Broadening Eligibility Criteria and Diversity among Patients for Cancer Clinical Trials.

BACKGROUND: Certain populations have been historically underrepresented in clinical trials. Broadening eligibility criteria is one approach to inclusive clinical research and achieving enrollment goals. How broadened trial eligibility criteria affect the diversity of eligible participants is unknown. METHODS: Using a nationwide electronic health record-derived deidentified database, we identified a retrospective cohort of patients diagnosed with 22 cancer types between April 1, 2013 and December 31, 2022 who received systemic therapy (N=235,234) for cancer. We evaluated strict versus broadened eligibility criteria using performance status and liver, kidney, and hematologic function around first line of therapy. We performed logistic regression to estimate odds ratios for exclusion by strict criteria and their association with measures of patient diversity, including sex, age, race or ethnicity, and area-level socioeconomic status (SES); estimated the impact of broadening criteria on the number and distribution of eligible patients; and performed Cox regression to estimate hazard ratios for real-world overall survival (rwOS) comparing patients meeting strict versus broadened criteria. RESULTS: When applying common strict cutoffs for eligibility criteria to patients with complete data and weighting each cancer type equally, 48% of patients were eligible for clinical trials. Female (odds ratio, 1.30; 95% confidence interval [CI], 1.25 to 1.35), older (age 75+ vs. 18 to 49 years old: odds ratio, 3.04; 95% CI, 2.85 to 3.24), Latinx (odds ratio, 1.46; 95% CI, 1.39 to 1.54), non-Latinx Black (odds ratio, 1.11; 95% CI, 1.06 to 1.16), and lower-SES patients were more likely to be excluded using strict eligibility criteria. Broadening criteria increased the number of eligible patients by 78%, with the strongest impact for older, female, non-Latinx Black, and lower-SES patients. Patients who met only broadened criteria had worse rwOS versus those with strict criteria (hazard ratio, 1.31; 95% CI, 1.27 to 1.34). CONCLUSIONS: Data-driven evaluation of clinical trial eligibility criteria may optimize the eligibility of certain historically underrepresented groups and promote access to more inclusive trials. (Sponsored by Flatiron Health.).

Sex Differences in Odds of Brain Metastasis and Outcomes by Brain Metastasis Status after Advanced Melanoma Diagnosis.

Sex differences in cancer are well-established. However, less is known about sex differences in diagnosis of brain metastasis and outcomes among patients with advanced melanoma. Using a United States nationwide electronic health record-derived de-identified database, we evaluated patients diagnosed with advanced melanoma from 1 January 2011-30 July 2022 who received an oncologist-defined rule-based first line of therapy (n = 7969, 33% female according to EHR, 35% w/documentation of brain metastases). The odds of documented brain metastasis diagnosis were calculated using multivariable logistic regression adjusted for age, practice type, diagnosis period (pre/post-2017), ECOG performance status, anatomic site of melanoma, group stage, documentation of non-brain metastases prior to first-line of treatment, and BRAF positive status. Real-world overall survival (rwOS) and progression-free survival (rwPFS) starting from first-line initiation were assessed by sex, accounting for brain metastasis diagnosis as a time-varying covariate using the Cox proportional hazards model, with the same adjustments as the logistic model, excluding group stage, while also adjusting for race, socioeconomic status, and insurance status. Adjusted analysis revealed males with advanced melanoma were 22% more likely to receive a brain metastasis diagnosis compared to females (adjusted odds ratio [aOR]: 1.22, 95% confidence interval [CI]: 1.09, 1.36). Males with brain metastases had worse rwOS (aHR: 1.15, 95% CI: 1.04, 1.28) but not worse rwPFS (adjusted hazard ratio [aHR]: 1.04, 95% CI: 0.95, 1.14) following first-line treatment initiation. Among patients with advanced melanoma who were not diagnosed with brain metastases, survival was not different by sex (rwOS aHR: 1.06 [95% CI: 0.97, 1.16], rwPFS aHR: 1.02 [95% CI: 0.94, 1.1]). This study showed that males had greater odds of brain metastasis and, among those with brain metastasis, poorer rwOS compared to females, while there were no sex differences in clinical outcomes for those with advanced melanoma without brain metastasis.

Systemic Anticancer Therapy and Overall Survival in Patients With Very Advanced Solid Tumors.

