Patient perceptions and willingness to participate in clinical trials.

OBJECTIVE: To evaluate gynecologic oncology patients' perceptions and willingness to participate in randomized clinical trials (RCT) among an inner city population. METHODS: Informed consent was obtained. Demographics were collected and willingness to participate in a RCT was measured by the Attitudes on Randomized Trials Questionnaire (ARTQ). The Hospital Anxiety and Depression Scale estimated levels of anxiety and depression. A Perception Survey was created and tested as a screening tool for patients considering RCTs. Standard statistical tests were used. RESULTS: One hundred and one women participated, 54 (53.5%) were black, 31 (30.7%) were white, non-Hispanic and 15 (14.9%) were Hispanic. Screening for anxiety and depression revealed an 18.8% rate of moderate to severe anxiety and an 11.9% rate of moderate to severe depression. Willingness to participate in a RCT as measured by ARTQ scores was not significantly associated with race, levels of anxiety or depression. Twenty-eight percent of women would agree to participate in a clinical trial at baseline. An additional, 33 (32.7%), for a total of 61.4%, indicated agreement after targeted education with no statistical differences by race or psychological stressor. However, sixty-one percent of these women were black. The Perception Survey approximated the results of the ARTQ with reasonable accuracy (AUC 0.758, p<0.001) CONCLUSIONS: Neither race nor psychological stressor were significant indicators of willingness to participate in a RCT. Targeted education resulted in a majority of patients indicating willingness to participate in trials, especially among black women. Additionally, a novel screening tool was tested and performed well in this setting.

Frailty index predicts severe complications in gynecologic oncology patients.

OBJECTIVE: The purpose of this study was to quantify the predictive value of frailty index on 30-day Clavien class IV (requiring critical care support) and class V (30-day mortality) complications after gynecologic cancer surgery. METHODS: Patients included in the National Surgical Quality Improvement Program (NSQIP) 2008-2011 had a final diagnosis of gynecologic malignancy. Modified frailty index (mFI) was calculated with 11 variables. Higher mFI scores indicated more severe comorbidities. Logistic regression was used to control for known predictors of complications. RESULTS: Of the total 6551 patients, 188 (2.9%) of the patients experienced a Clavien IV/V complication. 2958 patients had a score of 0 (45.2%), 2405 patients had a score of 1 (36.7%), 985 patients had a score of 2 (15%), 162 patients had a score of 3 (2.5%) and 41 patients had a score≥4 (0.6%). The rates of Clavien IV/V complications were 2%, 2.7%, 4.4%, 7.4% and 24.4% for mFI scores of 0, 1, 2, 3 and ≥4, respectively (p<0.001). Variables found to be significant for predicting Clavien IV and V complications on logistic regression modeling were preoperative albumin<3g/dL (OR=6.5), operative time (OR=1.003 per min increase), non-laparoscopic surgery (OR=3.3), and frailty index (OR score 0=reference, score 1=1.26, score 2=1.9, score 3=2.33 and score≥4=12.5). Taking the two preoperative factors of albumin and mFI allowed for greater precision in identifying women who are at higher risk for requiring ICU care (>10% risk). CONCLUSIONS: Modified frailty index (mFI) is predictive of the need for critical care support and 30-day mortality after surgery for gynecologic cancer.

Resident participation in laparoscopic hysterectomy: impact of trainee involvement on operative times and surgical outcomes.

