modestly associated with 1-year RSM (Spearman correlation coefficient, 0.34; p<0.05). The composite score explained only 2.53% and 10.18% of hospital-level variation in 30-day and 1-year RSM for patients with acute stroke. CONCLUSIONS:Adherence to evidence-based performance measures for acute ischaemic stroke was suboptimal in China. There were various correlations among hospital individual performance measures. The hospital performance measures had no correlations with 30-day RSM rate and modest correlations with 1-year RSM rate.
Open Access
Setting objective thresholds for rare event detection in flow cytometry.
(J Immunol Methods, 2014-07) Richards, Adam J; Staats, Janet; Enzor, Jennifer; McKinnon, Katherine; Frelinger, Jacob; Denny, Thomas N; Weinhold, Kent J; Chan, Cliburn
The accurate identification of rare antigen-specific cytokine positive cells from peripheral blood mononuclear cells (PBMC) after antigenic stimulation in an intracellular staining (ICS) flow cytometry assay is challenging, as cytokine positive events may be fairly diffusely distributed and lack an obvious separation from the negative population. Traditionally, the approach by flow operators has been to manually set a positivity threshold to partition events into cytokine-positive and cytokine-negative. This approach suffers from subjectivity and inconsistency across different flow operators. The use of statistical clustering methods does not remove the need to find an objective threshold between between positive and negative events since consistent identification of rare event subsets is highly challenging for automated algorithms, especially when there is distributional overlap between the positive and negative events ("smear"). We present a new approach, based on the Fβ measure, that is similar to manual thresholding in providing a hard cutoff, but has the advantage of being determined objectively. The performance of this algorithm is compared with results obtained by expert visual gating. Several ICS data sets from the External Quality Assurance Program Oversight Laboratory (EQAPOL) proficiency program were used to make the comparisons. We first show that visually determined thresholds are difficult to reproduce and pose a problem when comparing results across operators or laboratories, as well as problems that occur with the use of commonly employed clustering algorithms. In contrast, a single parameterization for the Fβ method performs consistently across different centers, samples, and instruments because it optimizes the precision/recall tradeoff by using both negative and positive controls.
Open Access
Statistical methods for the assessment of EQAPOL proficiency testing: ELISpot, Luminex, and Flow Cytometry.
(Journal of Immunological Methods, 2014-07) Rountree, Wes; Vandergrift, Nathan; Bainbridge, John; Sanchez, Ana M; Denny, Thomas N
In September 2011 Duke University was awarded a contract to develop the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) External Quality Assurance Program Oversight Laboratory (EQAPOL). Through EQAPOL, proficiency testing programs are administered for Interferon-γ (IFN-γ) Enzyme-linked immunosorbent spot (ELISpot), Intracellular Cytokine Staining Flow Cytometry (ICS) and Luminex-based cytokine assays. One of the charges of the EQAPOL program was to apply statistical methods to determine overall site performance. We utilized various statistical methods for each program to find the most appropriate for assessing laboratory performance using the consensus average as the target value. Accuracy ranges were calculated based on Wald-type confidence intervals, exact Poisson confidence intervals, or via simulations. Given the nature of proficiency testing data, which has repeated measures within donor/sample made across several laboratories; the use of mixed effects models with alpha adjustments for multiple comparisons was also explored. Mixed effects models were found to be the most useful method to assess laboratory performance with respect to accuracy to the consensus. Model based approaches to the proficiency testing data in EQAPOL will continue to be utilized. Mixed effects models also provided a means of performing more complex analyses that would address secondary research questions regarding within and between laboratory variability as well as longitudinal analyses.
Open Access
The External Quality Assurance Oversight Laboratory (EQAPOL) proficiency program for IFN-gamma enzyme-linked immunospot (IFN-γ ELISpot) assay.