Importance: Two prominent organizations, the American Society of Clinical Oncology and the National Quality Forum (NQF), have developed a cancer quality metric aimed at reducing systemic anticancer therapy administration at the end of life. This metric, NQF 0210 (patients receiving chemotherapy in the last 14 days of life), has been critiqued for focusing only on care for decedents and not including the broader population of patients who may benefit from treatment. Objective: To evaluate whether the overall population of patients with metastatic cancer receiving care at practices with higher rates of oncologic therapy for very advanced disease experience longer survival. Design, Setting, and Participants: This nationwide population-based cohort study used Flatiron Health, a deidentified electronic health record database of patients diagnosed with metastatic or advanced disease, to identify adult patients (aged ≥18 years) with 1 of 6 common cancers (breast cancer, colorectal cancer, non-small cell lung cancer [NSCLC], pancreatic cancer, renal cell carcinoma, and urothelial cancer) treated at health care practices from 2015 to 2019. Practices were stratified into quintiles based on retrospectively measured rates of NQF 0210, and overall survival was compared by disease type among all patients treated in each practice quintile from time of metastatic diagnosis using multivariable Cox proportional hazard models with a Bonferroni correction for multiple comparisons. Data were analyzed from July 2021 to July 2023. Exposure: Practice-level NQF 0210 quintiles. Main Outcome and Measure: Overall survival. Results: Of 78 446 patients (mean [SD] age, 67.3 [11.1] years; 52.2% female) across 144 practices, the most common cancer types were NSCLC (34 201 patients [43.6%]) and colorectal cancer (15 804 patients [20.1%]). Practice-level NQF 0210 rates varied from 10.9% (quintile 1) to 32.3% (quintile 5) for NSCLC and 6.8% (quintile 1) to 28.4% (quintile 5) for colorectal cancer. No statistically significant differences in survival were observed between patients treated at the highest and the lowest NQF 0210 quintiles. Compared with patients seen at practices in the lowest NQF 0210 quintiles, the hazard ratio for death among patients seen at the highest quintiles varied from 0.74 (95% CI, 0.55-0.99) for those with renal cell carcinoma to 1.41 (95% CI, 0.98-2.02) for those with urothelial cancer. These differences were not statistically significant after applying the Bonferroni-adjusted critical P = .008. Conclusions and Relevance: In this cohort study, patients with metastatic or advanced cancer treated at practices with higher NQF 0210 rates did not have improved survival. Future efforts should focus on helping oncologists identify when additional therapy is futile, developing goals of care communication skills, and aligning payment incentives with improved end-of-life care.

End-of-Life Systemic Oncologic Treatment in the Immunotherapy Era: The Role of Race, Insurance, and Practice Setting.

PURPOSE: Receipt of antineoplastic systemic treatment near end of life (EOL) has been shown to harm patient and caregiver experience, increase hospitalizations, intensive care unit and emergency department use, and drive-up costs; yet, these rates have not declined. To understand factors contributing to use of antineoplastic EOL systemic treatment, we explored its association with practice- and patient-level factors. METHODS: We included patients from a real-world electronic health record-derived deidentified database who received systemic therapy for advanced or metastatic cancer diagnosed starting in 2011 and died within 4 years between 2015 and 2019. We assessed use of EOL systemic treatment at 30 and 14 days before death. We divided treatments into three subcategories: chemotherapy alone, chemotherapy and immunotherapy in combination, and immunotherapy (with/without targeted therapy), and estimated conditional odds ratios (ORs) and 95% CIs for patient and practice factors using multivariable mixed-level logistic regression. RESULTS: Among 57,791 patients from 150 practices, 19,837 received systemic treatment within 30 days of death. We observed 36.6% of White patients, 32.7% of Black patients, 43.3% of commercially insured patients, and 37.0% of Medicaid patients received EOL systemic treatment. White patients and those with commercial insurance were more likely to receive EOL systemic treatment than Black patients or those with Medicaid. Treatment at community practices was associated with higher odds of receiving 30-day systemic EOL treatment than treatment at academic centers (adjusted OR, 1.51). We observed large variations in EOL systemic treatment rates across practices. CONCLUSION: In a large real-world population, EOL systemic treatment rates were related to patient race, insurance type, and practice setting. Future work should examine factors that contribute to this usage pattern and its impact on downstream care.[Media: see text].

Nonfulfillment of desired postpartum permanent contraception and resultant maternal and pregnancy health outcomes.

