Virginia Mason Medical Center Research Articles

Disparities in prevalence, location, and shape characteristics of colorectal neoplasia between South Korean and U.S. patients

Colon cancer screening is being introduced in many countries, but standard Western screening approaches may not be appropriate for Asian societies if differences in colon cancer epidemiology exist. Comparative analysis of colorectal neoplasia patterns in South Korean and Western subjects has implications for appropriate screening approaches in non-Western societies. The results of concurrent screening colonoscopies performed in average-risk patients 50 to 69 years old in 2 teaching hospitals, Kyung Hee University Hospital (Seoul, South Korea) and Virginia Mason Medical Center (Seattle, Wash), were compared with respect to prevalence, histologic features, anatomic distribution, and shape characteristics of colorectal neoplasia. The U.S. (n = 3460) and South Korean (n = 2193) cohorts were similar with regard to the prevalence of adenomas (28.5% vs 29.8%, respectively, P = .312) and advanced neoplasia (6.4% vs 5.4%, respectively, P = .102), but the proportion of proximal adenomas was greater in the U.S. cohort (62.8% vs 45.9%, P < .001). The prevalence of adenomas and advanced neoplasia was similar in male patients, but there was a greater prevalence of neoplasia (23.5% vs 18.8%, P = .006) and advanced neoplasia (5.1% vs 2.7%, P < .001) in U.S. women than South Korean women. When large (≥10 mm) adenomas were considered, proximal location and nonpolypoid (flat) shape were more common in the U.S. cohort (79.4% vs 37.1%, P = .003 and 43.5% vs 12.3%, P < .001, respectively). The overall prevalence of large flat adenomas in the U.S. cohort was 5 times that of the South Korean cohort (2.6% vs 0.5%, P < .001). Adjustment for sex ratio discrepancies (48.3% men in the U.S. cohort vs 60.8% in the South Korean cohort, P < .001) did not result in any significant changes in the conclusions. Compared with Westerners, South Koreans have a more distal distribution of adenomas and advanced neoplasia and lower prevalence of large flat adenomas. South Korean women have a lower prevalence of colorectal neoplasia than Western women. Such disparities suggest that Western screening strategies cannot be directly adopted by other countries, but need to be customized by society.

A standardized anesthetic and surgical clinical pathway for esophageal resection: impact on length of stay and major outcomes.

Esophageal cancer is a leading cause of cancer death worldwide, and esophageal resection is associated with extremely high perioperative morbidity and mortality. A perioperative clinical pathway for esophagectomy patients in which anesthetic care is both integral and standardized has not been described previously. A continuously refined clinical pathway for perioperative care of the esophagectomy patient has been developed at the Virginia Mason Medical Center over the past 22 years. Ongoing data collection records patient demographics, comorbidities, tumor stage, and various outcomes including intensive care unit and hospital length of stay, surgical complications, and morbidity and mortality rates. Over time, patients presenting for surgical treatment of esophageal cancer have had significantly higher Charlson comorbidity scores and a higher incidence of diabetes mellitus, hypertension, liver disease, and history of deep vein thrombosis or pulmonary embolism. During the same period, intensive care unit and hospital length of stays have decreased, whereas most complication rates have remained stable despite more advanced tumor stage and increased use of neoadjuvant chemoradiotherapy. In-hospital and 30-day mortality rates are well below national averages at 0.5% each. We present a detailed anesthetic and surgical perioperative pathway for esophageal resection, along with evidence of improved or stable patient outcomes despite an increase in comorbidity burden and increasingly advanced tumor stage.

Left Ventricular Ejection Fraction Measurement and Doxorubicin-Based Chemotherapy in Patients with Diffuse Large B-Cell Lymphoma

Purpose:Doxorubicin-based chemotherapy (DOX) is commonly administered to patients with diffuse large B-cell lymphoma (DLBCL). Prior to chemotherapy, left ventricular ejection fraction (LVEF) is routinely measured to assess left ventricular dysfunction. While LVEF screening is recommended by many national regulatory bodies, evidence supporting the usefulness of LVEF measurement prior to administering DOX is lacking. Our goal was to perform a retrospective analysis of patients with DLBCL to establish (1) how often LVEF was measured prior to administering DOX, and (2) whether the chemotherapy regimen was modified based on LVEF values. As cumulative doses of doxorubicin greater than 400 mg/m2 have been associated with an increased risk of congestive heart failure (CHF), we also determined the incidence of CHF in patients with DLBCL who did receive DOX.Patients and Methods:We identified 268 patients diagnosed with DLBCL at Virginia Mason Medical Center between 2001 and 2012 and collected the following data: age at diagnosis; stage of lymphoma; type of chemotherapy given; cumulative doxorubicin dose (mg/m2); LVEF status; and incidence of CHF or cardiac disease. We also compared the number of CHF risk factors between patients who did and did not have LVEF measured. Statistical analyses included a Fischer’s exact or Chi-squared test to compare study groups as well as the number of CHF risk factors. The level of significance was set at a P value of < 0.05.Results:LVEF was measured in 238 patients (89%) prior to initiation of chemotherapy. LVEF values were normal in 225 patients (95%) and low (< 50%) in 13 patients (5%). Of the patients with normal LVEF, 193 received DOX (86%), and of these patients, 14 developed CHF post-treatment (7%). For the 13 patients with low LVEF, 8 received DOX (62%) and 1 developed post-treatment CHF (13%). The remaining thirty patients did not have LVEF measured and none received DOX. Of the 268 patients studied, 176 are alive (66%) and 3 were lost to follow-up. The mean follow-up time was 43 months (range 3 d to 12.1 y). The mean number of CHF risk factors did not differ between patients who did and did not have LVEF measured (1.70 vs. 1.65, P = 0.87).Conclusion:Our results suggest that the decision to administer DOX was not directly affected by LVEF values. These findings challenge the existing policy of routinely screening patients with DLBCL with echocardiograms or MUGA scans prior to treatment. DisclosuresNo relevant conflicts of interest to declare.

