Impact of the COVID-19 pandemic on breast cancer screening volumes and patient screening behaviors.

PURPOSE: In order to facilitate targeted outreach, we sought to identify patient populations with a lower likelihood of returning for breast cancer screening after COVID-19-related imaging center closures. METHODS: Weekly total screening mammograms performed throughout 2019 (baseline year) and 2020 (COVID-19-impacted year) were compared. Demographic and clinical characteristics, including age, race, ethnicity, breast density, breast cancer history, insurance status, imaging facility type used, and need for interpreter, were compared between patients imaged from March 16 to October 31 in 2019 (baseline cohort) and 2020 (COVID-19-impacted cohort). Census data and an online map service were used to impute socioeconomic variables and calculate travel times for each patient. Logistic regression was used to identify patient characteristics associated with a lower likelihood of returning for screening after COVID-19-related closures. RESULTS: The year-over-year cumulative difference in screening mammogram volumes peaked in week 21, with 2962 fewer exams in the COVID-19-impacted year. By week 47, this deficit had reduced by 49.4% to 1498. A lower likelihood of returning for screening after COVID-19-related closures was independently associated with younger age (odds ratio (OR) 0.78, p < 0.001), residence in a higher poverty area (OR 0.991, p = 0.014), lack of health insurance (OR 0.65, p = 0.007), need for an interpreter (OR 0.68, p = 0.029), longer travel time (OR 0.998, p < 0.001), and utilization of mobile mammography services (OR 0.27, p < 0.001). CONCLUSION: Several patient factors are associated with a lower likelihood of returning for screening mammography after COVID-19-related closures. Knowledge of these factors can guide targeted outreach to vulnerable patients to facilitate breast cancer screening.

A Surgeon Badge or Text Message Sign-in Intervention Improves Operating Room Start Efficiency.

BACKGROUND: Operating room (OR) efficiency, often measured by first case on-time start (FCOTS) percentage, is an important driver of perioperative team morale and the financial success of a hospital. MATERIALS AND METHODS: In this quasi-experimental study of elective surgical procedures at a single tertiary academic hospital, an intervention requiring attending surgeon attestation of availability via SMS text message or identification badge swipe was implemented. Key measures of OR efficiency were compared before and after the change. RESULTS: FCOTS percentage increased from 61.6% to 66.9% after the intervention (P = 0.01). After adjusting for patient and procedural characteristics, postintervention period remained associated with an increased odds of an on-time start (odds ratio 1.29, P = 0.01). Additionally, procedural start times from the pre- to postintervention period were significantly improved (-0.08 min/day, P = 0.009). CONCLUSIONS: Implementation of an attending surgeon text or badge sign-in process was associated with improved FCOTS percentage and earlier procedure start times.

Pain Management in Breast Surgery: Recommendations of a Multidisciplinary Expert Panel-The American Society of Breast Surgeons.

Opioid overdose accounted for more than 47,000 deaths in the United States in 2018. The risk of new persistent opioid use following breast cancer surgery is significant, with up to 10% of patients continuing to fill opioid prescriptions one year after surgery. Over prescription of opioids is far too common. A recent study suggested that up to 80% of patients receiving a prescription for opioids post-operatively do not need them (either do not fill the prescription or do not use the medication). In order to address this important issue, The American Society of Breast Surgeons empaneled an inter-disciplinary committee to develop a consensus statement on pain control for patients undergoing breast surgery. Representatives were nominated by the American College of Surgeons, the Society of Surgical Oncology, The American Society of Plastic Surgeons, and The American Society of Anesthesiologists. A broad literature review followed by a more focused review was performed by the inter-disciplinary panel which was comprised of 14 experts in the fields of breast surgery, anesthesiology, plastic surgery, rehabilitation medicine, and addiction medicine. Through a process of multiple revisions, a consensus was developed, resulting in the outline for decreased opioid use in patients undergoing breast surgery presented in this manuscript. The final document was reviewed and approved by the Board of Directors of the American Society of Breast Surgeons.

