Cleveland Clinic Experience Research Articles

Implementing a comprehensive physician-communication-skills improvement initiative: The Cleveland Clinic experience.

186 Background: Physician communication skills are associated with important outcomes, including medical results, treatment adherence, malpractice claims, patient safety, and physician satisfaction. Recently, patient satisfaction with physicain communication became a factor influencing Medicare reimbursement. In 2010, the Cleveland Clinic began building a physician communication training program to improve doctor communication skills. Methods: Following a literature review and a survey of communication skills programs at a variety of U.S. hospitals, we collaborated with the American Academy of Communication in Healthcare (AACH) to develop a full-day course based on Frankel and Stein’s Four Habits model. The model emphasizes skills related to initiating the encounter, eliciting the patient’s story, expressing empathy, educating the patient and collaboratively developing a plan. The course was designed to be taught by physicians and was highly experiential and skills based, making extensive use of role-play exercises. An AACH consultant trained 15 physicians to teach the course during several 7-day train-the-trainer courses. Results: Between September 2011 and May 2013, over 800 physicians took the course. It became very popular and has been consistently oversubscribed. For the first 450 physicians trained, we reviewed patient satisfaction survey scores for the 6 months before and after they took the course. For all 13 items on the Press Ganey ambulatory patient survey used, scores were higher after taking the course. For 7 of the 13, the difference was statistically significant (p values ranging from .003 to .044). Conclusions: Our experience with communication skills training indicates that such training can be well received by physicians if it is high quality. Key elements of our program that we believe contributed to its success are the following: it was developed by physicians for physicians; it is taught by physicians with substantial clinical practices so that the atmosphere is colleagues teaching colleagues; and it is skills based rather than cognitive in focus so that participants have tangible tools that they can use in their practice.

Physician-leader on-boarding: the Cleveland Clinic experience

Purpose – Because leadership competencies differ from the clinical and scientific competencies that make physicians successful in their clinical and scientific roles, leadership development programs are now receiving attention. Design/methodology/approach – As one component of the leadership development program at the Cleveland Clinic, the Physician-Leader On-Boarding Program offers newly appointed chairs a structured interaction with executive coaches with the goal of increasing self-awareness and, secondarily, developing a personal leadership development plan. New leaders review their inventory of healthcare leadership competencies and receive expert guidance regarding their ratings on a 360o feedback assessment and a self-rated psychometric instrument. The final activity of the two- to three-month program is the new leader's presenting and discussing a personal leadership development plan with the coaches. Findings – Between December 2006 and June 2010, 25 new Cleveland Clinic department or institute chairs participated in the program, of whom 22 were invited to participate and 14 responded to a survey regarding their experience of the program. Respondents rated the program highly 4.92 out of maximum 5 on “I would recommend the program to my colleagues,” and also suggested that expectations could be better clarified, that the scope of on-boarding should be broader, and that longitudinal coaching should be offered. Originality/value – The results generally support the value of an on-boarding program for new physician-leaders while identifying future opportunities. The aforementioned suggestions regarding broader scope, clear expectations and follow-up are discussed as opportunities to strengthen the on-boarding experience, and to identify areas that may need to be reinforced.

Stereotactic radiosurgery — The Cleveland Clinic experience and future directions using a Gamma Knife

Stereotactic radiosurgery — The Cleveland Clinic experience and future directions using a Gamma Knife

Treatment strategies in patients with statin intolerance: The Cleveland Clinic experience

