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IntroductionPatients are uniquely positioned to identify issues and to provide innovative solutions to problems impacting their care. Yet, patient engagement in quality improvement (QI) and health care governance remains limited and underexplored. In the Veterans Health Administration, the work of women's health managers (WHMs) includes engaging women veterans, a numerical minority with unique health care needs, in QI. We aimed to understand the extent to which WHMs engage women veterans along a continuum, highlight challenges to engagement, and identify potential strategies to facilitate multilevel patient engagement.MethodsData were generated from a multisite evaluation to improve delivery of comprehensive women's health care in Veterans Health Administration primary care sites. We conducted 39 semistructured interviews with WHMs across 21 sites. Guided by Carman et al.'s patient engagement framework, we analyzed the interviews using rapid-qualitative and content analysis methods.ResultsWhen effectively engaged, women veterans were important champions and partners in QI activities to improve the structure and delivery of care. However, most WHMs engaged women veterans in mainly informal or passive ways-that is, solicited feedback through comment cards, surveys, focus groups, and townhall meetings-and did not report pursuing more in-depth or long-term forms of engagement. WHMs also identified a variety of facilitators and challenges to engaging women veterans in QI.ConclusionsThere may be unanticipated benefits to health care policy from engaging patients in QI, especially for patients with unique health care needs who represent a minority within the health care system. However, managers require training and workflow integration of patient engagement tasks to increase their efficiency and allow for meaningful patient engagement.

In this secondary analysis of Hispanic adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL) treated on Cancer and Leukemia Group B (CALGB) 10403, we evaluated outcomes and geographic enrollment patterns relative to US population data. We used demographic, clinical, and survival data on AYAs enrolled on CALGB 10403 (N = 295, 2007-2012). Surveillance, Epidemiology, and End Results registries provided overall survival (OS) for US AYA ALL by ethnicity/race. North American Association of Cancer Registries provided AYA ALL incidence overall and proportion among Hispanics by US state. Of AYAs enrolled on CALGB 10403, 263 (89%) reported ethnicity/race: 45 (17%) Hispanic, 172 (65%) non-Hispanic White (NHW), 25 (10%) non-Hispanic Black (NHB), and 21 (8%) other. Compared with NHWs, Hispanic and NHB patients had lower household income, and Hispanic patients were more likely to harbor high-risk CRLF2 aberrations. Relative to US estimates, where Hispanic patients represented 46% of newly diagnosed AYA ALL patients and experienced inferior OS compared with NHW (P < .001), Hispanic AYAs on CALGB 10403 did as well as NHW patients (3 year OS, 75% vs 74%; P = NS). Hispanic patients also had higher rates of protocol completion (P = .05). Enrollments on CALGB 10403 differed relative to the distribution of Hispanic AYA ALL in the United States: enrollment was highest in the Midwest; t and only 15% of enrollees were from states with a high proportion of Hispanic AYA ALL patients. In summary, Hispanic patients treated on CALGB 10403 did as well as NHWs and better than population estimates. Geographical misalignment between trial sites and disease epidemiology may partially explain the lower-than-expected enrollment of Hispanic AYA ALL patients.

PurposeManagers and leaders have a critical role to play in sexual and gender-based harassment prevention within organizations. Although the Veterans Health Administration has committed to eliminating harassment through national directives and training programs, it is unclear how aware local-level managers and leaders are about public harassment at their facilities and how they perceive sexual and gender-based harassment. We examined middle managers' and leaders' views about whether harassment is perceived as a problem locally, and what policies and procedures (if any) are in place to address public harassment.MethodsWe conducted 69 semistructured telephone interviews with middle managers and facility leaders before implementation of an evidence-based quality improvement project designed to improve delivery of comprehensive women's health care. Transcripts were coded using the constant comparative method and analyzed for overarching themes.ResultsPerceptions of the prevalence of sexual and gender-based public harassment varied among middle managers and leaders. A little more than one-half of respondents were unaware of facility-level policies and procedures to address public harassment between patients. To decrease patient-to-patient harassment, both groups generally supported the creation of separate clinical spaces for women. However, middle managers also stated that education was needed to change patient harassing behavior, which they tied to male military culture.ConclusionsAligning divergent perspectives of what constitutes sexual and gender-based harassment and how to address it is a necessary step towards tackling harassment at the local level. Managers and leaders should continue to assess environments of care and share findings widely among employees and leadership to improve awareness and inform a unified response.

