A Randomized Controlled Trial of the Implementation of BREASTChoice , a Multilevel Breast Reconstruction Decision Support Tool With Personalized Risk Prediction.

OBJECTIVE: To implement the BREASTChoice decision tool into the electronic health record and evaluate its effectiveness. BACKGROUND: BREASTChoice , is a multilevel decision tool that: 1) educates patients about breast reconstruction; 2) estimates personalized risk of complications; 3) clarifies patient preferences; and 4) informs clinicians about patients' risk and preferences. METHODS: A multisite randomized controlled trial enrolled adult women with stage 0-III breast malignancy undergoing mastectomy. Participants were randomized to BREASTChoice or a control website. A survey assessed knowledge, preferences, decisional conflict, shared decision-making, preferred treatment, and usability. We conducted intent-to-treat (ITT), per-protocol (PP) analyses (those randomized to BREASTChoice who accessed the tool), and stratified analyses. RESULTS: 23/25 eligible clinicians enrolled. 369/761 (48%) contacted patients enrolled and were randomized. Patients' average age was 51 years; 15% were older than 65. BREASTChoice participants had higher knowledge than control participants (ITT: mean 70.6 vs. 67.4, P =0.08; PP: mean 71.4 vs. 67.4, P =0.03), especially when stratified by site (ITT: P =0.04, PP: P =0.01), age (ITT: P =0.04, PP: P =0.02), and race (ITT: P =0.04, PP: P =0.01). BREASTChoice did not improve decisional conflict, match between preferences and treatment, or shared decision-making. In PP analyses, fewer high-risk patients using BREASTChoice chose reconstruction. BREASTChoice had high usability. CONCLUSIONS: BREASTChoice is a novel decision tool incorporating risk prediction, patient education, and clinician engagement. Patients using BREASTChoice had higher knowledge; older adults and those from racially minoritized backgrounds especially benefitted. There was no impact on other decision outcomes. Future studies should overcome implementation barriers and specifically examine decision outcomes among high-risk patients.

Factors associated with insomnia symptoms over three years among premenopausal women with breast cancer.

PURPOSE: We examined longitudinal trends and factors associated with insomnia over 3 years in a cohort of young breast cancer patients. METHODS: Women with stage I-III breast cancer at ≤ 45 years were recruited at five institutions from New York, Texas, and North Carolina, within 8 months of diagnosis (n = 836). Participants completed questionnaires every 6 months for 3 years. Linear mixed-effects models were used to examine insomnia over time, using the Women's Health Initiative Insomnia Rating Scale (WHIIRS). We evaluated the relations of insomnia with demographic (age, race, education, income, employment, marital status), clinical (cancer stage, histologic grade, chemotherapy, radiation, hormone therapy, surgery, tumor size, body mass index, hot flashes), and social/behavioral variables (smoking status, social support, physical activity, depressive symptoms). RESULTS: At baseline, 57% of participants met or exceeded the cut-off for clinical insomnia (WHIIRS score ≥ 9). Insomnia symptoms were most prevalent at baseline (p < 0.0001), but decreased significantly throughout follow-up (p < 0.001). However, 42% of participants still experienced insomnia symptoms 3 years after diagnosis. In multivariable models, older age (p = 0.02), hot flashes (p < 0.0001), and depressive symptoms (p < 0.0001) remained significantly associated with insomnia over time. CONCLUSIONS: Insomnia symptoms were most frequent closer to breast cancer diagnosis and treatment, but persisted for some women who were older and those reporting higher hot flashes and depressive symptoms. Survivorship care should include assessing insomnia symptoms, particularly during and immediately after primary treatment. Implementing early interventions for sleep problems may benefit young breast cancer survivors and improve their quality of life.

Deep learning of image-derived measures of body composition in pediatric, adolescent, and young adult lymphoma: association with late treatment effects.