Quality Oncology Practice Initiative (QOPI) participation as a means to physician engagement, performance improvement, and delivery of safe and high-quality cancer care.

80 Background: High quality and safe medical care has been a consistent goal of the medical community at Virginia Mason Medical Center (VMMC). The Am Soc of Clinical Oncology (ASCO) has set out a list of criteria as part of Its Quality Oncology Practice Initiative (QOPI), which are increasingly being adopted as standards for quality measurement in the Oncology community. Our practice at VMMC participated in the QOPI quality metric survey, with the intent of measuring and enhancing cancer care delivery. Methods: We participated in the web-based QOPI quality metric during the September, 2013 and April, 2014 sessions. Chart abstraction was shared by the providers. Following the Sept session, our performance was analyzed, and targeted areas of improvement were collectively identified by all providers. Following the April session, the clinical note format was changed to incorporate a standard template, addressing areas of underperformance. Results: In the September 2013 session, the primary areas of underperformance were assessment of: a) pain, b) emotional distress, c) performance status (PFS), and d) documentation of staging. Following the April 2014 session, we noted improved performance in all these assessments. Thus, pain reporting rates improved from 40.6 to 61.2%; emotional distress screening from 37.3% to 42.8%; PFS documentation from 42.6 to 53.7%; and staging at initial diagnosis from 74.6% to 80.9%. However our areas of underperformance continued to lag 10 to 30% behind QOPI aggregate reporting rates. With the introduction of a structured note in the electronic medical record (EMR), further improvements are expected the results of which will be reported at the time of the meeting. On the positive side, chemotherapy education and discussion of risk/benefit were consistently areas of superior performance in our practice with our reporting rates being 10 to 40% higher than the QOPI aggregate. Conclusions: QOPI participation is a useful tool for improving and sustaining a high level of practice performance in oncology. Structured notes in the EMR maybe indispensable for maintaining a high level of compliance with performance measures.

Immediate technical and delayed clinical outcome of fistula closure using an over-the-scope clip device.

An over-the-scope clip (OTSC) device was designed for closure of acute perforations, fistulas, leaks, and non-variceal gastrointestinal bleeding. Previous data show a high rate of early fistula closure using the OTSC; however, data on long-term fistula closure are scant. We report our experience using an OTSC for closure of chronic gastrointestinal fistulas. Retrospective review of all patients, who underwent OTSC placement at Mayo Clinic Rochester and Virginia Mason Medical Center for closure of chronic fistulas from October 2011 to September 2012, was performed. Initial technical success was defined by lack of contrast extravasation immediately after OTSC placement. Delayed success was defined by resolution of the fistula without the need for additional therapies. Recurrent fistula was defined by the recurrence of symptoms and/or re-demonstration of fistula after initial success. Forty-seven unique patients (24 men; mean age 57 ± 14 years) underwent 60 procedures using the OTSC for closure of gastrointestinal fistulas. Fistula locations were: small bowel (n = 18), stomach (n = 16), colo-rectum (n = 10), and esophagus (n = 3). Fistulas related to previous percutaneous endoscopic gastrostomy/jejunostomy (n = 10) or prior bariatric procedure (n = 10) were the most common etiologies. Initial technical success occurred in 42/47 (89%) index cases; however, 19/41 (46%) patients developed fistula recurrence at a median of 39 days (IQR 26-86 days). The retained OTSC was present adjacent to the fistula in 16/19 (84%) at repeat intervention. Patients were followed for a median length of 178 days (IQR 63-326 days), and only 25/47 (53%) patients demonstrated delayed clinical success using OTSC. Initial technical fistula closure can be achieved using OTSCs. Recurrent fistulas at the same location occur in approximately 50% of cases despite frequent OTSC clip retention.