Enhancing Medical Students' Interprofessional Teamwork Through Simulated Room of Errors Experience.

BACKGROUND: Fostering medical students' appreciation for team members particularly those from other disciplines with varying levels of experience promotes a promising beginning to a health care career. METHODS: During surgical clerkship orientation, third-year medical students completed 30-item TeamSTEPPS Teamwork Attitudes Questionnaire preintervention and postintervention, spent 7 min identifying errors in a simulated operating room, followed by recorded physician-led 30-min discussions. RESULTS: Postintervention (67) compared with preintervention (141) mean TeamSTEPPS Teamwork Attitudes Questionnaire domain scores were statistically significantly higher for team structure (4.59, 4.70; P = 0.03) and higher but not significant for leadership (4.74, 4.75; P = 0.86), situation monitoring (4.62, 4.68; P = 0.32), communication (4.40, 4.50; P = 0.14), and decreased for mutual support (4.43, 4.36; P = 0.43). Medical students identified 2%-93% of 33 staged errors and 291 additional errors, which were placed into 14 categories. Soiled gloves in the operative field and urinary bag on the floor were the most frequently identified staged errors. Experienced nurses compared with medical students identified significantly more errors (mean, 17.7 versus 11.7, respectively; P < 0.001). Recognizing errors when lacking familiarity with the operative environment and appreciating teammates' perspectives were themes that emerged from discussions. CONCLUSIONS: This well-received teamwork exercise enabled medical students to appreciate team members' contributions and other disciplines' perspectives, in addition to the synergy that occurs with multidisciplinary teams.

Diabetes Mellitus and Metformin Are Not Associated With Breast Cancer Pathologic Complete Response.

BACKGROUND: Metformin use has been linked to pathologic complete response (pCR) following neoadjuvant chemotherapy for several malignancies. We aimed to investigate the association of diabetes mellitus (DM) and metformin use with pCR in breast cancer. MATERIALS AND METHODS: All breast cancer patients who received neoadjuvant chemotherapy during June 2013-October 2016 at two academic medical centers were identified. A retrospective cohort study evaluated patients who did and did not achieve pCR. Multivariable logistic regression identified independent predictors of pCR, specifically looking at metformin use and DM. RESULTS: The study group included 351 breast cancer patients, with 90 (25.6%) achieving pCR after neoadjuvant chemotherapy. The rate of DM did not differ between those with and without pCR, nor did the rate of metformin use. Multivariable logistic regression identified HER2-positive tumors and smaller preoperative tumor size as predictors of pCR. The estrogen receptor (ER) positivity was associated with an absence of pCR. Importantly, neither DM nor metformin use was predictive of pCR. CONCLUSIONS: This study by the two institutions supports previous data of tumor-related factors known to be associated with pCR; however, the current analysis found neither DM nor metformin to be independently associated with pCR. Thus, additional prospective study is warranted prior to validating metformin as an antitumor agent.

The impact of bariatric surgery on qualitative and quantitative breast density.

BACKGROUND: Obesity and breast density are associated with breast cancer in postmenopausal women. Bariatric surgery effectively treats morbid obesity, with sustainable weight loss and reductions in cancer incidence. We evaluated changes in qualitative and quantitative density; hypothesizing breast density would increase following bariatric surgery. METHODS: Women undergoing bariatric surgery from 1990 to 2015 were identified, excluding patients without a mammogram performed both before and after surgery. Changes in body mass index (BMI), time between mammograms and surgery, and American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) scores were assessed. VolparaDensity™ automated software calculated volumetric breast density (VBD), fibroglandular volume (FGV), and total breast volume for the 82 women with digital data available. Differences between pre- and postsurgery values were assessed. RESULTS: One hundred eighty women were included. Median age at surgery was 50.0 years, with 8.8 months between presurgery mammogram and surgery and 62.3 months between surgery and postsurgery mammogram. Median BMI significantly decreased over the study period (46.0 vs 35.4 kg/m2 ; P < 0.001). No change in BI-RADS scores was seen between the pre- and postsurgery mammograms. Eighty-two women had VolparaDensity™ data available. While VBD increased in these patients, FGV and total breast volume both decreased following bariatric surgery. CONCLUSIONS: Increased VBD, decreased FGV, and decreased total breast volume were seen following bariatric surgery-induced weight loss. There was no difference in qualitative breast density, highlighting the discrepancy between BI-RADS and VolparaDensity™ measurements. Further investigation will be required to determine how differential changes in components of breast density may affect breast cancer risk.

