Overcoming Recruitment Challenges: A Pilot Study in Arab Americans

While diabetes prevalence and cardiovascular risk factors have been increasing among Arab populations worldwide, few studies of Arab Americans have been conducted because of the difficulty in recruiting Arab American participants. Cultural sensitivity and social awareness of different immigrant groups could ensure successful recruitment and retention in clinical studies. While the primary objective of our overall research project was to determine the prevalence of metabolic syndrome in Arab Americans, the focus of this article is to describe the methodology used to overcome challenges in recruiting and enrolling Arab Americans for a community-based study. We used novel methods, including open houses, religious-based venues, and engagement of community leaders, to encourage participation in this clinical and epidemiological study. A community-based approach involving community leaders and educators was useful in recruiting and encouraging participation in this study. As a result, we were able to collect clinical and anthropometric data from 136 Arab American men and women living in the Washington, DC, area and obtain information regarding their chronic diseases, mental health, and acculturation into U.S. culture and lifestyle. Our sampling methodology may serve as a model of a successful recruitment and enrollment strategy, and may assist other researchers to ensure sufficient power in future studies. Engagement of minority participants in clinical studies will enable the creation of targeted clinical intervention and prevention programs for underrepresented and understudied populations

Randomized Trial Comparing Two Algorithms for Levothyroxine Dose Adjustment in Pregnant Women With Primary Hypothyroidism.

CONTEXT: Regulation of maternal thyroid hormones during pregnancy is crucial for optimal maternal and fetal outcomes. There are no specific guidelines addressing maternal levothyroxine (LT4) dose adjustments throughout pregnancy. OBJECTIVE: To compare two LT4 dose-adjustment algorithms in hypothyroid pregnant women. DESIGN: Thirty-three women on stable LT4 doses were recruited at(G1) used an empiric two-pill/week dose increase followed by subsequent pill-per-week dose adjustments. In group 2 (G2), LT4 dose was adjusted in an ongoing approach in micrograms per day based on current thyroid stimulating hormone (TSH) level and LT4 dose. TSH was monitored every 2 weeks in trimesters 1 and 2 and every 4 weeks in trimester 3. SETTING: Academic endocrinology clinics in Washington, DC. MAIN OUTCOME MEASURE: Proportion of TSH values within trimester-specific goal ranges. RESULTS: Mean gestational age at study entry was 6.4 ± 2.1 weeks. Seventy-five percent of TSH values were within trimester-specific goal ranges in G1 compared with 81% in G2 (P = 0.09). Similar numbers of LT4 dose adjustments per pregnancy were required in both groups (G1, 3.1 ± 2.0 vs G2, 4.1 ± 3.2; P = 0.27). Women in G1 were more likely to have suppressed TSH CONCLUSIONS: We compared two options for LT4 dose adjustment and showed that an ongoing adjustment approach is as effective as empiric dose increase for maintaining goal TSH in hypothyroid women during pregnancy

Clinical, Pathological, and Molecular Profiling of Radioactive Iodine Refractory Differentiated Thyroid Cancer

© Copyright 2019, Mary Ann Liebert, Inc., publishers 2019. Background: Six to 20% of thyroid cancer (TC) patients develop distant metastases, and one-Third become radioiodine refractory (RAIR). Available targeted therapies increase progression-free survival but are associated with toxicities. This study aims to characterize clinical, pathological, and molecular profiles of patients with RAIR TC. Methods: Data of TC patients seen during 2013-2017 at two tertiary care centers were retrospectively analyzed. Patients were considered RAIR according to American Thyroid Association guidelines. The control cohort was sex matched and age matched and had either regression or stable disease (by Response Evaluation Criteria in Solid Tumors) on follow-up at least three years after initial therapy. Molecular profiles on a subset of RAIR patients were reviewed. Results: Compared with 22 matched controls, 54 RAIR patients had an average age of 57 years (standard deviation [SD] = 13), 56% were male (41% in the control group); the average tumor size was 4 cm (SD = 2.5); tumors were multifocal in 54%, with involved surgical margins in 42%, focal invasion in 79%, and extrathyroidal extension (ETE) in 61%. Sixty-six percent had distant metastases at initial presentation with metastases to the lungs in 85%, bone in 56%, both sites in 43%, brain in 9%, and liver in 4%. There were no statistically significant differences between RAIR and controls in tumor size, focal invasion, ETE, and histology. The RAIR group received a higher cumulative radioactive iodine (RAI) dose and number of therapies compared with the controls (518 mCi vs. 302 mCi, p = 0.002 and 2.2 vs. 1.3 treatments, p = 0.001). Overall, patients \u3e46 years had 4.5 times higher odds ratio (OR) of being RAIR; white race/ethnicity was associated with a reduced OR of RAIR disease (OR 0.33, p = 0.079). Molecular profiling data in the RAIR subgroup indicated that 50% of patients harbored mutations in the RAS/RAF pathway (11/22). Among 19 patients with a more extensive molecular panel, median tumor mutational burden was 5 megabase (range 3-16) and 26% (5/19) exhibited strong PD-L1 positivity. Conclusion: Among patients with metastatic differentiated thyroid carcinomas, patients with RAIR have similar histopathological and clinical characteristics as patients with RAI avid cancer. The risk of having RAIR TC is increased at age ≥46 and reduced in Caucasians