(Journal of Immunological Methods, 2014-07) Sanchez, Ana M; Rountree, Wes; Berrong, Mark; Garcia, Ambrosia; Schuetz, Alexandra; Cox, Josephine; Frahm, Nicole; Manak, Mark; Sarzotti-Kelsoe, Marcella; D'Souza, M Patricia; Denny, Thomas; Ferrari, Guido
The interferon-gamma enzyme-linked immunospot (IFN-γ ELISpot) assay has been developed and used as an end-point assay in clinical trials for infectious diseases and cancer to detect the magnitude of antigen-specific immune responses. The ability to compare data generated by different laboratories across organizations is pivotal to understand the relative potency of different therapeutic and vaccine strategies. We developed an external proficiency program for the IFN-γ ELISpot assay that evaluates laboratory performance based on five parameters: timeliness for data reporting; ability to handle cellular samples; detection of background (non-specific) responses; accuracy to consensus of the results; and precision of the measurements. Points are awarded for each criterion, and the sum of the points is used to determine a numeric and adjectival performance rating. Importantly, the evaluation of the accuracy to the consensus mean for the detection of antigen-specific responses using laboratory-specific procedures informs each laboratory and its sponsor on the degree of concordance of its results with those obtained by other laboratories. This study will ultimately provide the scientific community with information on how to organize and implement an external proficiency program to evaluate longitudinally the performance of the participating laboratories and, therefore, fulfill the requirements of the GCLP guidelines for laboratories performing end-point IFN-γ ELISpot assay for clinical trials.
Open Access
The Immunology Quality Assessment Proficiency Testing Program for CD3⁺4⁺ and CD3⁺8⁺ lymphocyte subsets: a ten year review via longitudinal mixed effects modeling.
(Journal of Immunological Methods, 2014-07) Bainbridge, J; Wilkening, CL; Rountree, W; Louzao, R; Wong, J; Perza, N; Garcia, A; Denny, TN
Since 1999, the National Institute of Allergy and Infectious Diseases Division of AIDS (NIAID DAIDS) has funded the Immunology Quality Assessment (IQA) Program with the goal of assessing proficiency in basic lymphocyte subset immunophenotyping for each North American laboratory supporting the NIAID DAIDS HIV clinical trial networks. Further, the purpose of this program is to facilitate an increase in the consistency of interlaboratory T-cell subset measurement (CD3(+)4(+)/CD3(+)8(+) percentages and absolute counts) and likewise, a decrease in intralaboratory variability. IQA T-cell subset measurement proficiency testing was performed over a ten-year period (January 2003-July 2012), and the results were analyzed via longitudinal analysis using mixed effects models. The goal of this analysis was to describe how a typical laboratory (a statistical modeling construct) participating in the IQA Program performed over time. Specifically, these models were utilized to examine trends in interlaboratory agreement, as well as successful passing of proficiency testing. Intralaboratory variability (i.e., precision) was determined by the repeated measures variance, while fixed and random effects were taken into account for changes in interlaboratory agreement (i.e., accuracy) over time. A flow cytometer (single-platform technology, SPT) or a flow cytometer/hematology analyzer (dual-platform technology, DPT) was also examined as a factor for accuracy and precision. The principal finding of this analysis was a significant (p<0.001) increase in accuracy of T-cell subset measurements over time, regardless of technology type (SPT or DPT). Greater precision was found in SPT measurements of all T-cell subset measurements (p<0.001), as well as greater accuracy of SPT on CD3(+)4(+)% and CD3(+)8(+)% assessments (p<0.05 and p<0.001, respectively). However, the interlaboratory random effects variance in DPT results indicates that for some cases DPT can have increased accuracy compared to SPT. Overall, these findings demonstrate that proficiency in and among IQA laboratories have, in general, improved over time and that platform type differences in performance do exist.
Open Access
Using Health System Data for Improvement Science: Charting Progress.
(AACN advanced critical care, 2019-01) Reynolds, Staci; Granger, Bradi B

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