Diversity and transparency in gynecologic oncology clinical trials.

PURPOSE: Clinical trials advance the standard of care for patients. Patients enrolled in trials should represent the population who would benefit from the intervention in clinical practice. The aim of this study was to assess whether clinical trials enrolling patients with gynecologic cancers report racial and ethnic participant composition and to examine the level of diversity in clinical trials. METHODS: Using ClinicalTrials.gov, we identified clinical trials enrolling patients with ovarian, uterine/endometrial, cervical, vaginal, and vulvar cancers from 1988 to 2019. Race and ethnicity data were extracted from participant demographics. Descriptive statistics on race, ethnicity, cancer type, location, study status, and sponsor type were calculated. Among trials which reported race and/or ethnicity, sub-analyses were performed on composition of race and ethnicity by funding source, location, and completed study status. RESULTS: A total of 1,882 trials met inclusion criteria; only 179 trials (9.5%) reported race information. Of these, the racial distribution of enrollees was 66.9% White, 8.6% Asian, 8.5% Black/African American, 0.4% Indian/Alaskan Native, 0.1% Native Hawaiian/Pacific Islander, 1.0% more than one race, and 14.5% unknown. Only 100 (5.3%) trials reported ethnicity. Except for trials enrolling patients with cervical cancer which enrolled 65.2% White and 62.1% Non-Hispanic/Latino/a patients, enrollees in trials for other gynecologic cancers were over 80% White and 88% Non-Hispanic/Latino/a. Industry funded trials enrolled higher proportions of White (68.4%) participants than non-industry funded trials (57.5%). Domestic trials report race (11.5%) and ethnicity (7.6%) at higher rates than international trials (6.9% and 2.3%, respectively). Reporting of race (1.7% vs. 13.9%) and ethnicity (1.7% vs. 11.1%) has increased over time for patients enrolled in 2000 vs. 2018. CONCLUSION: Less than 10% of trials enrolling patients with gynecologic malignancies report racial/ethnic participant composition on ClinicalTrials.gov. Accurate reporting of participant race/ethnicity is imperative to ensuring minority representation in clinical trials.

Understanding the spectrum of malignant bowel obstructions in gynecologic cancers and the application of the Henry score.

OBJECTIVE: Malignancy-associated bowel obstruction (MBO) is a potential sequela of advanced gynecologic cancers, adversely impacting both quality of life and prognosis. The Henry score (HS) was developed in a gastrointestinal cancer-predominant population to predict 30-day mortality. We aim to characterize MBO in gynecologic cancers and assess the utility of the HS in this population. METHODS: This is a retrospective review of patients with gynecologic cancer and MBO admitted to a single academic institution from 2016 to 2021. The primary outcome is to characterize malignant small and large bowel obstructions in primary and recurrent gynecologic cancer using readmission and mortality rates. Secondary outcomes are to assess the Henry score and inpatient MBO management. RESULTS: 179 patients totaling 269 were admissions identified, most commonly affecting patients with ovarian cancer. The majority (89.4%) were managed non-operatively while 10.6% were managed surgically. No significant differences were observed in survival for medical versus surgical management. Thirty-day mortality increased with increasing HS (0%, 0-1; 14.3%, 2-3; 40.9%, 4-5). Over 1/3 (34.1%) of patients were readmitted for recurrent or persistent MBO. Goals of care conversations were documented for 56.8% of patients with HS 4-5. Mortality rates across the entire cohort were high-20.1% and 60.9% had died by 1 and 6 months, respectively. CONCLUSIONS: Survival rates following an initial MBO admission are poor. The HS has utility in gynecologic cancers for assessing 30-day mortality and may be a useful tool to aid in the management and counseling of patients with gynecologic cancer and MBO.

Implementation of a Surgical Oncology Disparities Curriculum for Preclinical Medical Students.