OBJECTIVES: The objective of this study was to translate a deep learning (DL) approach for semiautomated analysis of body composition (BC) measures from standard of care CT images to investigate the prognostic value of BC in pediatric, adolescent, and young adult (AYA) patients with lymphoma. METHODS: This 10-year retrospective, single-site study of 110 pediatric and AYA patients with lymphoma involved manual segmentation of fat and muscle tissue from 260 CT imaging datasets obtained as part of routine imaging at initial staging and first therapeutic follow-up. A DL model was trained to perform semiautomated image segmentation of adipose and muscle tissue. The association between BC measures and the occurrence of 3-year late effects was evaluated using Cox proportional hazards regression analyses. RESULTS: DL-guided measures of BC were in close agreement with those obtained by a human rater, as demonstrated by high Dice scores (≥ 0.95) and correlations (r > 0.99) for each tissue of interest. Cox proportional hazards regression analyses revealed that patients with elevated subcutaneous adipose tissue at baseline and first follow-up, along with patients who possessed lower volumes of skeletal muscle at first follow-up, have increased risk of late effects compared to their peers. CONCLUSIONS: DL provides rapid and accurate quantification of image-derived measures of BC that are associated with risk for treatment-related late effects in pediatric and AYA patients with lymphoma. Image-based monitoring of BC measures may enhance future opportunities for personalized medicine for children with lymphoma by identifying patients at the highest risk for late effects of treatment. KEY POINTS: • Deep learning-guided CT image analysis of body composition measures achieved high agreement level with manual image analysis. • Pediatric patients with more fat and less muscle during the course of cancer treatment were more likely to experience a serious adverse event compared to their clinical counterparts. • Deep learning of body composition may add value to routine CT imaging by offering real-time monitoring of pediatric, adolescent, and young adults at high risk for late effects of cancer treatment.

Feasibility of an embedded palliative care clinic model for patients with an advanced thoracic malignancy.

PURPOSE: Early palliative care (PC) with standard oncology care has demonstrated improved patient outcomes, but multiple care delivery models are utilized. This study prospectively evaluated the feasibility of an embedded PC clinic model and collected patient-reported outcomes (PROs) and caregiver needs. METHODS: In this observational study of embedded outpatient PC for patients with advanced thoracic malignancies treated at The Ohio State University Thoracic Oncology clinic, patients received same-day coordinated oncology and palliative care visits at one clinic location. PC encounters included comprehensive symptom assessment and management, advanced care planning, and goals of care discussion. Multiple study assessments were utilized. We describe the feasibility of evaluating PROs and caregiver needs in an embedded PC model. RESULTS: Forty patients and 28 caregivers were enrolled. PROs were collected at baseline and follow-up visits. Over a 12-month follow-up, 36 patients discontinued study participation due to hospice enrollment, death, study withdrawal, or COVID restrictions. At baseline, 32 patients (80%) rated distress as moderate-severe with clinically significant depression (44%) and anxiety (36%). Survey completion rates significantly decreased over time: 3 months (24 eligible, 66% completed), 6 months (17 eligible; 41% completed), 9 months (9 eligible; 44% completed), and 12 months (4 eligible; 50% completed). CONCLUSION: We found that an embedded PC clinic was feasible, although there were challenges encountered in longitudinal collection of PROs due to high study attrition. Ongoing assessment and expansion of this embedded PC model will continue to identify strengths and challenges to improve patient and caregiver outcomes.

Emotion and contralateral prophylactic mastectomy: A prospective study into surgical decision-making.

OBJECTIVE: Patients with non-familial, unilateral breast cancer have a low risk of contralateral breast cancer. Thus, clinical studies have shown no survival benefit for patients who undergo contralateral prophylactic mastectomy (CPM) compared to those undergoing unilateral surgeries for non-familial unilateral breast cancers. Despite this evidence, there has been a steady increase in rates of CPM in the U.S. Patient factors influencing this choice have been identified in previous studies, but seldom in a prospective manner. This prospective study was designed to assess emotion and any association with a patient's decision to ultimately undergo CPM. METHODS: We recruited patients with newly diagnosed, unilateral, non-metastatic breast cancer, who had not yet had surgery, to participate in a prospective, longitudinal study to examine the impact of emotions on CPM decision-making. RESULTS: Among the 86 final participants, all completed the pre-visit survey (100%) and 52 patients completed the post-visit survey (60%). Patients undergoing CPM were significantly younger than those who did not. There was no statistically significant association between emotion and receipt of CPM. There was a trend towards undergoing CPM in patients with a less open personality type and those with more negative emotion, though not statistically significant. CONCLUSIONS: This study found a trend toward increased CPM receipt in those with less open personality types and more negative emotion, especially post-consultation, but none of these findings was significant. Future work should include development of cancer-specific emotion scales and larger studies of possible connections between emotion, personality type and surgical decision-making for breast cancer patients.

Providing a Constipation Action Plan to Families of Children With Constipation Decreases Health Care Utilization.