Variation in Patterns of Care in the United States for Clinical Stage I Seminoma: Results From the National Cancer Data Base (1998-2011)

Variation in Patterns of Care in the United States for Clinical Stage I Seminoma: Results From the National Cancer Data Base (1998-2011) C.J. Beard, C. Jeldres, K. Odem-Davis, K.E. Hoffman, N.E. Martin, P.L. Nguyen, C.R. Porter, C.J. Sweeney, C. Kollmannsberger, and C.R. Nichols; Brigham and Women’s Hospital, Boston, MA, Virginia Mason Medical Center, Seattle, WA, MD Anderson Cancer Center, Houston, TX, Dana-Farber Cancer Institute, Boston, MA, BC Cancer Agency, Vancouver, BC, Canada

Using Lean “Automation with a Human Touch” to Improve Medication Safety: A Step Closer to the “Perfect Dose”

Virginia Mason Medical Center (Seattle) employed the Lean concept of Jidoka (automation with a human touch) to plan for and deploy bar code medication administration (BCMA) to hospitalized patients. Integrating BCMA technology into the nursing work flow with minimal disruption was accomplished using three steps ofJidoka: (1) assigning work to humans and machines on the basis of their differing abilities, (2) adapting machines to the human work flow, and (3) monitoring the human-machine interaction. Effectiveness of BCMA to both reinforce safe administration practices and reduce medication errors was measured using the Collaborative Alliance for Nursing Outcomes (CALNOC) Medication Administration Accuracy Quality Study methodology. Trained nurses observed a total of 16,149 medication doses for 3,617 patients in a three-year period. Following BCMA implementation, the number of safe practice violations decreased from 54.8 violations/100 doses (January 2010-September 2011) to 29.0 violations/100 doses (October 2011-December 2012), resulting in an absolute risk reduction of 25.8 violations/100 doses (95% confidence interval [CI]: 23.7, 27.9, p < .001). The number of medication errors decreased from 5.9 errors/100 doses at baseline to 3.0 errors/100 doses after BCMA implementation (absolute risk reduction: 2.9 errors/100 doses [95% CI: 2.2, 3.6,p < .001]). The number of unsafe administration practices (estimate, -5.481; standard error 1.133; p < .001; 95% CI: -7.702, -3.260) also decreased. As more hospitals respond to health information technology meaningful use incentives, thoughtful, methodical, and well-managed approaches to technology deployment are crucial. This work illustrates how Jidoka offers opportunities for a smooth transition to new technology.

MP52-12 COMBINATION OF ANDROGEN RECEPTOR, PTEN AND TMPRSS2-ERG EXPRESSION MAY PREDICT ADVERSE CLINICAL OUTCOMES IN MEN UNDERGOING RADICAL PROSTATECTOMY FOR PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Basic Research V1 Apr 2014MP52-12 COMBINATION OF ANDROGEN RECEPTOR, PTEN AND TMPRSS2-ERG EXPRESSION MAY PREDICT ADVERSE CLINICAL OUTCOMES IN MEN UNDERGOING RADICAL PROSTATECTOMY FOR PROSTATE CANCER Claudio Jeldres, Khanh Pham, Xiaoyu Qu, Min Fang, and Christopher R. Porter Claudio JeldresClaudio Jeldres More articles by this author , Khanh PhamKhanh Pham More articles by this author , Xiaoyu QuXiaoyu Qu More articles by this author , Min FangMin Fang More articles by this author , and Christopher R. PorterChristopher R. Porter More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1622AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction and Objectives Several studies have linked genomics abnormality to prostate cancer (PCa), however, to date, a genomic signature to define aggressive disease is sill lacking. The androgen receptor (AR), PTEN and TMPRSS2-ERG expression are well known to be associated with PCa, however, it is unknown how informative they are when used in combination. We hypothesized that a small panel of genomic abnormalities using AR, PTEN and TMPRSS2-ERG expression may help to predict more aggressive disease. Methods We retrospectively reviewed a cohort of 210 patients diagnosed with PCa and treated with radical prostatectomy (RP) at Virginia Mason Medical Center, between 1995 and 2005. Identification of genomic abnormalities was performed for AR, PTEN and TMPRSS2-ERG on RP's specimens using fluorescent in situ hybridization (FISH) technology. AR expression was categorized as: normal vs. AR gain. PTEN expression was categorized as: normal vs. trisomy 10, monosomy 10, homozygous deletion and heterozygous deletion. TMPRSS2-ERG was categorized as: normal vs. single deletion fusion vs. atypical fusion vs. alternative rearrangements vs. rearranged 3'ERG vs. rearranged 5'TMPRSS2 vs. copy number increase without rearrangement. Clinical data such as age at RP, preoperative PSA, pathological Gleason score, pathological stage and biochemical-recurrence (BCR) status was available for all patients. Statistics relied on cross-tabulation and survival analysis. Results Complete clinical and genomic data was available for 151 patients. Median follow-up (n=151) was 5.7 years (range 0.1-16.6 years). The most common genomic features within our cohort were normal AR, PTEN and TMPRSS2-ERG (n=58, 36.5%), and normal AR and PTEN with single deletion fusion (n=33, 21.9%). Aggressive pathological characteristics such as locally advanced disease (pT3/pT4) or high grade Gleason (8-10) score at RP were more commonly seen in patients with normal AR, heterozygous deletion or monosomy 10/PTEN and normal TMPRSS2-ERG. When this group was compared to those with no genomic abnormalities, Gleason 8-10 was seen in 72.7% vs. 8.6% and pT3/T4 in 72.7% vs. 39.7%. Similarly, median BCR-free survival for this group was 1.6 years vs. none reach for the normal group (Log-rank p=0.02). Conclusions Abnormal expression of AR, PTEN and TMPRSS2-ERG are common at radical prostatectomy. Patients with normal AR, normal TMPRSS2-ERG but heterozygous deletion or monosomy 10/PTEN may be at higher risk of harboring adverse pathological features and biochemical recurrence. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e584 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Claudio Jeldres More articles by this author Khanh Pham More articles by this author Xiaoyu Qu More articles by this author Min Fang More articles by this author Christopher R. Porter More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