Travel patterns of cancer surgery patients in a regionalized system

© 2015 Elsevier Inc. All rights reserved. Background Regionalization of complex surgeries has increased patient travel distances possibly leaving a substantial burden on those at risk for poorer surgical outcomes. To date, little is known about travel patterns of cancer surgery patients in regionalized settings. To inform this issue, we sought to assess travel patterns of those undergoing a major cancer surgery within a regionalized system. Materials and methods We identified 4733 patients who underwent lung, esophageal, gastric, liver, pancreatic, and colorectal resections from 2002-2014 within a multihospital system in the Mid-Atlantic region of the United States. Patient age, race and/or ethnicity, and insurance status were extracted from electronic health records. We used Geographical Information System capabilities in R software to estimate travel distance and map patient addresses based on cancer surgery type and these characteristics. We used visual inspection, analysis of variance, and interaction analyses to assess the distribution of travel distances between patient populations. Results A total of 48.2% of patients were non-white, 49.9% were aged \u3e65 y, and 54.9% had private insurance. Increased travel distance was associated with decreasing age and those undergoing pancreatic and esophageal resections. Also, black patients tend to travel shorter distances than other racial and/or ethnic groups. Conclusions These maps offer a preliminary understanding into variations of geospatial travel patterns among patients receiving major cancer surgery in a Mid-Atlantic regionalized setting. Future research should focus on the impact of regionalization on timely delivery of surgical care and other quality metrics

The Affordable Care Act\u27s Medicaid expansion and utilization of discretionary vs. non-discretionary inpatient surgery

© 2018 Elsevier Inc. Background: While pre-Affordable Care Act expansions in Medicaid eligibility led to increased utilization of elective inpatient procedures, the impact of the Affordable Care Act on such preference-sensitive procedures (also known as discretionary procedures) versus time-sensitive non-discretionary procedures remains unknown. As such, we performed a hospital-level quasi-experimental evaluation to measure the differential effects of the Affordable Care Act\u27s Medicaid expansion on utilization of discretionary procedures versus non-discretionary procedures. Methods: The State Inpatient Database (2012–2014) yielded 476 hospitals providing selected discretionary procedures or non-discretionary procedures performed on 288,446 non-elderly, adult patients across 3 expansion states and 2 non-expansion control states. Discretionary procedures included non-emergent total knee and hip arthroplasty, while non-discretionary procedures included nine cancer surgeries. Mixed Poisson interrupted time series analyses were performed to determine the impact of the Affordable Care Act\u27s Medicaid expansion on the number of discretionary procedures versus non-discretionary procedures provided among non–privately insured patients (Medicaid and uninsured patients) and privately insured patients. Results: Analysis of the number of non–privately insured procedures showed an increase in discretionary procedures of +15.1% (IRR 1.15, 95% CI:1.11–1.19) vs –4.0% (IRR 0.96, 95% CI:0.94–0.99) and non-discretionary procedures of +4.1% (IRR 1.04, 95% CI:1.0–1.1) vs –5.3% (IRR 0.95, 95% CI:0.93–0.97) in expansion states compared to non-expansion states, respectively. Analysis of privately insured procedures showed no statistically meaningful change in discretionary procedures or non-discretionary procedures in either expansion or non-expansion states. Conclusion: In this multi-state evaluation, the Affordable Care Act\u27s Medicaid expansion preferentially increased utilization of discretionary procedures versus non-discretionary procedures in expansion states compared to non-expansion states among non–privately insured patients. These preliminary findings suggest that increased Medicaid coverage may have contributed to the increased use of inpatient surgery for discretionary procedures