OBJECTIVES: To evaluate whether providing a constipation action plan (CAP) to families of children with constipation at outpatient gastroenterology (GI) visits affects health care utilization of the GI department. METHODS: We created a CAP to be included in the after visit summary of children seen in our GI Clinic. We compared the number of patient telephone calls, electronic messages, and urgent care (UC) visits, emergency department (ED) visits, and hospitalizations within 3 months after the visit of patients who received the CAP compared to those who did not using inverse probability treatment weighting (IPTW) analysis. For families who received the CAP at a follow-up visit, we compared these variables in the 3 months before and after the CAP was provided using paired t test and McNemar's test as appropriate. RESULTS: We included 336 patients who received the CAP and 2812 who did not. After IPTW adjustment, there were fewer patient telephone calls for patients who received the CAP (P = 0.0006). The difference in patient electronic messages was not statistically significant (P = 0.09). For the 45 patients who received the CAP at a follow-up visit, there were on average 1.8 more patient telephone calls made prior to receiving the CAP than after (95% confidence interval (CI) = 0.8-2.8; P = 0.0007) and 2.3 more patient electronic messages received (95% CI = 0.1-4.5; P = 0.04). There were no differences in UC/emergency department visits or hospitalizations. CONCLUSIONS: We found that providing a CAP to families of children with constipation decreases health care utilization. Further studies are needed to determine whether this impacts patient outcomes.

Manifestations of Toxic Shock Syndrome in Children, Columbus, Ohio, USA, 2010-20171.

Data are limited on the incidence and management of streptococcal toxic shock syndrome (TSS) and nonstreptococcal TSS in children. We aimed to define the clinical patterns of TSS at Nationwide Children's Hospital in Ohio as they relate to published criteria, diagnostic decisions, and treatment options. Through retrospective chart reviews, we identified 58 patients with TSS (27 streptococcal, 31 nonstreptococcal) during January 2010-September 2017. We observed clinical and laboratory findings that are not part of TSS criteria, such as pyuria in streptococcal TSS (50% of patients) and pulmonary involvement (85%) and coagulopathy (92%) in nonstreptococcal TSS patients. Recommended treatment with clindamycin and intravenous immunoglobulin was delayed in streptococcal TSS patients without rash (3.37 days vs. 0.87 days in patients with rash), leading to prolonged hospitalization and complications. Incorporation of additional TSS signs and symptoms would be helpful in TSS diagnosis and management.

Prevalence and correlates of job and insurance problems among young breast cancer survivors within 18 months of diagnosis.

BACKGROUND: The prevalence and correlates of job and insurance problems were examined among a cohort of young U.S. breast cancer survivors during the first 18-months following diagnosis. METHODS: Participants were 708 women diagnosed at ≤45 years with stage I-III breast cancer. 90% were non-Hispanic white, 76% were married/partnered and 67% had ≥4-year college degree. Univariable and multivariable logistic regression examined the associations between demographic, lifestyle and clinical factors with job and insurance problems. RESULTS: 18-months after diagnosis, 56% of participants worked full-time, 16% part-time, 18% were homemakers and/or students, 4.5% were unemployed, and 2.4% were disabled. The majority (86%) had private insurance. Job-related problems were reported by 40% of women, and included believing they could not change jobs for fear of losing health insurance (35.0%), being fired (2.3%), and being demoted, denied promotion or denied wage increases (7.8%). Greater job-related problems were associated with being overweight vs. under/normal weight (p = 0.006), income <$50,000/per year (p = 0.01), and working full-time vs. part-time (p = 0.003). Insurance problems were reported by 27% of women, and included being denied health insurance (2.6%), health insurance increases (4.3%), being denied health benefit payments (14.8%) or denied life insurance (11.4%). Insurance problems were associated with being under/normal weight vs. obese (p = 0.01), not being on hormone therapy (p < 0.001), and a tumor size > 5 cm vs. < 2 cm (p = 0.01). CONCLUSIONS: Young survivors experienced significant job- and insurance-related issues following diagnosis. To the extent possible, work and insurance concerns should be addressed prior to treatment to inform work expectations and avoid unnecessary insurance difficulties.

SPECT/CT imaging of lower extremity perfusion reserve: A non-invasive correlate to exercise tolerance and cardiovascular fitness in patients undergoing clinically indicated myocardial perfusion imaging.