Cases and evidence for panel testing in cancer genetics: Is site-specific testing dead?

Historically in cancer genetic counseling, when a pathogenic variant is found which explains the cancers in the family, at risk family members are offered site-specific testing to identify whether or not they have the previously identified pathogenic variant. Factors such as turnaround times, cost, and insurance coverage all made site-specific testing the most appropriate testing option; however, as turnaround times and costs have substantially dropped and the recognition of double heterozygous families and families with nontraditional presentations has increased, the utility of site-specific testing should be questioned. We present four cases where ordering site-specific testing would have missed a clinically relevant pathogenic variant which raises the question of whether or not site-specific testing should be regularly used in cancer genetic testing.

Impact of Urban Neighborhood Disadvantage on Late Stage Breast Cancer Diagnosis in Virginia.

Research suggests that residents of inner-city urban neighborhoods have higher rates of late stage cancer diagnosis. Identifying urban neighborhoods with high rates of both concentrated disadvantage and late stage cancer diagnosis may assist health care providers to target screening interventions to reduce disparities. The purposes of this study were to (1) create an index to evaluate concentrated disadvantage (CD) using non-racial measures of poverty, (2) determine the impact of neighborhood CD on late stage breast cancer diagnosis in US cities, and (3) to understand the role of obesity on this relationship. We used census block group- (CBG) level poverty indicators from five Virginia cities to develop the index. Breast cancer cases of women aged 18-65 who lived in the five cities were identified from the 2000-2012 Virginia Cancer Registry. A logistic regression model with random intercept was used to evaluate the impact of disadvantage on late stage breast cancer diagnosis. CBG-level maps were developed to geographically identify neighborhoods with both high rates of CD and late breast cancer staging. Over 900 CBGs and 6000 breast cases were included. Global fit of the concentrated disadvantage model was acceptable. The effect of disadvantage on late stage was significant (OR = 1.0083, p = 0.032). Inner-city poverty impacts risk of late stage breast cancer diagnosis. Area-level obesity is highly correlated with neighborhood poverty (ρ = 0.74, p < 0.0001) but the mediating direct and indirect effects are non-significant. Intervening in these high poverty neighborhoods may help combat disparities in late stage diagnosis for urban poor and for minorities living in these underserved neighborhoods, but more study is needed to understanding the complex relationship between concentrated neighborhood poverty, obesity, and late stage diagnosis.

Does Mammographic Density have an Impact on the Margin Re-excision Rate After Breast-Conserving Surgery?