BackgroundAcute myeloid leukemia (AML) is fatal in elderly patients who are unfit for standard induction chemotherapy. The objective of this study was to evaluate the survival benefit of administering sapacitabine, an oral nucleoside analogue, in alternating cycles with decitabine, a low-intensity therapy, to elderly patients with newly diagnosed AML.MethodsThis randomized, open-label, phase 3 study (SEAMLESS) was conducted at 87 sites in 11 countries. Patients aged ≥70 years who were not candidates for or chose not to receive standard induction chemotherapy were randomized 1:1 to arm A (decitabine in alternating cycles with sapacitabine) received 1-hour intravenous infusions of decitabine 20 mg/m2 once daily for 5 consecutive days every 8 weeks (first cycle and subsequent odd cycles) and sapacitabine 300 mg twice daily on 3 consecutive days per week for 2 weeks every 8 weeks (second cycle and subsequent even cycles) or to control arm C who received 1-hour infusions of decitabine 20 mg/m2 once daily for 5 consecutive days every 4 weeks. Prior hypomethylating agent therapy for preexisting myelodysplastic syndromes or myeloproliferative neoplasms was an exclusion criterion. Randomization was stratified by antecedent myelodysplastic syndromes or myeloproliferative neoplasms, white blood cell count (

BackgroundQuantitative evaluations of the effectiveness of intensive primary care (IPC) programs for high-needs patients have yielded mixed results for improving healthcare utilization, cost, and mortality. However, IPC programs may provide other value.ObjectiveTo understand the perspectives of high-needs patients and primary care facility leaders on the effects of a Veterans Affairs (VA) IPC program on patients.DesignA total of 66 semi-structured telephone interviews with high-needs VA patients and primary care facility leaders were conducted as part of the IPC program evaluation.ParticipantsHigh-needs patients (n = 51) and primary care facility leaders (n = 15) at 5 VA pilot sites.ApproachWe used content analysis to examine interview transcripts for both a priori and emergent themes about perceived IPC program effects.Key resultsPatients enrolled in VA IPCs reported improvements in their experience of VA care (e.g., patient-provider relationship, access to their team). Both patients and leaders reported improvements in patient motivation to engage with self-care and with their IPC team, and behaviors, especially diet, exercise, and medication management. Patients also perceived improvements in health and described receiving assistance with social needs. Despite this, patients and leaders also outlined patient health characteristics and contextual factors (e.g., chronic health conditions, housing insecurity) that may have limited the effectiveness of the program on healthcare cost and utilization.ConclusionsPatients and primary care facility leaders report benefits for high-needs patients from IPC interventions that translated into perceived improvements in healthcare, health behaviors, and physical and mental health status. Most program evaluations focus on cost and utilization, which may be less amenable to change given this cohort's numerous comorbid health conditions and complex social circumstances. Future IPC program evaluations should additionally examine IPC's effects on quality of care, patient satisfaction, quality of life, and patient health behaviors other than utilization (e.g., engagement, self-efficacy).