Statin therapy is a proven effective treatment of hyperlipidemia. However, a significant number of patients cannot tolerate statins. This study was conducted to review treatment strategies for patients intolerant to statin therapy with a focus on intermittent statin dosing. We performed a retrospective analysis of medical records of 1,605 patients referred to the Cleveland Clinic Preventive Cardiology Section for statin intolerance between January 1995 and March 2010 with at least a 6-month follow-up. The changes in lipid profile, achievement of low-density lipoprotein cholesterol (LDL-C) goals, and statin tolerance rate were analyzed. Most (72.5%) of patients with prior statin intolerance were able to tolerate a statin for the median follow-up time of 31 months. Patients on intermittent statin dosing (n = 149) had significantly lower LDL-C reduction compared with daily dosing group (n = 1,014; 21.3% ± 4.0% vs 27.7% ± 1.4%, P < .04). However, compared with the statin discontinued group (n = 442), they had a significantly higher LDL-C reduction (21.3% ± 4.0% vs 8.3 ± 2.2%, P < .001), and a significantly higher portion achieved their Adult Treatment Panel III goal of LDL-C (61% vs 44%, P < .05). There was a trend toward a decrease in all-cause mortality at 8 years for patients on daily and intermittent statin dosing compared with those who discontinued statin (P = .08). Most patients with previous statin intolerance can tolerate subsequent trial of statin. A strategy of intermittent statin dosing can be an effective therapeutic option in some patients and may result in reduction in LDL-C and achievement of LDL-C goals.

Building an engaged workforce at Cleveland Clinic

Correspondence: Joseph M Patrnchak Cleveland Clinic, 9500 Euclid Avenue, NA #4, Cleveland, OH 44195, USA Tel +1 216 444 1917 Fax +1 216 444 0088 Email patrncj@ccf.org Abstract: Employee engagement is widely recognized as a critical factor in organizational performance. This article examines an ongoing cultural development initiative at Cleveland Clinic designed to significantly increase employee engagement. Key components of this initiative include the introduction of serving leadership, new caregiver wellness and recognition programs, “Cleveland Clinic Experience” training focused on the institution’s core mission, and changes in the institutional vocabulary. Since 2008, the results include a dramatic improvement in engagement, as measured by the Gallup Q survey, with parallel improvements in patient satisfaction, as measured by the clinic’s scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. In addition to a discussion of the key components of the clinic’s engagement initiative, the article provides a partial review of the literature focused on employee engagement as well as a summary of “lessons learned” that may serve as a guide for others facing the challenge of increasing employee engagement in large, mature health care institutions.

Outcome and Toxicity for Patients Treated with Intensity Modulated Radiation Therapy for Localized Prostate Cancer

We evaluate long-term disease control and chronic toxicities observed in patients treated with intensity modulated radiation therapy for clinically localized prostate cancer. A total of 302 patients with localized prostate cancer treated with image guided intensity modulated radiation therapy between July 2000 and May 2005 were retrospectively analyzed. Risk groups (low, intermediate and high) were designated based on National Comprehensive Cancer Network guidelines. Biochemical control was based on the American Society for Therapeutic Radiology and Oncology (Phoenix) consensus definition. Chronic toxicity was measured at peak symptoms and at last visit. Toxicity was scored based on Common Terminology Criteria for Adverse Events v4. The median radiation dose delivered was 75.6 Gy (range 70.2 to 77.4) and 35.4% of patients received androgen deprivation therapy. Patients were followed until death or from 6 to 138 months (median 91) for those alive at last evaluation. Local and distant recurrence rates were 5% and 8.6%, respectively. At 9 years biochemical control rates were 77.4% for low risk, 69.6% for intermediate risk and 53.3% for high risk cases (log rank p = 0.05). On multivariate analysis T stage and prostate specific antigen group were prognostic for biochemical control. At last followup only 0% and 0.7% of patients had persistent grade 3 or greater gastrointestinal and genitourinary toxicity, respectively. High risk group was associated with higher distant metastasis rate (p = 0.02) and death from prostate cancer (p = 0.0012). This study represents one of the longest experiences with intensity modulated radiation therapy for prostate cancer. With a median followup of 91 months, intensity modulated radiation therapy resulted in durable biochemical control rates with low chronic toxicity.

