Impact of steroid use and glycemic control on postoperative complications in diabetic gynecologic oncology patients undergoing laparotomy.

Objective: We aimed to assess the impact of preoperative steroid administration and perioperative glycemic control on postoperative complications in diabetic gynecologic oncology patients undergoing laparotomy. Methods: This retrospective cohort study included gynecologic oncology patients with Type I and Type II diabetes (DM) undergoing laparotomy for any gynecologic indication at a single academic center from 10/2017 to 09/2020. The primary outcome was the rate of postoperative complications. Preoperative steroid administration and 24-hour postoperative average serum blood glucose (BG) ≥ 180 mg/dL were the studied exposures. Data was analyzed with SPSS Statistics v.28. Results: 225 patients met inclusion criteria; 47.6 % had postoperative complications. Patient demographics were similar between patients with and without postoperative complications. Patients with complications had higher BMIs (36.8 vs. 34.0; p = 0.03), bowel surgery (33.0 % vs. 17.1 %; p = 0.008), operative time ≥ 240 min (14.2 % vs. 5.1 %; p = 0.02) and average BG ≥ 180 (63.6 % vs. 40.2 %; p < 0.01). On multivariate analysis, bowel surgery (OR 2.4 (1.2-4.8); p = 0.01) and average BG ≥ 180 (OR 2.8 (1.6-4.9); p < 0.01) remained significant predictors of postoperative complications. There were no differences in complication rates (42.3 % vs. 42.6 %; p = 1.0) between patients who received preoperative steroids and those who did not. When stratified by average postoperative BG < 180 mg/dL vs. BG ≥ 180 mg/dL, there was no difference in Clavien-Dindo classification, 30-day readmission rate (28.2 % vs. 22.1 %; p = 0.49) or 30-day mortality rate (2.9 % vs. 0.0 %; p = 0.53). Conclusion: The administration of preoperative steroids did not increase complication rates. Perioperative hyperglycemia was associated with an increased risk of postoperative complications. Optimizing perioperative glycemic control is imperative to decrease postoperative complications.

Early Experiences with Intrathecal Administration of Amphotericin B Liposomal Formulation at a Neurosurgical Center.

BACKGROUND: Intrathecal administration of amphotericin B represents an important adjunctive therapy for management of severe fungal meningitis. Intrathecal preparations have traditionally used amphotericin B deoxycholate. Liposomal amphotericin B is an alternative formulation with good clinical outcomes as systemic therapy, but scant data exist investigating intrathecal use. OBJECTIVE: The aim of this exploratory study was to evaluate outcomes following intrathecal administration of liposomal amphotericin B for treatment of severe fungal meningitis. METHODS: A national shortage of amphotericin B deoxycholate necessitated revision of institutional protocols at a southwestern neurosurgical center in Spring 2023. A starting intrathecal daily dose of 0.125-0.5 mg liposomal amphotericin B was recommended (dependent on insertion device), with 0.125-0.25 mg slow titration every 48 h and up to a 2 mg maximum daily dose. RESULTS: Four cases of fungal meningitis treated with adjunctive intrathecal amphotericin B liposomal formulation were reviewed. This included three cases of coccidioidal meningitis and one case of presumed Fusarium solani meningitis following an outbreak. All patients had initial disease improvement following initiation of intrathecal amphotericin B and were able to tolerate long-term therapy. One coccidioidal meningitis patient expired of neurologic complications shortly after being moved from the intensive care unit (ICU) to a floor unit. All other patients were successfully discharged from the hospital. New headache was the only reported adverse effect, which was managed with dose reduction and did not require therapy discontinuation. CONCLUSIONS: Liposomal amphotericin B may be feasibly administered intrathecally for the adjunctive treatment of severe fungal meningitis.

Rapid administration of undiluted loading doses of levetiracetam.

