Rodney Sparapani

Predictive Factors and Outcomes in Endoscopic Sinus Surgery for Chronic Rhinosinusitis

Purpose: To assess objective and quality of life (QOL) outcomes before and after endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS) and to determine preoperative factors that predict surgical outcome in these patients.

Clinical Significance of Thrombocytopenia During a Non–ST-Elevation Acute Coronary Syndrome The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) Trial Experience

BACKGROUND The significance of thrombocytopenia in patients experiencing an acute coronary syndrome (ACS) has not been examined systematically. We evaluated this condition in a large non-ST-elevation ACS clinical trial, with particular interest paid to its correlation with clinical outcomes. METHODS AND RESULTS Patients presenting without persistent ST elevation during an ACS were randomized to receive a double-blind infusion of the platelet glycoprotein (GP) IIb/IIIa inhibitor eptifibatide or placebo in addition to other standard therapies including heparin and aspirin. The primary end point was death/nonfatal myocardial infarction (MI) at 30 days, whereas bleeding and stroke were the main safety outcomes. Thrombocytopenia (nadir platelet count <100x10(9)/L or <50% of baseline) occurred in 7.0% of enrolled patients. The time to onset was a median of 4 days in both treatment arms. Patients with thrombocytopenia were older, weighed less, were more likely nonwhite, and had more cardiac risk factors. These patients experienced significantly more bleeding events: they were more than twice as likely to experience moderate/severe bleeding after adjustment for confounders. Univariably, ischemic events (stroke, MI, and death) occurred significantly (P<0.001) more frequently in patients with thrombocytopenia; multivariable regression modeling preserved this association with death/nonfatal MI at 30 days. Neither the use of heparin or eptifibatide was found to independently increase thrombocytopenic risk. CONCLUSIONS Although causality between thrombocytopenia and adverse clinical events could not be established definitively, thrombocytopenia was highly correlated with both bleeding and ischemic events, and the presence of this condition identified a more-at-risk patient population.

Randomized trial of candesartan cilexetil in the treatment of patients with congestive heart failure and a history of intolerance to angiotensin-converting enzyme inhibitors

BACKGROUND Many patients with congestive heart failure do not receive the benefits of angiotensin-converting enzyme (ACE) inhibitors because of intolerance. We sought to determine the tolerability of an angiotensin II receptor blocker, candesartan cilexetil, among patients considered intolerant of ACE inhibitors. METHODS Patients with CHF, left ventricular ejection fraction less than 35%, and history of discontinuing an ACE inhibitor because of intolerance underwent double-blind randomization in a 2:1 ratio to receive candesartan (n = 179) or a placebo (n = 91). The initial dosage of candesartan was 4 mg/d; the dosage was increased to 16 mg/d if the drug was tolerated. A history of intolerance of ACE inhibitor was attributed to cough (67% of patients), hypotension (15%), or renal dysfunction (11%). RESULTS The study drug was continued for 12 weeks by 82.7% of patients who received candesartan versus 86.8% of patients who received the placebo. This 4.1% greater discontinuation rate with active therapy was not significant; the 95% confidence interval ranged from 4.8% more discontinuation with placebo to 13% more with candesartan. Titration to the 16-mg target dose was possible for 69% of patients who received candesartan versus 84% of those who received the placebo. Frequencies of death and morbidity were not significantly different between the candesartan and placebo groups (death 3.4% and 3.3%, worsening heart failure 8.4% and 13.2%, myocardial infarction 2.8% and 5.5%, all-cause hospitalization 12.8% and 18.7%, and death or hospitalization for heart failure 11.7% and 14.3%). CONCLUSIONS Candesartan was well tolerated by this population. The effect of candesartan on major clinical end points, including death, remains to be determined.

Relationship Between Number of Breast Cancer Operations Performed and 5-Year Survival After Treatment for Early-Stage Breast Cancer

OBJECTIVES We examined the association between number of breast cancer operations performed in a hospital (hospital volume) and all-cause and breast cancer-specific mortality using a national database and statistical methods appropriate for clustering and reducing confounding. METHODS In a retrospective cohort study, we linked Surveillance, Epidemiology, and End Results tumor registry data with Medicare claims data. The cohort included 11225 Medicare patients who had undergone surgery for early-stage breast cancer from 1994 to 1996 in 457 different hospitals. Primary outcomes were all-cause and breast cancer-specific survival rates at a mean follow-up time of 62.5 months. RESULTS In comparison with treatment in a low-volume hospital, treatment in a high-volume hospital was associated with hazard ratios of 0.83 (95% confidence interval [CI]=0.75, 0.92) for all-cause mortality and 0.80 (CI=0.66, 0.97) for breast cancer-specific mortality. CONCLUSIONS An association between the volume of breast cancer operations performed in a hospital and 5-year survival rates was observed for both all-cause and breast cancer-specific mortality. Further work investigating the aspects of hospital volume that contribute to increased survival is warranted.

