Katherine L. Kahn

Previous studies have disagreed on whether patients who receive primary care from federally qualified health centers (FQHCs) have different utilization patterns than patients who receive care elsewhere. Our objective was to compare patterns of healthcare utilization between Medicare beneficiaries who received primary care from FQHCs and Medicare beneficiaries who received primary care from another source. We compared characteristics and ambulatory, emergency department (ED), and inpatient utilization during 2013 between 130,637 Medicare beneficiaries who visited an FQHC for the majority of their primary care in 2013 (FQHC users) and a random sample of 1,000,000 Medicare fee-for-service (FFS) beneficiaries who did not visit an FQHC (FQHC non-users). We then created a propensity-matched sample of 130,569 FQHC users and 130,569 FQHC non-users to account for differences in observable patient characteristics between the two groups and repeated all comparisons. Before matching, the two samples differed in terms of age (42% below age 65 for FQHC users vs. 16% among FQHC non-users, p < 0.001 for all comparisons), disability (52% vs. 24%), eligibility for Medicaid (56% vs. 21%), severe mental health disorders (17% vs. 10%), and substance abuse disorders (6% vs. 3%). FQHC users had fewer ambulatory visits to primary care or specialist providers (10.0 vs. 12.0 per year), more ED visits (1.2 vs. 0.8), and fewer hospitalizations (0.3 vs. 0.4). In the matched sample, FQHC users still had slightly lower utilization of ambulatory visits to primary care or specialist providers (10.0 vs. 11.2) and slightly higher utilization of ED visits (1.2 vs. 1.0), compared to FQHC users. Hospitalization rates between the two groups were similar (0.3 vs. 0.3). In this population of Medicare FFS beneficiaries, FQHC users had slightly lower utilization of ambulatory visits and slightly higher utilization of ED visits, compared to FQHC non-users, after accounting for differences in case mix. This study suggests that FQHC care and non-FQHC care are associated with broadly similar levels of healthcare utilization among Medicare FFS beneficiaries.

Background: Accurate information regarding race, ethnicity, and national origins is critical for identifying disparities in the cancer burden. Objectives: To examine the use of a Spanish surname list to improve the quality of race-related information obtained from rapid case ascertainment (RCA) and to estimate the accuracy of race-related information obtained from cancer registry records collected by routine reporting. Subjects: Self-reported survey responses of 3954 participants from California enrolled in the Cancer Care Outcomes Research and Surveillance Consortium. Measures: Sensitivity, specificity, positive predictive value, and percent agreement. We used logistic regression to identify predictors of underreporting and overreporting of a race/ethnicity. Results: Use of the Spanish surname list increased the sensitivity of RCA for Latino ethnicity from 37% to 83%. Sensitivity for cancer registry records collected by routine reporting was ≥95% for whites, blacks, and Asians, and specificity was high for all groups (86%–100%). However, patterns of misclassification by race/ethnicity were found that could lead to biased cancer statistics for specific race/ethnicities. Discordance between self-reported and registry-reported race/ethnicity was more likely for women, Latinos, and Asians. Conclusions: Methods to improve race and ethnicity data, such as using Spanish surnames in RCA and instituting data collection guidelines for hospitals, are needed to ensure minorities are accurately represented in clinical and epidemiological research.

Background: Healthcare–associated infections (HAIs) have long been the subject of research and prevention practice. When findings show potential to significantly impact outcomes, clinicians, policymakers, safety experts, and stakeholders seek to bridge the gap between research and practice by identifying mechanisms and assigning responsibility for translating research to practice. Objectives: This paper describes progress and challenges in HAI research and prevention practices, as explained through an examination of Health and Human Services (HHS) Action Plan’s goals, inputs, and implementation in each area. Research Design: We used the Context-Input-Process-Product evaluation model, together with an HAI prevention system framework, to assess the transformative processes associated with HAI research and adoption of prevention practices. Results: Since the introduction of the Action Plan, HHS has made substantial progress in prioritizing research projects, translating findings from those projects into practice, and designing and implementing research projects in multisite practice settings. Research has emphasized the basic science and epidemiology of HAIs, the identification of gaps in research, and implementation science. The basic, epidemiological, and implementation science communities have joined forces to better define mechanisms and responsibilities for translating HAI research into practice. Challenges include the ongoing need for better evidence about intervention effectiveness, the growing implementation burden on healthcare providers and organizations, and challenges implementing certain practices. Conclusions: Although these HAI research and prevention practice activities are complex spanning multiple system functions and properties, HHS is making progress so that the right methods for addressing complex HAI problems at the interface of patient safety and clinical practice can emerge.