PD5-04 UNITED STATES TRENDS IN PATTERNS OF CARE IN CLINICAL STAGE I TESTICULAR CANCER: RESULTS FROM THE NATIONAL CANCER DATA BASE (1998-2011)

You have accessJournal of UrologyPenis/Testis: Benign & Malignant Disease I1 Apr 2014PD5-04 UNITED STATES TRENDS IN PATTERNS OF CARE IN CLINICAL STAGE I TESTICULAR CANCER: RESULTS FROM THE NATIONAL CANCER DATA BASE (1998-2011) Claudio Jeldres, Craig R. Nichols, Khanh Pham, Sia Daneshmand, Christian Kollmannsberger, Brandon Hayes-Lattin, Erika Wolff, Katherine Odem-Davis, and Christopher R. Porter Claudio JeldresClaudio Jeldres More articles by this author , Craig R. NicholsCraig R. Nichols More articles by this author , Khanh PhamKhanh Pham More articles by this author , Sia DaneshmandSia Daneshmand More articles by this author , Christian KollmannsbergerChristian Kollmannsberger More articles by this author , Brandon Hayes-LattinBrandon Hayes-Lattin More articles by this author , Erika WolffErika Wolff More articles by this author , Katherine Odem-DavisKatherine Odem-Davis More articles by this author , and Christopher R. PorterChristopher R. Porter More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.407AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES There has been significant evolution in worldwide guidelines for management of clinical stage I (CS1) testicular cancer where active surveillance (AS) strategies are now considered a first choice, especially for patients with lower recurrence risk after orchiectomy. Conversely, local therapies for CS1 such as primary retroperitoneal lymphadenectomy (RPLND) in non-seminoma and regional radiation in seminoma are phasing out of recommendations. In the US, there have been no comprehensive efforts to measure uptake of guideline recommendations and modern patterns of care for early stage testicular cancer. METHODS Access to the testicular cancer data set within the National Cancer Data Base [NCDB] was granted to Virginia Mason Medical Center (A SWOG affiliated cancer research program) for this retrospective cohort study. We identified all patients with CS1 testicular cancer between 1998 and 2011. Management options after orchiectomy such as adjuvant radiotherapy, adjuvant chemotherapy, RPLND or AS were analyzed using cross tabulation and trend analysis. RESULTS Within the NCDB, of 75,902 patients with testicular cancer, 31,208 and 13,301 were diagnosed with CS1 seminoma and non-seminoma, respectively. For CS1 seminoma, AS use increased from 25.2% in 1998 to 55.8% in 2011 (Figure). Similarly adjuvant chemotherapy use also increased (1.9 % to 16.7%). Conversely, use of adjuvant radiation decreased from 72.9% to 27.5%. For CS1 non-seminoma, AS remained the main treatment modality ranging between 58.8% and 66.2%. The use of adjuvant chemotherapy increased (28.3% in 2011) and the rate of primary RPLND constantly decreased down to 12.9% that same year. Interestingly, 50.3% of patients with CS1 non-seminoma and negative lympho-vascular invasion status had chemotherapy rather than AS. Trends analyses were statistically significant for all treatment modalities (p<0.05). CONCLUSIONS Active surveillance as a management strategy has increased and is currently the most common treatment modality used for both CS1 seminoma and non-seminoma in the US. Regional therapies in CSI seminoma and non-seminoma are decreasing but persist even in patients with a low risk of recurrence. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e90-e91 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Claudio Jeldres More articles by this author Craig R. Nichols More articles by this author Khanh Pham More articles by this author Sia Daneshmand More articles by this author Christian Kollmannsberger More articles by this author Brandon Hayes-Lattin More articles by this author Erika Wolff More articles by this author Katherine Odem-Davis More articles by this author Christopher R. Porter More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Physician leadership in changing times

Today, hospitals and physicians are reorganizing themselves in novel ways to take advantage of payment incentives that reward shared accountability for the total health care experience. These delivery system changes will take place with our without physician leadership. To optimize change on behalf of patients, physicians must play a conscious role in shaping future health care delivery organizations. As physician leaders of three of the nation׳s largest integrated health care delivery systems – Kaiser Permanente, Virginia Mason Medical Center, and the Mayo Clinic Health System – we call on physicians to view leadership and the development of leaders as key aspects of their role as patient advocates.

United States trends in patterns of care in clinical stage I testicular cancer: Results from the National Cancer Database (1998-2011).