OBJECTIVE: Rapid administration of antiseizure medications is a critical concept in the treatment of status epilepticus. Although undiluted levetiracetam (LEV) doses of up to 2500 mg have been evaluated, minimal data exist to support the safety of loading doses up to 4500 mg. This study will evaluate intravenous (IV) push administration of undiluted LEV from 2500 to 4500 mg for safety outcomes as well as tolerability. METHODS: This is a retrospective, observational, cohort analysis of adult patients who received at least one loading dose of undiluted IV push LEV from October 15, 2019, to April 30, 2022, at a large academic medical center in Phoenix, Arizona. Relevant outcomes include the safety and tolerability of rapid administration of undiluted LEV at higher loading doses. RESULTS: We evaluated 518 loading doses in 518 unique patients included during the study period. LEV was a new medication for witnessed or suspected seizures in 80.3% of patients, with 31.2% having a documented history of epilepsy or seizure disorder. At the time of LEV administration, 52.9% of patients were on a general medicine floor, 34.3% were in the intensive care unit, and 12.7% were in the emergency department. The median loading dose of LEV was 3600 mg (3000-4000 mg), with 4000 mg being the most common loading dose given. Peripheral IV lines were documented as the only available line in 78.6% of patients for loading dose administration. No adverse events associated with LEV administration were documented. SIGNIFICANCE: Rapid IV administration of undiluted doses of LEV is both safe and tolerable in loading doses of 2500-4500 mg, allowing for rapid drug administration in the setting of status epilepticus.

Use of a mobile health patient engagement technology improves perioperative outcomes in gynecologic oncology patients.

OBJECTIVE: To evaluate the impact of a mobile health patient engagement technology (PET) on postoperative outcomes in gynecologic oncology patients. METHODS: All gynecologic oncology patients undergoing laparotomy on an enhanced recovery program (ERP) were approached from July 2019 to May 2021 to enroll in a PET, which can be accessed by computer, tablet, or smart phone. This platform provides enhanced pre- and postoperative patient education and remote patient monitoring. Patients who elected to participate were provided with targeted education based on their age and comorbidities and were asked to complete daily health checks during the postoperative period. Participants in the PET were compared to patients who opted out as well as to a historical cohort from prior to PET implementation. Patient and procedure-level factors were recorded. The primary outcomes were length of stay (LOS) and 30-day readmission rate. Analysis was performed using SPSS v.26. RESULTS: 682 women met inclusion criteria during the study time; 347 in the PET group and 335 in the control group. Demographic and other factors including race, BMI (kg/m2), Charlson Comorbidity Index (CCI), surgical complexity, and insurance status were not different between the PET and control group; however, patients in the PET cohort were slightly younger (55.0 yo vs. 57.2 yo; p = 0.04). Patients in the PET group had a significantly shorter LOS (2.9 days vs. 3.6 days; p < 0.01) and lower readmission rate (4.3% vs. 8.6%; p < 0.01) when compared with the control group. CONCLUSIONS: Use of a PET in our gynecologic oncology patients decreased LOS by nearly one day despite an absence of differences in other demographic and surgical factors other than age. Furthermore, there was a 50% reduction in readmission rates in the PET group. The use of a PET allows for healthcare professionals to engage, evaluate, and treat patients in a way that improves perioperative care.

Moderate to severe distress in half of ovarian cancer patients undergoing treatment highlights a need for more proactive symptom and psychosocial management.

OBJECTIVE: Distress screening and management is a recommended component of oncology care. Our objective was to evaluate distress rate, sources, and compliance with psychosocial follow-up among ovarian cancer patients receiving chemotherapy. METHODS: We reviewed patient distress surveys completed by ovarian cancer patients receiving chemotherapy from 10/2017-6/2019. Lay or nurse navigators conducted screening with the NCCN Distress Thermometer from 0 (none) to 10 (highest distress). A distress score ≥ 4 (moderate/severe) was considered a positive screen. A recommendation for psychosocial follow-up was automatically generated in the treatment care plan based upon a yes response to any depression-related concern, independent of distress score. Documentation of referral to a mental health professional or social worker for counseling was considered compliant with psychosocial follow-up. We performed descriptive statistics and bivariate analyses. RESULTS: 97/211 (46%) ovarian cancer patients screened positive for distress. Average score was 6.1 for those who screened positive and 3.3 for the entire cohort (range 0-10). Unmarried status (p < 0.01) was associated with positive screen, whereas non-white race (p = 0.26) and recurrent disease (p = 0.21) were not. Median age was older for patients with a positive distress screen (p < 0.01). Among screened patients, the most frequent sources of distress were: cognitive/physical (87%), psychosocial (62%), practical (84%), and family concerns (40%). Of 50 patients recommended to have psychosocial referral, 4 (8%) patients had documented psychiatric follow-up and 19 (38%) patients had documented psychosocial counseling by a social worker. CONCLUSIONS: Nearly half of ovarian cancer patients screened positive for moderate/severe distress. Cancer/treatment-related cognitive/physical symptoms were the most frequent sources. Improved methods of symptom monitoring and management during treatment and resources to address psychosocial concerns are needed to improve distress management of ovarian cancer patients.