Cisplatin and Etoposide Versus Carboplatin and Paclitaxel With Concurrent Radiotherapy for Stage III Non–Small-Cell Lung Cancer: An Analysis of Veterans Health Administration Data

PURPOSE The optimal chemotherapy regimen to use with radiotherapy in stage III non-small-cell lung cancer is unknown. Here, we compare the outcome of patents treated within the Veterans Health Administration with either etoposide-cisplatin (EP) or carboplatin-paclitaxel (CP). METHODS We identified patients treated with EP and CP with concurrent radiotherapy from 2001 to 2010. Survival rates were compared using Cox proportional hazards regression models with adjustments for confounding provided by propensity score methods and an instrumental variables analysis. Comorbidities and treatment complications were identified through administrative data. RESULTS A total of 1,842 patients were included; EP was used in 27% (n = 499). Treatment with EP was not associated with a survival advantage in a Cox proportional hazards model (hazard ratio [HR], 0.97; 95% CI, 0.85 to 1.10), a propensity score matched cohort (HR, 1.07; 95% CI, 0.91 to 1.24), or a propensity score adjusted model (HR, 0.97; 95% CI, 0.85 to 1.10). In an instrumental variables analysis, there was no survival advantage for patients treated in centers where EP was used more than 50% of the time as compared with centers where EP was used in less than 10% of the patients (HR, 1.07; 95% CI, 0.90 to 1.26). Patients treated with EP, compared with patients treated with CP, had more hospitalizations (2.4 v 1.7 hospitalizations, respectively; P < .001), outpatient visits (17.6 v 12.6 visits, respectively; P < .001), infectious complications (47.3% v 39.4%, respectively; P = .0022), acute kidney disease/dehydration (30.5% v 21.2%, respectively; P < .001), and mucositis/esophagitis (18.6% v 14.4%, respectively; P = .0246). CONCLUSION After accounting for prognostic variables, patients treated with EP versus CP had similar overall survival, but EP was associated with increased morbidity.

Heightened Attention to Medical Privacy: Challenges for Unbiased Sample Recruitment and a Possible Solution

Subject recruitment for epidemiologic studies is associated with major challenges due to privacy laws now common in many countries. Privacy policies regarding recruitment methods vary tremendously across institutions, partly because of a paucity of information about what methods are acceptable to potential subjects. The authors report the utility of an opt-out method without prior physician notification for recruiting community-dwelling US women aged 65 years or older with incident breast cancer in 2003. Participants (n = 3,083) and possibly eligible nonparticipants (n = 2,664) were compared using characteristics derived from billing claims. Participation for persons with traceable contact information was 70% initially (2005-2006) and remained over 90% for 3 follow-up surveys (2006-2008). Older subjects and those living in New York State were less likely to participate, but participation did not differ on the basis of socioeconomic status, race/ethnicity, underlying health, or type of cancer treatment. Few privacy concerns were raised by potential subjects, and no complaints were lodged. Using opt-out methods without prior physician notification, a population-based cohort of older breast cancer subjects was successfully recruited. This strategy may be applicable to population-based studies of other diseases and is relevant to privacy boards making decisions about recruitment strategies acceptable to the public.

Bone Density Testing in Older Women and Its Association with Patient Age

OBJECTIVES: To measure the early adoption of bone density testing and examine the association between older age and such testing.

Sex differences in outcomes of sinus surgery

Purpose: Sex has been demonstrated to affect outcome in many diseases. Our current aim is to investigate the relationship between sex and outcomes of endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS).

Emacs Speaks Statistics: A Multiplatform, Multipackage Development Environment for Statistical Analysis

Computer programming is an important component of statistical research and data analysis. It is a necessary skill for using sophisticated statistical packages and for writing custom scripts and software to perform data analysis using modern statistical methods. Emacs Speaks Statistics (ESS) provides an intelligent and consistent interface between the user and statistics software. ESS interfaces with SAS, S-Plus, R, and other statistics packages under the Unix, Microsoft Windows, and Apple Macintosh operating systems. ESS extends the Emacs text editor to streamline the use and creation of statistical software. ESS understands the syntax for numerous data analysis languages, provides consistent display and editing features across packages, and assists in the interactive or batch execution of statements by statistics packages. We describe in detail the features that ESS provides to increase efficiency.

Socioeconomic factors associated with adjuvant hormone therapy use in older breast cancer survivors.

The authors sought to identify socioeconomic (SES) factors associated with adjuvant hormone therapy (HT) use among a contemporary population of older breast cancer survivors.