369 Background: There has been significant evolution in worldwide guidelines for management of clinical stage I (CS1) testicular cancer where active surveillance (AS) strategies are now considered a first choice, especially for patients with lower recurrence risk after orchiectomy. Conversely, local therapies for CS1 such as primary retroperitoneal lymphadenectomy (RPLND) in non-seminoma and regional radiation in seminoma are phasing out of recommendations. In the US, there have been no comprehensive efforts to measure uptake of guideline recommendations and modern patterns of care for early-stage testicular cancer. Methods: Access to the testicular cancer data set within the National Cancer Data Base (NCDB) was granted to Virginia Mason Medical Center (A SWOG affiliated cancer research program) for this retrospective cohort study. We identified all patients with CS1 testicular cancer between 1998 and 2011. Management options after orchiectomy such as adjuvant radiotherapy, adjuvant chemotherapy, RPLND, or AS were analyzed using cross tabulation and trend analysis. Results: Within the NCDB, of 75,902 patients with testicular cancer, 31,208 and 13,301 were diagnosed with CS1 seminoma and non-seminoma, respectively. For CS1 seminoma, AS use increased from 25.2% in 1998 to 55.8% in 2011. Similarly adjuvant chemotherapy use also increased (1.9 % to 16.7%). Conversely, use of adjuvant radiation decreased from 72.9% to 27.5%. For CS1 non-seminoma, AS remained the main treatment modality ranging between 58.8% and 66.2%. The use of adjuvant chemotherapy increased (28.3% in 2011) and the rate of primary RPLND constantly decreased down to 12.9% that same year. Interestingly, 50.3% of patients with CS1 non-seminoma and negative lympho-vascular invasion status had chemotherapy rather than AS. Trends analyses were statistically significant for all treatment modalities (p&lt;0.05). Conclusions: Active surveillance as a management strategy has increased and is currently the most common treatment modality used for both CS1 seminoma and non-seminoma in the US. Regional therapies in CSI seminoma and non-seminoma are decreasing but persist even in patients with a low risk of recurrence.

Neoadjuvant Chemotherapy for Localized Pancreatic Cancer: Too Little or Too Long?

For a ‘‘systemic’’ disease such as pancreatic cancer, neoadjuvant chemotherapy is a logical approach that thus far has been limited largely by a lack of effective systemic agents. For example, when considering treatment sequencing for patients with resectable disease, the concept of offering a treatment with an objective response rate of less than 10 % (as for gemcitabine alone) has been unacceptable to most clinicians. (Chemo)radiation has therefore been the backbone of most neoadjuvant approaches, with the goal of improving local/regional disease control (preventing local recurrence) and avoiding operation in those with progressive disease found on post-treatment, preoperative restaging. A few neoadjuvant studies to date have included relatively short courses of chemotherapy—without any obvious improvement in outcomes compared with chemoradiation alone. To further complicate treatment sequencing controversy, surgeons have cautioned that many patients (and referring physicians) want their tumors resected tomorrow and can find a surgeon who will accommodate them. Concerns about increased perioperative morbidity (following neoadjuvant therapy) still exist but have been allayed by several studies, including a recent NSQIP analysis. Importantly, an ‘‘effective’’ neoadjuvant chemotherapy regimen could theoretically improve longterm outcomes by successfully treating (possibly even eradicating) micrometastatic disease in the setting of an immune-competent host who is not attempting to recover from a large operation. The duration of neoadjuvant chemotherapy is a critical variable. If the right drug is selected for the right patient, treatment will need to be long enough to effectively treat micrometastatic disease. If the wrong drug(s) is selected (we only learn this in retrospect when restaging is performed), treatment should be short enough to avoid losing a window of resectability due to local disease progression. This is an important consideration in patients with resectable and borderline resectable disease (in contrast to those patients with locally advanced pancreatic cancer—thus the importance of accurate pretreatment staging). At present, there is little evidence to support any specific neoadjuvant treatment duration, although opinions exist that are based largely on personal experience, extrapolation from other solid tumor sites, and translational laboratory science. Rose and coauthors from Virginia Mason Medical Center are to be commended for demonstrating that patients are willing and able to undergo almost 6 months (on average) of neoadjuvant chemotherapy with good results, both shortterm and long-term . To what degree this was the result of the well-known experience and talent of this multidisciplinary group will be reflected in the ability of others to duplicate these results. Although patients were not treated on a clinical trial, they were maintained in a prospective registry, which is a practice that should be encouraged. The major strength of the study was the relatively large (n = 64) and homogeneously staged patient population, all radiographically ‘‘borderline resectable’’ by the SSO/AHPBA consensus criteria and with no evidence of metastatic disease by pretreatment staging that included laparoscopy with peritoneal washings—which did introduce an added selection bias as most such reports have not included laparoscopic staging. The outcomes in this study are not entirely due to increased ‘‘selection’’ provided by the extended duration of therapy. There clearly was a treatment effect demonstrated at the site of the primary tumor. Almost half of patients underwent resection of the primary, with R0 Society of Surgical Oncology 2014

Isolated granulocytic sarcoma of the nasopharynx: a case report and review of the literature