Using an Environmentally Friendly Disposal Bag to Discard Leftover Opioids After Gynecologic Surgery.

OBJECTIVE: To evaluate the effects of an environmentally friendly drug deactivation bag on opioid disposal among patients undergoing gynecologic surgery. METHODS: This prospective cohort study included patients undergoing gynecologic procedures requiring an opioid prescription from March 2020 to December 2020. Patients were managed on a restrictive opioid prescribing algorithm and given an opioid disposal bag. The carbon drug deactivation bag neutralizes the opioid medication and can be discarded safely in the trash. Patients were educated about pain management goals and the disposal bag. Patients were surveyed at their postoperative visit to evaluate satisfaction, number of leftover pills, and disposal methods. Statistical analysis was performed using SPSS Statistics 26. RESULTS: Two hundred patients were asked to complete the survey, with a response rate of 78%. The most common procedures were exploratory laparotomy (50%) and minimally invasive hysterectomy (41%). Most patients (91%, 95% CI 91-97) filled their opioid prescription and 64 (41%, 95% CI 34-48) had leftover opioid pills. Most patients with leftover opioid pills (73%, 95% CI 67-79) discarded them; 78%, 95% CI 69-80 used the disposal bag. Patients undergoing an exploratory laparotomy most commonly used the disposal bag. All patients who used the disposal bag stated they would use it again. CONCLUSION: Despite a restrictive opioid prescribing algorithm, 41% of gynecologic surgical patients had leftover opioid pills. This study demonstrated that leftover opioid pills were safely discarded 73% of the time when patients were provided an opioid disposal bag and preoperative education.

An enhanced recovery protocol decreases complication rates in high-risk gynecologic oncology patients undergoing non-emergent laparotomy.

OBJECTIVE: Enhanced recovery protocols are now established as the standard of care leading to improved perioperative outcomes and associated cost-benefits. The objective of this study was to evaluate the impact of an enhanced recovery program on complication rates in high-risk gynecologic oncology patients undergoing surgery. METHODS: This retrospective cohort study included gynecologic oncology patients with pathology-proven malignancy undergoing non-emergent laparotomy from October 2016 to December 2018 managed on an enhanced recovery protocol, and a control group from October 2015 through September 2016 prior to enhanced recovery protocol implementation. The primary outcome was complication rates in a high-risk population pre- and post-enhanced recovery protocol. High-risk patients were defined as those with obesity (body mass index >30 kg/m2) and/or age ≥65 years. Analysis was performed using Statistical Package for Social Sciences (SPSS) v.24. RESULTS: A total of 363 patients met the inclusion criteria: 104 in the control group and 259 in the enhanced recovery protocol group. Patient demographics, including age, body mass index, diagnosis, and performance status, were similar. Overall complication rates were less in the enhanced recovery protocol group (29% vs 53.8%; p<0.0001). The enhanced recovery protocol group had a shorter length-of-stay compared with control (3.3 vs 4.2 days; p<0.0001). The 30-day readmission rates were similar between the groups (9.6% vs 13.5%; p=0.19). In the enhanced recovery protocol group compared with control, complication rates were less in obese patients (29.4% vs 57.8%; p<0.0001), morbidly obese patients (20.9% vs 76.2%; p<0.0001), and age ≥65 (36.1% vs 57.1%; p<0.0001). The most common complications in the enhanced recovery protocol group were ileus (9.7%), pulmonary complications (2.7%), and blood transfusions (10.8%). CONCLUSIONS: Implementation of an enhanced recovery protocol decreases complication rates and length-of-stay in morbidly obese and geriatric patients with gynecologic malignancy without an increase in readmission rates.

