Purpose

Inefficiencies in the clinical trial infrastructure result in protracted trial completion timelines, physician-investigator turnover, and a shrinking skilled labor force and present obstacles to research participation. Taken together, these barriers hinder scientific progress. Technological solutions to improve clinical trial efficiency have emerged, yet adoption remains slow because of concerns with cost, regulatory compliance, and implementation.

Methods

A prospective pilot study that compared regulatory-compliant digital and traditional wet ink paper signatures was conducted over a 6.5-month period in a hospital-based health system. Staff time and effort, error rate, costs, and time to completion were measured. Wilcoxon rank sum tests were used to compare staff time and time to completion. A value analysis was conducted. A survey was administered to measure user satisfaction.

Results

There where 96 participants (47 digital, 49 paper), 132 studies included (31 digital, 101 paper), and 265 documents processed (156 digital, 109 paper). A moderate reduction in staff time required to prepare documents for signature was observed (P < .0001). Error rates were reported in 5.1% of digital and 2.8% of paper documents, but this difference was not significant. Discrepancies requiring revisions included incomplete mandatory fields, inaccurate information submitted, and technical issues. A value analysis demonstrated a 19% labor savings with the use of digital signatures. Survey response rate was 57.4% (n = 27). Most participants (85.2%) preferred digital signatures. The time to complete documents was faster with digital signatures compared with paper (P = .0241).

Conclusion

The use of digital signatures resulted in a decrease in document completion time and regulatory burden as represented by staff hours. Additional cost and time savings and information liquidity could be realized by integrating digital signatures and electronic document management systems.

Objective

There are few studies analyzing surveillance for Type II endometrial cancer recurrence. Our objective was to determine the types of post treatment surveillance tests performed in our institution and the efficacy of these tests in detecting recurrence in type II endometrial cancer patients.

Methods

One hundred and thirty six cases of type II endometrial cancers at Cedars-Sinai Medical Center from January of 2000 to August of 2011 were identified and 106 patients met inclusion criteria. Medical charts were reviewed for surveillance methods and number of follow up visits. For patients who underwent a recurrence of disease, the surveillance method utilized for detection was documented.

Results

Forty-seven of the 106 (44%) patients developed recurrence with a mean progression free interval of 11 months. All patients had a history and physical at each surveillance visit, 78% had Pap testing, 57% had CA-125 levels drawn, 59% had CT (computed tomography) scans done, 6% had PET (positron emission tomography) scans done for surveillance. In our cohort, recurrence was detected by symptoms in 16, by CA-125 in 11, by physical exam in 7, by CT scan in 12, and by PET scan in one patient. No patients had recurrence detected by vaginal cytology.

Conclusions

Although performed in the majority of patients, Pap testing did not detect any recurrences within this cohort. History and physical exam detected the most recurrences. These findings suggest that educating patients about relevant symptoms and performing thorough follow-up exams may be the most important aspects of detecting type II endometrial cancer recurrence.

Objective This study describes the patterns of end of life (EOL) discussions and their impact on the use of aggressive measures in women with terminal gynecologic malignancies at a single institution. Methods An IRB-approved retrospective chart review identified 136 patients who died of gynecologic cancer between 2010 and 2012 with at least one interaction with their oncologists in the last 6 months of life. Aggressive measures were defined as chemotherapy within the last 14 days of life, emergency department (ED) visits, hospital and intensive care unit (ICU) admissions within the last 30 days of life, and inpatient deaths. The frequency and timing of EOL conversations were recorded. Utilization of hospice care was also described. Results In the last 30 days of life, 54 (40%) patients were evaluated in the ED, 67 (49%) were admitted into hospital, and 16 (12%) were admitted to the ICU. Thirteen patients (10%) had chemotherapy in the last 14 days of life. Ninety-seven (71%) patients had a documented EOL conversation, eighteen (19%) as outpatients, and 79 (81%) as inpatients. Thirty (22%) patients died in the hospital. At the time of death, 55 (40%) patients were enrolled in outpatient hospice care. The mean amount of time in hospice was 28 days. Conclusions End of life care discussions rarely occurred in the outpatient setting or > 30 days before death. Inpatient encounters led to discussions about hospice and code status. Evaluation in the ED frequently resulted in escalation of care. Earlier EOL care discussions resulted in less aggressive measures.

Data from colon, breast and prostate cancers suggest that aspirin users have reduced mortality. While the direct mechanism remains uncertain, aspirin can suppress the COX-dependent and independent pathways involved in tumor progression. We hypothesized that aspirin users with clear cell ovarian cancer would have improved survival outcomes. We performed a retrospective review of patients with clear cell ovarian cancer diagnosed between 1995 and 2010, and followed outcomes through 2016. Patients underwent primary cytoreductive surgery followed by platinum-based chemotherapy. Aspirin use was defined by medication documentation in two records more than six months apart. Statistical tests included Fisher's exact, Kaplan-Meier and Cox regression analyses. Seventy-seven patients met inclusion criteria. Fifty-four patients (70%) had stage I-II disease. Thirteen patients (17%) used aspirin. Aspirin users had a statistically longer disease-free survival compared to non-users (HR 0.13, p = .018). While median disease-free survival was not reached for either group, 1 of 13 (8%) aspirin users recurred at 24 months, compared to 18 of 64 (28%) non-users. Aspirin users demonstrated longer overall survival (HR 0.13, p = .015). Median survival was not reached for aspirin users, compared to 166 months for non-users. Aspirin use retained significance (HR 0.13, p = .044) after controlling for age, stage and cytoreductive status. In this small cohort of women with clear cell ovarian cancer, aspirin use correlated with improved disease-free and overall survival, and retained independent significance as a positive prognostic factor. Further research is warranted to confirm these findings before considering aspirin as a therapeutic intervention.