BACKGROUND: Underinsured and uninsured surgical-oncology patients are at higher risk of perioperative morbidity and mortality. Curricular innovation is needed to train medical students to work with this vulnerable population. We describe the implementation of and early educational outcomes from a student-initiated pilot program aimed at improving medical student insight into health disparities in surgery. MATERIALS/METHODS: First-year medical students participated in a dual didactic and perioperative-liaison experience over a 10-month period. Didactic sessions included surgical-skills training and faculty-led lectures on financial toxicity and management of surgical-oncology patients. Students were partnered with uninsured and Medicaid patients receiving surgical-oncology care and worked with these patients by providing appointment reminders, clarifying perioperative instructions, and accompanying patients to surgery and clinic appointments. Students' interest in surgery and self-reported comfort in 15 Association of American Medical Colleges core competencies were assessed with preparticipation and postparticipation surveys using a 5-point Likert scale. RESULTS: Twenty-four first-year students were paired with 14 surgical-oncology patients during the 2017-2018 academic year. Sixteen students (66.7%) completed both preprogram and postprogram surveys. Five students (31.3%) became "More Interested" in surgery, whereas 11 (68.8%) reported "Similar Interest or No Change." Half of the students (n = 8) felt more prepared for their surgery clerkship after participating. Median self-reported comfort improved in 7/15 competencies including Oral Communication and Ethical Responsibility. All students reported being "Somewhat" or "Extremely Satisfied" with the program. CONCLUSIONS: We demonstrate that an innovative program to expose preclinical medical students to challenges faced by financially and socially vulnerable surgical-oncology patients is feasible and may increase students' clinical preparedness and interest in surgery.

Clinical Impact of Routine Complete Blood Counts Following Total Knee Arthroplasty.

BACKGROUND: Routine laboratory studies are generally obtained following total knee arthroplasty (TKA), and often continued daily until discharge. This study aims to investigate the utility and cost-effectiveness of complete blood count (CBC) tests following TKA. METHODS: Retrospective review identified 484 patients who underwent primary TKA under a tourniquet at a single institution. Preoperative and postoperative CBC values were collected along with demographic data, use of tranexamic acid (TXA), and transfusion rates. Logistic regression models were calculated for all variables. RESULTS: Twenty-five patients required transfusion following TKA (5.2%). Patients requiring transfusion had significantly lower preoperative hemoglobin compared to patients who did not require transfusion (11.47 vs 13.58 g/dL, P = .005). Risk of transfusion was 5.2 times higher in patients with preoperative anemia (95% confidence interval 2.90-9.35, P < .001). Without TXA, patients were 2.75 times more likely to receive transfusion (95% confidence interval 1.43-5.30, P < .001). An average of 2.9 CBC tests were collected per patient who did not receive medical intervention, costing a total of $144,773.80 in associated hospital charges ($316.10 per patient). CONCLUSION: Ensuring quality, cost-effective patient care following total joint arthroplasty is essential in the era of bundled payments. Routine postoperative CBCs do not add value for patients with normal preoperative hemoglobin who receive TXA during TKA performed under tourniquet. Patients who are anemic preoperatively or do not receive TXA should obtain a postoperative CBC test. Daily CBCs are unnecessary if the first postoperative CBC does not prompt intervention.

When Should Complete Blood Count Tests Be Performed in Primary Total Hip Arthroplasty Patients?

BACKGROUND: Routine laboratory studies are often obtained following total hip arthroplasty (THA). Moreover, laboratory studies are often continued daily until the patient is discharged regardless of medical management. The purpose of this study was to investigate the use of routine complete blood count (CBC) tests following THA. Secondarily, the purpose was to identify patient factors associated with abnormal postoperative lab values. METHODS: This retrospective review identified 352 patients who underwent primary THA at a single institution from 2012 to 2014. Preoperative and postoperative CBC values were collected along with demographic data, use of tranexamic acid (TXA), and transfusion rates. Logistic regression models were used to identify factors associated with an abnormal postoperative lab and risk of transfusion. RESULTS: Of the 352 patients, 54 patients were transfused (15.3%). Patients who underwent transfusion had a significantly lower preoperative hemoglobin (Hb; 12.0 g/dL) compared to patients who did not undergo transfusion (13.5 g/dL; P < .001). Patients who did not receive TXA were 3.7 times more likely to receive a transfusion. No patients received medical intervention based on the outcome of postoperative platelet or white blood counts. A Hb value below 11.94 g/dL for patients who are anemic preoperative or did not receive TXA predicted transfusion after postoperative day 1. CONCLUSION: Under value-based care models, cost containment while maintaining high-quality patient care is critical. Routine postoperative CBC tests in patients with a normal preoperative Hb who receive TXA do not contribute to actionable information. Patients who are anemic before THA or do not receive TXA should at minimum obtain a CBC on postoperative day 1.