BACKGROUND: Up to half of the patients requesting postpartum permanent contraception do not undergo the desired procedure. Although nonfulfillment of desired postpartum permanent contraception is associated with increased risk of pregnancy within 12 months of delivery, its long-term reproductive and maternal health outcomes are less clear. OBJECTIVE: This study aimed to determine the association of fulfillment of postpartum permanent contraception with number and timing of subsequent pregnancies and maternal health outcomes. STUDY DESIGN: This was a retrospective single-center cohort chart review study of health outcomes in the 4 years following delivery (2016-2018) for 1331 patients with a documented contraceptive plan of female permanent contraception at time of postpartum discharge from 2012 to 2014. Rates of permanent contraception fulfillment within 90 days of delivery and clinical and demographic characteristics associated with permanent contraception were calculated. We determined number of and time to subsequent pregnancies, and diagnoses of medical comorbidities (hypertension, diabetes mellitus, depression, anxiety, asthma, anemia), sexually transmitted infection, and pregnancy comorbidities (preterm birth, gestational diabetes mellitus, gestational hypertension, preeclampsia, postpartum hemorrhage, low birthweight, intrauterine fetal demise) in the 4 years following delivery. RESULTS: Of the 1331 patients desiring permanent contraception postpartum, 588 (44.1%) had their requests fulfilled within 90 days of delivery and 743 (55.8%) did not. Patients who achieved permanent contraception fulfillment tended to have attended more outpatient prenatal visits, delivered via cesarean delivery, and were older, married, college-educated, and privately insured. Patients who received their desired postpartum permanent contraception were less likely to have subsequent intrauterine pregnancies (P<.001). In those who did not achieve permanent contraception, 22 (9.0%) subsequent pregnancies occurred within 6 months of previous deliveries, and 223 (91.0%) occurred after short interpregnancy intervals (within 18 months). Of 178 continued pregnancies, 26 (14.6%) were delivered preterm. There were no differences between the 2 groups in terms of ever attending an outpatient, preventive, or emergency room visit, or in most nonreproductive health outcomes investigated. CONCLUSION: Nonfulfillment of desired postpartum permanent contraception is associated with subsequent maternal reproductive and nonreproductive health ramifications. Given the barriers to permanent contraception, alternative plans for contraception should be discussed proactively if permanent contraception is not provided.

Systemic Anticancer Therapy at the End of Life-Changes in Usage Pattern in the Immunotherapy Era.

This cohort study evaluates the rate of systemic anticancer therapy use among patients dying of cancer.

Racial inequities in second-line treatment and overall survival among patients with metastatic breast cancer.

BACKGROUND: Black women in the USA have a higher incidence and mortality of metastatic breast cancer (mBC) than White women, while Hispanic women have lower rates. Previous studies have focused on first-line (1L) treatment, but little is known about racial differences in treatment beyond 1L and their impact on outcomes. METHODS: This analysis utilized data from an electronic health record derived de-identified database and included patients with HR+HER2- mBC initiating 2L treatment (including CDK4/6-inhibitor [CDKi]-based, endocrine monotherapy, everolimus combination therapy, and chemotherapy and other systemic therapies) between 2/3/2015 and 7/31/2021. Real-world overall survival (rwOS) was defined as time from 2L initiation to death. Multinomial logistic regression assessed the likelihood of 2L treatment between race/ethnicity groups. Median rwOS was estimated using the Kaplan-Meier method and adjusted hazard ratios were estimated using multivariable Cox proportional hazards models. RESULTS: Among all patients who received 2L, non-Hispanic Black (NHB) and Hispanic/Latino patients were less likely to receive 2L CDKi compared to non-Hispanic White (NHW) patients (36%, 39% vs 42%, respectively). Median rwOS was 20.4, 37.6, and 25.3 months, in NHB, Hispanic/Latino and NHW patients, respectively. The rwOS remained poorer among NHB patients after adjustment (HR = 1.16; p = 0.009). In stratified analysis, adjusted rwOS was similar between NHB and NHW patients among those who received 1L CDKi. CONCLUSIONS: These findings suggest that among patients with HR+HER2- mBC, NHB patients had worse survival beyond front-line setting, mainly among the subset of women who did not receive CDKi at 1L. This inequities in rwOS between race/ethnicity groups was not observed among patients who received 1L CDKi.

An informatics infrastructure to catalyze cancer control research and practice.

