An Assessment of Race as a Risk Factor for Doxorubicin-Related Cardiotoxicity in Diffuse Large B-Cell Lymphoma.

BACKGROUND: Doxorubicin carries a risk of congestive heart failure (CHF). Black race has been suggested as a risk factor for doxorubicin-related cardiotoxicity, but data are limited. We assessed whether HF occurs at higher rates in Black patients compared to White patients who receive doxorubicin for DLBCL, and evaluated race as an independent risk factor for the development of HF after adjusting for known risk factors. PATIENTS AND METHODS: We used SEER-Medicare to identify patients 66 years and older with DLBCL. We excluded patients with CHF documented prior to diagnosis with DLBCL. We assessed for hypertension, type 2 diabetes, coronary artery disease, and arrhythmias prior to diagnosis with DLBCL. The primary outcome was documented CHF at any point following DLBCL diagnosis. Secondary outcomes included CHF in the first year following diagnosis and death. We performed analyses additionally stratified by cumulative dose of doxorubicin. RESULTS: Our study population consisted of 8,604 patients (White 96.8%, Black 3.2%). In both Kaplan-Meier and competing risk analyses, we observed no significant difference in the incidence of CHF between Black and White patients, both before and after adjusting for covariates. Finally, we observed no significant differences in the incidence of CHF by race after stratification by cumulative doxorubicin dose. CONCLUSIONS: CHF is common following doxorubicin chemotherapy for DLBCL in older patients. No association was observed between Black race and the onset of heart failure in this setting. Rigorous screening for known clinical risk factors is likely more relevant than race in treatment selection and optimization.

Achieving universal genetic assessment for women with ovarian cancer: Are we there yet? A systematic review and meta-analysis.

PURPOSE: Several professional organizations recommend universal genetic assessment for people with ovarian cancer as identifying pathogenic variants can affect treatment, prognosis, and all-cause mortality for patients and relatives. We sought to evaluate the literature on genetic assessment for women with ovarian cancer and determine if any interventions or patient characteristics drive utilization of services. METHODS: We searched key electronic databases to identify trials that evaluated genetic assessment for people with ovarian cancer. Trials with the primary aim to evaluate utilization of genetic assessment with or without interventions were included. Eligible trials were subjected to meta-analysis and the moderating influence of health interventions on rates of genetic assessment were examined. RESULTS: A total of 35 studies were included (19 report on utilization of genetic services without an intervention, 7 with an intervention, and 9 with both scenarios). Without an intervention, pooled estimates for referral to genetic counseling and completion of genetic testing were 39% [CI 27-53%] and 30% [CI 19-44%]. Clinician-facilitated interventions included: mainstreaming of genetic services (99% [CI 86-100%]), telemedicine (75% [CI 43-93%]), clinic-embedded genetic counselor (76% [CI 32-95%]), reflex tumor somatic genetic assessment (64% [CI 17-94%]), universal testing (57% [28-82%]), and referral forms (26% [CI 10-53%]). Random-effects pooled proportions demonstrated that Black vs. White race was associated with a lower rate of genetic testing (26%[CI 17-38%] vs. 40% [CI 25-57%]) as was being un-insured vs. insured (23% [CI 18-28%] vs. 38% [CI 26-53%]). CONCLUSIONS: Reported rates of genetic testing for people with ovarian cancer remain well below the goal of universal testing. Interventions such as mainstreaming can improve testing uptake. Strategies aimed at improving utilization of genetic services should consider existing disparities in race and insurance status.

Financial toxicity, mental health, and gynecologic cancer treatment: The effect of the COVID-19 pandemic among low-income women in New York City.