Granulocytic sarcoma (GS) is a rare extramedullary manifestation of acute myeloid leukemia (AML). It may also represent blastic transformation of myelodysplastic syndromes or myeloproliferative neoplasms. Although usually seen in the context of advanced and poorly controlled disease, it may also present as the first manifestation of illness, without concurrent bone marrow or blood involvement. In the medical literature, chloroma and GS are terms that have been used interchangeably with myeloid sarcoma. GS usually manifests as soft tissue or bony masses in several extracranial sites, such as bone, periosteum, and lymph nodes; involvement of the head and neck region is uncommon. We report a case of a woman with insidious onset of progressive nasal congestion and diminished hearing who was diagnosed with an isolated GS of the nasopharynx. With involved field radiotherapy, she achieved a complete remission of 12-months duration before being diagnosed with overt AML. She has remained disease-free for greater than 18 months following induction and consolidation chemotherapy. Through a MEDLINE®/PubMed® search we identified an additional 13 cases of nasopharyngeal GS. The median age was 37 years (range 1 to 81 years). The cases were equally distributed among the sexes. The most common presenting symptoms were conductive hearing loss and sinonasal congestion. Isolated GS was identified in six cases, and the median time from diagnosis of GS to AML was 12 months (range 3 to 48 months). The treatment varied, but responses were seen in all the patients who received chemotherapy with or without radiotherapy.

Utility Of Routine Left Ventricular Ejection Fraction (LVEF) Measurement Prior To Administration Of Anthracycline-Based Chemotherapy In Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Anthracycline-based chemotherapy regimens are considered the gold standard for treating patients with DLBCL. Prior to administration of chemotherapy, LVEF is routinely measured, usually by multiple-gated acquisition (MUGA) scans or echocardiography, as a screening tool for detecting asymptomatic left ventricular dysfunction. LVEF screening is recommended by the National Comprehensive Cancer Network clinical practice guidelines, is endorsed by the American Heart Association and the American College of Cardiology, appears on Federal Drug Administration-approved labeling guidelines, and is often required for patients to participate in US cancer cooperative group clinical trails. However, despite these recommendations, evidence supporting the utility of LVEF measurement prior to administration of anthracycline-based chemotherapy in patients with DLBCL is lacking (Conrad, J Oncol Pract 2012).The most common chemotherapy regimen currently administered to DLBCL patients is rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Patients with stage III or IV DLBCL typically receive 6 to 8 cycles of R-CHOP, with cumulative doses of doxorubicin ranging from 300 - 400 mg/m2. Cumulative doses of doxorubicin greater than 400 mg/m2have been associated with an increased risk of congestive heart failure (CHF) (Von Hoff, Ann Intern Med 1979).We are performing a retrospective analysis of approximately 325 patients with DLBCL who received treatment at Virginia Mason Medical Center from 2001-2011. Our objectives include the following: (1) to determine whether LVEF was measured by echocardiogram or MUGA scan prior to administration of anthracycline-based chemotherapy, (2) to establish whether the chemotherapy treatment regimen was modified based on LVEF values, and (3) to document the incidence of CHF in patients with DLBCL who did receive anthracycline-based chemotherapy.Patients were identified through a search of the Virginia Mason Cancer Registry. Specific data currently being collected through chart review include the following: age at diagnosis; Ann Arbor lymphoma stage; type of chemotherapy given; cumulative doxorubicin dose administered (mg/m2); LVEF measurement and modality used to assess LVEF; and incidence of CHF. We are also recording the number of CHF risk factors that patients possess, including male sex, obesity, hypertension, hyperlipidemia, prior cardiac disease, diabetes mellitus, smoking history, prior chemotherapy, radiation to the chest area, and other cardio-toxic exposures. Statistical analyses will include a Fischer's exact or Chi-squared test to compare study groups and a Wilcoxon rank sum test to compare the number of CHF risk factors. A P value of less than 0.05 will be used to determine if an association is significant.In a preliminary sample of DLBCL patients (n = 50), 28 are men (56%). LVEF was measured in 40 patients (80%) prior to initiation of chemotherapy using echocardiogram (95%) and MUGA scan (5%). LVEF values were normal (55 – 75%) in 36 patients (90%), low (< 55%) in 3 patients (8%), and unknown in 1 patient (2%). Of the 36 patients with normal LVEF values, 30 received CHOP or R-CHOP regimens (83%), 2 received non-anthracycline chemotherapy (5%), 1 was treated by surgical excision alone (3%), 2 received no treatment (6%), and 1 patient's treatment was unknown (3%). Of the 3 patients with initial low screening LVEF values, none had a prior history of CHF and all received R-CHOP (100%). Three patients did have CHF prior to treatment; however, only one received CHOP therapy. Of our initial 50 patients, 31 (62%) are alive and 2 (4%) were lost to follow-up. CHF was listed as a major contributor of death in 3 patients (6%). The median number of CHF risk factors did not differ significantly between patients who did develop CHF post-treatment and those who did not (4 vs. 2, P = 0.133).Our preliminary results suggest that the decision to administer an anthracycline-based chemotherapy regimen was not directly affected by echocardiogram or MUGA scan results. If these findings are reinforced at completion of our chart review, it may challenge the existing policy of routinely screening patients with DLBCL with echocardiograms or MUGA scans prior to initiation of treatment. Disclosures:No relevant conflicts of interest to declare.