BACKGROUND: Limited and conflicting data exist on an association between mammographic density (MD) and re-excision rates after breast-conserving surgery (BCS). Additionally, the correlation of MD with resection of unnecessary margins during initial BCS is unknown. METHODS: All women with a diagnosis of breast cancer from 2003 to 2012 and enrolled in a larger study on MD were evaluated. Operative and pathology reports were reviewed to determine margin resection and involvement. Mammographic density was determined both by breast imaging-reporting and data system (BI-RADS) classification and by an automated software program (Volpara Solutions). Additional margins were deemed unnecessary if the lumpectomy specimen margin was free of invasive tumor [≥2 mm for ductal carcinoma in situ (DCIS)] or if further re-excision was needed. RESULTS: Of 655 patients, 398 (60.8%) had BCS, whereas 226 (34.5%) underwent initial mastectomy. The women with denser breasts (BI-RADS 3 or 4) underwent initial mastectomy more frequently than the women with less dense breasts (40.0 vs. 30.5%, respectively; p = 0.0118). Of the patients with BCS, 166 (41.7%) required separate re-excision. Additional margins were taken during BCS in 192 (48.2%) patients, with 151 (78.6%) proving to be unnecessary. In the bivariable analysis, the patients with denser breasts according to BI-RADS classification and volumetric density showed a trend toward requiring more frequent re-excision, but this association was not seen in the multivariable analysis. The rate of unnecessary margins did not differ by breast density. In the multivariate analysis, the re-excision rates increased with DCIS (p < 0.0003) and decreased with resection of additional margins (p = 0.0043). CONCLUSIONS: Mammographic density is not associated with an increased need for re-excision or resection of unnecessary margins at initial BCS.

Relationships between preclinical course grades and standardized exam performance.

Success in residency matching is largely contingent upon standardized exam scores. Identifying predictors of standardized exam performance could promote primary intervention and lead to design insights for preclinical courses. We hypothesized that clinically relevant courses with an emphasis on higher-order cognitive understanding are most strongly associated with performance on United States Medical Licensing Examination Step exams and National Board of Medical Examiners clinical subject exams. Academic data from students between 2007 and 2012 were collected. Preclinical course scores and standardized exam scores were used for statistical modeling with multiple linear regression. Preclinical courses were categorized as having either a basic science or a clinical knowledge focus. Medical College Admissions Test scores were included as an additional predictive variable. The study sample comprised 795 graduating medical students. Median score on Step 1 was 234 (interquartile range 219-245.5), and 10.2 % (81/795) scored lower than one standard deviation below the national average (205). Pathology course score was the strongest predictor of performance on all clinical subject exams and Step exams, outperforming the Medical College Admissions Test in strength of association. Using Pathology score <75 as a screening metric for Step 1 score <205 results in sensitivity and specificity of 37 and 97 %, respectively, and a likelihood ratio of 11.9. Performance in Pathology, a clinically relevant course with case-based learning, is significantly related to subsequent performance on standardized exams. Multiple linear regression is useful for identifying courses that have potential as risk stratifiers.

Vessel ligation training via an adaptive simulation curriculum.

BACKGROUND: A cost-effective model for open vessel ligation is currently lacking. We hypothesized that a novel, inexpensive vessel ligation simulator can efficiently impart transferrable surgical skills to novice trainees. MATERIALS AND METHODS: VesselBox was designed to simulate vessel ligation using surgical gloves as surrogate vessels. Fourth-year medical students performed ligations using VesselBox and were evaluated by surgical faculty using the Objective Structured Assessments of Technical Skills global rating scale and a task-specific checklist. Subsequently, each student was trained using VesselBox in an adaptive practice session guided by cumulative sum. Posttesting was performed on fresh human cadavers by evaluators blinded to pretest results. RESULTS: Sixteen students completed the study. VesselBox practice sessions averaged 21.8 min per participant (interquartile range 19.5-27.7). Blinded posttests demonstrated increased proficiency, as measured by both Objective Structured Assessments of Technical Skills (3.23 versus 2.29, P < 0.001) and checklist metrics (7.33 versus 4.83, P < 0.001). Median speed improved from 128.2 s to 97.5 s per vessel ligated (P = 0.001). After this adaptive training protocol, practice volume was not associated with posttest performance. CONCLUSIONS: VesselBox is a cost-effective, low-fidelity vessel ligation model suitable for graduating medical students and junior residents. Cumulative sum can facilitate an adaptive, individualized curriculum for simulation training.

Use of prophylactic postoperative antibiotics during surgical drain presence following mastectomy.