Improved Survival after Multimodal Approach with \u3csup\u3e131\u3c/sup\u3eI Treatment in Patients with Bone Metastases Secondary to Differentiated Thyroid Cancer

© Copyright 2019, Mary Ann Liebert, Inc., publishers 2019. Background: The objective of this study was to evaluate the overall survival (OS) of radioiodine (131I) treatments alone or combined with non-131I treatments in patients with bone metastases (BM) of differentiated thyroid cancer (DTC). Methods: This was a retrospective study of patients who were evaluated between 2001 and 2018 at MedStar Washington Hospital Center and who had DTC, BM, and at least one 131I treatment after the diagnosis of BM. The OS was analyzed by Kaplan-Meier survival curves and was compared by log-rank test between two groups: patients who received 131I treatments alone and those who received treatments combining 131I with non-131I treatments (CombTx). Non-131I treatments include surgery, radiofrequency ablation, cryotherapy, arterial embolization, external beam radiation, Cyberknife, systemic targeted therapy, and anti-resorptive medication. Results: A total of 77 patients met the above criteria and were followed up to 41 years. Thirty percent (23/77) of patients received 131I treatment alone, and 70% (54/77) received CombTx. For 131I treatment alone, the median survival was 3.9 years, and the 1-, 2-, 3-, 5-, and 10-year OS rates were 86%, 81%, 61%, 35%, and 23%, respectively. For CombTx, the median survival was 7.7 years, and the 1-, 2-, 3-, 5-, and 10-year OS rates were 96%, 92%, 86%, 69%, and 30%, respectively. Patients who had undergone initial 131I therapy within six months post thyroidectomy demonstrated a better median survival after BM diagnosis than those whose initial 131I therapy was six months or more after thyroidectomy (6.5 vs. 0.5 years; p \u3c 0.001). Patients who received external beam radiation therapy demonstrated a better median survival than those who did not (7.8 vs. 4.4 years; p = 0.016). Patients who received denosumab demonstrated a better median survival than those who did not (7.7 vs. 5.2 years; p = 0.03). Patients who were \u3c55 years of age at the initial diagnosis of DTC or at the initial diagnosis of BM had a better median OS than those diagnosed at ≥55 years of age (both p = 0.01). In the multivariate analysis, only age at initial diagnosis of DTC and initial 131I therapy within six months post thyroidectomy, and multiple 131I treatments were independent prognostic factors. Conclusions: In patients with DTC with BM, 131I treatment in combination with one or more non-131I direct and systemic treatments was associated with a significant increase in OS compared with those patients who were treated by 131I treatment alone

Brain metastases from differentiated thyroid carcinoma: Prevalence, current therapies, and outcomes

© 2019 Endocrine Society. Background and Objective: The brain is an unusual site for distant metastases of differentiated thyroid carcinoma (DTC). The aim of this study was to document the prevalence of brain metastases from DTC at our institutions and to analyze the current therapies and the outcomes of these patients. Methods: We performed a retrospective chart review of patients with DTC and secondary neoplasia of the brain. Results: From 2002 to 2016, 9514 cases of thyroid cancer were evaluated across our institutions and 24 patients met our inclusion criteria, corresponding to a prevalence of 0.3% of patients with DTC. Fourteen (58.3%) were female and 10 (41.7%) weremale. Fifteen patients had papillary thyroid cancer (PTC) (62.5%). Brainmetastases were diagnosed 0 to 37 years (mean± SD, 10.6 ± 10.4 years) after the initial diagnosis of thyroid cancer. Patients undergoing surgery had a median survival time longer than those that did not undergo surgery (27.3 months vs 6.8 months; P = 0.15). Patients who underwent stereotactic radiosurgery (SRS) had a median survival time longer than those that did not receive SRS (52.5 months vs 6.7 months; P = 0.11). Twelve patients (50%) were treated with tyrosine kinase inhibitors (TKIs), and they had a better survival than those who have not used a TKI (median survival time, 27.2 months vs 4.7 months; P , 0.05). Conclusion: The prevalence of brain metastases of DTC in our institutions was 0.3% over 15 years. The median survival time after diagnosis of brain metastases was 19 months. In our study population, the use of TKI improved the survival rates