Showing papers by "RAND Corporation published in 2015"

A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project.

Abstract: Identifying, developing, and testing implementation strategies are important goals of implementation science. However, these efforts have been complicated by the use of inconsistent language and inadequate descriptions of implementation strategies in the literature. The Expert Recommendations for Implementing Change (ERIC) study aimed to refine a published compilation of implementation strategy terms and definitions by systematically gathering input from a wide range of stakeholders with expertise in implementation science and clinical practice. Purposive sampling was used to recruit a panel of experts in implementation and clinical practice who engaged in three rounds of a modified Delphi process to generate consensus on implementation strategies and definitions. The first and second rounds involved Web-based surveys soliciting comments on implementation strategy terms and definitions. After each round, iterative refinements were made based upon participant feedback. The third round involved a live polling and consensus process via a Web-based platform and conference call. Participants identified substantial concerns with 31% of the terms and/or definitions and suggested five additional strategies. Seventy-five percent of definitions from the originally published compilation of strategies were retained after voting. Ultimately, the expert panel reached consensus on a final compilation of 73 implementation strategies. This research advances the field by improving the conceptual clarity, relevance, and comprehensiveness of implementation strategies that can be used in isolation or combination in implementation research and practice. Future phases of ERIC will focus on developing conceptually distinct categories of strategies as well as ratings for each strategy’s importance and feasibility. Next, the expert panel will recommend multifaceted strategies for hypothetical yet real-world scenarios that vary by sites’ endorsement of evidence-based programs and practices and the strength of contextual supports that surround the effort.

Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study

Abstract: Poor terminological consistency for core concepts in implementation science has been widely noted as an obstacle to effective meta-analyses. This inconsistency is also a barrier for those seeking guidance from the research literature when developing and planning implementation initiatives. The Expert Recommendations for Implementing Change (ERIC) study aims to address one area of terminological inconsistency: discrete implementation strategies involving one process or action used to support a practice change. The present report is on the second stage of the ERIC project that focuses on providing initial validation of the compilation of 73 implementation strategies that were identified in the first phase. Purposive sampling was used to recruit a panel of experts in implementation science and clinical practice (N = 35). These key stakeholders used concept mapping sorting and rating activities to place the 73 implementation strategies into similar groups and to rate each strategy’s relative importance and feasibility. Multidimensional scaling analysis provided a quantitative representation of the relationships among the strategies, all but one of which were found to be conceptually distinct from the others. Hierarchical cluster analysis supported organizing the 73 strategies into 9 categories. The ratings data reflect those strategies identified as the most important and feasible. This study provides initial validation of the implementation strategies within the ERIC compilation as being conceptually distinct. The categorization and strategy ratings of importance and feasibility may facilitate the search for, and selection of, strategies that are best suited for implementation efforts in a particular setting.

Assessing the Effects of Medical Marijuana Laws on Marijuana Use: The Devil is in the Details

Abstract: This paper sheds light on previous inconsistencies identified in the literature regarding the relationship between medical marijuana laws (MMLs) and recreational marijuana use by closely examining the importance of policy dimensions (registration requirements, home cultivation, dispensaries) and the timing of when particular policy dimensions are enacted. Using data from our own legal analysis of state MMLs, we evaluate which features are associated with adult and youth recreational and heavy use by linking these policy variables to data from the Treatment Episode Data Set (TEDS) and National Longitudinal Survey of Youth (NLSY97). We employ differences-in-differences techniques, controlling for state and year fixed effects, allowing us to exploit within-state policy changes. We find that while simple dichotomous indicators of MML laws are not positively associated with marijuana use or abuse, such measures hide the positive influence legal dispensaries have on adult and youth use, particularly heavy use. Sensitivity analyses that help address issues of policy endogeneity and actual implementation of dispensaries support our main conclusion that not all MML laws are the same. Dimensions of these policies, in particular legal protection of dispensaries, can lead to greater recreational marijuana use and abuse among adults and those under the legal age of 21 relative to MMLs without this supply source.