BACKGROUND: National guidelines recommend one dose of perioperative antibiotics for breast surgery and discourage postoperative continuation. However, reported skin and soft tissue infection (SSI) rates after mastectomy range from 1-26 %, higher than expected for clean cases. Utility of routine or selective postoperative antibiotic use for duration of drain presence following mastectomy remains uncertain. METHODS: This study included all female patients who underwent mastectomy without reconstruction at our institution between 2005 and 2012. SSI was defined using CDC criteria or clinical diagnosis of cellulitis. Information on risk factors for infection (age, body mass index [BMI], smoking status, diabetes, steroid use), prior breast cancer treatment, drain duration, and antibiotic use was abstracted from medical records. Multivariable logistic regression was used to assess the association between postoperative antibiotic use and the occurrence of SSI, adjusting for concurrent risk factors. RESULTS: Among 480 patients undergoing mastectomy without reconstruction, 425 had sufficient documentation for analysis. Of these, 268 were prescribed antibiotics (63 %) at hospital discharge. An overall SSI rate of 7.3 % was observed, with 14 % of patients without postoperative antibiotics developing SSI compared with 3.4 % with antibiotics (p < 0.0001). Factors independently associated with SSI were smoking and advancing age. Diabetes, steroid use, BMI, prior breast surgery, neoadjuvant chemotherapy, prior radiation, concomitant axillary surgery, and drain duration were not associated with increased SSI rates. CONCLUSIONS: SSI rates among patients who did and did not receive postoperative antibiotics after mastectomy were significantly different, particularly among smokers and women of advanced age. These patient subgroups may warrant special consideration for postoperative antibiotics.

Concordance of leadership documentation in curricula vitae and recommendation letters among applicants for general surgery residency.

BACKGROUND: Letters of recommendation (LOR) are vital to surgical residency applications. Our prior study demonstrated differences in letter content by applicant sex, including more frequent reference to leadership and awards for male applicants. This study evaluates if leadership activities and awards as documented by the applicant's curriculum vitae (CV) corroborate differences noted in corresponding recommendation letters. METHODS: LORs and CVs for 2016-2017 surgery resident applicants selected for interview at single academic institution were analyzed for documentation of leadership and awards and assessed for concordance. RESULTS: 89 applicant CVs (45 male, 44 female) and 332 LORs (165 male, 167 female) were reviewed for evidence of leadership and awards. While 94 â€‹% of CVs had evidence of leadership, leadership was referenced in LORs more often for men than women (45 â€‹% vs 30 â€‹%, p â€‹= â€‹0.004). References to leadership skills (38 â€‹% vs 21 â€‹%, p=<0.001), elected/appointed office (33 â€‹% vs 16 â€‹%, p â€‹< â€‹0.001), and volunteer/work-related leadership role (12 â€‹% vs 3 â€‹%, p â€‹= â€‹0.001) occurred more commonly for men. Similarly, awards were present in 74 â€‹% of CVs without difference by sex but referenced more commonly for men compared to women (64 â€‹% vs 46 â€‹%, p â€‹= â€‹0.001). CONCLUSION: References to leadership and awards in LORs were more common for men than women applicants, which is not reflective of CV content. Although LOR need not recapitulate CVs, fair appraisal of leadership abilities is encouraged.

Prepectoral Breast Reconstruction Prompts Revisiting the Anatomic Boundaries of the Breast: A Radiographic and Cadaveric study.