BACKGROUND: Although exercise is often prescribed for the management of cardiovascular diseases, a non-invasive imaging approach that quantifies skeletal muscle physiology and correlates with patients' functional capacity and cardiovascular fitness has been absent. Therefore, we evaluated the potential of lower extremity single photon emission computed tomography (SPECT)/CT perfusion imaging as a non-invasive correlate to exercise tolerance and cardiovascular fitness. METHODS: Patients (n = 31) undergoing SPECT/CT myocardial perfusion imaging underwent additional stress/rest SPECT/CT imaging of the lower extremities. CT-based image segmentation was used for regional quantification of perfusion reserve within the tibialis anterior, soleus, and gastrocnemius muscles. Metabolic equivalents (METs) at peak exercise and heart rate recovery (HRR) after exercise were recorded. RESULTS: Peak METs were significantly associated with perfusion reserve of tibialis anterior (p = 0.02), soleus (p = 0.01) and gastrocnemius (p = 0.01). HRR was significantly associated with perfusion reserve of the soleus (p = 0.02) and gastrocnemius (p = 0.04) muscles. Perfusion reserve of the tibialis anterior (40.6 ± 20.2%), soleus (35.4 ± 16.7%), and gastrocnemius (29.7 ± 19.1%) all significantly differed from each other. CONCLUSIONS: SPECT/CT imaging provides regional quantification of skeletal muscle perfusion reserve which is significantly associated with exercise tolerance and cardiovascular fitness. Future application of SPECT/CT may elucidate the underlying skeletal muscle adapations to exercise therapy in patients with cardiovascular diseases.

Patient and caregiver preferences for the potential benefits and risks of a seizure forecasting device: A best-worst scaling.

BACKGROUND: Epilepsy is the 4th most common neurological disorder and is characterized by recurrent, unpredictable seizures. The ability to forecast seizures is a significant unmet need and would have a transformative effect on the lives of people living with epilepsy. In an effort to address this need, the Epilepsy Foundation has committed effort and resources to promote the development of seizure forecasting devices (SFD). OBJECTIVE: To promote user-centered design of future SFD, we sought to quantify patient and caregiver preferences for the potential benefits and risks of SFD. METHODS: A community-centered approach was used to develop a survey incorporating a novel best-worst scaling (BWS) to assess preferences for SFD. A main-effect orthogonal array was used to design and generate 18 "prototypes" that systematically varied across six attributes: seizure forecasting probability, seizure forecasting range, inaccuracy of forecasting, amount of time required to use the device, how the device is worn, and cost. The dependent variable was the attributes that respondents selected the best and worst in each profile, and a choice model was estimated using conditional logistic regression, which was also stratified and compared across patients and caregivers. Respondents also indicated that they would accept each of the prototype SFDs if it were real. These acceptance data and net monetary benefits (relative to the least preferred SFD) were explored. RESULTS: There were 633 eligible respondents; 493 (78%) completed at least one task. Responses indicated that 346 (68%) had epilepsy, and 147 (29%) were primary caregivers or family members of someone with epilepsy. The data show that short forecasting range is the most favored among experimental attributes, followed by mid forecasting range and notification of high chance of seizure. Having the device implanted is the least favorable attribute. Stated preferences differed between patients and caregivers (p < 0.001) for range of forecasting and inaccuracy of device. Caregivers preferred any range of forecasting, regardless of length, more than patients. Patients cared less about inaccuracy of the device compared to caregivers. The groups also differ in impact of fear of having seizures (versus actually having seizures) (p = 0.034) and on device acceptance. The acceptance of devices ranged from 42.3% to 95%, with caregivers being more likely to use a device (p < 0.05) for the majority of device profiles. Acceptance of devices varied with net monetary benefit of the best device being $717.44 more per month relative to the least preferred device. CONCLUSION: Our finding extends previous calls for seizure forecasting devices by demonstrating the value that they might provide to patients and caregivers affected by epilepsy and the feature that might be most and least desirable. In addition to guiding device development, the data can help inform regulatory decisions makers.

The FITNESS study: longitudinal geriatric assessment, treatment toxicity, and biospecimen collection to assess functional disability among older adults with lung cancer.