Treatment of Cerebral Radiation Necrosis with Bevacizumab: The Cleveland Clinic Experience (S56.005)

Treatment of Cerebral Radiation Necrosis with Bevacizumab: The Cleveland Clinic Experience (S56.005)

Treatment of Cerebral Radiation Necrosis with Bevacizumab: The Cleveland Clinic Experience (IN10-1.003)

Treatment of Cerebral Radiation Necrosis with Bevacizumab: The Cleveland Clinic Experience (IN10-1.003)

Definitive radiotherapy for early (T1-T2) Glottic Squamous cell carcinoma: a 20 year Cleveland clinic experience

PurposeTo report our 20 yr experience of definitive radiotherapy for early glottic squamous cell carcinoma (SCC).Methods and materialsRadiation records of 141 patients were retrospectively evaluated for patient, tumor, and treatment characteristics. Cox proportional hazard models were used to perform univariate (UVA) and multivariate analyses (MVA). Cause specific survival (CSS) and overall survival (OS) were plotted using cumulative incidence and Kaplan-Meir curves, respectively.ResultsOf the 91% patients that presented with impaired voice, 73% noted significant improvement. Chronic laryngeal edema and dysphagia were noted in 18% and 7%, respectively. The five year LC was 94% (T1a), 83% (T1b), 87% (T2a), 65% (T2b); the ten year LC was 89% (T1a), 83% (T1b), 87% (T2a), and 53% (T2b). The cumulative incidence of death due to larynx cancer at 10 yrs was 5.5%, respectively. On MVA, T-stage, heavy alcohol consumption during treatment, and used of weighted fields were predictive for poor outcome (p < 0.05). The five year CSS and OS was 95.9% and 76.8%, respectively.ConclusionsDefinitive radiotherapy provides excellent LC and CSS for early glottis carcinoma, with excellent voice preservation and minimal long term toxicity. Alternative management strategies should be pursued for T2b glottis carcinomas.

Combined Heart and Liver Transplantation: The Cleveland Clinic Experience

Combined heart-liver transplantation (CHLT) has been utilized as a life-saving procedure in those with end-stage cardiac and hepatic pathology. Techniques and outcomes of this procedure are varied. We sought to review the Cleveland Clinic experience with CHLT. This study is a retrospective chart review of patients who received simultaneous heart and liver transplantation between January 2006 and December 2012. Five patients received CHLT. The mean age was 49 (± 20) years. All cardiac pathology was nonischemic cardiomyopathy, with a mean ejection fraction of 0.36 (± 0.13). Three of the 5 were on preoperative inotropic support, 1 of which required placement of a total artificial heart for support pretransplant. Liver pathology was amyloid in 1 patient and hepatitis C in the remaining 4. Mean Model for End-Stage Liver Disease score was 17 (± 5), and mean Childs-Pugh score was 8 (± 1). Survival, now at a mean of 38 (± 20) months remains 100%, with no cardiac or hepatic graft dysfunction or episodes of rejection. One hospital readmission was required for gastroenteritis at 15 months posttransplant. These results suggest that excellent outcomes can be achieved in this extremely sick cohort of patients, and add to the growing literature of perioperative management of CHLT recipients.

Adrenal Nodular Hyperplasia in Hereditary Leiomyomatosis and Renal Cell Cancer

The condition hereditary leiomyomatosis and renal cell carcinoma is characterized by cutaneous leiomyomas, uterine fibroids and aggressive papillary renal cell carcinoma. A number of our patients with hereditary leiomyomatosis and renal cell carcinoma had atypical adrenal nodules, which were further evaluated to determine whether these nodules were associated with hereditary leiomyomatosis and renal cell carcinoma. Patients with hereditary leiomyomatosis and renal cell carcinoma underwent a comprehensive clinical and genetic evaluation. We reviewed the clinical presentation, anatomical and functional imaging, endocrine evaluation, pathological examination and germline mutation testing results. Of 255 patients with hereditary leiomyomatosis and renal cell carcinoma 20 (7.8%) had primary adrenal lesions, including 4 with bilateral adrenal lesions and 4 with multiple nodules. Two patients had adrenocorticotropic hormone independent hypercortisolism. A total of 27 adrenal lesions were evaluated. The imaging characteristics of 5 of these lesions (18.5%) were not consistent with adenoma by noncontrast computerized tomography criteria. Positron emission tomography was positive in 7 of 10 cases (70%). A total of 12 nodules were surgically resected from 10 adrenal glands. Pathological examination revealed macronodular adrenal hyperplasia in all specimens. Unilateral and bilateral adrenal nodular hyperplasia was detected in a subset of patients with hereditary leiomyomatosis and renal cell carcinoma. A functional endocrine evaluation is recommended when an adrenal lesion is discovered. Imaging frequently reveals lesions that are not typical of adenomas and positron emission tomography may be positive. To date no patient has had adrenal malignancy, and active surveillance of hereditary leiomyomatosis and renal cell carcinoma adrenal nodules appears justified.