Implementation and evaluation of a novel subspecialty society fellows robotic surgical course: the SGO minimally invasive academy surgical curriculum.

OBJECTIVE: To evaluate the utility of a society-based robotic surgery training program for fellows in gynecologic oncology. METHODS: All participants underwent a 2-day robotic surgery training course between 2015-2017. The course included interactive didactic sessions with video, dry labs, and robotic cadaver labs. The labs encompassed a wide range of subject matter including troubleshooting, instrument variation, radical hysterectomies, and lymph node dissections. Participants completed a pre- and post-course survey using a 5-point Likert scale ranging from "not confident" to "extremely confident" on various measures. Statistical analysis was performed using SPSS Statistics v. 24. RESULTS: The response rate was high with 86% of the 70 participants completing the survey. Sixteen (26.7%) of these individuals were attending physicians and 44 (73.3%) were fellows. In general, there was a significant increase in confidence in more complex procedures and concepts such as radical hysterectomy (p=0.01), lymph node dissection (p=0.01), troubleshooting (p=0.001), and managing complications (p=0.004). Faculty comfort and practice patterns were cited as the primary reason (58.9%) for limitations during robotic procedures followed secondarily by surgical resources (34.0%). CONCLUSION: In both gynecologic oncology fellows and attendings, this educational theory-based curriculum significantly improved confidence in the majority of procedures and concepts taught, emphasizing the value of hands-on skill labs.

Class I histone deacetylase inhibition promotes CD8 T cell activation in ovarian cancer.

OBJECTIVE: Patients with epithelial ovarian cancer (EOC) typically present with late-stage disease, posing a significant challenge to treatment. Although taxane and platinum-based chemotherapy plus surgical debulking are initially effective, EOC is marked by frequent recurrence with resistant disease. Immunotherapy represents an appealing treatment paradigm given the ability of immune cells to engage metastatic sites and impede recurrence; however, response rates to checkpoint blockade in ovarian cancer have been disappointing. Here, we tested whether class I HDAC inhibition can promote anti-tumor T cell responses in a spontaneous and nonspontaneous murine model of EOC. METHODS: We used the spontaneous Tg-MISIIR-Tag and nonspontaneous ID8 models of murine ovarian cancer to test this hypothesis. Whole tumor transcriptional changes were assessed using the nCounter PanCancer Mouse Immune Profiling Panel. Changes in select protein expression of regulatory and effector T cells were measured by flow cytometry. RESULTS: We found that treatment with the class I HDAC inhibitor entinostat upregulated pathways and genes associated with CD8 T cell cytotoxic function, while downregulating myeloid derived suppressor cell chemoattractants. Suppressive capacity of regulatory T cells within tumors and associated ascites was significantly reduced, reversing the CD8-Treg ratio. CONCLUSIONS: Our findings suggest class I HDAC inhibition can promote activation of intratumoral CD8 T cells, potentially by compromising suppressive networks within the EOC tumor microenvironment. In this manner, class I HDAC inhibition might render advanced-stage EOC susceptible to immunotherapeutic treatment modalities.

Levetiracetam pharmacokinetics in critically ill patients undergoing renal replacement therapy.