Introduction: Older adults with chronic disease prioritize functional independence. We aimed to describe the feasibility of capturing functional disability and treatment toxicity among older adults with lung cancer using a longitudinal comprehensive geriatric assessment (CGA) and molecular biomarkers of aging. Methods: This prospective study included adults ≥60 years with any newly diagnosed non-small-cell lung cancer. Participants were recruited from central Ohio (2018-2020). Study assessments included the Cancer and Aging Research Group CGA (CARG-CGA), short physical performance battery (SPPB), and the blessed orientation-memory concentration (BOMC) test at baseline, 3, 6, and 12 months. Activities of daily living (ADLs) and instrumental ADLs (IADLs), quality of life (QoL, PROMIS 10), and treatment toxicity were captured monthly. Stool and blood were collected to characterize the gut microbiome and age-related blood biomarkers. Results: This study enrolled 50 participants with an average age of 71.7 years. Ninety-two percent of participants were Caucasian, 58% were male, and all were non-Hispanic. Most had advanced stage (stage III/IV: 90%; stage I/II: 10%), with adenocarcinoma the predominant histologic subtype (68% vs. 24% squamous). First-line treatments included chemotherapy (44%), immune checkpoint inhibitors (ICIs, 22%), chemotherapy and ICIs (30%), or tyrosine kinase inhibitors (4%). The median baseline CARG toxicity score was 8 (range 2-12). Among patients with treatment-related toxicity (n = 49), 39 (79.6%) cases were mild (grade 1-2), and 10 (20.4%) were moderate to severe (≥ grade 3). Treatment toxicity was greater among those with a CARG score ≥8 (28.0% vs. 13.6%). Higher IADL independence, QoL, and SPPB scores at baseline were positively associated with Candidatus Gastranaerophilales bacterium, Lactobacillus rogosae, and Enterobacteria phage P4. Romboutsia ilealis, Streptococcus, and Lachnoclostridium sp An138 and T cell lag3 and cd8a were associated with worse IADLs, QoL, and SPPB scores at baseline. Discussion: A longitudinal CGA and biomarker collection is feasible among older adults undergoing lung cancer treatment. Gut microbe and T cell gene expression changes correlated with subjective and objective functional status assessments. Future research will test causality in these associations to improve outcomes through novel supportive care interventions to prevent functional disability.

Functional resilience and overall survival in adults treated for advanced non-small-cell lung cancer.

PURPOSE: As more treatments emerge for advanced, stage IV non-small-cell lung cancer (NSCLC), oncologists have difficulty predicting functional resiliency versus functional decline throughout cancer treatment. Our study evaluates functional resilience among patients with advanced NSCLC. METHODS: Functional status was evaluated through 12 months of follow-up based on disability score using the modified EQ-5D-5L (mEQ-5D-5L) survey. Participants were classified into 4 groups: functional maintenance, decline, resilient, or variable. Characteristics of 207 participants with newly diagnosed NSCLC included demographics, comorbidities, baseline Eastern Cooperative Oncology Group (ECOG) performance status (PS), mEQ-5D-5L scores, psychological symptoms, and lung cancer-specific symptoms. Treatment toxicity and grade were recorded. Resilience was defined as improvement from baseline disability scores. A 1-point increase in functional status score represents a 0.5 standard deviation change on the mEQ-5D-5L. Differences between the 4 groups were determined through Fisher's exact test or ANOVA. Kaplan-Meier curves describe overall survival (baseline through 18 months) stratified by baseline mEQ-5D-5L scores. RESULTS: Among participants, 42.0 % maintained functional status, 37.7 % experienced functional decline, 10.6 % were resilient, and 9.7 % had variable functional status. Participants with the best baseline function (score of 0) had the longest overall survival and participants with the worst baseline function (score of 5 + ) had the shortest overall survival. Among the healthiest patients, early score increases indicated shorter overall survival. Baseline ECOG PS was not associated with overall survival (p = 0.47). CONCLUSION: Baseline functional status may help better predict functional resiliency and overall survival than ECOG PS among patients receiving treatment for advanced NSCLC.

Quantification of Skeletal Muscle Perfusion in Peripheral Artery Disease Using 18F-Sodium Fluoride Positron Emission Tomography Imaging.

BACKGROUND: Perfusion deficits contribute to symptom severity, morbidity, and death in peripheral artery disease (PAD); however, no standard method for quantifying absolute measures of skeletal muscle perfusion exists. This study sought to preclinically test and clinically translate a positron emission tomography (PET) imaging approach using an atherosclerosis-targeted radionuclide, fluorine-18-sodium fluoride (18F-NaF), to quantify absolute perfusion in PAD. METHODS AND RESULTS: Eight Yorkshire pigs underwent unilateral femoral artery ligation and dynamic 18F-NaF PET/computed tomography imaging on the day of and 2 weeks after occlusion. Following 2-week imaging, calf muscles were harvested to quantify microvascular density. PET methodology was validated with microspheres in 4 additional pig studies and translated to patients with PAD (n=39) to quantify differences in calf perfusion across clinical symptoms/stages and perfusion responses in a case of revascularization. Associations between PET perfusion, ankle-brachial index, toe-brachial index, and toe pressure were assessed in relation to symptoms. 18F-NaF PET/computed tomography quantified significant deficits in calf perfusion in pigs following arterial occlusion and perfusion recovery 2 weeks after occlusion that coincided with increased muscle microvascular density. Additional studies confirmed that PET-derived perfusion measures agreed with microsphere-derived perfusion measures. Translation of imaging methods demonstrated significant decreases in calf perfusion with increasing severity of PAD and quantified perfusion responses to revascularization. Perfusion measures were also significantly associated with symptom severity, whereas traditional hemodynamic measures were not. CONCLUSIONS: 18F-NaF PET imaging quantifies perfusion deficits that correspond to clinical stages of PAD and represents a novel perfusion imaging strategy that could be partnered with atherosclerosis-targeted 18F-NaF PET imaging using a single radioisotope injection. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03622359.