Time to Steroid Independence After Laser Interstitial Thermal Therapy vs Medical Management for Treatment of Biopsy-Proven Radiation Necrosis Secondary to Stereotactic Radiosurgery for Brain Metastasis.

BACKGROUND: Radiation necrosis (RN) after stereotactic radiosurgery (SRS) for brain metastases (BM) can result in significant morbidity, compounded by the effects of extended steroid therapy. Laser interstitial thermal therapy (LITT) is a minimally invasive procedure that can offer definitive treatment for RN while potentially obviating the need for prolonged steroid use. OBJECTIVE: To compare LITT vs medical management (MM) in the treatment of RN. METHODS: A multicenter, retrospective study was performed of SRS-treated patients with BM who developed biopsy-proven RN and were treated with LITT or MM. Clinical outcome data were compared by treatment modality. RESULTS: Seventy-two patients met criteria with a median follow-up of 10.0 months (4.2-25.1), and 57 patients (79%) underwent LITT. Four MM (27%) and 3 LITT patients (5%) demonstrated radiographic progression (P = .031) at a median of 5.3 and 4.0 months (P = .40). There was no significant difference in overall survival (LITT median of 15.2 vs 11.6 months, P = .60) or freedom from local progression (13.6 vs 7.06 months, P = .40). Patients stopped steroid therapy earlier in the LITT cohort at a median of 37 days compared with 245 days (P < .001). When controlled for follow-up duration, patients treated with LITT were 3 times more likely to be weaned off steroids before the study end point (P = .003). CONCLUSION: These data suggest that LITT for treatment of biopsy-proven RN after SRS for BM significantly decreases time to steroid independence. Prospective trials should be designed to further validate the utility of LITT for RN and its impact on steroid-induced morbidity.

Muscle Flap Closures in Spine Surgery: Predictors of Usage Patterns and Factors Associated With Postoperative Complications From the NSQIP Database.

STUDY DESIGN: Retrospective cohort study using the National Surgical Quality Improvement Program. OBJECTIVE: The objective of this study was to identify preoperative factors that impact the decision to perform prophylactic muscle flap closure and assess risk factors for wound healing complications in patients undergoing spinal procedures with and without muscle flap closure. SUMMARY OF BACKGROUND DATA: Prior studies suggest that muscle flap closure following complex spine surgery results in a lower risk of wound healing complications. However, these studies have been limited to single institutions and/or surgeons. METHODS: The National Surgical Quality Improvement Program database was queried for all patients undergoing spine surgery between 2005 and 2017 with and without concomitant muscle flaps. Preoperative and perioperative variables were extracted. Univariate and multivariate analyses were performed to assess risk factors influencing surgical site infection (SSI) and wound disruption, as well as to delineate which preoperative factors increased the likelihood of patients receiving flap closures a priori. RESULTS: Concomitant muscle flaps were performed on 758 patients; 301,670 patients did not receive a flap. Overall 29 (3.83%) patients in the flap group experienced SSI compared to 5154 (1.71%) in the nonflap group (P<0.0001). Preoperative steroid use [odds ratio (OR) 0.5; P<0.0001], wound infection (OR 0.24; P<0.0001), elevated white blood cell count (OR 1.034; P<0.0001), low hematocrit (OR 0.94; P<0.0001), preoperative transfusion (OR 0.22; P=0.0068) were significantly associated with utilization of muscle flaps. Perioperative factors including a contaminated wound (OR 4.72; P<0.0001), the American Society of Anesthesiologists classification of severe disease (OR 1.92; P=0.024), and longer operative time (OR 1.001; P=0.0024) were significantly associated with postoperative wound disruption. In addition, after propensity score matching for these factors that increase risk of wound complications, there was no difference in the rates of SSI between the flap and nonflap group. CONCLUSION: Our results suggest that patients with a higher burden of illness preoperatively are more likely to receive prophylactic paraspinal flaps which can reduce the rates of wound-related complications.

Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database.

