Correlation of surgeon radiology assessment with laparoscopic disease site scoring in patients with advanced ovarian cancer.

BACKGROUND: Radiographic triage measures in patients with new advanced ovarian cancer have yielded inconsistent results. OBJECTIVE: To determine the correlation between surgeon radiology assessment and laparoscopic scoring by disease sites in patients with newly diagnosed advanced stage ovarian cancer. METHODS: Fourteen gynecologic oncology surgeons from a single institution performed a blinded review of pre-operative contrast-enhanced CT imaging from patients with advanced stage ovarian cancer. Each of the patients had also undergone laparoscopic scoring assessment, between April 2013 and December 2017, to determine primary resectability using the validated Fagotti scoring method, and assigned a predictive index value score. Surgeons were asked to provide expected predictive index value scores based on their blinded review of the antecedent CT imaging. Linear mixed models were conducted to calculate the correlation between radiologic and laparoscopic score for surgeons individually, and as a group. Once the model was fit, the inter-class correlation and 95% CI were calculated. RESULTS: Radiology review was performed on 20 patients with advanced stage ovarian cancer who underwent laparoscopic scoring assessment. Surgeon faculty rank included assistant professor (n=5), associate professor (p=4), and professor (n=5). The kappa inter-rater agreement was -0.017 (95% CI -0.023 to -0.005), indicating low inter-rater agreement between radiology review and actual laparoscopic score. The inter-class correlation in this model was 0.06 (0.02-0.21), indicating that surgeons do not score the same across all the images. When using a clinical cut-off point for the predictive index value of 8, the probability of agreement between radiology and actual laparoscopic score was 0.56 (95% CI 0.49 to 0.73). Examination of disease site sub-scales showed that the probability of agreement was as follows: peritoneum 0.57 (95% CI 0.51 to 0.62), diaphragm 0.54 (95% CI 0.48 to 0.60), mesentery 0.51 (95% CI 0.45 to 0.57), omentum 0.61 (95% CI 0.55 to 0.67), bowel 0.54 (95% CI 0.44 to 0.64), stomach 0.71 (95% CI 0.65 to 0.76), and liver 0.36 (95% CI 0.31 to 0.42). The number of laparoscopic scoring cases, tumor reductive surgery cases, or faculty rank was not significantly associated with overall or sub-scale agreement. CONCLUSIONS: Surgeon radiology review did not correlate highly with actual laparoscopic scoring assessment findings in patients with advanced stage ovarian cancer. Our study highlights the limited accuracy of surgeon radiographic assessment to determine resectability.

Postoperative Urinary Tract Infection Quality Assessment and Improvement: The S.T.O.P. UTI Program and Its Impact on Hospitalwide CAUTI Rates.

BACKGROUND: Postoperative urinary tract infection (UTI) is a frequent complication that diminishes patient experience and incurs substantial costs. The purpose of this project was to develop a urinary tract care assessment tool that would lead to actionable quality improvement initiatives. METHODS: Multidisciplinary teams at a single institution developed the S.T.O.P. UTI algorithm to assess elements related to urinary catheter care: Sterile catheter placement, Timely catheter removal, Optimal collection bag position, and Proper urine sampling for urinalysis and culture. Based on this evaluation, a targeted intervention was applied to address deficient areas in surgical patients. UTI rates were monitored. RESULTS: The assessment revealed that best practice for sterile placement was being performed but that time to removal, optimal positioning, and proper sampling could be improved. Providers were educated on best practice for catheter removal, nurses placed a reminder note on the chart, personnel were taught about optimal catheter positioning, and nursing assistants were educated on best practices for collection of urine. From 2012 to 2015, non-risk-adjusted UTI rates in surgical patients decreased from 2.90% to 0.46% (p = 0.0003), and the American College of Surgeons National Surgical Quality Improvement Program risk-adjusted comparison improved from the 8th to the 4th decile. Simultaneously, hospitalwide catheter-associated UTI rates also decreased, from 2.24/1,000 catheter-days in 2014 to 0.70/1,000 catheter-days in 2016 (p < 0.001). CONCLUSION: The S.T.O.P. UTI algorithm is a tool that hospitals can use to systematically assess UTI processes. The program can identify areas for improvement specific to an institution, directing the allocation of quality improvement resources to decrease both surgical and medical UTIs.

Choosing Wisely: Decreasing the incidence of perioperative blood transfusions in gynecologic oncology.