Intraoperative radiation therapy with the photon radiosurgery system in locally advanced and recurrent rectal cancer: retrospective review of the Cleveland clinic experience

BackgroundPatients with locally advanced or recurrent rectal cancer often require multimodality treatment. Intraoperative radiation therapy (IORT) is a focal approach which aims to improve local control.MethodsWe retrospectively reviewed 42 patients treated with IORT following definitive resection of a locally advanced or recurrent rectal cancer from 2000–2009. All patients were treated with the Intrabeam® Photon Radiosurgery System (PRS). A dose of 5 Gy was prescribed to a depth of 1 cm (surface dose range: 13.4-23.1, median: 14.4 Gy). Median survival times were calculated using Kaplan-Meier analysis.ResultsOf 42 patients, 32 had recurrent disease (76%) while 10 had locally advanced disease (24%). Eighteen patients (43%) had tumors fixed to the sidewall. Margins were positive in 19 patients (45%). Median follow-up after IORT was 22 months (range 0.2-101). Median survival time after IORT was 34 months. The 3-year overall survival rate was 49% (43% for recurrent and 65% for locally advanced patients). Local recurrence was evaluable in 34 patients, of whom 32% failed. The 1-year local recurrence rate was 16%. Distant metastasis was evaluable in 30 patients, of whom 60% failed. The 1-year distant metastasis rate was 32%. No intraoperative complications were attributed to IORT. Median duration of IORT was 35 minutes (range: 14–39). Median discharge time after surgery was 7 days (range: 2–59). Hydronephrosis after IORT occurred in 10 patients (24%), 7 of whom had documented concomitant disease recurrence.ConclusionsThe Intrabeam® PRS appears to be a safe technique for delivering IORT in rectal cancer patients. IORT with PRS marginally increased operative time, and did not appear to prolong hospitalization. Our rates of long-term toxicity, local recurrence, and survival rates compare favorably with published reports of IORT delivery with other methods.

Adult low-grade gliomas: The Cleveland Clinic experience.

2076 Background: Low-grade gliomas account for 10-20% of all primary brain tumors. There is limited data on specific prognostic factors for patients with low-grade gliomas. Methods: After obtaining IRB approval, the Cleveland Clinic Brain Tumor and Neuro-Oncology Center’s database was used to identify patients with histologically confirmed grade 2 glioma at the time of diagnosis. Multivariable analysis was conducted with use of a Cox proportional hazards model and a stepwise selection algorithm that used p&lt;0.10 as the criteria for entry and p&lt;0.05 as retention in the model to identify independent predictors of survival. Results: Chart records of 478 patients (54% of whom were men) diagnosed between 1991 and 2010 were included for analysis. The median age at presentation was 41 years (range, 18-83 years). 42% of patients had biopsy only, 27% had gross total resection, 6% had near total resection, and 25% had subtotal resection. 22% of patients were initially treated with radiation, 30% with adjuvant chemotherapy, and 7% with concurrent chemotherapy. Median progression free survival and median overall survival (OS) were 5.1 years and 12.8 years, respectively. On multivariate analysis, independent of additional therapy, five factors were identified as independent predictors of OS: age at diagnosis (p=0.002), Karnofsky performance status (KPS, p&lt;0.0001), histology (astrocytoma vs. other, p=0.001), hemispheric location (left or bilateral involvement vs. right, p=0.02) and gender (male vs. female, p=0.0003). Conclusions: Older age, male gender, poor performance status, astrocytic histology, and left hemispheric or bilateral involvement are associated with higher mortality. [Table: see text]

Primary central nervous system lymphoma: The Cleveland Clinic experience.