OBJECTIVE: To characterize the interventional clinical trials in infertility and to assess whether trial location or industry sponsorship was associated with trial noncompletion. DESIGN: Retrospective review of trials registered with ClinicalTrials.gov. SETTING: None. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Descriptive statistics characterizing the attributes of the clinical trials including intervention type, topic, population, completion status, size, location, sponsor, and results. The effects of the sponsor and trial location on trial noncompletion were assessed via logistic regression. RESULT(S): In total, 505 trials initiated between 2010 and 2020 were included in our analysis. Drug interventions were the most commonly studied (45%); ovarian stimulation trials accounted for 27% of the studies. Live birth was tracked as an outcome by 20% of the studies; 3% of the trials included mental health outcomes. Few trials (15%) enrolled male participants. Only 11% of the trials reported results, and 4% of the trials reported the race or ethnicity of the participants. Most trials (82%) were conducted outside the United States. Overall, 18% of the trials were not completed, most often because of lack of accrual (47%). United States trials had over twice the odds of noncompletion in univariate analysis (odds ratio = 2.48, 95% confidence interval = [1.47, 4.17]); however, this relationship lost significance after adjusting for potential confounders (odds ratio = 0.95, 95% confidence interval = [0.42, 2.14]). Trial sponsorship was not associated with trial noncompletion. CONCLUSION(S): Infertility trials predominantly investigated drug interventions, particularly ovarian stimulation. Live birth was an infrequent outcome despite its relevance to patients. Clinical trials should aim to address the unmet needs in fertility care and be inclusive of underserved populations affected by infertility.

Inpatient palliative care utilization for patients with brain metastases.

INTRODUCTION: Given the high symptom burden and complex clinical decision making associated with a diagnosis of brain metastases (BM), specialty palliative care (PC) can meaningfully improve patient quality of life. However, no prior study has formally evaluated patient-specific factors associated with PC consultation among BM patients. METHODS: We examined the rates of PC consults in a cohort of 1303 patients with BM admitted to three tertiary medical centers from October 2015 to December 2018. Patient demographics, surgical status, 30-day readmission, and death data were collected via retrospective chart review. PC utilization was assessed by identifying encounters for which an inpatient consult to PC was placed. Statistical analyses were performed to compare characteristics and outcomes between patients who did and did not receive PC consults. RESULTS: We analyzed 1303 patients admitted to the hospital with BM. The average overall rate of inpatient PC consultation was 19.6%. Rates of PC utilization differed significantly by patient race (17.5% in White/Caucasian vs 26.0% in Black/African American patients, P = .0014). Patients who received surgery during their admission had significantly lower rates of PC consultation (3.9% vs 22.4%, P < .0001). Patients who either died during their admission or were discharged to hospice had significantly higher rates of PC than those who were discharged home or to rehabilitation (P < .0001). CONCLUSIONS: In our dataset, PC consultation rates varied by patient demographic, surgical status, discharging service, and practice setting. Further work is needed to identify the specific barriers to optimally utilizing specialty PC in this population.

Communication Matters: a Survey Study of Communication Didactics in Obstetrics/Gynecology Residency.

BACKGROUND: Delivery of excellent patient care hinges on effective communication. Improved communication between physicians, patients, and colleagues can facilitate shared decision-making and foster successful interprofessional teams. Despite the importance of this skill, little is understood about the status or acceptability of dedicated communication training during obstetrics and gynecology (OB/GYN) residency. OBJECTIVE: To explore the national landscape of dedicated communication didactics during OB/GYN training. METHODS: Residents and program directors (PDs) at ACGME-accredited programs were emailed anonymized surveys. Survey responses pertaining to communication didactics and trainee experiences were evaluated using descriptive statistics and chi-squared tests. RESULTS: Of 143 PDs, 45 responded (31.5%). Although the total number of residents receiving our survey is unattainable, our 215 resident respondents can be estimated to represent at least 4.4% of trainees. 98.1% of residents reported challenging clinical communication at least monthly, with many reporting this weekly (47.9%) and daily (30.0%). A majority of PDs (77.8%) and residents (67.0%) endorsed interest in communication training. 62.2% of programs reported formally teaching communication skills. Certain topics were infrequently taught yet cited by residents as particularly challenging-such as "diffusing conflict" and "angry patient or family members." PDs tended to significantly overestimate trainee competence in conducting difficult conversations with both patients (p = 0.0003) and interdisciplinary colleagues (p < 0.0001), as compared with resident self-assessments. CONCLUSIONS: Residents encounter frequent challenging communications interactions, and often feel inadequately equipped to navigate them. Dedicated didactics may provide a critical component to optimally educating of the next generation of trainees within OB/GYN and more broadly.

