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Partially Linear Single Index Hazards Regression with Time-Dependent Covariates [Meeting Abstract]
Lee, Myeonggyun; Troxel, Andrea B; Liu, M; Kwon, Sophia; Nolan, Anna
ORIGINAL:0016986
ISSN: 0379-1718
CID: 5524432
Effect of Citalopram on Hippocampal Atrophy in First-Episode Psychosis: Structural MRI Results From the DECIFER Trial [Meeting Abstract]
Qi, Wei; Li, Chenxiang; Blessing, Esther; Ardekani, Babak; Freudenreich, Oliver; Cather, Corinne; Holt, Daphne; Bello, Iruma; Diminich, Erica; Tang, Yingying; Worthington, Michelle; Zeng, Botao; Wu, Renrong; Fan, Xiaoduo; Wang, Jijun; Zhao, Jingping; Troxel, Andrea; Goff, Donald C.
ISI:000535308200399
ISSN: 0006-3223
CID: 4560802
A Nomogram to Predict Factors Associated with Lymph Node Metastasis in Ductal Carcinoma In Situ with Microinvasion
Gooch, Jessica C; Schnabel, Freya; Chun, Jennifer; Pirraglia, Elizabeth; Troxel, Andrea B; Guth, Amber; Shapiro, Richard; Axelrod, Deborah; Roses, Daniel
INTRODUCTION/BACKGROUND:Ductal carcinoma in situ (DCIS) with foci of invasion measuring ≤ 1 mm (DCISM), represents < 1% of all invasive breast cancers. Sentinel lymph node biopsy (SLNB) has been a standard component of surgery for patients with invasive carcinoma or extensive DCIS. We hypothesize that selective performance of SLNB may be appropriate given the low incidence of sentinel node (SN) metastasis for DCISM. We investigated the clinicopathologic predictors for SN positivity in DCISM, to identify which patients might benefit from SLNB. METHODS:A retrospective review of the National Cancer Database was performed for cases from 2012 to 2015. Clinical and tumor characteristics, including SN results, were evaluated, and Pearson's Chi square tests and logistic regression were performed. RESULTS:Of 7803 patients with DCISM, 306 (4%) had at least one positive SN. Patients with positive SNs were younger, more often of Black race, had higher-grade histology and larger tumor size, and were more likely to have lymphovascular invasion (LVI; all p < 0.001). In an adjusted model, the presence of LVI was associated with the highest odds ratio (OR) for node positivity (OR 8.80, 95% confidence interval 4.56-16.96). CONCLUSIONS:Among women with DCISM, only 4% had a positive SN. Node positivity was associated with more extensive and higher-grade DCIS, and the presence of LVI was strongly correlated with node positivity. Our data suggest that LVI is the most important factor in determining which patients with DCISM will benefit from SN biopsy.
PMID: 31529311
ISSN: 1534-4681
CID: 4097972
Caregiver satisfaction with interim silver diamine fluoride applications for their children with caries prior to operating room treatment or sedation
Cernigliaro, Dana; Kumar, Anjali; Northridge, Mary E; Wu, Yinxiang; Troxel, Andrea B; Cunha-Cruz, Joana; Balzer, Jay; Okuji, David M
OBJECTIVE:To ascertain caregiver satisfaction with silver diamine fluoride (SDF) application(s) as an intermediate care path for their children with caries. METHODS:Caregivers were recruited at two community health centers when they arrived for a previously scheduled operating room/sedation appointment for their children with caries who had previously been treated with SDF. They were asked to complete a survey regarding their satisfaction with SDF treatment while they waited during their children's dental treatment. RESULTS:Caregivers overwhelmingly reported that they were satisfied with SDF treatment (81.3%), and that the black mark was not an issue for their children (91.7%) or themselves (87.5%). Moreover, their perception of their children's oral health quality of life was high. CONCLUSIONS:By arresting caries, SDF offers an intermediate care path for pediatric patients for whom OR/sedation treatment was not immediately available. Moreover, most caregivers were satisfied with SDF treatment for their children.
