Updates in Pediatric Cholesteatoma: Minimizing Intervention While Maximizing Outcomes.

Advances in pediatric otology have provided new tools to diagnose and manage complex otologic disease. Diffusion-weighted MRI provides the surgeon with a tool to detect recurrent or residual cholesteatoma that may obviate a second look surgery. Surgical trends move toward less invasive surgery. The literature provides good evidence to advocate for preserving the posterior ear canal and single stage ossiculoplasty. The growing popularity and increasing evidence in the literature supports otoendoscopy as a means to minimize invasiveness while eradicating disease in previously difficult to reach anatomic locations. These advances have allowed the otologic surgeon to improve surgical outcomes while minimizing intervention.

Oncologic Outcomes After Transoral Robotic Surgery: A Multi-institutional Study.

IMPORTANCE: Large patient cohorts are necessary to validate the efficacy of transoral robotic surgery (TORS) in the management of head and neck cancer. OBJECTIVES: To review oncologic outcomes of TORS from a large multi-institutional collaboration and to identify predictors of disease recurrence and disease-specific mortality. DESIGN, SETTING, AND PARTICIPANTS: A retrospective review of records from 410 patients undergoing TORS for laryngeal and pharyngeal cancers from January 1, 2007, through December 31, 2012, was performed. Pertinent data were obtained from 11 participating medical institutions. INTERVENTIONS: Select patients received radiation therapy and/or chemotherapy before or after TORS. MAIN OUTCOMES AND MEASURES: Locoregional control, disease-specific survival, and overall survival were calculated. We used Kaplan-Meier survival analysis with log-rank testing to evaluate individual variable association with these outcomes, followed by multivariate analysis with Cox proportional hazards regression modeling to identify independent predictors. RESULTS: Of the 410 patients treated with TORS in this study, 364 (88.8%) had oropharyngeal cancer. Of these 364 patients, information about post-operative adjuvant therapy was known about 338: 106 (31.3) received radiation therapy alone, and 72 (21.3%) received radiation therapy with concurrent chemotherapy. Neck dissection was performed in 323 patients (78.8%). Mean follow-up time was 20 months. Local, regional, and distant recurrence occurred in 18 (4.4%), 15 (3.7%), and 10 (2.4%) of 410 patients, respectively. Seventeen (4.1%) died of disease, and 13 (3.2%) died of other causes. The 2-year locoregional control rate was 91.8% (95% CI, 87.6%-94.7%), disease-specific survival 94.5% (95% CI, 90.6%-96.8%), and overall survival 91% (95% CI, 86.5%-94.0%). Multivariate analysis identified improved survival among women (P = .05) and for patients with tumors arising in tonsil (P = .01). Smoking was associated with worse overall all-cause mortality (P = .01). Although advanced age and tobacco use were associated with locoregional recurrence and disease-specific survival, they, as well as tumor stage and other adverse histopathologic features, did not remain significant on multivariate analysis. CONCLUSIONS AND RELEVANCE: This large, multi-institutional study supports the role of TORS within the multidisciplinary treatment paradigm for the treatment of head and neck cancer, especially for patients with oropharyngeal cancer. Favorable oncologic outcomes have been found across institutions. Ongoing comparative clinical trials funded by the National Cancer Institute will further evaluate the role of robotic surgery for patients with head and neck cancers.

Development of quality indicators for women with urinary incontinence.

AIMS: To develop a means to measure the quality of care provided to women treated for urinary incontinence (UI) through the development of quality-of-care indicators (QIs). METHODS: We performed an extensive literature review to develop a set of potential quality indicators for the management of UI. QIs were modeled after those previously described in the Assessing the Care of Vulnerable Elders (ACOVE) project. Nine experts ranked the indicators on a nine-point scale for both validity and feasibility. We analyzed preliminary rankings of each indicator using the RAND Appropriateness Method. A forum was then held in which each indicator was thoroughly discussed by the panelists as a group, after which the indicators were rated a second time individually using the same nine-point scale. RESULTS: QIs were developed that addressed screening, diagnosis, work-up, and both non-surgical and surgical management. Areas of controversy included whether routine screening for incontinence should be performed, whether urodynamics should be performed before non-surgical management is initiated, and whether cystoscopy should be part of the pre-operative work-up of uncomplicated stress incontinence. Following the expert panel discussion, 27 of 40 potential indicators were determined to be valid for UI with a median score of at least seven on a nine-point scale. CONCLUSIONS: We identified 27 quality indicators for the care of women with UI. Once these QIs are pilot-tested for feasibility, they will be applied on a larger scale to measure the quality of care provided to women with UI in the United States.

