Publications

Ibrutinib, a Bruton tyrosine kinase inhibitor, is approved for treatment of various B-cell malignancies. In ibrutinib clinical studies, low-grade haemorrhage was common, whereas major haemorrhage (MH) was infrequent. We analysed the incidence of and risk factors for MH from 15 ibrutinib clinical studies (N = 1768), including 4 randomised controlled trials (RCTs). Rates of any-grade bleeding were similar for single-agent ibrutinib and ibrutinib combinations (39% and 40%). Low-grade bleeding was more common in ibrutinib-treated than comparator-treated patients (35% and 15%), and early low-grade bleeding was not associated with MH. The proportion of MH in RCTs was higher with ibrutinib than comparators (4.4% vs. 2.8%), but after adjusting for longer exposure with ibrutinib (median 13 months vs. 6 months), the incidence of MH was similar (3.2 vs. 3.1 per 1000 person-months). MH led to treatment discontinuation in 1% of all ibrutinib-treated patients. Use of anticoagulants and/or antiplatelets (AC/AP) during the study was common (~50% of patients) and had an increased exposure-adjusted relative risk for MH in both the total ibrutinib-treated population (1.9; 95% confidence interval, 1.2-3.0) and RCT comparator-treated patients (2.4; 95% confidence interval, 1.0-5.6), indicating that ibrutinib may not alter the effect of AC/AP on the risk of MH in B-cell malignancies.

Evaluations of community-based antiretroviral therapy (ART) programmes have demonstrated positive outcomes, but little is known about the impact of tapering community-based ART. The objective of this study was to assess 24-month HIV retention outcomes of a community-based ART programme and its tapered visit frequency in Koidu City, Sierra Leone. This retrospective, quasi-experimental study compared outcomes of 52 HIV-infected persons initiated on community-based ART against 91 HIV-infected persons receiving the standard of care from November 2009 to February 2013. The community-based ART pilot programme was designed to strengthen the standard of care through a comprehensive, patient-centred case management strategy. The strategy included medical, educational, psychological, social, and economic support. Starting in October 2011, the frequency of home visits was tapered from twice daily every day per week to once daily three days per week. Outcomes were retention in care at 12 and 24 months and adherence to ART over a three-month time period. Participants who received community-based ART had significantly higher retention than those receiving standard of care. At 12 months, retention rates for community-based ART and standard of care were 61.5% and 31.9%, respectively (p < .01). At 24 months, retention rates for community-based ART and standard of care were 73.1% and 44.0%, respectively (p < .01). Significant differences in levels of adherence were observed when comparing community-based ART against persons receiving standard of care (p < .05). No differences in adherence levels were observed between groups of people receiving various frequencies of home visits. Our pilot programme in Koidu City provides new evidence that community-based ART has the potential to improve retention and adherence outcomes for HIV-infected persons, regardless of the frequency of home visits. Overcoming the barriers to HIV care requires a comprehensive, patient-centred approach that may include clinic-based and community-based interventions.

Patient engagement in primary care leadership is an important means to involve community voices at community health centers. Federally qualified health centers (FQHCs) are mandated to have patient representation within their governing boards, while practices seeking patient-centered medical home certification receive credit for implementing patient advisory councils (PACs). Our objective was to compare and contrast how community health centers engage patients in clinic management, decision-making and planning within governing boards versus PACs. Qualitative study conducted from August 2016 to June 2017 at community health centers in California, Arizona and Hawaii. We interviewed practice leaders of patient engagement programs at their site. Eligible clinics had patient representatives within their governing board, PAC, or both. We assessed patient demographics, roles and responsibilities of patients participating, and extent of involvement in quality improvement among governing boards versus PACs. We interviewed 19 sites, of which 17 were FQHCs that had governing boards. Of the 17 FQHCs, 11 had also implemented PACs. Two non-FQHC safety-net sites had PACs but did not have governing boards. Governing board members had formal, structured membership responsibilities such as finances and hiring personnel. PAC roles were more flexible, focusing on day-to-day clinic operations. Clinics tended to recruit governing board patient members for their skill set and professional experience; PAC member recruitment focused more on demographic representation of the clinic's patient population. Both groups worked on quality improvement, but governing boards tended to review clinic performance metrics, while PAC members were involved in specific project planning and implementation to improve clinical outcomes and patient experience. Patient involvement in clinic improvement in CHCs includes higher-level decision-making and governance through mechanisms such as governing boards, as well as engagement in day-to-day practice improvement through PACs. These roles offer differing, but valuable insights to clinic programs and policies.

The California Tobacco Control Program is the longest standing, publicly funded tobacco control program in the U.S. California's adult smoking rate declined from 23.7% (1989) to 11% (2016) but California still has more than 3 million smokers dispersed over 58 counties, requiring a coordinated approach to further tobacco control. Early California Tobacco Control Program success is rooted in public health policy strategies and a statewide media campaign that shifted social norms. In 2009, concepts for a coordinated approach were introduced by the California Tobacco Control Program in the state's first tobacco quit plan. The state quit plan called for public health's tobacco control programs to engage healthcare systems and insurers to work more directly with the California Smoker's Helpline (Helpline). With California's Medicaid (Medi-Cal) program expansion and the implementation of electronic medical record systems, health care plans and providers received additional support for system changes. Simultaneous with these changes, coordinated tobacco control efforts began, including California's Medi-Cal Incentives to Quit Smoking project (2012-2015). In the Medi-Cal Incentives to Quit Smoking project, safety-net providers and Medi-Cal plans were outreached and engaged to promote incentives for Medi-Cal members to utilize Helpline services. In another effort, UC Quits (2013-2015), the five University of California health systems used electronic medical record tools to promote tobacco treatments and electronic referrals to the Helpline. Now, as tobacco prevention is increasingly prioritized for quality improvement, California Tobacco Control Program is funding CA Quits, a statewide tobacco-cessation learning collaborative and technical assistance resource to promote integration of tobacco treatment services and quality improvement activities into safety-net health systems. CA Quits, in coordination with the Helpline, will connect public health departments, Medi-Cal plans, and safety-net providers to accelerate health systems change for tobacco-cessation treatment throughout the state. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Advancing Smoking Cessation in California's Medicaid Population, which is sponsored by the California Department of Public Health.