PURPOSE: To determine clearance of levetiracetam in patients requiring continuous renal replacement therapy (CRRT) or sustained low efficiency dialysis (SLED). MATERIALS AND METHODS: Adult patients with acute kidney injury or end stage renal disease requiring either CRRT or SLED and levetiracetam were eligible for inclusion. Simultaneous arterial, venous, and effluent samples for analysis of levetiracetam concentrations were collected every two hours for up to 6-8 h. Levetiracetam clearance (CL) and half-life (t1/2) were calculated for each modality. RESULTS: Eight CRRT patients and 4 SLED patients completed the study: 67% male, mean age 50 ± 13 years, and 83% had AKI. Seven CRRT patients received continuous venovenous hemodiafiltration (CVVHDF) [median pre-replacement rate 700 mL/h (range 500-1000), post-replacement rate 500 mL/h (range 200-1000), effluent rate 2500 mL/h (range 1700-3650) and delivered CRRT dose 27 mL/kg/h (range 19-54)] and one patient received CVV hemofiltration (CVVH). The mm mean levetiracetam CL during CVVHDF was 31.2 ± 8.5 mL/min, and the and the mean t1/2 was 10.4 ± 2.2 h. For the patient requiring CVVH, clearance and t1/2 were 22.5 mL/min and 9.5 h, respectively. Mean levetiracetam CL during SLED performed at a blood flow rate of 250 mL/min and a dialysate flow rate of 100 mL/min was 74.0 ± 25.3 mL/min and t1/2 was 4.8 ± 2.3 h. CONCLUSIONS: Levetiracetam clearance was substantial with both modalities under the operating conditions reported. There is the potential for subtherapeutic concentrations with current recommended dosing strategies that account only for kidney function and not these extracorporeal routes of elimination.

Implementation and evaluation of a novel subspecialty society fellows robotic surgical course: the SGO minimally invasive academy surgical curriculum / 부인종양

Objective@#To evaluate the utility of a society-based robotic surgery training program for fellows in gynecologic oncology. @*Methods@#All participants underwent a 2-day robotic surgery training course between 2015–2017. The course included interactive didactic sessions with video, dry labs, and robotic cadaver labs. The labs encompassed a wide range of subject matter including troubleshooting, instrument variation, radical hysterectomies, and lymph node dissections.Participants completed a pre- and post-course survey using a 5-point Likert scale ranging from “not confident” to “extremely confident” on various measures. Statistical analysis was performed using SPSS Statistics v. 24. @*Results@#The response rate was high with 86% of the 70 participants completing the survey.Sixteen (26.7%) of these individuals were attending physicians and 44 (73.3%) were fellows.In general, there was a significant increase in confidence in more complex procedures and concepts such as radical hysterectomy (p=0.01), lymph node dissection (p=0.01), troubleshooting (p=0.001), and managing complications (p=0.004). Faculty comfort and practice patterns were cited as the primary reason (58.9%) for limitations during robotic procedures followed secondarily by surgical resources (34.0%). @*Conclusion@#In both gynecologic oncology fellows and attendings, this educational theorybased curriculum significantly improved confidence in the majority of procedures and concepts taught, emphasizing the value of hands-on skill labs.

An Association Between Hyperchloremia and Acute Kidney Injury in Patients With Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: While an association between hyperchloremia and worse outcomes, such as acute kidney injury and increased mortality, has been demonstrated in hemorrhagic stroke, it is unclear whether the same relationship exists after acute ischemic stroke. This study aims to determine the relationship between moderate hyperchloremia (serum chloride ≥115 mmol/L) and acute kidney injury in patients with ischemic stroke. METHODS: This is a multicenter, retrospective, propensity-matched cohort study of adults admitted for acute ischemic stroke. The primary objective was to determine the relationship between moderate hyperchloremia and acute kidney injury, as defined by the Acute Kidney Injury Network criteria. Secondary objectives included mortality and hospital length of stay. RESULTS: A total of 407 patients were included in the unmatched cohort (332 nonhyperchloremia and 75 hyperchloremia) and 114 patients (57 in each group) were matched based upon propensity scores. In the matched cohort, hyperchloremia was associated with an increased risk of acute kidney injury (relative risk 1.91 [95% confidence interval 1.01-3.59]) and a longer hospital length of stay (16 vs 12 days; P = .03). Mortality was higher in the hyperchloremia group (19.3% vs 10.5%, P = .19), but this did not reach statistical significance. CONCLUSIONS: In this study, hyperchloremia after ischemic stroke was associated with increased rates of acute kidney injury and longer hospital length of stay. Further research is needed to determine which interventions may increase chloride levels in patients with acute ischemic stroke and the association between hyperchloremia and clinical outcomes.

Decreasing opioid use in postoperative gynecologic oncology patients through a restrictive opioid prescribing algorithm.