OBJECTIVE: The purpose of this study was to determine the impact of resident involvement on morbidity after total laparoscopic hysterectomy for benign disease. STUDY DESIGN: We performed a retrospective review of a National Surgical Quality Improvement Program database of total laparoscopic hysterectomy for benign disease that was performed with resident involvement vs attending alone between Jan. 1, 2008, and Dec. 31, 2011. Surgical operative times and morbidity and mortality rates were compared. Binary logistic regression was used to control for covariates that were significant on univariate analysis (P < .05). RESULTS: A total of 3441 patients were identified as having undergone a total laparoscopic hysterectomy for benign disease. The mean age of patients was 47.4 ± 11.1 years; the mean body mass index was 30.6 ± 7.9 kg/m(2). A resident participated in 1591 of cases (46.2%); 1850 of the procedures (53.8%) were done by an attending physician alone. Cases with resident involvement had higher mean age, Charlson morbidity scoring, and American Society of Anesthesiologists classification and were more likely to be inpatient cases. With resident involvement, the mean operative time was increased (179.29 vs 135.46 minutes; P < .0001). There were no differences in the rates of experiencing at least 1 complication (6.8% for resident involvement vs 5.4% for attending alone; P = .5), composite severe morbidity (1.3% resident vs 1.0% attending alone), or 30-day mortality rate (0% resident vs 0.1% attending alone). Additionally, there were no differences between groups in the infectious, wound, neurorenal, thromboembolic, septic, and cardiopulmonary complications. Cases with resident involvement had significantly increased rates of postoperative transfusion of packed red blood cells (2% vs 0.4%; P < .0001), reoperation (2.2% vs 1.3%; P = .048), and a 30-day readmission (5.5% vs 2.9%; P = .015). In models that were adjusted for factors that differed between the 2 groups, cases with resident involvement had increased odds of receiving postoperative blood transfusion (odds ratio [OR], 4.98; 95% confidence interval [CI], 2.18-11.33), reoperation (OR, 1.7, 95% CI, 1.01-2.89) and readmission (OR, 1.93, 95% CI, 1.09-3.42). CONCLUSION: Resident involvement in total laparoscopic hysterectomy for benign disease was associated with clinically appreciable longer surgical time and small differences in the rates of postoperative transfusions, reoperation, and readmission. However, the rates of overall complications, severe complications, and 30-day mortality rate remain comparable.

Prenatal detection of fetal growth restriction in newborns classified as small for gestational age: correlates and risk of neonatal morbidity.

We examined the rate of detecting small for gestational age (SGA; birth weight < 10%) as intrauterine growth restriction (IUGR) prenatally at four centers and determined risks of composite neonatal morbidity (CNM) and mortality among detected versus undetected (no antenatal diagnosis of IUGR). A multicenter cohort study of 11,487 nonanomalous, singleton live births with sonographic exam before 22 weeks was performed. Of 11,487 births, 8% (n = 929) were SGA that met the inclusion criteria, with 25% of them being prenatally detected. The CNM among SGA births that were prenatally detected as IUGR was higher (23.3%) than undetected SGA (9.7%), but this difference was no longer significant following adjustments for confounding factors. Among preterm births (< 37 weeks), undetected SGA had significantly higher CNM (risk ratio [RR] 10.0, 95% confidence interval [CI] 6.3, 16.1) for deliveries at 24 to 33 weeks and RR 3.0, 95% CI 1.7, 5.4 for 34 to 36 weeks). In summary, only a quarter of SGA births were detected prenatally as IUGR and among preterm SGA, the CNM is significantly higher when SGA births are undetected as IUGR.

Diffuse large B cell lymphoma of the cervix with rectal involvement.

•Diffuse large B cell lymphoma of the cervix is a very rare gynecologic malignancy and difficult to diagnose.•This case is the youngest reported occurrence of cervical DLBCL with interesting considerations of GI involvement and fertility.

The role of telemedicine in the management of the pregnancy complicated by diabetes.

The use of technology to deliver health care over a distance has drawn considerable attention and shown dramatic growth over the last decade because of the possibility it has to reduce cost and improve access to modern medical care. Diabetes in pregnancy, which requires tight glycemic control in order to reduce perinatal complications, is a prime telemedicine intervention target. A review of the literature suggests that telemedicine, although not perfect, can potentially play a role in reducing patient visits and could improve quality of life without jeopardizing the outcome.

Clinical collection and protein properties of expressed prostatic secretions as a source for biomarkers of prostatic disease.

The prostate gland secretes many proteins in a prostatic fluid that combines with seminal vesicle derived fluids to promote sperm activation and function. Proximal fluids of the prostate that can be collected clinically are seminal plasma and expressed-prostatic secretion (EPS) fluids. EPS represents the fluid being secreted by the prostate following a digital rectal prostate massage, which in turn can be collected in voided urine post-exam. This collection is not disruptive to a standard urological exam, and it can be repeatedly collected from men across all prostatic disease states. A direct EPS fluid can also be collected under anesthesia prior to prostatectomy. While multiple genetic assays for prostate cancer detection are being developed for the shed epithelial cell fraction of EPS urines, the remaining fluid that contains many prostate-derived proteins has been minimally characterized. Approaches to optimization and standardization of EPS collection consistent with current urological exam and surgical practices are described, and initial proteomic and glycomic evaluations of the of EPS fluid are summarized for prostate specific antigen and prostatic acid phosphatase. Continued characterization of the prostate specific protein components of EPS urine combined with optimization of clinical collection procedures should facilitate discovery of new biomarkers for prostate cancer.