BACKGROUND: This study aimed to determine the location of superficial fascial system (SFS) condensations in relation to classic anatomic breast boundaries. Cadaveric studies have provided some understanding, but knowledge about the precise location of these condensations remains limited. METHODS: Preoperative breast MRI was conducted to assess the fascial condensations defining the breast footprint relative to landmarks like the latissimus, clavicle, sternal border, and inframammary fold (IMF). Concurrently, cadaveric mastectomies were performed to measure the breast borders in relation to these landmarks for comparison. RESULTS: 290 breasts underwent preoperative MRI. Eight cadaveric breast dissections were completed. Radiographically, the lateral breast fascial condensation was 3.9 cm medial to the latissimus dorsi, while cadaveric measurements were 4.5 cm. The medial condensation was 2.1 cm lateral to the sternal border radiographically and 4.8 cm to midline in cadavers. The superior fascial condensation was 2.3 cm inferior to the clavicle radiographically and 5.5 cm by dissection. The inferior condensation was above the IMF in 82.7% of breasts by MRI and 100% of cadaveric breasts. MRI and cadaveric investigation showed similar patterns of breast tissue fascial condensations relative to standard breast boundaries. Breast skin flap thickness was greater peripherally (MRI: 11.5 mm, cadaver: 11.1 mm) than centrally (MRI: 6.6 mm, cadaver: 5.5 mm). CONCLUSIONS: MRI and cadaveric analysis demonstrated a close correlation between SFS and standard breast boundaries, although variations existed among subjects. Collaborating with breast oncologists and utilizing preoperative imaging to identify individual fascial condensations may enhance the camouflage of prepectoral implants after mastectomy.

Novel Form of Breast Intraoperative Radiation Therapy with CT-Guided High-Dose-Rate Brachytherapy: Interim Results of a Prospective Phase-II Clinical Trial.

BACKGROUND: Precision breast intraoperative radiation therapy (PB-IORT) is a novel method of IORT that uses customized CT-based treatment plans and high-dose-rate (HDR) brachytherapy. We conducted a phase-II multi-institution trial to evaluate the efficacy of PB-IORT. STUDY DESIGN: Between 2015 and 2022, 3 centers enrolled women aged 45 years and older with invasive or in situ carcinoma measuring 3 cm or smaller and N0 status (n = 358). Breast-conserving surgery was performed, and a multilumen balloon catheter was placed in the lumpectomy bed. CT images were used to create customized HDR brachytherapy plans that delivered 12.5 Gy to the tumor bed. The primary outcome assessed was the 5-year rate of index quadrant tumor recurrence. An interim analysis was conducted after one-third of eligible participants completed 5 years of follow-up. This trial is registered with clinicaltrials.gov (NCT02400658). RESULTS: The cohort comprised 153 participants with a median age of 64 years and median follow-up time of 5.9 years. The estimated 5-year index quadrant tumor recurrence rate and overall survival were 5.08% (95% CI 2.23 to 9.68) and 95.1%, respectively. Locoregional (ipsilateral breast and axilla) and distant recurrence rates were each 1.96%. Seven deaths occurred during the first 5 years of follow-up, with only 1 attributable to breast cancer. Overall, 68.6% of patients experienced any adverse effects, and 4 cases of breast-related severe toxicities were observed. CONCLUSIONS: This study presents the results of a planned interim analysis of a phase-II trial investigating PB-IORT and demonstrates the efficacy and safety of single-fraction, CT-based, HDR brachytherapy after breast-conserving surgery. These findings provide valuable insights into the use of PB-IORT as a treatment modality.

MRI utilization in newly diagnosed breast cancer: a survey of practicing surgeons.

BACKGROUND: Whereas guidelines supporting breast MRI in high-risk screening exist, guidelines for MRI use in newly diagnosed breast cancer are lacking. We, therefore, conducted a study of breast surgeons to determine practice beliefs surrounding MRI use in newly diagnosed breast cancer. METHODS: A survey sent to 2,274 American Society of Breast Surgeons members in December 2010 queried routine MRI use (defined as >75 % of time) in specific clinical scenarios. Analyses were performed by respondent practice setting, practice volume, and practice specialization. Descriptive statistics and subgroup analysis using a χ(2) and logistic regression were used. RESULTS: Responses from 1,012 surgeons (45.5 % response rate) were eligible for analysis. Respondents represented diverse practice settings (20 % academic, 72 % private practice) and volume (≤50 new breast cancer patients, 36 %; 51-100, 26 %; 101-200, 25 %; >200, 13 %). Also, 41 % of surgeons indicated routine MRI use for newly diagnosed patients, with higher rates of use among surgeons from high-volume practices, high specialization, and private practice. Greater consensus in routine MRI use was seen in the setting of extreme mammographic density (87.9 %), strong family history of breast cancer (73.4 %), and invasive lobular carcinoma (69.4 %). Responses were increasingly discordant in setting of pursuing breast conservation (47.4 %), invasive ductal carcinoma (41.8 %), and ductal carcinoma in situ (37.2 %). Personal experience was the most commonly cited influence on MRI use. CONCLUSIONS: Divergent responses in MRI use in newly diagnosed breast cancer reflect clinical uncertainty and variable practice beliefs among breast surgeons. Such diverging practice patterns highlight areas where clinical research and guidelines may be most helpful.