OBJECTIVE: The objective of this study was to evaluate the impact of a post-surgical restrictive opioid prescribing algorithm (ROPA) in gynecologic oncology patients. METHODS: This cohort study included gynecologic oncology patients undergoing any surgical procedure from 08/2018-7/2019 after implementation of a ROPA. Patients were compared to historical controls managed without a ROPA from 10/2016-9/2017. Patients were educated preoperatively about pain management goals, the ROPA, and opioid disposal. A 4-tiered system was developed to standardize prescriptions at discharge based on surgical complexity and inpatient opioid requirements. Patients were surveyed at their postoperative visit to assess home opioid use and satisfaction. Statistical analysis was performed using SPSS Statistics v.24. RESULTS: 2549 patients met inclusion criteria; 1321 in the historical control group and 1228 in the ROPA group. Demographics, including age, BMI, and performance status were similar. Compared with the control group, the average number of opioid pills prescribed was significantly lower in the ROPA group (30.5 vs 11.3; p < 0.001) along with the morphine milligram equivalents (MME) (152.5 MME vs. 83.3 MME; p < 0.001). The percentage of patients requiring opioid refill within 30 days was similar (13.0% vs. 12.6%; p = 0.71). 95.7% of patients surveyed were satisfied with their pain regimen. The total number of pills prescribed annually decreased from 34,130 in the control group to 13,888 in the ROPA group. CONCLUSIONS: A restrictive prescribing practice allows for a significantly lower number of opioids to be prescribed to postoperative patients while maintaining patient satisfaction. There was no increase in opioid refill requests using a ROPA in patients undergoing surgery.

Niraparib maintenance in frontline management of ovarian cancer: a cost effectiveness analysis.

OBJECTIVES: Niraparib maintenance after frontline chemotherapy for advanced ovarian cancer extends progression free survival. The objective of this study was to determine the cost effectiveness of niraparib maintenance therapy in patients with newly diagnosed ovarian cancer. METHODS: Decision analysis models compared the cost of observation versus niraparib maintenance following chemotherapy for five groups: all newly diagnosed ovarian cancer patients (overall), those with homologous recombination deficiency, those harboring BRCA mutations (BRCA), homologous recombination deficiency patients without BRCA mutations (homologous recombination deficiency non-BRCA), and non-homologous recombination deficiency patients. Drug costs were estimated using average wholesale prices. Progression free survival was estimated from published data and used to estimate projected overall survival. Incremental cost effectiveness ratios per quality adjusted life year were calculated. Sensitivity analyses varying the cost of niraparib were performed. The willingness-to-pay threshold was set at US$100 000 per quality adjusted life year saved. RESULTS: For the overall group, the cost of observation was US$5.8 billion versus $20.5 billion for niraparib maintenance, with an incremental cost effectiveness ratio of $72 829. For the homologous recombination deficiency group, the observation cost was $3.0 billion versus $14.8 billion for niraparib maintenance (incremental cost effectiveness ratio $56 329). Incremental cost effectiveness ratios for the BRCA, homologous recombination deficiency non-BRCA, and non-homologous recombination deficiency groups were $58 348, $50 914, and $88 741, respectively. For the overall and homologous recombination deficiency groups, niraparib remained cost effective if projected overall survival was 2.2 and 1.5 times progression free survival, respectively. CONCLUSIONS: For patients with newly diagnosed ovarian cancer, maintenance therapy with niraparib was cost effective. Cost effectiveness was improved when analyzing those patients with homologous recombination deficiency and BRCA mutations. Efforts should continue to optimize poly-ADP-ribose polymerase utilization strategies.

Effect of Alteplase Administration on International Normalized Ratio in Patients With Acute Ischemic Stroke.