Using Lean to Improve Medication Administration Safety: In Search of the “Perfect Dose”

At Virginia Mason Medical Center (Seattle), the Collaborative Alliance for Nursing Outcomes (CALNOC) Medication Administration Accuracy Quality Study was used in combination with Lean quality improvement efforts to address medication administration safety. Lean interventions were targeted at improving the medication room layout, applying visual controls, and implementing nursing standard work. The interventions were designed to prevent medication administration errors through improving six safe practices: (1) comparing medication with medication administration record, (2) labeling medication, (3) checking two forms of patient identification, (4) explaining medication to patient, (5) charting medication immediately, and (6) protecting the process from distractions/interruptions. Trained nurse auditors observed 9,244 doses for 2,139 patients. Following the intervention, the number of safe-practice violations decreased from 83 violations/100 doses at baseline (January 2010-March 2010) to 42 violations/100 doses at final follow-up (July 2011-September 2011), resulting in an absolute risk reduction of 42 violations/100 doses (95% confidence interval [CI]: 35-48), p < .001). The number of medication administration errors decreased from 10.3 errors/100 doses at baseline to 2.8 errors/100 doses at final follow-up (absolute risk reduction: 7 violations/100 doses [95% CI: 5-10, p < .001]). The "perfect dose" score, reflecting compliance with all six safe practices and absence of any of the eight medication administration errors, improved from 37 in compliance/100 doses at baseline to 68 in compliance/100 doses at the final follow-up. Lean process improvements coupled with direct observation can contribute to substantial decreases in errors in nursing medication administration.

Applying Lean Methods to Improve Quality and Safety in Surgical Sterile Instrument Processing

Surgical instrument processing is critical to safe, high-quality surgical care but has received little attention in the medical literature. Typical hospitals have inventories in the tens of thousands of surgical instruments organized into thousands of instrument sets. The use of these instruments for multiple procedures per day leads to millions of instrument sets being reprocessed yearly in a single hospital. Errors in the processing of sterile instruments may lead to increased operative times and costs, as well as potentially contributing to surgical infections and perioperative morbidity. At Virginia Mason Medical Center (Seattle), a quality monitoring approach was developed to identify and categorize errors in sterile instrument processing, through use of a daily defect sheet. Lean methods were used to improve the quality of surgical instrument processing through redefining operator roles, alteration of the workspace, mistake-proofing, quality monitoring, staff training, and continuous feedback. To study the effectiveness of the quality improvement project, a before/after comparison of prospectively collected sterile processing error rates during a 37-month time frame was performed. Before the intervention, instrument processing errors occurred in 3.0% of surgical cases, decreasing to 1.5% at the final follow-up (p < .001). Improvements were observed in multiple categories of error types, particularly the assembly errors of packaging (from 0.66 to 0.24 errors per hundred cases, p = .004), and foreign objects (0.17 to 0.02 errors per hundred cases, p = .025). Surgical instrument processing errors are a barrier to the highest quality and safety in surgical care but are amenable to substantial improvement using Lean techniques.

Nurse Practitioner–Staffed Clinic At Virginia Mason Improves Care And Lowers Costs For Women With Benign Breast Conditions

The implementation of a breast clinic based on the use of an advanced registered nurse practitioner at Virginia Mason Medical Center in Seattle, Washington, substantially improved care timeliness and efficiency for women with symptomatic benign breast conditions. Women received their final benign diagnosis in an average of four rather than sixteen days, with fewer imaging studies and physician visits, when compared to a control group. Savings to the employer were estimated at $316 per woman, primarily from increased work productivity. Direct care costs decreased an estimated 19 percent, to $213 per woman. By decreasing both direct medical costs and indirect costs such as work absenteeism and presenteeism, the Virginia Mason Breast Clinic has created substantial savings for providers and employers while delivering care that patients rate highly. This model demonstrates the feasibility of achieving higher quality at lower cost through integrated care.

It’s Past Time To Get Serious About Transforming Care

It’s Past Time To Get Serious About Transforming Care

Book Review: Lean-Led Hospital Design: Creating the Efficient Hospital of the Future