Quality-of-care indicators for pelvic organ prolapse: development of an infrastructure for quality assessment.

INTRODUCTION AND HYPOTHESIS: A paucity of data exists addressing the quality of care provided to women with pelvic organ prolapse (POP). We sought to develop a means of measuring this quality through the development of quality-of-care indicators (QIs). METHODS: QIs were modeled after those previously described in the Assessing the Care of Vulnerable Elders (ACOVE) project. The indicators were then presented to a panel of nine experts. Using the RAND Appropriateness Method, we analyzed each indicator's preliminary rankings. A forum was then held in which each indicator was thoroughly discussed by the panelists as a group, after which panelists individually re-rated the indicators. QIs with median scores of at least 7 were considered valid. RESULTS: QIs were developed that addressed screening, diagnosis, work-up, and both nonsurgical and surgical management. Areas of controversy included whether screening should be performed to identify prolapse, whether pessary users should undergo a vaginal examination by a health professional every 6 months versus annually, and whether a colpocleisis should be offered to older women planning to undergo surgery for POP. Fourteen out of 21 potential indicators were rated as valid for pelvic organ prolapse (median score ≥7). CONCLUSION: We developed and rated 14 potential quality indicators for the care of women with POP. Once these QIs are tested for feasibility they can be used on a larger scale to measure and compare the care provided to women with prolapse in different clinical settings.

Patients' understanding of pelvic floor disorders: what women want to know.

OBJECTIVE: To assess the effect of initial visit with a specialist on disease understanding in women with pelvic floor disorders. METHODS: Women with referrals or chief complaints suggestive of urinary incontinence or pelvic organ prolapse were recruited from an academic urology clinic. The patients completed a Test of Functional Health Literacy in Adults and scripted interview sessions before and after a physician encounter. Physician's treatment plans were standardized based on diagnosis and were explained using models. Interview transcripts were analyzed using qualitative grounded theory methodology. RESULTS: Twenty women with pelvic floor disorders (urinary incontinence or pelvic organ prolapse) were recruited and enrolled in this pilot study. The mean age was 60.5 years (range, 31-87 years) and most of the women were white, with a college degree or beyond. Test of Functional Health Literacy in Adults scores indicated adequate to high levels of health literacy. Preliminary themes before and after the physician encounter were extracted from interviews, and 2 main concepts emerged. First, after the initial physician's visit, knowledge of their diagnosis and the ability to treat their symptoms relieved the patients' concerns related to misunderstandings of the severity of their disease, Second, the patients tended to focus on treatment and had difficulty grasping certain diagnostic terms. This resulted in good understanding of treatment plans despite an inconsistent understanding of diagnosis. CONCLUSION: Our findings demonstrated a significant effect of the initial physician's visit on the patients' understanding of their pelvic floor disorder. Despite the variation in diagnostic recall after the physician encounter, the patients had a good understanding of treatment plans. This served to increase perceived control and adequately relieve patients' fears.

The long-term outcome of treated sensitized patients who undergo heart transplantation.