A design space for effective privacy notices

Abstract: Notifying users about a system's data practices is supposed to enable users to make informed privacy decisions. Yet, current notice and choice mechanisms, such as privacy policies, are often ineffective because they are neither usable nor useful, and are therefore ignored by users. Constrained interfaces on mobile devices, wearables, and smart home devices connected in an Internet of Things exacerbate the issue. Much research has studied usability issues of privacy notices and many proposals for more usable privacy notices exist. Yet, there is little guidance for designers and developers on the design aspects that can impact the effectiveness of privacy notices. In this paper, we make multiple contributions to remedy this issue. We survey the existing literature on privacy notices and identify challenges, requirements, and best practices for privacy notice design. Further, we map out the design space for privacy notices by identifying relevant dimensions. This provides a taxonomy and consistent terminology of notice approaches to foster understanding and reasoning about notice options available in the context of specific systems. Our systemization of knowledge and the developed design space can help designers, developers, and researchers identify notice and choice requirements and develop a comprehensive notice concept for their system that addresses the needs of different audiences and considers the system's limitations and opportunities for providing notice.

Racial-Ethnic Disparities in Management and Outcomes Among Children With Type 1 Diabetes

Abstract: BACKGROUND AND OBJECTIVES: Previous research has documented racial/ethnic disparities in diabetes treatments and outcomes. It remains controversial whether these disparities result from differences in socioeconomic status (SES) or other factors. We examined racial/ethnic disparities in therapeutic modalities and diabetes outcomes among the large number of pediatric participants in the T1D Exchange Clinic Registry. METHODS: The cohort included 10 704 participants aged RESULTS: Insulin pump use was higher in white participants than in black or Hispanic participants (61% vs 26% and 39%, respectively) after adjusting for gender, age, diabetes duration, and SES (P CONCLUSIONS: Even after SES adjustment, marked disparities in insulin treatment method and treatment outcomes existed between black versus Hispanic and white children within this large pediatric cohort. Barriers to insulin pump use and optimal glycemic control beyond SES should be explored in all ethnic groups.

How long does biomedical research take? Studying the time taken between biomedical and health research and its translation into products, policy, and practice

Abstract: Background: The time taken, or ‘time lags’, between biomedical/health research and its translation into health improvements is receiving growing attention. Reducing time lags should increase rates of return to such research. However, ways to measure time lags are under-developed, with little attention on where time lags arise within overall timelines. The process marker model has been proposed as a better way forward than the current focus on an increasingly complex series of translation ‘gaps’. Starting from that model, we aimed to develop better methods to measure and understand time lags and develop ways to identify policy options and produce recommendations for future studies. Methods: Following reviews of the literature on time lags and of relevant policy documents, we developed a new approach to conduct case studies of time lags. We built on the process marker model, including developing a matrix with a series of overlapping tracks to allow us to present and measure elements within any overall time lag. We identified a reduced number of key markers or calibration points and tested our new approach in seven case studies of research leading to interventions in cardiovascular disease and mental health. Finally, we analysed the data to address our study’s key aims. Results: The literature review illustrated the lack of agreement on starting points for measuring time lags. We mapped points from policy documents onto our matrix and thus highlighted key areas of concern, for example around delays before new therapies become widely available. Our seven completed case studies demonstrate we have made considerable progress in developing methods to measure and understand time lags. The matrix of overlapping tracks of activity in the research and implementation processes facilitated analysis of time lags along each track, and at the cross-over points where the next track started. We identified some factors that speed up translation through the actions of companies, researchers, funders, policymakers, and regulators. Recommendations for further work are built on progress made, limitations identified and revised terminology.

Diet and Perceptions Change with Supermarket Introduction in a Food Desert, but Not Because of Supermarket Use

Abstract: Placing full-service supermarkets in food deserts--areas with limited access to healthy food--has been promoted as a way to reduce inequalities in access to healthy food, improve diet, and reduce the risk of obesity. However, previous studies provide scant evidence of such impacts. We surveyed households in two Pittsburgh, Pennsylvania, neighborhoods in 2011 and 2014, one of which received a new supermarket in 2013. Comparing trends in the two neighborhoods, we obtained evidence of multiple positive impacts from new supermarket placement. In the new supermarket neighborhood we found net positive changes in overall dietary quality; average daily intakes of kilocalories and added sugars; and percentage of kilocalories from solid fats, added sugars, and alcohol. However, the only positive outcome in the recipient neighborhood specifically associated with regular use of the new supermarket was improved perceived access to healthy food. We did not observe differential improvement between the neighborhoods in fruit and vegetable intake, whole grain consumption, or body mass index. Incentivizing supermarkets to locate in food deserts is appropriate. However, efforts should proceed with caution, until the mechanisms by which the stores affect diet and their ability to influence weight status are better understood.