PURPOSE: A disconnect often exists between those with the expertise to manage and analyze complex, multi-source data sets, and the clinical, social services, advocacy, and public health professionals who can pose the most relevant questions and best apply the answers. We describe development and implementation of a cancer informatics infrastructure aimed at broadening the usability of community cancer data to inform cancer control research and practice; and we share lessons learned. METHODS: We built a multi-level database known as The Ohio Cancer Assessment and Surveillance Engine (OH-CASE) to link data from Ohio's cancer registry with community data from the U.S. Census and other sources. Space-and place-based characteristics were assigned to individuals according to residential address. Stakeholder input informed development of an interface for generating queries based on geographic, demographic, and disease inputs and for outputting results aggregated at the state, county, municipality, or zip code levels. RESULTS: OH-CASE contains data on 791,786 cancer cases diagnosed from 1/1/2006 to 12/31/2018 across 88 Ohio counties containing 1215 municipalities and 1197 zip codes. Stakeholder feedback from cancer center community outreach teams, advocacy organizations, public health, and researchers suggests a broad range of uses of such multi-level data resources accessible via a user interface. CONCLUSION: OH-CASE represents a prototype of a transportable model for curating and synthesizing data to understand cancer burden across communities. Beyond supporting collaborative research, this infrastructure can serve the clinical, social services, public health, and advocacy communities by enabling targeting of outreach, funding, and interventions to narrow cancer disparities.

A Novel Metric for Hospital Quality in Kidney Cancer Surgery: A Veterans Affairs National Health System Validation of Concept.

INTRODUCTION: We aimed to develop and validate a Compound Quality Score (CQS) as a metric for hospital-level quality of surgical care in kidney cancer at the Veterans Affairs National Health System. METHODS: A retrospective review of 8,965 patients with kidney cancer treated at Veterans Affairs (2005-2015) was performed. Two previously validated process quality indicators (QIs) were explored: the proportion of patients with 1) T1a tumors undergoing partial nephrectomy and 2) T1-T2 tumors undergoing minimally invasive radical nephrectomy. Demographics/comorbidity/tumor characteristics/treatment year were used for case mix adjustments at hospital level. The predicted versus observed ratio of cases was calculated per hospital to generate QI scores using indirect standardization and multivariable regression models. CQS represents the sum of both scores. A total of 96 hospitals were grouped by CQS, and short-term patient-level outcomes were regressed on CQS levels to assess for length of stay (LOS), 30-day complications/readmission, 90-day mortality and total cost of surgical admission. RESULTS: CQS identified 25/33/38 hospitals with higher/lower/average performance, respectively. High performance hospitals had higher nephrectomy volumes (p <0.01). Total CQS independently associated with LOS (ß=-0.04, p <0.01, predicted LOS 0.84 days shorter for CQS=2 versus CQS=-2), 30-day surgical complications (OR=0.88, p <0.01) or 30-day medical complications (OR=0.93, p <0.01) and total cost of surgical admission (ß =-0.014, p <0.01, predicted 12% lower cost for CQS=2 versus CQS=-2). No association was found between CQS and 30-day readmissions or 90-day mortality (all p >0.05), although low event rates were observed (8.9% and 1.7%, respectively). CONCLUSIONS: Variability in quality of surgical care at hospital level can be captured with the CQS among patients with kidney cancer. CQS is associated with relevant short-term perioperative outcomes and surgical cost. QIs should be used to identify, audit and implement quality improvement strategies across health systems.

Why it's hard to see a dermatologist for a skin exam: the patient perspective.

BACKGROUND: In-office skin exams are recommended at least annually for patients who are diagnosed with a basal cell carcinoma or squamous cell carcinoma, but it is unknown what proportion of these patients are receiving skin exams. There are a multitude of reasons why patients have difficulty getting skin exams. AIM: To assess the proportion of patients at our institution who received a skin exam in the 12 months following removal of a basal cell carcinoma or squamous cell carcinoma by Mohs micrographic surgery and to assess the barriers to care that patients faced in receiving a skin exam. METHODS: We conducted an IRB-approved online patient survey. RESULTS: 161 survey respondents said they were able to get a skin exam and 14 said they were not. Patients who did not receive a skin exam agreed significantly more often with the following barriers to care: patient's own schedule, dermatologists' availability, and not knowing a skin exam was recommended (p < 0.005). Patients who did not receive a skin exam said that a reminder text/email/phone call would make them more likely to receive a skin exam. CONCLUSIONS: Patients identify their own schedule, the provider's schedule, and not knowing that a skin exam is recommended as factors making it more difficult for them to receive a skin exam. It is likely that further emphasis about the importance of skin exams, written instructions, or text/email/phone call reminders would make patients who have been previously diagnosed with basal cell carcinoma or squamous cell carcinoma more likely to receive skin exams.