BACKGROUND/OBJECTIVE: Alteplase may elevate international normalized ratio (INR) results, although the exact rate of elevation occurrence is not firmly established in the literature. The purpose of this study is to determine the occurrence rate of INR elevation following alteplase administration. We also aimed to determine what factors are independently associated with the development of elevated INR following alteplase administration for ischemic stroke. METHODS: We conducted a multicenter, retrospective, cohort study of patients who received alteplase for acute ischemic stroke. Patients were screened for baseline INR measurement and a repeat value within 24 hours of alteplase administration. The primary outcome was the percent of patients who experienced ≥0.4-point increase in INR. Secondary outcomes included the rate of adverse bleeding events and identification of factors independently associated with elevated INR following alteplase administration. RESULTS AND CONCLUSIONS: Two hundred and sixty-one patients were included, with 44 (16.9%) patients having an INR increase of 0.4 or more. Patients with an INR increase ≥0.4 experienced a nonstatistically significant increase in bleeding episodes (8.8% vs 18.2%; P = .10). We identified African American race (odds ratio, 3.48, 95% confidence interval, 1.5-7.6; P = .002) as an independent predictor of INR increase ≥0.04. An INR elevation is common following receipt of alteplase for ischemic stroke. Those of African American race were at increased risk of INR elevation; however, more studies are needed to determine whether these patients are at a higher bleeding risk as a result of INR elevation.

Use of Intraventricular Medications in Critically Ill Patients: A Systematic Review.

New evidence and increased use of intracranial devices have increased the frequency of intraventricular (IVT) medication administration in the neurologic intensive care unit. Significant benefits and risks are associated with administration of medications directly into the central nervous system. This review summarizes important literature, along with key information for clinicians regarding the administration, dosing, monitoring, and adverse effects related to IVT medication usage. Multiple medications have supporting literature for their use in critically ill patients including amphotericin B, aminoglycosides, colistimethate, daptomycin, quinupristin/dalfopristin, vancomycin, alteplase, and nicardipine. Sterile preparation and delivery, along with different types of devices that support medication administration, are also reviewed. One randomized, placebo-controlled trial of alteplase demonstrated decreased mortality but no change in good functional outcome. Other reports of IVT medication use are mainly limited to case reports and retrospective case series. There is a need for increased research on the topic; however, several practical barriers decrease the likelihood of a large, placebo-controlled, prospective study for most indications. Providers should consider implementing protocols to maximize safety of IVT medication delivery to ensure optimal patient outcomes.

The financial impact of an enhanced recovery after surgery (ERAS) protocol in an academic gynecologic oncology practice.

OBJECTIVE: To determine the financial impact of an enhanced recovery after surgery (ERAS) protocol in gynecologic oncology patients. METHODS: This study identified gynecologic oncology patients who were placed on the ERAS protocol after elective laparotomy from 10/2016-6/2017. A control group was identified from the year prior to ERAS implementation. Financial experts assisted in procuring data for these patient encounters, including payer status, direct and indirect costs, contribution margin, and length of stay (LOS). SPSS Statistics v. 24 was used for statistical analysis. RESULTS: 376 patients met criteria for inclusion: 179 in the ERAS group and 197 in the control group. Patient demographics were similar between the two cohorts. Payer status across the groups was not statistically significant in patients with private insurance (control 43.7% vs. ERAS 41.3%), Medicare (38.1% vs. 31.8%), or self-pay patients (12.2% vs. 15.1%). There was a significantly higher number of Medicaid patients in the ERAS group (6.1% vs. 11.7%; p = 0.05). Hospital direct costs ($5596 vs. 5346) and indirect costs ($5182 vs. $4954) per encounter were similar between groups. However, overall contribution margin per encounter decreased in the ERAS group ($11,619 vs. $8528; p = 0.01). LOS was significantly lower in the ERAS group (4.1 vs. 2.9 days; p = 0.04). CONCLUSIONS: Implementation of the ERAS protocol in gynecologic oncology patients does not lead to increased costs for the patient or hospital system. The decreased contribution margin is likely due to a reduction in per diem payments caused by the reduction in LOS. On a per-patient-day basis, contribution margin was the same for both groups ($2877 vs $2857). The reduction in LOS also created capacity for additional cases, the financial impact of which was not evaluated.

Reducing emergency department (ED) computed tomography (CT) utilization in women treated for gynecologic cancers.