A theory-based decision aid for patients with cancer: results of feasibility and acceptability testing of DecisionKEYS for cancer.

PURPOSE: Appropriate utilization of treatment is a goal for all patients undergoing cancer treatment. Proper treatment maximizes benefit and limits exposure to unnecessary measures. This report describes findings of the feasibility and acceptability of implementing a short, clinic-based decision aid and presents an in-depth clinical profile of the participants. METHODS: This descriptive study used a prospective, quantitative approach to obtain the feasibility and acceptability of a decision aid (DecisionKEYS for Balancing Choices) for use in clinical settings. It combined results of trials of patients with three different common malignancies. All groups used the same decision aid series. Participants included 80 patients with solid tumors (22 with newly diagnosed breast cancer, 19 with advanced prostate cancer, and 39 with advanced lung cancer) and their 80 supporters as well as their physicians and nurses, for a total of 160 participants and 10 health professionals. RESULTS: The decision aid was highly acceptable to patient and supporter participants in all diagnostic groups. It was feasible for use in clinic settings; the overall value was rated highly. Of six physicians, all found the interactive format with the help of the nurse as feasible and acceptable. Nurses also rated the decision aid favorably. CONCLUSIONS: This intervention provides the opportunity to enhance decision making about cancer treatment and warrants further study including larger and more diverse groups. Strengths of the study included a theoretical grounding, feasibility testing of a practical clinic-based intervention, and summative evaluation of acceptability of the intervention by patient and supporter pairs. Further research also is needed to test the effectiveness of the decision aid in diverse clinical settings and to determine if this intervention can decrease overall costs.

Usefulness of prestudy assessment of patient willingness to undergo tissue biopsy for correlative studies in a melanoma vaccine trial.

BACKGROUND: Performing biopsies for correlative studies in cancer trials raises ethical and regulatory concerns and may impact trial accrual negatively. However, strategies to address these concerns remain largely unexplored. PURPOSE: We sought to assess the perceived risk of mandatory tissue biopsies to be performed for research purposes as part of a clinical trial of a melanoma vaccine by administering a pretrial accrual assessment questionnaire in the population of interest. Furthermore, we explored how such survey data may be used to address potential concerns of regulatory and funding organizations that may not be able to assess the risks of those biopsies. Method A total of 91 melanoma patients, similar to potential participants in a melanoma vaccine pilot study, scored their willingness, on a 9-point Likert scale, to participate in vaccine trials involving no skin biopsy versus a skin biopsy resulting in a 3-, 6-, or 12-cm scar. The vaccine trial was performed with skin biopsies leaving a 6-cm scar. Accrual rate was assessed and that accrual was compared to the accrual of two similar vaccine trials without biopsy requirements. RESULTS: A total of 95% of the participants expressed willingness to enter a vaccine trial (likely to highly likely). This proportion decreased to 74%, 63%, and 59%, respectively, for vaccine trials requiring skin biopsy leaving a 3-, 6-, or 12-cm scar. The trial was designed with an estimated 40% decrease in accrual rate compared to prior studies (2 participants expected/month). The resulting trial with a 6-cm biopsy exceeded that accrual rate estimate and had a similar accrual rate to vaccine trials without a biopsy (4.1 vs 2.7-4.6 participants/month). LIMITATIONS: Potential limitations of this study include the exclusion of some questionnaire responses and the post hoc nature of the analysis. CONCLUSION: Willingness to participate in vaccine trials was decreased by the requirement for skin biopsy, but the size of the biopsy was less of a deterrent than expected. Findings from brief surveys may aid in risk assessment during regulatory review, predict acceptability of tissue collection for correlative studies, and support regulatory approval and meeting accrual goals of the study.