New Baseline Renal Function after Radical or Partial Nephrectomy: A Simple and Accurate Predictive Model.

PURPOSE: Preoperative estimation of new baseline glomerular filtration rate after partial nephrectomy or radical nephrectomy for renal cell carcinoma has important clinical implications. However, current predictive models are either complex or lack external validity. We aimed to develop and validate a simple equation to estimate postoperative new baseline glomerular filtration rate. MATERIALS AND METHODS: For development and internal validation of the equation, a cohort of 7,860 patients with renal cell carcinoma undergoing partial nephrectomy/radical nephrectomy (2005-2015) at the Veterans Affairs National Health System was analyzed. Based on preliminary analysis of 94,327 first-year postoperative glomerular filtration rate measurements, new baseline glomerular filtration rate was defined as the final glomerular filtration rate within 3 to 12 months after surgery. Multivariable linear regression analyses were applied to develop the equation using two-thirds of the renal cell carcinoma Veterans Administration cohort. The simplest model with the highest coefficient of determination (R2) was selected and tested. This model was then internally validated in the remaining third of the renal cell carcinoma Veterans Administration cohort. Correlation/bias/accuracy/precision of equation were examined. For external validation, a similar cohort of 3,012 patients with renal cell carcinoma from an outside tertiary care center (renal cell carcinoma-Cleveland Clinic) was independently analyzed. RESULTS: New baseline glomerular filtration rate (in ml/minute/1.73 m2) can be estimated with the following simplified equation: new baseline glomerular filtration rate = 35 + preoperative glomerular filtration rate (× 0.65) - 18 (if radical nephrectomy) - age (× 0.25) + 3 (if tumor size >7 cm) - 2 (if diabetes). Correlation/bias/accuracy/precision were 0.82/0.00/83/-7.5-8.4 and 0.82/-0.52/82/-8.6-8.0 in the internal/external validation cohorts, respectively. Additionally, the area under the curve (95% confidence interval) to discriminate postoperative new baseline glomerular filtration rate ≥45 ml/minute/1.73 m2 from receiver operating characteristic analyses were 0.90 (0.88, 0.91) and 0.90 (0.89, 0.91) in the internal/external validation cohorts, respectively. CONCLUSIONS: Our study provides a validated equation to accurately predict postoperative new baseline glomerular filtration rate in patients being considered for radical nephrectomy or partial nephrectomy that can be easily implemented in daily clinical practice.

Association between neighborhood disadvantage and fulfillment of desired postpartum sterilization.

BACKGROUND: Adequacy of prenatal care is associated with fulfillment of postpartum sterilization requests, though it is unclear whether this relationship is indicative of broader social and structural determinants of health or reflects the mandatory Medicaid waiting period required before sterilization can occur. We evaluated the relationship between neighborhood disadvantage (operationalized by the Area Deprivation Index; ADI) and the likelihood of undergoing postpartum sterilization. METHODS: Secondary analysis of a single-center retrospective cohort study examining 8654 postpartum patients from 2012 to 2014, of whom 1332 (15.4%) desired postpartum sterilization (as abstracted from the medical record at time of delivery hospitalization discharge) and for whom ADI could be calculated via geocoding their home address. We determined the association between ADI and sterilization completion, postpartum visit attendance, and subsequent pregnancy within 365 days of delivery via logistic regression and time to sterilization via Cox proportional hazards regression. RESULTS: Of the 1332 patients included in the analysis, patients living in more disadvantaged neighborhoods were more likely to be younger, more parous, delivered vaginally, Black, unmarried, not college educated, and insured via Medicaid. Compared to patients living in less disadvantaged areas, patients living in more disadvantaged areas were less likely to obtain sterilization (44.8% vs. 53.5%, OR 0.84, 95% CI 0.75-0.93), experienced greater delays in the time to sterilization (HR 1.23, 95% CI 1.06-1.44), were less likely to attend postpartum care (58.9% vs 68.9%, OR 0.86, CI 0.79-0.93), and were more likely to have a subsequent pregnancy within a year of delivery (15.1% vs 10.4%, OR 1.56, 95% CI 1.10-1.94). In insurance-stratified analysis, for patients with Medicaid, but not private insurance, as neighborhood disadvantage increased, the rate of postpartum sterilization decreased. The rate of subsequent pregnancy was positively associated with neighborhood disadvantage for both Medicaid as well as privately insured patients. CONCLUSION: Living in an area with increased neighborhood disadvantage is associated with worse outcomes in terms of desired postpartum sterilization, especially for patients with Medicaid insurance. While revising the Medicaid sterilization policy is important, addressing social determinants of health may also play a powerful role in reducing inequities in fulfillment of postpartum sterilization.