2092 Background: Primary central nervous system lymphoma (PCNSL) is an uncommon variant of extranodal non-Hodgkin lymphoma that involves the brain, leptomeninges, eyes, or spinal cord without evidence of systemic disease. Untreated PCNSL has a rapidly fatal course, with survival of approximately 1.5 months from the time of diagnosis. In this study, we sought to describe the demographics, diagnoses, management, and outcomes of patients with PCNSL at a single institution. Methods: After obtaining IRB approval, the Cleveland Clinic Brain Tumor and Neuro-Oncology Center’s database was used to identify patients with histologically proven PCNSL at the Cleveland Clinic between 1986 and 2010. Data were subjected univariate and multivariate analysis followed by recursive partitioning analysis in order to generate a prognostic model. Results: 153 patients were diagnosed with PCNSL with a median age of 61 and Karnofsky performance status (KPS) of 70. The progression-free survival (PFS) was 9.3 months; the overall survival (OS) was 27 months. The treatment regimen included methotrexate-based chemotherapy (MTX) or a combination of methotrexate-based chemotherapy and whole brain radiation therapy (WBRT). Patients treated with the MTX regimen had an OS of 65 months; those treated with the MTX + WBRT regimen had an OS of 74 months. The Cox proportional hazards regression identified age and KPS as the only prognostic indicators to OS and PFS. Recursive partitioning analysis categorized the patients into three groups according to these prognostic factors. Patients with KPS ≥ 70 had a favorable outcome compared to patients with KPS &lt; 70. This held true especially for patients age 60 and younger, whose median OS was 100 months. Conclusions: The survival and prognostic indicators approximate those reported previously and provide independent validation for a simple yet powerful prognostic model that uses age and KPS to predict survival. [Table: see text]

Anaplastic oligodendroglial tumors: The Cleveland Clinic experience.

2100 Background: Anaplastic oligodendroglial tumors include both anaplastic oligodendroglioma (AO), and anaplastic oligoastrocytoma (AOA), histological categories of WHO grade 3 gliomas. There is limited data on specific prognostic factors for patients with these tumors. Methods: After obtaining IRB approval, the Cleveland Clinic Brain Tumor and Neuro-Oncology Center’s database was used to identify patients with histologically confirmed AO and AOA at the time of diagnosis. Multivariable analysis was conducted with use of a Cox proportional hazards model and a stepwise selection algorithm that used p&lt;0.05 both as the criteria for entry and retention in the model to identify independent predictors of survival. Results: Chart records of 139 patients, 52% of whom were male, diagnosed between 1992 and 2009 were included for analysis. Median age at presentation was 47 years (range, 18-83 years). 22% of patients had biopsy only, 35% had gross total resection, 43% had near total resection or subtotal resection. Following surgery, 30% of patients were treated with chemotherapy (CT) alone, 14% were treated with radiotherapy (RT) and 47% received both CT and RT. Median progression free survival and median overall survival (OS) were 29.0 and 58.7 months respectively. On multivariate analysis, four factors were identified as independent predictors of OS: age at diagnosis (≥50 vs. &lt;50, p=0.004), Hypothyroidism (p=0.009), multifocal disease (p=0.005) and 1p 19q co-deletion (p&lt;0.001). Choice of initial therapy did not impact survival in this cohort of patients. Conclusions: Older age, hypothyroidism and multifocal disease were associated with higher mortality. 1p, 19q co-deletion was associated with lower mortality. [Table: see text]

Presentation and Treatment of Subfertile Men with Balanced Translocations: The Cleveland Clinic Experience

