Purpose: Each of the participating patient-centered medical home (PCMH) received coaching and participated in learning collaborative for improving teamwork. The objective of the study was to assess the impact of trainings on patient-centered teamwork. Methods: The Teamwork Perception Questionnaire (TPQ) was administered once in spring 2014 and then in fall 2015. The TPQ consists of 35 questions across 5 domains: mutual support, situation monitoring, communication, team structure, and leadership. Based on our objective we compared the frequencies of strongly agree/agree by domain. The difference was tested using chi-square test. We compared the scores on each domain (strongly agree/agree = 1; maximum score = 7) via Wilcoxon rank sum test. Results: The response rate for this survey was n = 29 (80.6%) in spring 2014, and n = 31 (86.1%) in fall 2015. We found that the practice members significantly (P < .05) strongly agreed/agreed more in fall 2015 than spring 2014 for characteristics—“staff relay relevant information in a timely manner” (64.5% vs 83.9%) and “staff follow a standardized method of sharing information when handing off patients” (67.7% vs 90.3%) under communication domain and for characteristic—“staff within my practice share information that enables timely decision making” (74.2% vs 90.3%). However, there was no statistical significant difference observed in the scores for the overall TPQ at the 2 time points. Conclusion: Despite the statistical insignificance, the observations in PCMHs across the spectrum of practices participating in the Maryland Multi-Payer Program demonstrated enhanced teamwork specifically in communication and in leadership. This we believe will continue to result in enhanced patient access to care and safety.
Background: Patients with advanced urothelial carcinoma (UC) have poor outcomes, with 5-year survival rates of < 5% for those with metastatic, stage IV disease. We have reviewed current treatment paradigms and emerging treatment options for these patients. Methods: The websites of seven national or international organizations were searched for metastatic UC treatment guidelines. Systematic literature reviews were conducted to identify evidence from randomized controlled trials (RCTs) of chemotherapy for patients with previously untreated, unresectable, stage IV UC. Searches included congress databases and articles published between 1990 and 2018. In order to align with the latest treatment paradigms in first-line advanced UC, a focused literature search was conducted to identify evidence supporting immuno-oncology (IO) agents. Results: For advanced UC, guidelines universally recommend cisplatin-based chemotherapy as first-line treatment for eligible patients and carboplatin-based regimens for those unfit to receive cisplatin. Despite the evaluation of a number of different cytotoxic regimens over the years, including triplet combinations, survival outcomes have not improved markedly with chemotherapy. Median overall survival with standard of care chemotherapy is ~13 months. Based on the results of single-arm, phase II studies, recent treatment guidelines have included atezolizumab (anti-PD-L1) and pembrolizumab (anti-PD-1) as first-line options for cisplatin-ineligible patients whose tumors express high levels of PD-L1. However, emerging evidence from RCTs of IO agents, including both cisplatin-eligible and cisplatin-ineligible patients, suggest that survival times exceeding 20 months are possible. Conclusions: After having reached a plateau with chemotherapy, the treatment landscape for advanced UC is evolving. Survival outcomes for patients with advanced UC are improving with treatment modalities involving IO agents.
Objective We examined the treatment patterns among adults with rheumatoid arthritis (RA) and identified factors influencing access to traditional and biological disease modifying antirheumatic drugs (DMARDs). Methods We analyzed visits recorded in the National Ambulatory Medical Care Survey from 2005 to 2014 with a RA diagnosis. The primary outcome was DMARD use (traditional and/or biological). We included prescriptions of all RA-related treatments such as traditional and biological DMARDs, glucocorticoids, gold preparations, immunosuppressants, and non-steroidal anti-inflammatory drugs. Covariates in the logistic regression models included age, gender, race/ethnicity, type of health care coverage, provider type, geographic region, and number of comorbidities. Results Among 1405 visits with a RA diagnosis, 60.4% (n = 807) were prescribed DMARDs and 23.8% (n = 334) biological DMARDs. In fully adjusted models, females have 1.57 times higher odds of any DMARD use (95% confidence interval (CI): 1.02–2.46). Also, Medicare beneficiaries as compared to privately insured have 2.31 times higher odds of receiving any DMARDs (95% CI: 1.40–3.82), while visits with specialist vs. general physician are 2.38 times more associated with any DMARD use (95% CI: 1.37–4.14). For biological DMARDs, Medicare beneficiaries were at 2.58 times higher odds (95% CI: 1.42–4.70) than privately insured, while visits with specialist are at 3.37 times higher odds than general physician (95% CI: 1.40–8.23). Conclusion Visits with a specialist and Medicare beneficiaries were significantly associated with any DMARD or biological DMARD use. Additionally, contrary to prior evidence, race/ethnicity was not associated with any DMARD or biological DMARD use, which may indicate reduction in disparity of treatment access.