BACKGROUND: New York City (NYC) emerged as an epicenter of the COVID-19 pandemic, and marginalized populations were affected at disproportionate rates. The authors sought to determine the impact of COVID-19 on cancer treatment, anxiety, and financial distress among low-income patients with gynecologic cancer during the peak of the NYC pandemic. METHODS: Medicaid-insured women who were receiving gynecologic oncology care at 2 affiliated centers were contacted by telephone interviews between March 15 and April 15, 2020. Demographics and clinical characteristics were obtained through self-report and retrospective chart review. Financial toxicity, anxiety, and cancer worry were assessed using modified, validated surveys. RESULTS: In total, 100 patients completed the telephone interview. The median age was 60 years (range, 19-86 years), and 71% had an annual income <$40,000. A change in employment status and early stage cancer (stage I and II) were associated with an increase in financial distress (P < .001 and P = .008, respectively). Early stage cancer and telehealth participation were significantly associated with increased worry about future finances (P = .017 and P = .04, respectively). Lower annual income (<$40,000) was associated with increased cancer worry and anxiety compared with higher annual income (>$40,000; P = .036 and P = .017, respectively). When controlling for telehealth participation, income, primary language, and residence in a high COVID-19 prevalence area, a delay in medical care resulted in a 4-fold increased rate of anxiety (P = .023, 95% CI, 1.278-14.50). Race was not significantly associated with increased financial distress, cancer worry, or anxiety. CONCLUSIONS: Low socioeconomic status was the most common risk factor for increased financial distress, cancer worry, and anxiety. Interventions aimed at improving access to timely oncology care should be implemented during this ongoing pandemic.

Sex-based differences in outcomes, 30-day readmissions, and costs following catheter ablation of atrial fibrillation: the United States Nationwide Readmissions Database 2010-14.

AIMS: Although catheter ablation has emerged as an important therapy for patients with symptomatic atrial fibrillation (AF), there are limited data on sex-based differences in outcomes. We sought to compare in-hospital outcomes and 30-day readmissions of women and men undergoing AF ablation. METHODS AND RESULTS: Using the United States Nationwide Readmissions Database, we analysed patients undergoing AF ablation between 2010 and 2014. Based on ICD-9-CM codes, we identified co-morbidities and outcomes. Multivariable logistic regression and inverse probability-weighting analysis were performed to assess female sex as a predictor of endpoints. Of 54 597 study patients, 20 623 (37.7%) were female. After adjustment for age, co-morbidities, and hospital factors, women had higher rates of any complication [adjusted odds ratio (aOR) 1.39; P < 0.0001], cardiac perforation (aOR 1.39; P = 0.006), and bleeding/vascular complications (aOR 1.49; P < 0.0001). Thirty-day all-cause readmission rates were higher for women compared to men (13.4% vs. 9.4%; P < 0.0001). Female sex was independently associated with readmission for AF/atrial tachycardia (aOR 1.48; P < 0.0001), cardiac causes (aOR 1.40; P < 0.0001), and all causes (aOR 1.25; P < 0.0001). Similar findings were confirmed with inverse probability-weighting analysis. Despite increased complications and readmissions, total costs for AF ablation were lower for women than men due to decreased resource utilization. CONCLUSIONS: Independent of age, co-morbidities, and hospital factors, women have higher rates of complications and readmissions following AF ablation. Sex-based differences and disparities in the management of AF need to be explored to address these gaps in outcomes.

Exercise and Self-Reported Limitations in Patients with Inflammatory Bowel Disease.

BACKGROUND: Limited evidence suggests that exercise may have beneficial, anti-inflammatory effects in patients with inflammatory bowel disease (IBD). AIMS: The purpose of this study was to evaluate the prevalence of exercise in patients with IBD and the limitations they experience secondary to their disease. METHODS: Two hundred and fifty IBD patients were prospectively enrolled in this study at an academic medical center at the time of their outpatient visits between March and October 2013. Subjects were asked to complete a one-time survey that asks questions about medical and surgical history, exercise frequency and intensity, and the limitations and barriers they experience. RESULTS: Two hundred and twenty-seven patients (148 female patients) completed the survey. Crohn's disease was present in 140 patients (61.5 %), while 87 had ulcerative colitis. Forty-one patients (16.4 %) never exercised, 82 patients (32.8 %) exercised 1-2 times per week, 59 (23.6 %) exercised 3-4 times per week, and 45 (18.0 %) exercised more than four times per week. Of the 186 who regularly exercise, 95 (51 %) reported moderate exercise intensity, 61 (33 %) reported light intensity, and 30 (16 %) reported vigorous intensity. Ninety-nine patients (44 %) reported that their IBD limited their exercise for reasons including fatigue (n = 81), joint pain (n = 37), embarrassment (n = 23), weakness (n = 21), and others. CONCLUSIONS: Although they may benefit from exercise, IBD patients experience considerable barriers to regular exercise secondary to the relapsing and remitting nature of IBD. Larger studies are needed to determine the effects of exercise on disease symptomatology and activity.