Introduction: Balanced chromosomal translocations are a relatively common (2–7%) finding among infertile couples. We report clinical features of males with translocations at our institution. Materials and Methods: Data was collected on men presenting for infertility evaluation between July 2006 March 2010, including presentation, medical history, and infertility treatments. Criteria for genetic evaluation, consisting of karyotype and Y-linked microdeletion assay, included severe oligozoospermia or azoospermia (sperm concentration < 2.5×106/ml) or a history of recurrent miscarriages. Results: Of the 4,612 patients in our male infertility clinic 306 met criteria for genetic evaluation. Three patients had a balanced translocation, of which 2 had Robertsonian translocations, and 1 had a balanced translocation. One patient had normal bulk semen parameters, normal volume azoospermia, and oligoasthenoteratozoospermia. All patients were offered medical genetics consultation. Potential pregnancy outcomes were evaluated using a predictive software package. One patient had intratubular germ cell neoplasia and underwent orchiectomy; subsequent fertility evaluation has been deferred. The other 2 are considering in-vitro fertilization with pre-implantation genetic evaluation. Conclusions: Given the low incidence of balanced translocations detected in our population, better clinical indicators other than semen parameters or history of recurrent pregnancy loss are needed to determine screening for this finding.

Modern Outcomes of Inflammatory Breast Cancer: The Cleveland Clinic Experience

Inflammatory breast cancer (IBC) is associated with poor outcomes. The purpose of this study was to report recent outcomes for IBC patients treated at the Cleveland Clinic in the modern era of trastuzumab and taxane-based chemotherapy.

4012 POSTER Stereotactic Radiosurgery of Brain Metastases in Elderly Patients: the Cleveland Clinic Experience

4012 POSTER Stereotactic Radiosurgery of Brain Metastases in Elderly Patients: the Cleveland Clinic Experience

The effect of antiepileptic drugs on coagulation and bleeding in the perioperative period of epilepsy surgery: The Cleveland Clinic experience

Antiepileptic drugs (AED) are known to cause coagulation disturbances. We retrospectively analyzed the effect of AED on coagulation parameters in children who underwent craniotomy for epilepsy surgery. A total of 84 children were included. Perioperative coagulation parameters, the number and type of AED, estimated blood loss and the amount of blood products transfused were recorded. The most commonly used AED was lamotrigine. Of all patients, 7.1% were taking valproate. None of the patients showed significantly abnormal prothrombin time, activated partial thromboplastin time, or platelet count preoperatively. Thirty-eight percent of patients were transfused with allogeneic red blood cells and 4.7% of all patients showed significant coagulopathy intraoperatively and postoperatively. We concluded that the number of AED does not appear to be associated with preoperative coagulation disorders or blood transfusion requirements. However, caution should be taken in patients taking AED who undergo complex brain epilepsy surgery due to the potential for significant blood loss.

Probe ablation as salvage therapy for renal tumors in von Hippel-Lindau patients: The Cleveland Clinic experience with 3 years follow-up

BackgroundTo evaluate the efficacy and safety of probe ablative therapy as salvage treatment for renal tumor in von Hippel-Lindau (VHL) patients after previous partial nephrectomy (PN). MethodsMedical records of VHL patients undergoing probe ablative treatment for renal tumors from March 2003 to January 2010 at our institution were retrospectively analyzed. ResultsFourteen VHL patients who were submitted to salvage probe ablative therapy were included in the analysis. Twelve patients (85%) had a solitary kidney. Overall, 33 tumors were ablated by either percutaneous cryoablation (P-Cryo) (n of procedures = 13), radiofrequency ablation (RFA) (n = 14), and laparoscopic cryoablation (L-Cryo) (n = 3). Average maximal renal tumor diameter was 2.6 ± 1 cm. Average ablation time was 18.3 ± 2.1 minutes for P-Cryo, 36.7 ± 17 minutes for RFA, and 17.3 ± 4 minutes for L-Cryo. All procedures were successfully completed without transfusions and intraoperative complications. No early postoperative complications were recorded. Postoperative decline in renal function was minimal and not clinically significant. With a mean follow-up of 37.6 months (range 12–82), 4 patients had a suspicious recurrence on computed tomogaphy/magnetic resonance imaging (CT/MRI) scan and in 3 of them a re-ablation was performed. Actuarial overall and cancer-specific survivals were 92% and 100%, respectively. ConclusionsProbe ablative therapy seems to represent a suitable treatment option for VHL patients with a previous history of PN as it offers a repeatable operation, with a high technical success rate and causing minor changes in renal function.