Prevalence of, risk factors for, and consequences of posttraumatic stress disorder and other mental health problems in military populations deployed to Iraq and Afghanistan

Abstract: This review summarizes the epidemiology of posttraumatic stress disorder (PTSD) and related mental health problems among persons who served in the armed forces during the Iraq and Afghanistan conflicts, as reflected in the literature published between 2009 and 2014. One-hundred and sixteen research studies are reviewed, most of which are among non-treatment-seeking US service members or treatment-seeking US veterans. Evidence is provided for demographic, military, and deployment-related risk factors for PTSD, though most derive from cross-sectional studies and few control for combat exposure, which is a primary risk factor for mental health problems in this cohort. Evidence is also provided linking PTSD with outcomes in the following domains: physical health, suicide, housing and homelessness, employment and economic well-being, social well-being, and aggression, violence, and criminality. Also included is evidence about the prevalence of mental health service use in this cohort. In many instances, the current suite of studies replicates findings observed in civilian samples, but new findings emerge of relevance to both military and civilian populations, such as the link between PTSD and suicide. Future research should make effort to control for combat exposure and use longitudinal study designs; promising areas for investigation are in non-treatment-seeking samples of US veterans and the role of social support in preventing or mitigating mental health problems in this group.

Quantile Regression with Nonadditive Fixed Effects

Abstract: This paper introduces a quantile regression estimator for panel data (QRPD) with nonadditive fixed effects, maintaining the nonseparable disturbance term commonly associated with quantile estimation. QRPD estimates the impact of exogenous or endogenous treatment variables on the outcome distribution using “within” variation in the treatment variables or instruments for identification purposes. Most quantile panel data estimators include additive fixed effects which separates the disturbance term and assumes the parameters vary based only on the time-varying components of the disturbance term. QRPD is consistent for small T and straightforward to implement. The nonadditive fixed effects are never estimated or even specified. Simulation results show that QRPD works well even when instrumental variables quantile regression and additive fixed effect quantile estimators are biased. I estimate the effect of the 2008 tax rebates on the distribution of consumption, finding evidence of substantial heterogeneity in the household spending response to transitory income.

The opportunity costs of informal elder-care in the United States: new estimates from the American time use survey

Abstract: Objectives To provide nationally representative estimates of the opportunity costs of informal elder-care in the United States. Data Sources Data from the 2011 and 2012 American Time Use Survey. Study Design Wage is used as the measure of an individual's value of time (opportunity cost), with wages being imputed for nonworking individuals using a selection-corrected regression methodology. Principal Findings The total opportunity costs of informal elder-care amount to $522 billion annually, while the costs of replacing this care by unskilled and skilled paid care are $221 billion and $642 billion, respectively. Conclusions Informal caregiving remains a significant phenomenon in the United States with a high opportunity cost, although it remains more economical (in the aggregate) than skilled paid care.

The Role of Early-Life Educational Quality and Literacy in Explaining Racial Disparities in Cognition in Late Life