Three-dimensional volumetric assessment of the nasolacrimal duct in patients with obstruction.

PURPOSE: The purpose of this study was to determine if a significant difference exists in the nasolacrimal duct volume of subjects with primary nasolacrimal duct obstruction compared with that of controls. METHODS: This was a retrospective, case-control study of 70 subjects with prior maxillofacial CT scans, including 35 subjects with obstruction and 35 controls. Volume measurements of the nasolacrimal duct were made on a GE Advantage Workstation using volume viewer software, and measurements were compared using an unpaired Student t test. Interrater and intrarater reliabilities were calculated. RESULTS: There was no significant difference in the nasolacrimal duct volume of patients (0.411 ± 0.18 cm) compared with that of controls (0.380 ± 0.13 cm(3)) (p = 0.23). Women had smaller volume ducts (0.356 ± 0.11 cm(3)) than that of men (0.482 ± 0.19 cm(3)) (p < 0.001). Male patients had smaller volume ducts (0.470 ± 0.23 cm(3)) than that of male controls (0.493 ± 0.14 cm(3)) (p = 0.70), while female patients (0.384 ± 0.13 cm(3)) had significantly larger volume ducts than that of female controls (0.328 ± 0.08 cm(3)) (p = 0.01). There was excellent interrater and intrarater reliabilities. CONCLUSIONS: CT 3-dimensional volumetric software can be used to accurately measure the nasolacrimal duct volume in patients with obstruction. Both the absence of a significant difference in patient's and control's nasolacrimal duct volumes and the overlap in range between the 2 groups imply that the volume of the tear duct is likely not related to the etiology of obstruction. The increase in volume seen in females with obstruction may be due to expansion of the bony canal during the postmenopausal years. The exact etiology of primary nasolacrimal duct obstruction requires further investigation.

Assessment of pain as a sequela in patients treated with intracavitary brachytherapy accelerated partial breast irradiation (IBAPBI): preliminary results of a prospective study.

To assess pain rates and relationship to radiation-induced fibrosis (RIF) in patients treated with intracavitary brachytherapy accelerated partial breast irradiation (IBAPBI). Thirty-nine patients treated with IBAPBI were assessed prospectively for development of pain pretreatment, 1 month post-IBAPBI, and every 6 months thereafter. A qualitative subjective Late Effects of Normal Tissue-Subjective Objective Management Analytical (LENT-SOMA) questionnaire assessed pain. Use of pain medications was assessed as "no", "sometimes", or "regularly". A quantitative objective validated pressure threshold (PTH) measured pain in the site of IBAPBI breast (index) and its mirror-image in the nonirradiated breast (control). A validated tissue compliance meter (TCM) quantitatively assessed RIF in the index and control breasts at all time points. Mean ΔPTH(kg) and ΔTCM(mm) values reflected mean difference between the index and control breasts. Median follow-up is 44 months (range 5-59 months). According to LENT-SOMA, pain occurred in 89% at 1 and 24 months, 67% at 30 months, 30% at 36 months, 29% at 40 months, and 20% at 48 months. No patient used pain medication "regularly" but the use "sometimes" decreased over time: 61% at 1 month, 42% at 18 and 24 months, 13% at 36 months, and 10% at 40 months. Mean ΔPTH values, compared to Δ0 kg at baseline, peaked in absolute value by 1 month to -1.36 kg (p < 0.0001), persisted after 18 months at -0.99 kg (p < 0.0001) and 24 months at -0.73 kg (p < 0.0001), and returned to nearly baseline by 40 months at -0.11 kg (p < 0.57). Mean ΔPTH and ΔTCM correlated significantly with subjective patient reports of pain at each time point (p < 0.0001). To date, this is the first report to prospectively assess pain employing quantitative and qualitative inventories in patients treated with IBAPBI. Pain is experienced in the majority of patients experienced pain within the first 2 years, sometimes requiring a medication, and though subsides, it may persist 4 years after IBAPBI.