Lean-Led Hospital Design: Creating the Efficient Hospital of the FutureNaida Grunden and Charles Hagood, MBA. (2012). Boca Raton, FL: CRC Press, Taylor and Francis Group. Hardcover, 338 pages. ISBN-10: 143986828X; ISBN-13: 978-1439868287In June 2012, a group of CEOs from some of the most innovative healthcare organizations in the country issued an Institute of Medicine (IOM) discussion paper offering a CEO Checklist for High-Value Health Care (Cosgrove et al., 2012). The purpose of the checklist is to provide CEOs and their boards a guide for making sustainable transformation toward continuous improvement in the changing landscape of healthcare. The checklist is supported with case studies and experiences from their own organizations, including references to Lean and the Toyota Production System. So it is significant that several of the participants in the IOM discussion paper are also leaders of the hospitals whose case studies appear in this book by Grunden and Hagood.As we move into the immediate future, performance will be a key determiner of value for healthcare organizations and the facilities that support them. Finding value is going to be an increasingly critical role for designers of healthcare environments as the industry addresses growing policy and market pressures to improve quality and significantly reduce cost while maintaining high levels of patient and staffsatisfaction. During the past two decades the healthcare environments research and community has learned much about what works and why. Meanwhile, in the search for value, some healthcare organizations have successfully adopted a Lean philosophy and implemented operational changes with demonstrable results. These organizations now experience a steady stream of inquiries and visits from other organizations, curious about how they've adapted a manufacturing philosophy to healthcare, and what performance gains have realized.To create facilities for high-value healthcare, designers need more than a passive understanding of how care is delivered. Which brings us to the core message of this book written by a Lean Healthcare writer and Lean Healthcare Practitioner: Lean can inform the of healthcare facilities through active collaboration by care delivery designers and facility designers. This book is an introduction to what may be an emerging model of interdisciplinary design. It is a book that aspires to influence and move the industry in a new direction, to address years of process workarounds and poor space utilization. It is a practical book. And it opens the door to a conversation about the roles and relationship of Lean Healthcare and evidence-based (EBD).We learn that Lean is first a management philosophy. It is more an operating system than an isolated project or a set of tools. It uses a structured approach to continuous improvement through exposing and solving problems and removing waste in systems. The objective of Lean-Led Design is to a facility that paves the way for non-value-added activities to be removed from the processes and systems and hence out of the building. This book succeeds in making a case for the potential of Lean to inform architectural design. But as for leading design, the case for Lean is not as strong-in fact some of the case studies are instead examples of collaboration between Lean and architecture, which is the direction in which I believe we are headed. A similar thought was expressed in a recent Center for Health Design blog post about Lean and EBD, stating they should be considered symbiotic approaches to achieving better design (Marberry, 2012).If there is a Lean wave sweeping the industry, the success stories coming out of Virginia Mason Medical Center, University of Pittsburgh Medical Center, Seattle Children's, and ThedaCare are providing momentum. Even so, Lean is just getting started. It is estimated that only a small percentage of hospitals have full Lean deployment as a management philosophy. …

Adapting to the New Healthcare Market

THE FEATURE ARTICLES included in this issue of Frontiers of Health Services Management, authored by John Toussaint and Gary Kaplan, have much in common. Both address one of the most critical mandates in healthcare delivery: the need for transformational change. Both share essential guidance-which leaders may find difficult accept-on how be successful in adapting today's healthcare market. And both have documented measurable outcomes that demonstrate marked improvements in their respective organizations, allowing them verify the effectiveness of the improvement process and promote its continued use.I can attest the importance of the authors' suggested improvement approaches because I and other senior leaders implemented similar principles and practices at two healthcare organizations. In my 12 years as CEO of CHRISTUS Health, in Irving, Texas, and during my nine-month tenure as the interim CEO at Parkland Health & Hospital System, in Dallas, I witnessed gains at both organizations as they developed verifiable and measurable improvements in the quality and safety of the clinical services they provided at their numerous hospitals and clinics.THE PRESENT UNSUSTAINABLE HEALTHCARE ENVIRONMENTBoth Toussaint and Kaplan define in their opening paragraphs the operational characteristics of most healthcare delivery today, which industry leaders generally accept as valid. I attribute the poor performance outcomes they note four drivers of the need for transformational change, a critical factor for future success that both authors mention in their articles.The first driver is the lack of consistency and coordination of services among providers that results in much of the poor quality of care delivered today. Toussaint highlights this problem by noting the excessive levels of medical errors, readmissions within 30 days of discharge, and unnecessary deaths.The second driver is the high cost of care in the United States, where prices and charges bear no relationship actual cost structures. Exacerbating the high cost of poor outcomes is the unnecessary duplication of services and tests caused by the aforementioned absence of care coordination among providers.The third driver is increased physician dissatisfaction, often triggered by physicians' realization that they are being asked relinquish their independent practice style. Although Toussaint knows firsthand that doctors in training are taught that individual judgment is more important than best-practice protocols and independence is more important than group critical thinking, he understands that this mind-set no longer has a place in today's healthcare marketplace.The fourth driver is a misaligned vision of leadership teams that results in a focus on illness rather than wellness and on volume rather than value. Kaplan and the leadership team at Virginia Mason Medical Center confront this driver by working to avoid the mentality that bigger is inherently better (page 24).When considering these four drivers of change, it appears that the only health systems that will survive in the future are those that can prove by their outcome metrics that they are providing consistent, high-quality, and safe services at accessible sites and times and at affordable costs.THE KEY QUESTION AND KEY ANSWERSBoth authors ask this critical question: What must we do ignite the enthusiasm and will in our organization - at the front lines, in the leadership and management teams, and in the board and governance processes - create not only a sustainable but a thriving healthcare industry for all who enter our doors?Not surprisingly, Toussaint and Kaplan provide similar answers. Each repeatedly stresses that transformational change throughout all levels of the delivery system is essential, noting that changing the way the people in the organization think and perform is the most important step toward ensuring success in the future marketplace. …