Gender Bias in Clinical Trial Enrollment: Female Authorship Matters.

BACKGROUND: Despite initiatives to promote equal enrollment of human subjects in clinical trials, females continue to be underrepresented. The goal of this work is to determine if female enrollment in human clinical trials published in 3 high-impact journals from 2015 to 2019 is correlated with gender of first and/or senior authors. METHODS: Clinical trials published in the Journal of the American Medical Association (JAMA), The Lancet, and the New England Journal of Medicine (NEJM) from January 1, 2015, to December 31, 2019, were reviewed. Trials were excluded for ongoing enrollment, sex-specific disease research, or author name without gender assignment. One-sample χ2 pairwise comparisons and two-tailed proportion tests on the proportion of females between gender author pairings were done overall and for each subset analysis. RESULTS: In total, 1,427 articles enrolled a total of 2,104,509 females and 2,616,981 males (44.6% vs. 55.4%, P ≤ 0.0001) in clinical trials. Overall, more females were enrolled if both first and senior authors were female (51.7% vs. 48.3%, P ≤ 0.0001). Proportion of females enrolled decreased with the following first and senior author pairings: female-male (48.9%), male-female (48.6%), and male-male (40.5%, P ≤ 0.0001 compared to female-female authorship). Greater female enrollment in clinical trials with female-female compared to male-male authorship persisted in subset analyses by funding source, phase, randomization for study participants, drug and/or device trial, and geographic location. Female enrollment was higher in 3 surgical specialties: neurosurgery (all authors: 52%, P ≤ 0.01), ophthalmology (all authors: 53.6%, P ≤ 0.0001), and surgery (all authors: 54.4%, P ≤ 0.0001). The majority of surgical specialties did not publish trials with female-female authorship but when stratifying by author gender pairing, surgical oncology had the highest female enrollment with female-female authorship (98.4%, P ≤ 0.0001). CONCLUSIONS: Female authorship of clinical trial publications, specifically having both first and senior authors as female, was correlated with higher female enrollment in clinical trials when compared to male authorship and endured with multiple subset analyses.

High Acuity of Postoperative Consults to Emergency General Surgery at an Urban Safety Net Hospital.

BACKGROUND: Emergency general surgery (EGS) has high rates of morbidity, mortality, and readmission. Therefore, it might be expected that an EGS service fields many consultations for postoperative patients. However, with the known overutilization of emergency department visits for nonurgent conditions, we hypothesized most postoperative consults received by an EGS service would be nonurgent and could be appropriately managed as an outpatient. METHODS: We reviewed all EGS consults at a single urban safety net hospital over a 12-month period, screening for patients who had undergone surgery in the previous 12 mo. This included consultations from the emergency room and inpatient setting. Demographics, admission status, procedures performed, and other details were abstracted from the chart and Vizient reports. Consultation questions were categorized and then reviewed by an expert panel to determine if conditions could have been managed as an outpatient. RESULTS: The EGS service received a total of 1112 consults, with 99 (9%) for a postoperative condition. Overall, 85% of postoperative consults were admitted after consultation, 19% underwent surgery and 21% underwent a procedure with gastroenterology or interventional radiology. Expert review classified slightly over one-third (36%) of consults as nonurgent. CONCLUSIONS: Most postoperative consults seen at our urban safety net hospital represent true morbidity that required admission, intervention, or surgery. Despite this high acuity, one-third of postoperative consults could have been managed as an outpatient. Efforts to improve discharge instructions and set patient expectations could limit unnecessary postoperative emergency department visits.

Incidence and Cost of Deep Vein Thrombosis in Emergency General Surgery Over 15 Years.

BACKGROUND: Deep vein thromboses (DVTs) are a significant sequela of surgery and are associated with significant of morbidity and mortality in the United States. Operative emergency general surgery (EGS) cases have been demonstrated to have a greater burden of DVT than other types of surgery. MATERIALS AND METHODS: DVT in EGS cases were identified from the National Inpatient Sample-Healthcare Cost and Utilization Project database from 2001 to 2015 Q3 based on ICD-9 code specification. National incidence of DVT in EGS was calculated using the National Inpatient Sample-Healthcare Cost and Utilization Project sampling methodology, and propensity score matching was used to assess costs associated with DVT. RESULTS: Among 15,148,352 sample-weighted hospitalizations, 0.623% (94,392) experienced DVT. Incidence of DVT was greatest in GI ulcer surgery (1.705%) and lowest in appendectomy (0.095%). Patients with a perioperative DVT incurred $22,301 more in hospital-related costs than their counterparts who did not have a DVT. Although rates of DVT remained stable over the period analyzed, DVT-associated costs increased at a 2.09% annual rate in excess of inflation during the period analyzed. This increase in costs was most significant for laparotomy, which increased at a rate of 8.09% annually. CONCLUSIONS: DVT continues to be a significant burden on resources in EGS in spite of efforts with DVT prophylaxis. Considering the increase in costs and little change in incidence, further research on cost-effective management of DVT in EGS is warranted.