Cochlear Implantation in Patients With Menière's Disease: Does Disease Activity Affect the Outcome?

OBJECTIVE: Menière's disease (MD) is characterized by episodes of vertigo, tinnitus, and sensorineural hearing loss. In the setting of bilateral deafness due to MD alone or contralateral pathology, cochlear implantation (CI) improves hearing. Active MD is characterized by fluctuating auditory symptoms and vertigo; whereas remittance of vertiginous symptoms and severe, permanent sensorineural hearing loss characterizes the inactive disease state. This study evaluates outcomes for MD patients compared with the general CI population and assesses if disease activity affects implant outcomes. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary referral center. PATIENTS: Twenty-four patients with MD that received CI (7 active, 16 inactive, and 1 Probable Menière's), and 24 age-matched controls. INTERVENTIONS: Cochlear implantation. MAIN OUTCOME MEASURES: Word Recognition Score, Sentence Recognition Score (SRS), and Speech Reception Threshold. RESULTS: Best-aided preoperative and postoperative audiometric data were compared per ear between MD patients and controls and stratified by disease status using descriptive statistics with mixed-effects modeling. Patients with MD derived significantly more benefit from CI than controls when comparing differences between preoperative and postoperative levels for Word Recognition Score (12.2%, p = 0.0236), SRS (12.8%, p = 0.0375), and Speech Reception Threshold (-14.4 dB, p = 0.0188). Active disease status does not negatively impact CI outcomes and patients with active MD may benefit from greater gains in SRS (23.5%, p = 0.0107). CONCLUSIONS: CI provides greater gains in functional hearing for patients with MD compared with age-matched controls. Patients with active MD seem to perform better with respect to SRS following CI than patients with inactive status.

Impact of multidisciplinary engagement in a quality improvement blood conservation protocol for craniosynostosis.

OBJECTIVE: Patients undergoing open cranial vault remodeling for craniosynostosis frequently experience substantial blood loss requiring blood transfusion. Multiple reports in the literature have evaluated the impact of individual blood conservation techniques on blood transfusion rates during craniosynostosis surgery. The authors engaged a multidisciplinary team and assessed the impact of input from multiple stakeholders on the evolution of a comprehensive quality improvement protocol aimed at reducing or eliminating blood transfusion in patients undergoing open surgery for craniosynostosis. METHODS: Over a 4-year period from 2012 to 2016, 39 nonsyndromic patients were operated on by a single craniofacial plastic surgeon. Initially, no clear blood conservation protocol existed, and specific interventions were individually driven. In 2014, a new pediatric neurosurgeon joined the craniofacial team, and additional stakeholders in anesthesiology, transfusion medicine, critical care, and hematology were brought together to evaluate opportunities for developing a comprehensive blood conservation protocol. The initial version of the protocol involved the standardized administration of intraoperative aminocaproic acid (ACA) and the use of a cell saver. In the second version of the protocol, the team implemented the preoperative use of erythropoietin (EPO). In addition, intraoperative and postoperative resuscitation and transfusion guidelines were more clearly defined. The primary outcomes of estimated blood loss (EBL), transfusion rate, and intraoperative transfusion volume were analyzed. The secondary impact of multidisciplinary stakeholder input was inferred by trends in the data obtained with the implementation of the partial and full protocols. RESULTS: Implementing the full quality improvement protocol resulted in a 66% transfusion-free rate at the time of discharge compared to 0% without any conservation protocol and 27% with the intermediate protocol. The administration of EPO significantly increased starting hemoglobin/hematocrit (11.1 g/dl/31.8% to 14.7 g/dl/45.6%, p < 0.05). The group of patients receiving ACA had lower intraoperative EBL than those not receiving ACA, and trends in the final-protocol cohort, which had received both preoperative EPO and intraoperative ACA, demonstrated decreasing transfusion volumes, though the decrease did not reach statistical significance. CONCLUSIONS: Patients undergoing open calvarial vault remodeling procedures benefit from the input of a multidisciplinary stakeholder group in blood conservation protocols. Further research into comprehensive protocols for blood conservation may benefit from input from the full surgical team (plastic surgery, neurosurgery, anesthesiology) as well as additional pediatric subspecialty stakeholders including transfusion medicine, critical care, and hematology.