Accurate risk assessment of patients with asymptomatic hematuria for the presence of bladder cancer.

PURPOSE: Bladder cancer is frequently diagnosed during a workup for hematuria. However, most patients with microscopic hematuria and many with gross hematuria are not appropriately referred to urologists. We hypothesized that in patients presenting with asymptomatic hematuria the risk of having bladder cancer can be predicted with high accuracy. Toward this end, we analyzed risk factors in patients with asymptomatic hematuria and developed a nomogram for the prediction of bladder cancer presence. METHODS: Data from 1,182 consecutive subjects without a history of bladder cancer undergoing initial evaluation for asymptomatic hematuria were collected at three centers. Clinical risk factors including age, gender, smoking status, and degree of hematuria were recorded. All subjects underwent standard workup including voided cytology, upper tract imaging, and cystourethroscopy. Factors associated with the presence of bladder cancer were evaluated by univariable and multivariable logistic regression analyses. The multivariable analysis was used to construct a nomogram. Internal validation was performed using 200 bootstrap samples. RESULTS: Of the 1,182 subjects who presented with asymptomatic hematuria, 245 (20.7 %) had bladder cancer. Increasing age (OR = 1.03, p < 0.0001), smoking history (OR = 3.72, p < 0.0001), gross hematuria (OR = 1.71, p = 0.002), and positive cytology (OR = 14.71, p < 0.0001) were independent predictors of bladder cancer presence. The multivariable model achieved 83.1 % accuracy for predicting the presence of bladder cancer. CONCLUSIONS: Bladder cancer presence can be predicted with high accuracy in patients who present with asymptomatic hematuria. We developed a nomogram to help optimize referral patterns (i.e., timing and prioritization) of patients with asymptomatic hematuria.

Validating the clinical assessment of eustachian tube dysfunction: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7).

OBJECTIVES/HYPOTHESIS: Eustachian tube dysfunction (ETD) is a common condition that is associated with otologic and rhinologic symptoms. The complete assessment of ETD is limited without a valid symptom score. We developed and conducted initial validation of the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7), a disease-specific instrument to assess symptoms with respect to ETD. STUDY DESIGN: Validation study. METHODS: The ETDQ-7 was developed using standard survey methodology. The ETDQ-7 was completed by a group of 50 consecutive adult patients diagnosed with ETD and 25 non-ETD patients who served as a control group. Tympanometry was used as a criterion standard to distinguish the two groups. A subset of respondents repeated the ETDQ-7 at a time point 4 weeks later. RESULTS: Content validity for the ETDQ-7 was established by focus group and review of the literature. Reliability testing indicated acceptable internal consistency for the entire instrument (Cronbach α = .71). The test-retest reliability indicated good correlation between the two questionnaires completed by the same patient 4 weeks apart (r = 0.78). The ETDQ-7 was able to discriminate between patients with ETD and those without (P < .001), indicating excellent discriminant validity. CONCLUSIONS: The ETDQ-7 is a valid and reliable symptom score for use in adult patients with ETD that may facilitate clinical practice by highlighting the impact of ETD. Further testing is needed to determine its usefulness in assessing treatment response.

Quantitative assessment of radiation-induced fibrosis of the breast with tissue compliance meter, palpation, and radiological imaging: preliminary results.