Resiliency among older adults receiving lung cancer treatment (ROAR-LCT): A novel supportive care intervention for older adults with advanced lung cancer.

INTRODUCTION: Novel supportive care interventions designed for an aging population with lung cancer are urgently needed. We aimed to determine the feasibility of a novel supportive care physical therapy (PT) plus progressive muscle relaxation (PMR) intervention delivered to older adults with advanced lung cancer in the United States (US). MATERIALS AND METHODS: This clinical trial, Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT: NCT04229381), recruited adults aged ≥60 years with unresectable stage III/IV non-small cell (NSCLC) or small cell lung cancer (SCLC) receiving cancer treatment at The James Thoracic Oncology Center (planned enrollment, N = 20). There were no exclusion criteria pertaining to performance status, laboratory values, prior cancer diagnoses, comorbidities, or brain metastases. Participants were evaluated by PT and psychology and given an exercise pedaler, resistance bands, a relaxation voice recording, and instructions at study initiation. Participants were evaluated in-person by PTs and psychologists at the start and end of the 12-session intervention, with the intervening sessions conducted via virtual health. Participants completed self-reported measures of functional status, symptoms, and mood longitudinally with the following instruments: EQ-5D-5L, Patient Health Questionnaire-9, and General Anxiety Disorder-7. PT assessments included the Short Physical Performance Battery (SPPB) and the two-minute walk test. Feasibility was defined as at least 60% of participants completing at least 70% of all intervention sessions. Optional gut microbiome samples and activity monitoring data (ActiGraph®) were also collected. RESULTS: The ROAR-LCT study concluded after consenting 22 patients. Among the 22 consented, 18 (81.8%) started the intervention; 11 participants (61.1%) completed at least 70% of all study sessions. All participants with SCLC completed the intervention. Reasons for withdrawal included progression of disease or hospitalization. The majority (88.9%) of patients who started were able to complete at least one virtual health session. Participants' functional status, SPPB, depression, and anxiety scores were stable from pre- to post-intervention. Participants who withdrew had worse baseline scores across domains. Seven microbiome and six ActiGraph® samples were collected. DISCUSSION: This is one of the first PT + PMR supportive care interventions using virtual health among older adults with advanced lung cancer to achieve feasibility in the US.

Another Day, Another 82 Cents: A National Survey Assessing Gender-based Wage Differences in Board-certified Plastic Surgeons.

Background: Of 7461 actively practicing United States American Board of Plastic Surgery certified plastic surgeons, only 17% are women. In relation to this small number, gender inequities within the field have been the source of national discussions. Our study assessed the status of the gender-based wage-gap in plastic surgery and sought to identify possible causes. Methods: An anonymous 43-question survey was distributed to 2981 members of the American Society of Plastic Surgeons in 2021. Male and female responses were compared; an analysis also considering board-certification year was performed. Chi-square and Fisher exact tests were used for bivariate analysis. Continuous variables were compared with two-sample t tests and Wilcoxon rank sum tests. Results: Ten percent of contacted American Society of Plastic Surgeons members responded to our survey. Of the 288 respondents, 111 (38.5%) were women, and 177 (61.5%) were men. Men were more likely to have salaries over $400K USD per year (P < 0.0001). Earlier certification year was associated with pay greater than $400K per year (P = 0.0235) but was insignificant once stratified by gender (women: P = 0.2392, men: P = 0.7268). Earlier certification year was associated with production-based and self-determined wages (P = 0.0097), whereas later board-certification year was associated with nonnegotiable salaries (P < 0.0001). Conclusions: Women are significantly less likely to make salaries comparable to those of male plastic surgeons, related to shorter careers on average. An increase in female representation and career duration within the field is needed to improve the current wage-gap.

A Personalized Opioid Prescription Model for Predicting Postoperative Discharge Opioid Needs.