OBJECTIVES: The objective of this quality improvement (QI) project was to decrease the rate of low-value computed tomography (CT) imaging in established gynecologic oncology patients presenting to the emergency department (ED). METHODS: This was a cohort study with a before and after design that evaluated implementation of a QI project designed to decrease CT utilization in established gynecologic oncology patients in the ED. The pre-intervention cohort included patients admitted through the ED from 4/1/17 to 5/31/18, while the post-intervention cohort was from 6/1/18 to 5/31/19. The intervention included gynecologic oncology consultation before CT on patients who had imaging within the prior 3 weeks. Details regarding CT, ED length of stay (LOS), and oncologic history were abstracted. The value of CT was determined by consensus from 2 reviewers. Prospective data monitoring evaluated for patient safety. RESULTS: Prior to intervention, there were 129 unique ED encounters in gynecologic oncology patients leading to admission. CT scans were performed in 101 (78.3%) encounters, 57.7% of which were deemed to be of low-value. Following implementation, the CT utilization rate decreased significantly from median monthly rate of 75.2% to 49.1% (p < 0.00001), and the ED LOS decreased from 8.1 to 6.9 h (p = 0.0102). The number of CT scans deemed to be low-value in the post-intervention group decreased to 2 (3.8%). CONCLUSIONS: Implementation of an early consultation policy and imaging guidelines led to a significant decrease in unnecessary CT utilization and shorter ED LOS in gynecologic oncology patients presenting to the ED.

Pyridoxine for prevention and treatment of PARP inhibitor induced nausea and vomiting.

Poly-ADP ribose polymerase inhibitors (PARPi) are a promising new treatment option for patients with ovarian cancer and are moderately emetogenic. Tolerance of therapy is paramount, and uncontrolled nausea and vomiting may limit use. Although most patients will experience improvement in nausea and vomiting after one to two months, approximately one in twenty patients will discontinue therapy due to unrelieved symptom burden. Three cases of olaparib-related nausea and vomiting mitigated by primary pyridoxine use are reported. Case 1 demonstrates successful use of pyridoxine in breakthrough nausea. Case 2 details the use of pyridoxine following refractory nausea and vomiting requiring hospitalization. Case 3 describes a prophylactic approach for a patient with significant anticipatory nausea. All three patients tolerated olaparib after starting and continuing pyridoxine. Vitamin B6, or pyridoxine, was successful as both a therapeutic and prophylactic option for significant treatment-related nausea and vomiting with PARPi use.

Pembrolizumab in advanced recurrent endometrial cancer: A cost-effectiveness analysis.

OBJECTIVE: To determine the cost-effectiveness of pembrolizumab in patients with recurrent endometrial cancer that have failed first-line chemotherapy. METHODS: We created a model to evaluate the cost-effectiveness of pembrolizumab compared to pegylated liposomal doxorubicin (PLD) or bevacizumab for the treatment of women with recurrent endometrial cancer who have failed carboplatin and paclitaxel. Microsatellite instability-high (MSI-H) and non-microsatellite instability-high (non-MSI-H) tumors were evaluated. We included 4400 patients in the model; 800 patients were assumed to have MSI-H tumors. Drug costs were calculated using 2016-2017 wholesale acquisition costs, and cost of Grade III-IV toxicities was estimated from clinical experience. Effectiveness was calculated as 2-year overall survival (OS). We calculated incremental cost-effectiveness ratios (ICERs) to determine the cost per 2-year survivor. Univariate sensitivity analyses were performed. The willingness to pay threshold was $100,000 per year of OS. RESULTS: The cost of therapy with PLD and bevacizumab were $33.2 million (M) and $167.9 M, respectively. The cost of pembrolizumab therapy was $318.3 M for non-MSI-H patients compared to $57.9 M for MSI-H patients. For non-MSI-H patients, bevacizumab was cost-effective relative to PLD with an ICER of $153,028, while pembrolizumab was not cost-effective relative to bevacizumab with an ICER of $341,830. For MSI-H patients, pembrolizumab was cost-effective compared to PLD with an ICER of $147,249, while bevacizumab was subjected to extended dominance. Sensitivity analysis revealed that for non-MSI-H patients, one cycle of pembrolizumab would need to cost $7253 or less to be cost-effective. CONCLUSIONS: For patients with MSI-H recurrent endometrial cancers who have failed first-line chemotherapy, pembrolizumab is cost-effective relative to other single agent drugs. To be cost-effective in non-MSI-H patients, the cost of pembrolizumab should decrease substantially.