Quantification of radiation (RT)-induced fibrosis (RIF) continues to present a challenge in breast cancer survivors. We compare assessment of RIF by palpation and tissue compliance meter (TCM) to the radiological findings in women treated with RT. Of 300 patients treated with adjuvant RT, 17 women had > or =2-year follow-up sufficient to document RIF. Palpation and TCM were employed by three radiation oncologists in a blinded fashion. Palpation grades 1, 2, and 3 denoted mild, moderate, and severe RIF. TCM measured degree of compliance (DC) of RIF in irradiated (RTB) and nonirradiated breasts (NRTB). Architectural distortions (AD) on mammograms, ultrasound (US), and MRI were assessed. Median time of follow up was 3.9 years (range 2.1-6.5 years). Palpation revealed RIF grades 1, 2, and 3 in four, 10, and three patients, respectively. Mean percent changes (PC) in DC between RTB and NRTB by TCM were 19.5%, 37.1%, and 57.5% for grades 1, 2, and 3 RIF, respectively (p < 0.0001). There was a strong linear correlation between palpation grade and PC of DC by TCM (spearman-rank correlation=0.88, p < 0.0001). Interobserver variability (reliability) was computed using intraclass correlation coefficient (ICC) for TCM and kappa statistic for clinical palpation (ICC=0.99 [p < 0.0001] and kappa=0.70 [p < 0.0001], respectively). There was no correlation between average size of the AD as measured by the imaging modalities and RIF as assessed by palpation or TCM. Our preliminary data suggest that quantification of RIF is best with TCM. TCM results correlate better with palpation than with radiological imaging. The study with larger number of patients required to confirm our findings is underway.

Intraoperative assessment of endoscopic third ventriculostomy success.

OBJECT: The authors' aim in this study was to determine if standardizing the evaluation of intraoperative findings during endoscopic third ventriculostomy (ETV) could predict patients with hydrocephalus in whom endoscopic treatment will fail and require ventriculoperitoneal shunt treatment. The creation of a uniform scale with predictive outcomes may reduce returns to the operating room for shunt treatment and reliance on postoperative externalized ventricular monitoring and MR imaging. METHODS: The authors evaluated the preoperative history, intraoperative findings, and postoperative monitoring and imaging findings in 109 consecutive patients undergoing 112 consecutive attempted ETVs for obstructive hydrocephalus. A 5-grade scale was developed to assess preoperative risk factors and intraoperative evaluation to unify criteria that have been suspected to influence outcome independently. A grade of 0 was assigned to patients with no negative predictors, whereas increasing scores were assigned to patients who had multiple preoperative and intraoperative risks identified. Patients' grades were compared with outcome of the procedure, utility of externalized ventricular monitoring, and results of postoperative MR imaging. RESULTS: Of 112 ETVs, 77 were successful and 35 were unsuccessful. Fifty-nine patients received a grade of 0, 27 received a grade of 1, 11 received a grade of 2, and 15 received a grade of > or = 3. In all 15 patients receiving a grade > or = 3 attempted ETV procedures failed, and the patients required a ventriculoperitoneal shunt. Postoperative monitoring with externalized ventricular drains and MR images demonstrating radiographic evidence of flow was independently less reliable than intraoperative grading in predicting success. Patients with a grade of 0 almost uniformly had successful surgery, independent of MR imaging findings. Patients with a grade of 1 or 2 who had successful surgery almost always lacked negative intraoperative predictive findings. CONCLUSIONS: Despite reliance in recent years on post-ETV MR images and externalized ventricular monitoring, these modalities, although often useful adjuncts, appear less reliable as predictive tests than a simple assessment at the time of endoscopic fenestration. By using a uniform grading scale, the authors have introduced a novel means through which intraoperative and postoperative decision making can be aided, with the goal of reducing unnecessary procedures and tests and preventing unnecessary returns to the operating room.

Role of radiologic imaging at the time of initial diagnosis of stage T1b-T3b melanoma.