PMID: 31418870
ISSN: 1752-7325
CID: 4042862
Effect of Escalating Financial Incentive Rewards on Maintenance of Weight Loss: A Randomized Clinical Trial
Yancy, William S; Shaw, Pamela A; Reale, Catherine; Hilbert, Victoria; Yan, Jiali; Zhu, Jingsan; Troxel, Andrea B; Foster, Gary D; Volpp, Kevin G
Importance/UNASSIGNED:Identifying effective strategies for treating obesity is a public health priority. Objective/UNASSIGNED:To test an escalating lottery-based incentive tied to daily self-weighing for weight loss maintenance. Design, Setting, and Participants/UNASSIGNED:This 2-phase, 2-arm randomized clinical trial enrolled participants aged 30 to 80 years with an initial body mass index (calculated as weight in kilograms divided by height in meters squared) of 30.0 to 45.0 who lost at least 5 kg during 4 to 6 months in a national online weight management program. Study investigators and outcomes assessors were blinded to participant groups. Data were collected and analyzed from May 23, 2016, through November 13, 2017, based on intention to treat. Interventions/UNASSIGNED:All participants were advised to weigh themselves daily, with a goal of 6 or more days per week, and received text messaging feedback on their performance. Incentive group participants were eligible for a lottery-based incentive worth an expected value of $3.98 in week 1 that escalated by $0.43 each week they achieved their self-weighing goal during months 1 to 6 (phase 1), followed by no incentives during months 7 to 12 (phase 2). Main Outcomes and Measures/UNASSIGNED:The primary outcome was weight change at the end of phase 1. Secondary outcomes included weight change at the end of phase 2 and changes in self-reported physical activity and eating behaviors. Results/UNASSIGNED:A total of 258 participants (128 in the incentive group and 130 in the control group) had a mean (SD) age of 48.0 (10.5) years and mean (SD) body mass index of 32.1 (3.9); 225 (87.2%) were women; 235 (91.1%) were white; and 102 (39.5%) had an annual income of at least $100 000. Weight measurement was transmitted by 250 participants (96.9%) at 6 months and 227 (88.0%) at 12 months. The percentage of weeks that incentive and control participants achieved a mean self-weighing of at least 6 times was 85.3% vs 75.8%, respectively (P = .002) in phase 1 and 37.7% vs 50.2%, respectively (P = .009) in phase 2. Mean weight changes at the end of phase 1 were -1.1 (95% CI, -2.1 to -0.1) kg in the incentive group and -1.9 (95% CI, -2.9 to -0.8) kg in the control group, with a mean difference of 0.7 (95% CI, -0.7 to 2.2) kg (P = .30 for comparison). At the end of phase 2, mean weight changes were 0.2 (95% CI, -1.2 to 1.7) kg in the incentive group and -0.6 (95% CI, -2.0 to 0.8) kg in the control group, with a mean difference of 0.8 (95% CI, -1.2 to 2.8) kg (P = .41 for comparison). Conclusions and Relevance/UNASSIGNED:Compared with an active control condition of weekly messages, escalating lottery-based incentives transiently increased rates of self-weighing but did not significantly enhance weight loss maintenance. Trial Registration/UNASSIGNED:ClinicalTrials.gov identifier: NCT01900392.
PMID: 31675083
ISSN: 2574-3805
CID: 4163462
Effect of Home-Based Exercise and Weight Loss Programs on Breast Cancer-Related Lymphedema Outcomes Among Overweight Breast Cancer Survivors: The WISER Survivor Randomized Clinical Trial
Schmitz, Kathryn H; Troxel, Andrea B; Dean, Lorraine T; DeMichele, Angela; Brown, Justin C; Sturgeon, Kathleen; Zhang, Zi; Evangelisti, Margaret; Spinelli, Bryan; Kallan, Michael J; Denlinger, Crystal; Cheville, Andrea; Winkels, Renate M; Chodosh, Lewis; Sarwer, David B
Importance/UNASSIGNED:To our knowledge, no randomized clinical trials have assessed the effects of the combination of weight loss and home-based exercise programs on lymphedema outcomes. Objective/UNASSIGNED:To assess weight loss, home-based exercise, and the combination of weight loss and home-based exercise with clinical lymphedema outcomes among overweight breast cancer survivors. Design, Setting, and Participants/UNASSIGNED:This randomized clinical trial (Women in Steady Exercise Research [WISER] Survivor clinical trial ) of 351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention. Statistical analysis by intention to treat was performed from September 26, 2018, to October 28, 2018. Interventions/UNASSIGNED:A 52-week, home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs. Main Outcomes and Measures/UNASSIGNED:The 12-month change in the percentage of interlimb volume difference. Results/UNASSIGNED:Of 351 participants, 90 were randomized to the control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities. Median time since breast cancer diagnosis was 6 years (range, 1-29 years). Mean (SD) total upper extremity score changes from the objective clinical evaluation were -1.40 (11.10) in the control group, -2.54 (13.20) in the exercise group, -3.54 (12.88) in the weight loss group, and -3.84 (10.09) in the combined group. Mean (SD) overall upper extremity score changes from the self-report survey were -0.39 (2.33) in the control group, -0.12 (2.14) in the exercise group, -0.57 (2.47) in the weight loss group, and -0.62 (2.38) in the combined group. Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI, -8.90% to -5.84%) in the weight loss group, and -0.44% (95% CI, -1.81% to 0.93%) in the exercise group. Conclusions and Relevance/UNASSIGNED:Study results indicate that weight loss, home-based exercise, and combined interventions did not improve BCRL outcomes; a supervised facility-based program of exercise may be more beneficial than a home-based program for improving lymphedema outcomes. Trial Registration/UNASSIGNED:ClinicalTrials.gov identifier: NCT01515124.