OBJECTIVE: To evaluate the efficacy and economic impact of a transfusion reduction initiative for patients undergoing gynecologic surgery. METHODS: We conducted a prospective healthcare improvement study to align transfusion practices with the American Society of Hematology's Choosing Wisely® campaign. Baseline transfusion rates were determined retrospectively for all major gynecologic surgical cases from 3/1/14 to 6/30/14. Data for the post-intervention period from 5/15/15 to 5/16/16 were captured prospectively. The primary outcome was transfusion within 72 h of surgery. Secondary outcomes included perioperative morbidity, mortality, number of units ordered per transfusion episode and cost. RESULTS: We identified 1281 surgical cases, 334 in the baseline and 947 in the post-implementation cohort. The baseline cohort was noted to have a higher median estimated blood loss (100 v. 75 mL, P < 0.01). Otherwise, there were no differences in clinical or perioperative characteristics between the two cohorts. The perioperative transfusion rate decreased from 24% to 11% (adjusted OR 0.27, 95% CI 0.16 to 0.45; P < 0.001). The perioperative laparotomy transfusion rate decreased from 48% to 23% (adjusted OR 0.21, 95% CI 0.12, 0.37; P < 0.001). The number of occurrences in which more than one unit of blood was ordered at a time decreased from 65% to 23%, P < 0.001. The incidence of surgical site infections declined in the post-intervention group, otherwise there were no differences in 30-day mortality, cardiac, venous thromboembolism or readmission rates between the groups. The projected cost savings was $161,112 over the 12-month intervention period. CONCLUSIONS: Implementation of an educational based transfusion reduction program was associated with substantial reductions in perioperative transfusions and cost without significant changes in morbidity or mortality.

Reporting of quality measures in gynecologic oncology programs at Prospective Payment System (PPS)-Exempt Cancer Hospitals: an early glimpse into a challenging initiative.

OBJECTIVE: The Affordable Care Act mandates the Prospective Payment System (PPS)-Exempt Cancer Hospitals Quality Reporting program. These 11 hospitals (which are paid fee-for-service rather than on a DRG system) began reporting measures (2 general safety, 2 breast, 1 colon) in 2013. Given this reporting mandate, we set out to determine whether the PPS-exempt gynecologic oncology programs could identify quality measures specific to the care of our patients. METHODS: A list of 12 quality measures specific to gynecologic oncology was created (from sources including the National Quality Forum and the SGO). Measures already in use were not included. The list was ranked by the gynecologic oncology program directors at the PPS-exempt hospitals. Descriptive statistics (including mean and SD for rankings) were utilized. RESULTS: Despite mandatory reporting of quality measures for PPS-exempt cancer hospitals, little consensus exists regarding specific gynecologic cancer measures. Documentation of debulking status, cancer survival, and offering minimally invasive surgery (for endometrial cancer) and intraperitoneal chemotherapy (for ovarian cancer) are important, but with widely variable responses (when ranked 1-12, standard deviations are 2-3). General issues regarding adherence to guidelines for the use of GCSF, documentation of functional status, and tracking of patient satisfaction scores were ranked the lowest. Three of the directors reported that their compensation is partially linked to quality outcomes. CONCLUSIONS: There is wide variability in ranking of quality measures, and may relate to provider or institutional factors. Despite the mandatory reporting in PPS-exempt cancer hospitals, work remains to define gynecologic cancer quality measures.

Patient cost associated with filling a prescription for extended-duration venous thromboembolism (VTE) prophylaxis following surgery for gynecologic cancer.

OBJECTIVE: The primary purpose of this study was to determine the average patient cost for filling a prescription for extended-duration enoxaparin prophylaxis. METHODS: Women who underwent major abdominal/pelvic surgery for histologically confirmed gynecologic malignancy were included. Patients who underwent minimally invasive surgery, had benign disease or were on treatment for existing VTE were excluded. Pharmacy resource specialists electronically submitted test prescriptions to verify enoxaparin coverage in the outpatient setting prior to hospital discharge. Patient co-pay information collected included: the number of patients requiring prescription insurance prior authorization, those qualifying for the Lovenox Patient Assistance Program® (PAP) and insurance status. RESULTS: Three hundred and sixty-four patients were discharged with extended-duration enoxaparin prophylaxis for 28 days between October 2009 and May 2011. The average patient cost to complete 28 days of enoxaparin prophylaxis was $62 (median $21, range $0-1210). Prior authorization was required for 32 patients (10%). Two patients (0.6%) qualified for the Lovenox Patient Assistance Program®. A decrease in the average patient cost from $71 to $52 (median $30 to $10) was observed after generic enoxaparin approval in July 2011. CONCLUSION: Our results show that at least 90% of patients filled their prescription of extended-duration enoxaparin prophylaxis after major abdominal surgery for cancer regardless of cost.