Gender Disparity in the Citation of Surgical Research.

BACKGROUND: Women surgeons face numerous barriers to career advancement. Inequitable citation of surgical literature may represent a contributing factor to gender disparities in academic surgery. STUDY DESIGN: This was a cross-sectional analysis of publications from 50 top-ranking surgery journals in 2017 and 2018, as defined by the 2019 InCites Journal Citation Reports. The citation rate of publications by women vs men first authors was compared. Similarly, the citation rate of publications by men vs women last authors was also compared. Adjusted regression analyses of citation rates accounted for the time interval since publication as well as the journal within which the article was published, among other potential confounding factors. RESULTS: A total of 19,084 publications from 48 surgery journals with a median (interquartile range) of 8 (4 to 15) citations contributing to a median (interquartile range) Journal Impact Factor of 4.0 (3.4 to 4.6) were analyzed. Compared with man-first author publications, woman-first author publications demonstrated a 9% lower citation rate (incidence rate ratio 0.91, p < 0.001). Similarly, compared with publications by man-last authors, woman-last author publications demonstrated a 4% lower citation rate (incidence rate ratio 0.96, p = 0.03). These associations persisted after multivariable adjustment for additional confounding factors, however, not on sensitivity analysis of 24 of the highest-ranking journals. CONCLUSIONS: Among top-tier surgical journals, publications by women-first and -last authors were less cited compared with publications by men-first and -last authors, but not among the highest-tier surgical journals. Gender bias may exist in the citation of surgical research, contributing to gender disparities in academic surgery.

Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials.

BACKGROUND: Research on barriers to accrual has typically emphasized factors influencing participation after trial activation. PURPOSE: We sought to identify factors influencing trial design and accrual predictions prior to trial activation associated with sufficient accrual. METHODS: A 30-question web-based survey was sent to the study chair and lead statistician for all 248 phase III trials open in 1993-2002 by five Clinical Trials Cooperative Groups. Questions addressed prior trial experience, trial design elements, accrual predictions, and perceived accrual influences. Accrual sufficiency categorization was derived from Clinical Trials Cooperative Group records: sufficient accrual included trials closed with complete accrual or at interim analysis, insufficient accrual included trials closed with inadequate accrual. Responses were analyzed by respondent role (study chair/lead statistician) and accrual sufficiency. RESULTS: Three hundred and nine eligible responses were included (response rate, 63%; lead statisticians, 81%; and study chairs, 45%), representing trials with sufficient (63%) and insufficient accruals (37%). Study chair seniority or lead statistician experience was not linked to accrual sufficiency. Literature review, study chair's personal experience, and expert opinion within Clinical Trials Cooperative Group most commonly influenced control arm selection. Clinical Trials Cooperative Group experience most influenced accrual predictions. These influences were not associated with accrual sufficiency. Among respondents citing accrual difficulties (41%), factors negatively influencing accrual were not consistently identified. Respondents credited three factors with positively influencing accrual: clinical relevance of study, lack of competing trials, and protocol paralleling normal practice. LIMITATIONS: Perceptions of lead statisticians and study chairs may not accurately reflect accrual barriers encountered by participating physicians or patients. Survey responses may be subject to recall bias. CONCLUSION: Consistent factors explaining poor accrual were not identified, suggesting reasons for poor accrual are not well understood and warrant further study. Alternate strategies for accrual prediction are needed since Clinical Trials Cooperative Group experience is linked to successful and unsuccessful accrual.