PMID: 31415063
ISSN: 2374-2445
CID: 4043362
Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence (Way 2 Text): a Randomized Clinical Trial
Mehta, Shivan J; Volpp, Kevin G; Troxel, Andrea B; Day, Susan C; Lim, Raymond; Marcus, Noora; Norton, Laurie; Anderson, Sophia; Asch, David A
BACKGROUND:Poor medication adherence contributes to inadequate control of hypertension. However, the value of adherence monitoring is unknown. OBJECTIVE:To evaluate the impact of monitoring adherence with electronic pill bottles or bidirectional text messaging on improving hypertension control. DESIGN/METHODS:Three-arm pragmatic randomized controlled trial. PATIENTS/METHODS:One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12 months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit. INTERVENTIONS/METHODS:Patients were randomized in a 1:2:2 ratio to receive (1) usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text). MAIN MEASURES/METHODS:Change in systolic BP during the final 4-month visit compared with baseline. KEY RESULTS/RESULTS:At the 4-month follow-up visit, mean (SD) change values in systolic blood pressure were - 4.7 (23.4) mmHg in usual care, - 4.3 (21.5) mmHg in the pill bottle arm, and - 4.6 (19.8) mmHg in the text arm. There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93). CONCLUSIONS:Despite good measured adherence, neither feedback with electronic pill bottles nor bidirectional text messaging about medication adherence improved blood pressure control. Adherence to prescribed medications was not improved enough to affect BP control or it was not the primary driver of poor control. TRIAL REGISTRATION/BACKGROUND:clinicaltrials.gov ( NCT02778542 ).
PMID: 31396815
ISSN: 1525-1497
CID: 4034462
A survey of caregiver acculturation and acceptance of silver diamine fluoride treatment for childhood caries
Kumar, Anjali; Cernigliaro, Dana; Northridge, Mary E; Wu, Yinxiang; Troxel, Andrea B; Cunha-Cruz, Joana; Balzer, Jay; Okuji, David M
BACKGROUND:Interest in aqueous silver diamine fluoride (SDF) has been growing as a treatment for caries arrest. A cross-sectional study was conducted to identify factors associated with caregiver acceptance of SDF treatment for children presenting with caries at 8 Federally Qualified Health Centers. The study purpose was to examine associations between caregiver acceptance of SDF treatment for children with caries and (1) sociodemographic and acculturation characteristics of caregivers and (2) clinical assessments of the children by dentists. METHODS:A caregiver survey collected information on: sociodemographic characteristics; acculturation characteristics, measured using the validated Short Acculturation Scale for Hispanics (SASH); perceived benefits and barriers of SDF treatment, including caregiver comfort; and perceived health-related knowledge. Chart reviews were conducted to assess: the medical / dental insurance of pediatric patients; cumulative caries experience, measured using decayed, missing, filled teeth total scores (dmft / DMFT); whether operating room treatment was needed; and a record of caregiver acceptance of SDF treatment (the outcome measure). Standard logistic regression models were developed for caregiver acceptance of SDF treatment for their children as the binary outcome of interest (yes / no) to calculate unadjusted odds ratios (OR) and adjusted ORs for covariates of interest. RESULTS:Overall, 434 of 546 caregivers (79.5%) accepted SDF treatment for their children. A U-shaped relationship between caregiver odds of accepting SDF treatment and age group of pediatric patients was present, where caregivers were most likely to accept SDF treatment for their children who were either < 6 years or 9-14 years, and least likely to accept SDF treatment for children 6 to < 9 years. The relationship between acculturation and caregiver acceptance of SDF treatment depended upon whether or not caregivers were born in the United States: greater acculturation was associated with caregiver acceptance of SDF treatment among caregivers born in this country, and lower acculturation was associated with caregiver acceptance of SDF treatment among caregivers born elsewhere. CONCLUSIONS:Caregiver acceptance of SDF treatment is high; child's age and caregiver comfort are associated with acceptance. Providers need to communicate the risks and benefits of evidence-based dental treatments to increasingly diverse caregiver and patient populations.