The Veterans Health Administration (VHA) has undertaken primary care transformation based on patient-centered medical home (PCMH) tenets. VHA PCMH models are designed for the predominantly male Veteran population, and require tailoring to meet women Veterans' needs. We used evidence-based quality improvement (EBQI), a stakeholder-driven implementation strategy, in a cluster randomized controlled trial across 12 sites (eight EBQI, four control) that are members of a Practice-Based Research Network. EBQI involves engaging multilevel, inter-professional leaders and staff as stakeholders in reviewing evidence and setting QI priorities. The goal of this analysis was to examine processes of engaging stakeholders in early implementation of EBQI to tailor VHA's medical home for women. Four inter-professional regional stakeholder planning meetings were conducted; these meetings engaged stakeholders by providing regional data about gender disparities in Veterans' care experiences. Subsequent to each meeting, qualitative interviews were conducted with 87 key stakeholders (leaders and staff). Stakeholders were asked to describe QI efforts and the use of data to change aspects of care, including women's health care. Interview transcripts were summarized and coded using a hybrid deductive/inductive analytic approach. The presentation of regional-level data about gender disparities resulted in heightened awareness and stakeholder buy-in and decision-making related to women's health-focused QI. Interviews revealed that stakeholders were familiar with QI, with regional and facility leaders aware of inter-disciplinary committees and efforts to foster organizational change, including PCMH transformation. These efforts did not typically focus on women's health, though some informal efforts had been undertaken. Barriers to engaging in QI included lack of communication across clinical service lines, fluidity in staffing, and lack of protected time. Inter-professional, multilevel stakeholders need to be engaged in implementation early, with data and discussion that convey the importance and relevance of a new initiative. Stakeholder perspectives on institutional norms (e.g., gender norms) and readiness for population-specific QI are useful drivers of clinical initiatives designed to transform care for clinical subpopulations.

Introduction: Busulfan is a common component of allogeneic hematopoietic cell transplant (alloHCT) conditioning, however interpatient pharmacokinetic variability can result in enhanced toxicity or increased relapse risk. Therapeutic drug monitoring (TDM) can minimize variability, yet the optimal frequency of TDM is unknown. We compared outcomes for patients with one versus two sets of busulfan TDM during myeloablative conditioning (MAC) prior to alloHCT. Methods: We analyzed the impact of busulfan TDM frequency and dose adjustments, with the primary outcome being relapse-free survival (RFS). Other outcomes included the incidence of acute and chronic graft versus host disease (GVHD), oral mucositis, pulmonary toxicity, sinusoidal obstruction syndrome (SOS), the cumulative incidence of relapse (CIR), and overall survival (OS). Results: Twenty-two patients underwent one set of sampling while 53 patients underwent two sets. Similar baseline characteristics were observed between the groups. There were no significant differences observed in RFS by day +180 (77.3% vs. 79.2%, p = 1.0), CIR by day +180 (18.2% vs. 17.8%, p = 0.74), or OS (p = 0.73). The incidences of acute GVHD, chronic GVHD, SOS, and severe mucositis were also similar. In each group, 63% received busulfan dose adjustments after one set, with 52.8% receiving further dose adjustments following the second set. Conclusion: We observed no significant difference in alloHCT outcomes between patients who underwent one versus two sets of busulfan TDM sampling, suggesting that a single-time TDM and dose adjustment may be adequate to maximize outcomes after MAC alloHCT. [ABSTRACT FROM AUTHOR]

Chromosomal rearrangements are initiating events in acute lymphoblastic leukaemia (ALL). Here using RNA sequencing of 560 ALL cases, we identify rearrangements between MEF2D (myocyte enhancer factor 2D) and five genes (BCL9, CSF1R, DAZAP1, HNRNPUL1 and SS18) in 22 B progenitor ALL (B-ALL) cases with a distinct gene expression profile, the most common of which is MEF2D-BCL9. Examination of an extended cohort of 1,164 B-ALL cases identified 30 cases with MEF2D rearrangements, which include an additional fusion partner, FOXJ2; thus, MEF2D-rearranged cases comprise 5.3% of cases lacking recurring alterations. MEF2D-rearranged ALL is characterized by a distinct immunophenotype, DNA copy number alterations at the rearrangement sites, older diagnosis age and poor outcome. The rearrangements result in enhanced MEF2D transcriptional activity, lymphoid transformation, activation of HDAC9 expression and sensitive to histone deacetylase inhibitor treatment. Thus, MEF2D-rearranged ALL represents a distinct form of high-risk leukaemia, for which new therapeutic approaches should be considered.