BACKGROUND: In patients with T1b-T3b cutaneous melanoma the utility of radiologic imaging at the time of diagnosis is unclear. Whether initial imaging led to a change in stage or treatment plan was investigated. METHODS: The melanoma database was searched for patients with T1b-T3b primary lesions, clinically N0, and asymptomatic for metastatic disease. Radiologic studies conducted before wide local excision +/- sentinel lymph node biopsy as well as all further imaging and investigations were analyzed. Outcome measures included upstaging, change in initial surgical management, true-positive, false-positive, true-negative, and false-negative rates of each imaging modality. RESULTS: In all, 344 preoperative imaging studies (chest x-ray [CXR], computed tomography [CT], positron emission tomography [PET]/CT) were performed on 158 patients, resulting in 49 findings suspicious for metastatic melanoma and 134 findings suggestive of nonmelanoma pathology. Only 1 of 344 (0.3%) studies, a PET/CT, correlated with confirmed metastatic melanoma. The false-positive rates were CXR 5 of 7 (71.4%), chest CT 21 of 24 (87.5%), abdomen/pelvis CT 10 of 11 (90.9%), head CT 2 of 2 (100.0%), PET/CT 3 of 5 (60.0%). No patient was upstaged or had a change in initial surgical management based on preoperative imaging. The cost of all initial imaging and imaging to follow-up abnormal findings was estimated as $555,308 for the 158 patients studied. CONCLUSIONS: Imaging at the time of initial diagnosis of T1b-T3b, clinically N0, M0 melanoma was of low yield with a high false-positive rate, and did not lead to upstaging or change in initial surgical management. These findings suggest that imaging of asymptomatic patients at the time of diagnosis may not be warranted.

Explaining insurance-related and racial disparities in the surgical management of patients with acute appendicitis.

BACKGROUND: Race and insurance status influence the likelihood of undergoing laparoscopic appendectomy (LA) versus open appendectomy for the treatment of acute appendicitis. We hypothesized that these disparities are caused by presenting hospitals' use of LA. METHODS: The analysis included 26,104 appendectomies for acute appendicitis in New York State during 2003 and 2004. Multiple logistic regression was used to determine independent predictors for undergoing LA versus open appendectomy. RESULTS: Before adjustment for individual hospital use of LA, both white patients (odds ratio [OR] = 1.28, 95% confidence interval [CI] 1.21-1.36; P < .0001] and privately insured patients (OR = 1.52, 95% CI 1.44-1.61; P < .0001) were more likely to undergo LA. Controlling for differential hospitals' use of LA decreased the OR for laparoscopic surgery to 1.08 (95% CI 1.01-1.15; P = .04) for white patients and to 1.22 (95% CI 1.15-1.31; P < .0001) for privately insured patients. CONCLUSIONS: Differences in presenting hospitals' use of LA maintain racial and, to a lesser extent, insurance-related disparities in the surgical management of patients with acute appendicitis.

Use of nonphysician health care providers for skin cancer screening in the primary care setting.

BACKGROUND: Nonphysician health care providers are in an optimal position to provide cancer prevention and screening services. METHODS: We conducted a survey of primary care physicians to determine physician use and amenability to use of nonphysician health care providers to perform skin cancer screening in comparison with other cancer screening examinations. RESULTS: A total of 1,363 eligible physicians completed the survey. Of these, 631 physicians (46%) reported a nurse practitioner or physician assistant performing at least one type of cancer screening examination on their patients. Twenty-nine and 22% of all physicians reported nurse practitioners or physician assistants performing skin cancer screening, respectively. Family physicians were more likely to use nurse practitioners and physician assistants to perform these cancer screening examinations than internists (chi(2) test, P = 0.001 for each examination). Skin examinations were performed less frequently by nurse practitioners and physician assistants than all other cancer screening examinations. A total of 73-79% of family physicians and 60-70% of internists were amenable to having a nonphysician health care provider perform one or more of these examinations. CONCLUSIONS: Primary care physicians are currently utilizing nonphysician health care providers to perform cancer screening examinations and the majority of those surveyed are amenable to the use of these providers for such examinations. This suggests that one possible strategy for increasing skin cancer screening is through an expanded role of nonphysician health care providers.