Background: The widespread prevalence and enormous cost of healthcare–associated infections (HAIs) constitute a major public health problem and patient safety concern. Objectives: In 2009, IMPAQ International and the RAND Corporation initiated an independent, outside evaluation of Health and Human Services’ HAI prevention efforts as guided and driven by the Action Plan. The 3-year evaluation, whose findings are presented in this special issue, was intended to assess the outcomes of the US Department of Health and Human Services’ (HHS’s) past efforts, and also to provide ongoing, formative feedback to Action Plan leadership to guide their efforts. Research Design: This special issue presents results from the evaluation of the Action Plan, along with related articles intended to examine the issue of HAIs from many angles. Results: To address the national epidemic of HAIs, in 2009 HHS released the HHS National Action Plan to Prevent Healthcare-associated Infections, which was updated and expanded in 2012. The Action Plan established national goals for HAI prevention and identified key actions needed to reduce, prevent, and eventually eliminate the burden posed by HAIs. Conclusions: Broad lessons learned from the Action Plan evaluation document changes in structures, processes, and outcomes pertinent to eradicating HAIs, and identify lessons that are applicable to other large federal implementation efforts.

Background: Historically, the ability to accurately track healthcare–associated infections (HAIs) was hindered due to a lack of coordination among data sources and shortcomings in individual data sources. Objectives: This paper presents the results of the evaluation of the HAI data and the monitoring component of the Action Plan, focusing on context (goals), inputs, and processes. Research Design: We used the Content-Input-Process-Product framework, together with the HAI prevention system framework, to describe the transformative processes associated with data and monitoring efforts. Results: Six HAI priority conditions in the 2009 Action Plan created a focus for the selection of goals and activities. Key Action Plan decisions included a phased-in data and monitoring approach, commitment to linking the selection of priority HAIs to highly visible national 5-year prevention targets, and the development of a comprehensive HAI database inventory. Remaining challenges relate to data validation, resources, and the opportunity to integrate electronic health and laboratory records with other provider data systems. Conclusions: The Action Plan’s data and monitoring program has developed a sound infrastructure that builds upon technological advances and embodies a firm commitment to prioritization, coordination and alignment, accountability and incentives, stakeholder engagement, and an awareness of the need for predictable resources. With time, and adequate resources, it is likely that the investment in data-related infrastructure during the Action Plan’s initial years will reap great rewards.

Background The research goals of the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium are to determine how characteristics and beliefs of patients, providers, and health care organizations influence the treatments and outcomes of individuals with newly diagnosed lung and colorectal cancers. As CanCORS results will inform national policy, it is important to know how they generalize to the United States population with these cancers. Research Design This study assessed the representativeness of the CanCORS cohort of 10,547 patients with lung cancer (LC) or colorectal cancer (CRC) enrolled between 2003 and 2005. We compared characteristics (sex, race, age, and disease stage) with the Surveillance, Epidemiology, and End Results (SEER) population of 234,464 patients with new onset of these cancers during the CanCORS recruitment period. Results The CanCORS sample is well matched to the SEER Program for both cancers. In CanCORS, 41% LC/47% CRC were female versus 47% LC/49% CRC in SEER. African American, Hispanic, and Asian cases differed by no more than 5 percentage points between CanCORS and SEER. The SEER population is slightly older, with the percentage of patients older than 75 years 33.1% LC/37.3% CRC in SEER versus 26.9% LC/29.4% in CanCORS, and also has a slightly higher proportion of early stage patients. We also found that the CanCORS cohort was representative within specific SEER regions that map closely to CanCORS sites. Conclusions This study demonstrates that the CanCORS Consortium was successful in enrolling a demographically representative sample within the CanCORS regions.

Federal regulations mandate independent review and approval by an "institutional review board" (IRB) before studies that involve human research subjects may begin. Although many researchers strongly support the need for IRB review, they also contend that it is burdensome when it imposes costs that do not add to the protections afforded to research participants and that this burden threatens the viability of research. The U.S. Department of Health and Human Services recently announced its intention to reform the regulations governing IRB review. We used a search of the PubMed database, supplemented by a bibliographic review, to identify all existing primary data on the costs of IRB review. "Costs" were broadly defined to include both expenditures of time or money and constraints imposed on the scope of the research. Burdensome costs were limited to those that did not contribute to greater protections for the participants. Evidence from a total of fifty-two studies shows that IRBs operate at different levels of efficiency; that waiting to obtain IRB approval has, in some instances, delayed project initiation; that IRBs presented with identical protocols sometimes asked for different and even competing revisions; and that some decisions made (and positions held) by IRBs are not in accord with federal policy guidance. While the evidence is sufficient to conclude that there is burden associated with IRB review, it is too limited to allow for valid estimates of its magnitude or to serve as the basis for formulating policies on IRB reform. The single exception is multicenter research, for which we found that review by several local IRBs is likely to be burdensome. No mechanism currently exists at the national level to gather systematic evidence on the intersection between research and IRB review. This gap is of concern in light of the changing nature of research and the increasingly important role that research is envisioned to play in improving the overall quality of health care.

We describe early dissemination patterns for first-line bevacizumab given for metastatic colorectal cancer treatment.