BACKGROUND: Sensitized patients prior to heart transplantation are reportedly at risk for hyperacute rejection and for poor outcome after heart transplantation. It is not known whether the reduction of circulating antibodies pre-transplant alters post-transplant outcome. METHODS AND RESULTS: Between July 1993 and July 2003, we reviewed 523 heart transplant patients of which 95 had pre-transplant panel reactive antibody (PRAs) >10%; 21/95 were treated pre-transplant for circulating antibodies. These 21 patients had PRAs > 10% (majority 50-100%) and were treated with combination therapy including plasmapheresis, intravenous gamma globulin and rituximab to reduce antibody counts. The 74 untreated patients with PRAs > 10% (untreated sensitized group) and those patients with PRAs < 10% (control group) were used for comparison. Routine post-transplant immunosuppression included triple-drug therapy. After desensitization therapy, circulating antibody levels pre-transplant decreased from a mean of 70.5 to 30.2%, which resulted in a negative prospective donor-specific crossmatch and successful heart transplantation. Compared to the untreated sensitized group and the control group, the treated sensitized group had similar five-yr survival (81.1% and 75.7% vs. 71.4%, respectively, p = 0.523) and freedom from cardiac allograft vasculopathy (74.3% and 72.7% vs. 76.2%, respectively, p = 0.850). CONCLUSION: Treatment of sensitized patients pre-transplant appears to result in acceptable long-term outcome after heart transplantation.

Benefit of immune monitoring in heart transplant patients using ATP production in activated lymphocytes.

BACKGROUND: Balancing immunosuppression to prevent rejection while minimizing infection or drug toxicity risk is a major challenge in heart transplantation. Therapeutic drug monitoring alone is inadequate to measure the immune response. An immune monitoring (IM) assay (ImmuKnow; Cylex, Columbia, MD) performed on peripheral blood measures adenosine triphosphatase (ATP) release from activated lymphocytes and may predict the immune state. Therefore, we sought to determine the utility of IM in heart transplant recipients. METHODS: Between November 2005 and July 2008, 296 heart transplant recipients had a total of 864 IM assays performed at 2 weeks to 10 years post-transplant and were correlated with infection and rejection events that occurred within 1 month after IM testing. All patients received standard triple-drug immunosuppressive therapy with tacrolimus, mycophenolate mofetil and corticosteroids, without induction therapy. RESULTS: There were 38 infectious episodes and 8 rejection episodes. The average IM score was significantly lower during infection than steady state (187 vs 280 ng ATP/ml, p < 0.001). The average IM score was not significantly different during rejection when compared with steady state (327 vs 280 ng ATP/ml, p = 0.35). Interestingly, 3 of 8 rejection episodes were antibody-mediated rejections and had hemodynamic compromise and, for these, the mean IM score was significantly higher than for steady-state patients (491 vs 280 ng ATP/ml, p < 0.001). CONCLUSIONS: The non-invasive IM test appears to predict infectious risk in heart transplant patients. The association between high IM scores and rejection risk is inconclusive due to the small number of rejection episodes. Further studies with larger sample sizes for rejection episodes are required.

Asymptomatic antibody-mediated rejection after heart transplantation predicts poor outcomes.

BACKGROUND: Antibody-mediated rejection (AMR) has been associated with poor outcome after heart transplantation. The diagnosis of AMR usually includes endomyocardial biopsy findings of endothelial cell swelling, intravascular macrophages, C4d+ staining, and associated left ventricular dysfunction. The significance of AMR findings in biopsy specimens of asymptomatic heart transplant patients (normal cardiac function and no symptoms of heart failure) is unclear. METHODS: Between July 1997 and September 2001, AMR was found in the biopsy specimens of 43 patients. Patients were divided into 2 groups: asymptomatic AMR (AsAMR, n = 21) and treated AMR (TxAMR with associated left ventricular dysfunction, n = 22). For comparison, a control group of 86 contemporaneous patients, without AMR, was matched for age, gender, and time from transplant. Outcomes included 5-year actuarial survival and development of cardiac allograft vasculopathy (CAV). Patients were considered to have AMR if they had > or = 1 endomyocardial biopsy specimen positive for AMR. RESULTS: The 5-year actuarial survival for the AsAMR (86%), TxAMR (68%), and control groups (79%) was not significantly different (p = 0.41). Five-year freedom from CAV (> or = 30% stenosis in any vessel) was AsAMR, 52%; TxAMR, 68%; and control, 79%. Individually, freedom from CAV was significantly lower in the AsAMR group compared with the control group (p = 0.02). There was no significant difference between AsAMR vs TxAMR and TxAMR vs control for CAV. CONCLUSIONS: Despite comparable 5-year survival with controls after heart transplantation, AsAMR rejection is associated with a greater risk of CAV. Trials to treat AsAMR to alter outcome are warranted.