BACKGROUND: Opioid overprescribing after surgery is common. There is currently no universal predictive tool available to accurately anticipate postdischarge opioid need in a patient-specific manner. This study examined the efficacy of a patient-specific opioid prescribing framework for estimating postdischarge opioid consumption. METHODS: A total of 149 patients were evaluated for a single-center retrospective cohort study of plastic and reconstructive surgery patients. Patients with length of stay of 2 to 8 days and quantifiable inpatient opioid consumption (n = 116) were included. Each patient's daily postoperative inpatient opioid consumption was used to generate a personalized logarithmic regression model to estimate postdischarge opioid need. The validity of the personalized opioid prescription (POP) model was tested through comparison with actual postdischarge opioid consumption reported by patients 4 weeks after surgery. The accuracy of the POP model was compared with two other opioid prescribing models. RESULTS: The POP model had the strongest association (R2 = 0.899; P < 0.0001) between model output and postdischarge opioid consumption when compared to a procedure-based (R2 = 0.226; P = 0.025) or a 24-hour (R2 = 0.152; P = 0.007) model. Accuracy of the POP model was unaffected by age, gender identity, procedure type, or length of stay. Odds of persistent use at 4 weeks increased, with a postdischarge estimated opioid need at a rate of 1.16 per 37.5 oral morphine equivalents (P = 0.010; 95% CI, 1.04 to 1.30). CONCLUSIONS: The POP model accurately estimates postdischarge opioid consumption and risk of developing persistent use in plastic surgery patients. Use of the POP model in clinical practice may lead to more appropriate and personalized opioid prescribing.

Improving Access to Early Palliative Care Delivery for Patients With an Advanced Thoracic Malignancy Through an Embedded Oncopalliative Clinic Model.

PURPOSE: Early integration of palliative care (PC) with standard oncology care is driving the development of innovative PC delivery models. METHODS: This was a single-institution retrospective study of outpatient PC before and after the opening of an embedded thoracic oncology-palliative clinic at The Ohio State University. Patients included in the preintervention (October 2017-July 2018) and postintervention (October 2018-July 2019) cohorts had a diagnosis of any non-small-cell lung cancer (stages I-IV) or small-cell lung cancer (limited or extensive stage) and were newly established in the thoracic medical oncology clinic during the study time periods. All patients in the preintervention cohort had access to outpatient PC through a freestanding clinic, while the postintervention cohort had access to both freestanding and embedded clinics. Using time-to-event analyses, we evaluated differences in time intervals from first medical oncology visit to PC referral and first PC visit between cohorts. RESULTS: The majority of patients in both cohorts had metastatic disease at diagnosis. In the postintervention cohort, 20.9% of patients were referred to outpatient PC compared with 9.2% in the preintervention cohort (P < .01). PC referrals for patients outside of Franklin and adjacent counties increased from 4.0% to 14.2% after opening the embedded clinic (P < .01). Completion percentages of PC referrals increased from 57.6% to 76.0% in the preintervention versus postintervention cohorts (P = .048). Median time from palliative referral order to first PC visit decreased from 29 to 20 days (P = .047). Similarly, median time from the first oncology visit to PC referral completion decreased from 103 to 41 days (P = .08). CONCLUSION: Implementation of an embedded PC model was associated with increased access to early PC among patients with thoracic malignancies.

Vessel-by-vessel analysis of lower extremity 18F-NaF PET/CT imaging quantifies diabetes- and chronic kidney disease-induced active microcalcification in patients with peripheral arterial disease.

BACKGROUND: Positron emission tomography (PET)/computed tomography (CT) imaging with fluorine-18 (18F)-sodium fluoride (NaF) provides assessment of active vascular microcalcification, but its utility for evaluating diabetes mellitus (DM)- and chronic kidney disease (CKD)-induced atherosclerosis in peripheral arterial disease (PAD) has not been comprehensively evaluated. This study sought to use 18F-NaF PET/CT to quantify and compare active microcalcification on an artery-by-artery basis in healthy subjects, PAD patients with or without DM, and PAD patients with or without CKD. Additionally, we evaluated the contributions of DM, CKD, statin use and established CT-detectable calcium to 18F-NaF uptake for each lower extremity artery. METHODS: PAD patients (n = 48) and healthy controls (n = 8) underwent lower extremity 18F-NaF PET/CT imaging. Fused PET/CT images guided segmentation of arteries of interest (i.e., femoral-popliteal, anterior tibial, tibioperoneal trunk, posterior tibial, and peroneal) and quantification of 18F-NaF uptake. 18F-NaF uptake was assessed for each artery and compared between subject groups. Additionally, established calcium burden was quantified for each artery using CT calcium mass score. Univariate and multivariate analyses were performed to evaluate DM, CKD, statin use, and CT calcium mass as predictors of 18F-NaF uptake in PAD. RESULTS: PAD patients with DM or CKD demonstrated significantly higher active microcalcification (i.e., 18F-NaF uptake) for all arteries when compared to PAD patients without DM or CKD. Univariate and multivariate analyses revealed that concomitant DM or CKD was associated with increased microcalcification for all arteries of interest and this increased disease risk remained significant after adjusting for patient age, sex, and body mass index. Statin use was only associated with decreased microcalcification for the femoral-popliteal artery in multivariate analyses. Established CT-detectable calcium was not significantly associated with 18F-NaF uptake for 4 out of 5 arteries of interest. CONCLUSIONS: 18F-NaF PET/CT imaging quantifies vessel-specific active microcalcification in PAD that is increased in multiple lower extremity arteries by DM and CKD and decreased in the femoral-popliteal artery by statin use. 18F-NaF PET imaging is complementary to and largely independent of established CT-detectable arterial calcification. 18F-NaF PET/CT imaging may provide an approach for non-invasively quantifying vessel-specific responses to emerging anti-atherogenic therapies or CKD treatment in patients with PAD.