Objective To address a deficiency in clinical trial and research enrollment in gynecologic cancer studies, we launched a paper based patient research registry. To improve registry enrollment, we transitioned to an online registry and trial matching mechanism to aid women in accessing open studies. Methods Utilizing a validated verification platform, we designed a web-based registry and trial matching mechanism for women over age 18. Participants completed a questionnaire to provide information for trial matching. A focus group of registry participants was held 9 months after the start of the study to evaluate barriers to participation. Results A total of 322 women were enrolled in the online registry over a 14 month period which was a 4.3 fold increase over the paper-based registry (p < 0.0001). Two hundred and sixty three (82%) women were matched to at least one study. Fifteen percent (39/263) of those eligible for studies went on to enroll. The online enrollment rate to studies was not different from that observed in the paper-based registry (26/172, p = 0.934), however, the web-based registry linked participants to subsequent studies 27% more rapidly (68 (+/- 98) days vs. 93 (+/- 81) days for the paper-based registry, p = 0.017). Focus group participants identified areas for improvement. Conclusion Web-based patient driven registry provides dramatic improvement in the number of participants enrolled and the time to trial linkage compared to a paper based registry at a single institution. Further studies of barriers to research participation are necessary to improve on this model.

Transversus abdominis plane (TAP) block is a peripheral nerve block directed at the nerves in the anterior abdominal wall. We sought to determine whether TAP block reduces post-operative narcotic use or length of stay after open gynecologic surgery. Among 98 women who underwent an open hysterectomy between July 2016 - July 2017 by a gynecologic oncologist, 73 (74.5%) received a TAP block. The majority of patients who received a TAP block had a vertical incision (86.3%) while the majority of patients who did not receive TAP block had a transverse incision (64%). More patients in the TAP block group underwent cancer debulking compared to the no TAP block group (65.7% versus 8%). The two groups did not differ in post-operative pain scores on day 1, 2, or 3, cumulative narcotic use by post-operative day 3, length of stay, or ileus. We found TAP block after vertical skin incision results in comparable pain scores, narcotic use, and length of stay compared to patients undergoing transverse incisions without TAP block.

Objective

To address a deficiency in clinical trial and research enrollment in gynecologic cancer studies, we launched a paper based patient research registry. To improve registry enrollment, we transitioned to an online registry and trial matching mechanism to aid women in accessing open studies.

Methods

Utilizing a validated verification platform, we designed a web-based registry and trial matching mechanism for women over age 18. Participants completed a questionnaire to provide information for trial matching. A focus group of registry participants was held 9 months after the start of the study to evaluate barriers to participation.

Results

A total of 322 women were enrolled in the online registry over a 14 month period which was a 4.3 fold increase over the paper-based registry (p<0.0001). Two hundred and sixty three (82%) women were matched to at least one study. Fifteen percent (39/263) of those eligible for studies went on to enroll. The online enrollment rate to studies was not different from that observed in the paper-based registry (26/172, p=0.934), however, the web-based registry linked participants to subsequent studies 27% more rapidly (68 (+/-98) days vs. 93 (+/-81) days for the paper-based registry, p=0.017). Focus group participants identified areas for improvement.

Conclusion

Web-based patient driven registry provides dramatic improvement in the number of participants enrolled and the time to trial linkage compared to a paper based registry at a single institution. Further studies of barriers to research participation are necessary to improve on this model.

Objective

This study describes the patterns of end of life (EOL) discussions and their impact on the use of aggressive measures in women with terminal gynecologic malignancies at a single institution.

Methods

An IRB-approved retrospective chart review identified 136 patients who died of gynecologic cancer between 2010 and 2012 with at least one interaction with their oncologists in the last 6 months of life. Aggressive measures were defined as chemotherapy within the last 14 days of life, emergency department (ED) visits, hospital and intensive care unit (ICU) admissions within the last 30 days of life, and inpatient deaths. The frequency and timing of EOL conversations were recorded. Utilization of hospice care was also described.

Results

In the last 30 days of life, 54 (40%) patients were evaluated in the ED, 67 (49%) were admitted into hospital, and 16 (12%) were admitted to the ICU. Thirteen patients (10%) had chemotherapy in the last 14 days of life. Ninety-seven (71%) patients had a documented EOL conversation, eighteen (19%) as outpatients, and 79 (81%) as inpatients. Thirty (22%) patients died in the hospital. At the time of death, 55 (40%) patients were enrolled in outpatient hospice care. The mean amount of time in hospice was 28 days.

Conclusions

End of life care discussions rarely occurred in the outpatient setting or >30 days before death. Inpatient encounters led to discussions about hospice and code status. Evaluation in the ED frequently resulted in escalation of care. Earlier EOL care discussions resulted in less aggressive measures.