Preconception Evaluation Before In Vitro Fertilization.

IMPORTANCE: Infertility poses a substantial public health problem for women of reproductive age, in the United States and globally. Infertility can be overcome with a variety of emerging assisted reproductive technologies (ARTs). In vitro fertilization (IVF) currently represents the most commonly utilized method of ART and is typically associated with the highest clinical pregnancy rate and live birth rate compared with other infertility treatment options. However, proper preconception evaluation and counseling is paramount for optimizing IVF and pregnancy outcomes. OBJECTIVE: This article aims to outline current guidelines and recommendations for comprehensive preconception evaluation before initiation of IVF. EVIDENCE ACQUISITION: Articles were obtained from PubMed, ACOG committee opinions 781 and 762, and relevant textbook chapters. RESULTS: A variety of recommendations and best practices exist for optimally managing patients seeking IVF. Special attention must be paid to the workup of certain patient populations, such as those with age older than 35 years, uterine abnormalities, comorbidities (especially hypertension, diabetes, and thrombophilias), and obesity. In addition, many lifestyle factors must be addressed before IVF initiation, such as smoking, illicit drug use, and inadequate nutrition. Preconception counseling and expectation management is key to optimizing pregnancy outcome. CONCLUSION AND RELEVANCE: A myriad of patient and environmental factors impact the potential success rates of IVF in treating infertility. Providers must be equipped to provide data-driven, patient-centered counseling before initiation of IVF.

Restarting Therapeutic Anticoagulation After Elective Craniotomy for Patients with Chronic Atrial Fibrillation: A Review of the Literature.

The decision to restart systemic anticoagulation after surgery requires a nuanced risk-benefit analysis. The potential for surgical site bleeding must be balanced against the risk of thromboembolic events. In the context of postoperative neurosurgical patients, the consequences of either hemorrhage or thromboembolism can be devastating. However, few studies to date have attempted to determine the optimal time to resume anticoagulation after craniotomy. As a result, the decision of when to restart anticoagulation remains largely subjective and highly variable between surgeons and institutions. In this study, we aim to develop an algorithm that incorporates existing metrics and expert opinion toward the goal of developing guidelines for restarting anticoagulation after elective craniotomy.

Patient outcomes and tumor control in single-fraction versus hypofractionated stereotactic body radiation therapy for spinal metastases.

OBJECTIVE: Stereotactic body radiation therapy (SBRT) offers efficient, noninvasive treatment of spinal neoplasms. Single-fraction (SF) high-dose SBRT has a relatively narrow therapeutic window, while hypofractionated delivery of SBRT may have an improved safety profile with similar efficacy. Because the optimal approach of delivery is unknown, the authors examined whether hypofractionated SBRT improves pain and/or functional outcomes and results in better tumor control compared with SF-SBRT. METHODS: This is a single-institution retrospective study of adult patients with spinal metastases treated with SF- or three-fraction (3F) SBRT from 2008 to 2019. Demographics and baseline characteristics, radiographic data, and posttreatment outcomes at a minimum follow-up of 3 months are reported. RESULTS: Of the 156 patients included in the study, 70 (44.9%) underwent SF-SBRT (median total dose 1700 cGy) and 86 (55.1%) underwent 3F-SBRT (median total dose 2100 cGy). At baseline, a higher proportion of patients in the 3F-SBRT group had a worse baseline profile, including severity of pain (p < 0.05), average use of pain medication (p < 0.001), and functional scores (p < 0.05) compared with the SF-SBRT cohort. At the 3-month follow-up, the 3F-SBRT cohort experienced a greater frequency of improvement in pain compared with the SF-SBRT group (p < 0.05). Furthermore, patients treated with 3F-SBRT demonstrated a higher frequency of improved Karnofsky Performance Scale (KPS) scores (p < 0.05) compared with those treated with SF-SBRT, with no significant difference in the frequency of improvement in modified Rankin Scale scores. Local tumor control did not differ significantly between the two cohorts. CONCLUSIONS: Patients who received spinal 3F-SBRT more frequently achieved significant pain relief and an increased frequency of improvement in KPS compared with those treated with SF-SBRT. Local tumor control was similar in the two groups. Future work is needed to establish the relationship between fractionation schedule and clinical outcomes.