Prognostic Value of Fluorine-18-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Imaging for Predicting Venous Thromboembolism in Children With Lymphoma.

BACKGROUND: Positron emission tomography (PET)/computed tomography (CT) imaging can detect changes in arterial inflammation, but has not been used to evaluate chemotherapy-induced venous inflammation or assess risk for venous thromboembolism (VTE) in pediatric oncology. Therefore, the purpose of this study was to evaluate the prognostic value of fluorine-18-fluorodeoxyglucose PET/CT imaging of venous inflammation for predicting VTE occurrence in the 12 months after lymphoma diagnosis in pediatric, adolescent, and young adult patients. METHODS: Pediatric, adolescent, and young adult patients with lymphoma diagnoses (n=71) who underwent whole-body PET/CT imaging at initial staging of disease and first therapeutic follow-up were retrospectively evaluated for serial changes in lower extremity venous uptake of fluorine-18-fluorodeoxyglucose. PET/CT images were used to segment and quantify serial changes in fluorine-18-fluorodeoxyglucose uptake for veins of interest (ie, popliteal and femoral). Incidence of VTE was assessed for 12 months after lymphoma diagnosis. RESULTS: PET/CT detected a significantly higher inflammatory response in the femoral (P=0.012) and popliteal (P=0.013) veins of patients who experienced a VTE event compared with those who remained VTE free in the 12 months after diagnosis. The area under the curve values for receiver operator characteristics analyses were 0.76 (femoral vein) and 0.77 (popliteal vein) based on incidence of VTE occurrence. Univariate analyses demonstrated that PET/CT-derived changes in femoral (P=0.008) and popliteal (P=0.002) vein inflammation were significantly associated with VTE-free survival at 12 months after diagnosis. CONCLUSIONS: Fluorine-18-fluorodeoxyglucose PET/CT imaging detects treatment-induced venous toxicity that may provide insight into risk of VTE events in pediatric and adolescent and young adult patients with lymphoma.

Longitudinal Durability of Patient-Reported Pain Outcomes after Targeted Muscle Reinnervation at the Time of Major Limb Amputation.

BACKGROUND: Phantom limb pain (PLP) and residual limb pain (RLP) are debilitating sequelae of major limb amputation. Targeted muscle reinnervation (TMR), when performed at the time of amputation, has been shown to be effective for management of this pain; however, its long-term effects and the longitudinal trend of patient-reported outcomes is unknown. The purpose of this study was to characterize the longitudinal patient-reported outcomes of pain and quality of life following TMR at the time of initial amputation. STUDY DESIGN: A prospective case series of patients undergoing major limb amputation with TMR performed at the time of amputation were followed from October 2015 to December 2020 with outcomes measured 3, 6, 12, and 18 months or longer after amputation and TMR. Outcomes included patient-reported severity of PLP and RLP as measured by the numeric rating scale (NRS). Secondary outcomes included the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Behavior Questionnaires. RESULTS: Eighty-one patients with 83 treated limbs were included in the study, and 23 patients completed surveys at 18 months or later, with an average follow-up time of 2.4 years. By 3 months after operation, all patient-reported outcomes for PLP and RLP were consistent with previously reported data that demonstrated superiority to non-TMR amputees. Mixed-model linear regression analysis showed that PLP NRS severity scores continued to improve over the study period (p = 0.022). The remaining outcomes for RLP severity and PROMIS quality-of-life measures demonstrated that these scores remained stable over the study period (p > 0.05). CONCLUSION: TMR is an effective surgical procedure that improves the chances of having reduced RLP and PLP when performed at the time of amputation, and our study demonstrates the long-term durability of its efficacy.