PMCID:6814040
PMID: 31651325
ISSN: 1472-6831
CID: 4161862
The paradoxical effect of depression on psoriatic arthritis outcomes in a combined psoriasis-psoriatic arthritis center [Meeting Abstract]
Haberman, R; Adhikari, S; Ramirez, D; Lydon, E; Attur, M; Neimann, A; Reddy, S; Troxel, A; Scher, J
Background/Purpose : Psoriatic arthritis (PsA) is a heterogenous inflammatory disease affecting skin, joints, and other domains. While psychiatric diseases (i.e., depression and anxiety) are known comorbidities, little is known about their impact on disease severity and patient reported outcomes (PROs). The objective of this study was to characterize the prevalence of psychiatric comorbidities in an academic combined psoriasis-psoriatic arthritis center and determine their impact on PsA clinical and patient derived outcomes. Methods : Consecutive adult patients meeting CASPAR criteria for PsA (n=436) were prospectively recruited at the NYU Psoriatic Arthritis Center. All data was collected from clinical visits utilizing a standardized EPIC template. Depression was defined by established diagnosis and/or use of anti-depressant medications. Objective measures of disease severity included swollen and tender joint counts (SJC/TJC) and PROs including RAPID3 scores. Data was analyzed using statistical software R. Results : Our cohort was comprised of 436 patients: 54% male, mean age of 47 years, and mostly Caucasians (74.1%). Within our population, 19.5% had depression, 15.6% had anxiety, and 4.8% had ADHD (Table 1). Of those with depression, 71% were on anti-depressive medication. At the initial visit, patients with PsA and depression were more likely to be on medication(s) for PsA (80% vs 65%, p=.01) and had a trend towards higher rates of biologic use (47.5% vs 40.4%, p=.126). Those with depression had a similar TJC to their non-depressed counterparts, but had a trend towards fewer swollen joints and concomitant higher RAPID3 scores (Table 2). When analyzing repeated outcome measures over subsequent visits, individuals with depression were similarly more likely to have a higher TJC, a lower SJC, and a higher RAPID3 score (although only RAPID3 was found to be statistically significant, p=.004). Importantly, these findings persisted when analyzing participants that were matched with propensity scores to adjust for age, sex, comorbidities, and medication use. In addition to joint activity, psoriasis activity measured by body surface area (BSA) was lower in those who were depressed (1.4% vs 3.03%, p=.001) and these differences were maintained over subsequent visits. Conclusion : Our results expand on prior reports of significantly elevated rates of depression in PsA. Notably, individuals with depression were more likely to be on medication(s) for their PsA, had fewer swollen joints, and a lower BSA but, paradoxically reported higher RAPID3 scores. This discrepancy is likely a manifestation of how depression could affect the way patients experience their PsA despite apparent improvement in skin and joint symptoms. Depression should, therefore, be considered a critical comorbidity when addressing PsA care in routine visits. Further work is needed to understand whether modulation of psychiatric comorbidities can lead to improved PsA outcomes
EMBASE:633059649
ISSN: 2326-5205
CID: 4633462
Tumor-Infiltrating Lymphocytes in a Contemporary Cohort of Women with Ductal Carcinoma In Situ (DCIS)
Darvishian, Farbod; Ozerdem, Ugur; Adams, Sylvia; Chun, Jennifer; Pirraglia, Elizabeth; Kaplowitz, Elianna; Guth, Amber; Axelrod, Deborah; Shapiro, Richard; Price, Alison; Troxel, Andrea; Schnabel, Freya; Roses, Daniel
BACKGROUND:Growing evidence suggests that the tumor immune microenvironment influences breast cancer development and prognosis. Density of tumor-infiltrating lymphocytes (TILs) within invasive breast cancer is correlated with response to therapy, especially in triple-negative disease. The clinical relevance and outcomes of TILs within ductal carcinoma in situ (DCIS) are less understood. METHODS:Our institutional database of 668 patients with pure DCIS from 2010 to 2018 was queried. TILs were evaluated by International TILs Working Group guidelines. Percentage of TILs was assessed from the densest focus (hotspot) in one high-power field of stroma touching the basement membrane. Statistical methods included cluster analyses (to define sparse versus dense TILs), logistic, and Cox regression models. RESULTS:Sixty-nine patients with DCIS and TILs were evaluated, of whom 54 (78%) were treated by breast-conserving surgery. Thirteen (19%) patients had ipsilateral recurrence. Each recurrence (n = 13) was matched to four controls (n = 56) based on date of surgery. Median follow-up was 6.7 years. TILs were defined as sparse (< 45%) or dense (≥ 45%). Dense TILs were associated with younger age (p = 0.045), larger tumor size (p < 0.001), high nuclear grade (p = 0.010), comedo histology (p = 0.033), necrosis (p = 0.027), estrogen receptor (ER) negativity (p = 0.037), and ipsilateral recurrence (p = 0.001). Nine patients with dense TILs had mean time to recurrence of 73.5 months compared with four patients with sparse TILs with mean time to recurrence of 97.9 months (p = 0.003). CONCLUSIONS:Dense TILs were significantly associated with age, tumor size, nuclear grade, comedo histology, necrosis, and ER status and was a significant predictor of recurrence in patients with pure DCIS.
PMID: 31240590
ISSN: 1534-4681
CID: 3954082