Split cord malformation in adults: Literature review and classification.

The objective of this study was to summarize the available literature describing the presentation, diagnostic evaluation, and management for adults with Type 1 and Type 2 split spinal cord malformations. A review of the literature was performed using the CINAHL, PubMed, Embase, and Web of Science database, alongside all associated bibliographies, to include studies describing Type 1 and Type 2 split cord malformations diagnosed in patients above the age of 18. All relevant studies of split cord malformations were included, regardless of the year published and terminology used to describe the dysraphism. Clinical case series (≥ 2 patients), cohort studies, and review articles comprising adult patients with radiographically diagnosed diastematomyelia, diplomyelia, or dimyelia were included (Class of Evidence I-IV). A total of 17 unique articles, describing 146 unique adult spinal cord malformation subjects, were included. The most common associated condition was tethered cord syndrome (59.8 %). Operative management for symptomatic split cord malformation was performed in 72.3 % of cases. For those with preoperative neurologic deficits, operative management resulted in symptomatic improvement in 96.6 %, compared to 0 % conservative management (p < 0.05). For those with pain alone, operative management resulted in improvement of 91.1 %, compared to 12.5 % conservative management (p < 0.05). To date, this is the only literature review to include all split cord malformations (SCM Types I and II) presenting in adulthood, with clinical characteristics, associated conditions, and long-term treatment outcomes.

Top Ten Tips Palliative Care Clinicians Should Know About Spinal Tumors.

Nearly 20% of cancer patients develop symptomatic spine metastases. Metastatic spine tumors are most commonly extradural tumors that grow quickly and often cause persistent pain, weakness, paresthesias, urinary/bowel dysfunction, and/or paralysis. Surgical intervention aims to achieve more effective pain management, preserve/restore neurological function, provide local tumor control, and stabilize the spinal column. The desired result of treatment is ultimately to improve a patient's quality of life. Neurosurgeons employ multiple decision frameworks and grading scales to assess the need and effectiveness of a variety of surgical interventions ranging from minimally to maximally invasive. Likewise, palliative care offers an array of treatment options that allows the best, individualized plan to be determined for a given patient. Therefore, crossfunctional collaboration between palliative care, radiation oncology, medical oncology, and neurosurgery is crucial both in the maximization of available treatment options and optimization of quality of life for patients.

Importance of Spinal Alignment in Primary and Metastatic Spine Tumors.

Spinal alignment, particularly with respect to spinopelvic parameters, is highly correlated with morbidity and health-related quality-of-life outcomes. Although the importance of spinal alignment has been emphasized in the deformity literature, spinopelvic parameters have not been considered in the context of spine oncology. Because the aim of oncologic spine surgery is mostly palliative, consideration of spinopelvic parameters could improve postoperative outcomes in both the primary and metastatic tumor population by taking overall vertebral stability into account. This review highlights the relevance of focal and global spinal alignment, particularly related to spinopelvic parameters, in the treatment of spine tumors.

Total en bloc resection of primary and metastatic spine tumors.

Primary and metastatic tumors of the spine represent a significant cause of patient morbidity, and present a management challenge to treating providers. From a neurosurgical standpoint, resection surgery may be warranted in cases of spinal instability, progressive disease, neurological compromise, or intractable symptoms. Removal of a tumor "en bloc" offers a more aggressive modality over more conservative resection techniques. En bloc resection entails the removal of the entirety of a tumor without violation of its capsule, and may offer improved rates of local control and overall survival in appropriately selected patients. Conversely, this technique carries a higher complication rate, and requires a unique set of technical skills as compared to more traditional resection. Here, we describe the technical aspects of en bloc resection, as well as specific indications and considerations when employing this operative technique.