Follow-up study of the correlation between postoperative computed tomographic scan and primary surgeon assessment in patients with advanced ovarian, tubal, or peritoneal carcinoma reported to have undergone primary surgical cytoreduction to residual disease of 1 cm or smaller.

INTRODUCTION: We previously reported a 52% correlation between the primary surgeon's assessment and the postoperative computed tomographic (CT) scan findings of residual disease in patients reported to have undergone cytoreduction to residual disease of 1 cm or smaller. This is a follow-up analysis of survival and prognostic factors for patients who had concordant and discordant postoperative CT scan findings. METHODS: Patients scheduled for primary cytoreductive surgery for presumed advanced ovarian carcinoma were offered enrollment in a prospective study evaluating the ability of preoperative CT scan to predict cytoreductive outcome. If cytoreduction to residual disease of 1 cm or smaller was reported, a CT scan was done 7 to 35 days postoperatively. The CT scan findings were graded by protocol radiologists using a qualitative analysis scale from 1 (normal) to 5 (definitely malignant). RESULTS: From January 2001 to September 2006, 285 patients were enrolled; 67 patients were eligible. Postoperative CT scans confirmed the primary surgeon's assessment of no residual disease larger than 1 cm in 38 cases (57%). In 29 cases (43%), the radiologist found residual disease larger than 1 cm and reported it as probably or definitely malignant. Comparing concordant versus discordant findings, there was no significant difference in median progression-free survival (21 vs 17 months; P = 0.365) or overall survival (60 vs 43 months; P = 0.146). Age (P = 0.040), stage (P = 0.038), and residual disease of 0.5 mm or smaller versus 0.6 to 1.0 cm (P = 0.018) were significant for overall survival on multivariate analysis. CONCLUSIONS: On this follow-up analysis, only age, stage, and residual disease were significant prognostic factors for overall survival. Discordant findings between the primary surgeon's assessment and the postoperative CT scan findings of residual disease was not an independent prognostic factor.

A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer.

STUDY OBJECTIVE: Cervical cancer is a significant health problem in countries of the developing world. Although case series suggest advantages of total laparoscopic radical hysterectomy (TLRH) compared with total abdominal radical hysterectomy (TARH), no randomized controlled trial is currently available to establish TLRH as the new standard treatment. In this study, TLRH or total robotic radical hysterectomy (TRRH) will be performed without a vaginally assisted portion of the procedure. DESIGN: A biphasic randomized controlled trial was designed to test feasibility of recruitment and equivalence in regard to disease-free survival (Canadian Task Force classification I). SETTING: Tertiary referral hospital. PATIENTS: Patients with histologically confirmed invasive squamous cell carcinoma or adenocarcinoma of the cervix, stage IA1 (with lymphovascular space invasion), IA2, and IB1 are eligible. INTERVENTIONS: During the first phase, 100 patients will be randomized (1:1) to receive either TLRH/TRRH or TARH, with the primary end point being the rate of enrollment. During the second phase, recruitment will be extended by another 640 patients in a 1:1 TLRH/TRRH:TARH allocation, to determine equivalence with respect to disease-free survival with 80% power and alpha=0.05. MEASUREMENTS AND MAIN RESULTS: Equivalence will be assumed if the difference in disease-free survival does not exceed 7% at 4 years. Secondary outcomes include treatment-related morbidity, costs and cost effectiveness, patterns of recurrence, quality of life, pelvic floor function, feasibility of intraoperative sentinel node sampling, and overall survival. All data from this multicenter study will be entered using online electronic case report forms, allowing real-time assessment of data completeness and patient follow-up. CONCLUSION: This prospective trial aims to show the equivalence of a TLRH/TRRH versus TARH approach for patients with early stage cervical cancer following a 2-phase protocol. This trial was developed and designed with the input and approval of the members of the Gynecologic Oncology Committee from the American Association of Gynecologic Laparoscopists.