Introduction: Acalabrutinib (A) and ibrutinib (I) are both highly effective Bruton tyrosine kinase inhibitors (BTKi) approved for the treatment of chronic lymphocytic leukemia (CLL) and given as continuous treatments until disease progression or unacceptable toxicity. Venetoclax is a BH3 mimetic compound and B-cell lymphoma-2 inhibitor prescribed in combination with obinutuzumab (V+O) for a fixed (12-cycle) duration in treatment-naïve CLL patients. Although the ELEVATE-RR study demonstrated an improved safety profile of A compared with I in a head-to-head clinical trial, this study did not include treatment-naïve CLL patients (Byrd et al. J Clin Oncol. 2021). This MAIC builds upon the published analysis by Davids et al (Leuk Lymphoma. 2021) in treatment-naïve patients with CLL (which demonstrated a favorable safety profile for A-based therapy compared with other targeted therapies without compromising efficacy) by including longer follow-up data for A and the comparators. Methods: Individual patient data for A ± obinutuzumab (A+O) from ELEVATE-TN (47 months median follow-up) (Sharman et al. ASCO 2021) were weighted to match the aggregate baseline characteristics of the I monotherapy arm from the ALLIANCE trial (Woyach et al. NEJM. 2018) (I + rituximab was not included as this treatment is not approved for CLL) and the V+O arm from the CLL-14 trial (Al-Sawaf et al. Lancet Oncol 2020). These baseline characteristics, TP53 mutation, serum β 2 microglobulin, ECOG, IGHV status, del(11q), CrCl, Rai stage or CLL-IPI, are potential prognostic variables (PV). Pseudo-individual patient data were generated from the digitized Kaplan-Meier curves published in the aforementioned comparator trials. An unanchored MAIC was conducted to adjust for these PVs between trials. The PVs selected were based on literature, clinical judgement, and demonstrated statistically significant association with progression-free survival (PFS) in univariate and multivariate regression analysis (Ahn et al. J Clin Oncol. 2020; Eichorst and Hallek. Hematol Am Soc Hematol Educ Prog. 2016). After matching, a weighted Cox proportional hazard model was used to analyze PFS and overall survival (OS) while a weighted logistic regression model was used for comparative safety analysis (grade ≥3 adverse events [AEs]). Two-sided p<0.05 was considered statistically significant. Results: This MAIC included 47-month data from ELEVATE-TN, 38-month data from ALLIANCE, and 40-month data from CLL-14 as opposed to 28-month data from ELEVATE-TN, 29-month data from RESONATE-2, and 29-month data from CLL-14 included in the previously published analysis. In the A vs I comparison, the PFS (hazard ratio [HR] 0.83 [95% CI 0.50, 1.37]) and OS (HR 0.69 [95% CI 0.37, 1.29]) numerically favored A but the difference was not significant. The A vs V+O comparison did not show significant differences in PFS (HR 0.96 [95% CI 0.56, 1.65] and OS (HR 0.99 [95% CI 0.51, 1.91]). For A+O vs I, significant differences in PFS (HR 0.48 [95% CI 0.27, 0.88]) and OS (HR 0.41 [95% CI 0.18, 0.91]) were observed. Similarly, for A+O vs V+O, significant differences were observed for PFS (HR 0.38 [95% CI 0.20, 0.73]) and OS (HR 0.43 [95% CI 0.19, 0.99]). Significant differences in rate of grade ≥3 AEs in favor of A and A+O were observed vs I for atrial fibrillation, hypertension, decreased neutrophil count, and decreased platelet count. Compared with V+O, patients treated with A had significantly lower rates of febrile neutropenia, leukopenia, neutropenia, thrombocytopenia, non-melanoma skin cancer, and secondary primary malignancies, excluding non-melanoma skin cancer. For A+O vs V+O, significantly lower rates of infusion-related reaction, neutropenia, and non-melanoma skin cancer were observed among patients treated with A+O. Conclusions: Based on these MAIC results, A and A+O are associated with a favorable safety profile vs both I and V+O while, with longer follow-up, these MAIC results demonstrate that A+O is associated with a significant efficacy benefit vs both I and V+O. A limitation of this MAIC is not including all potential PVs as a trade-off to conserve the effective sample size. Our findings are consistent with the results of ELEVATE-RR comparing A with I in the relapsed population and also provide insight into comparisons of A-based therapy with V+O as we await more definitive prospective data on this question from a phase 3 trial. Figure 1 Figure 1. Disclosures Davids: Genentech: Consultancy, Research Funding; Ascentage Pharma: Consultancy, Research Funding; Surface Oncology: Research Funding; AbbVie: Consultancy; Adaptive Biotechnologies: Consultancy; BeiGene: Consultancy; Celgene: Consultancy; Eli Lilly and Company: Consultancy; BMS: Consultancy, Research Funding; MEI Pharma: Consultancy, Research Funding; TG Therapeutics: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding; Verastem: Consultancy, Research Funding; Janssen: Consultancy; Novartis: Consultancy, Research Funding; Astra-Zeneca: Consultancy, Research Funding; MEI Pharma: Consultancy; Merck: Consultancy; Research to Practice: Consultancy; Takeda: Consultancy. Emeribe: AstraZeneca: Current Employment, Current holder of stock options in a privately-held company. Gaitonde: AstraZeneca: Current Employment, Current holder of stock options in a privately-held company, Research Funding. Cai: AstraZeneca: Current Employment, Current equity holder in publicly-traded company; Google: Current equity holder in publicly-traded company; Celgene Corporation: Ended employment in the past 24 months.
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