Abstract: Racial disparities in late-life cognitive test performance are well documented (Alley, Suthers, & Crimmins, 2007; Fillenbaum et al., 2001; Masel & Peek, 2009; Masel, Raji, & Peek, 2010; Rodgers, Ofstedal, & Herzog, 2003; Schwartz et al., 2004; Zsembik & Peek, 2001). Studies have shown that nondemented black older adults demonstrate lower cognitive test performance compared with white peers. These disparities are sometimes attenuated by demographic factors such as educational attainment and socioeconomic status (Barnes et al., 2011; Schwartz et al., 2004) or other predictors of cognitive function such as physical activity (Masel et al., 2010), occupational attainment (Manly et al., 1998), occupational prestige (Albert, 1995; Del Ser, Hachinsky, Merskey, & Munoz, 1999; Fratiglioni, 1996; Friedland, 1993; Katzman, 1993), and health-related variables (Manly et al., 1998; Mungas et al., 2009). Some studies suggest that race-related differences in late-life cognitive performance are sometimes (Fillenbaum et al., 2001), but not typically, eliminated by accounting for such variables. Literacy in late life, though highly correlated with years of education (Verhaeghen, 2003), has proven to be a stronger predictor of late-life cognitive functioning than years of education, especially for blacks (Dotson, Kitner-Triolo, Evans, & Zonderman, 2009). Adjusting for literacy has also been shown to greatly attenuate the estimated effect of race and to eliminate most racial differences on neuropsychological test performance in multiethnic elderly samples matched on years of education (Manly et al., 1999; Manly, Jacobs, Touradji, Small, & Stern, 2002; Touradji, Manly, Jacobs, & Stern, 2001). Literacy has been proposed to be a better predictor of late-life cognitive differences than years of education, especially for minorities, because it better approximates the cognitive benefits conferred by the early-life educational experience. Educational experiences can be characterized with respect to duration, for example, using years of schooling completed or degrees attained, or with respect to quality of schooling. The degree of cognitive benefit from education may better correspond with indices of educational quality than measures of educational attainment (Dotson et al., 2009). As Manly, Touradji, Tang, and Stern (2003) demonstrated, educational quality as approximated by literacy in later life is a stronger predictor of late-life cognitive performance than years of education. Evidence also suggests that educational quality, measured by state education policies, independently predicts late-life differences in cognition (Glymour, 2004). Historically, educational quality has varied widely across states and over time in the United States (Berkman & Glymour, 2006), with pronounced differences especially between northern and southern parts of the country. A majority of adults now aged 50 and older grew up during the influence of Jim Crow laws. Many blacks received their education in the South, where social conditions differed greatly from the North (Barnes, 1983). For example, most Southerners attended segregated schools, and schools for black students offered significantly lower quality education than schools for whites (Glymour & Manly, 2008). Because many of today’s black elders attended school under Jim Crow laws in segregated schools, race-based differences in educational quality may account for a substantial portion of the racial differences observed in late-life cognition. It is difficult to collect direct data on the quality of education received many decades ago, but recent research has taken advantage of historical state and local laws and records. For example, Lleras-Muney (2002) found that state-level compulsory school attendance laws predicted mortality in addition to average years of education completed for people born in a state. Related to the present study, Glymour (2004) found that individuals born in states that had high levels of mandatory schooling performed better on cognitive testing decades after finishing school, after controlling for demographic characteristics. This finding suggests that historical indices of early-life educational experiences, albeit imprecise on an individual level, may partly explain cognitive performance in later life. Considering the significant social and educational disparities that existed during early childhood for today’s older adults, state laws dictating educational policy, as well as other indices of educational quality (e.g., classroom size, student:teacher ratio), may independently explain a substantial portion of race-based differences in late-life cognition. The WHICAP (Washington Heights-Inwood Columbia Aging Project) study, used in the present study, is a community-based study of cognitive aging in a multiethnic population of communities in New York City. WHICAP measured several individual- and state-level characteristics of early-life educational quality and collected individual-level measures of cognition and literacy during late life. The present study examined the utility of both early-life educational quality and literacy in explaining race-related differences in late-life cognitive performance within the WHICAP sample. We hypothesized that both educational quality and literacy account for a significant amount of the variance in general and domain-specific late-life cognitive performance, and both factors significantly attenuate the apparent racial disparities in level and pace of change in late-life cognitive functioning. We hypothesized that literacy is a stronger predictor of late-life cognitive functioning than educational quality for two reasons. First, literacy was measured more proximally to cognitive outcomes. Second, many indicators of early-life educational quality were obtained based on state records at the time participants were in school, and such area-level measures typically show weaker associations than those obtained at the individual level.

Common patterns of morbidity and multi-morbidity and their impact on health-related quality of life: evidence from a national survey.

Abstract: Background There is limited evidence about the impact of specific patterns of multi-morbidity on health-related quality of life (HRQoL) from large samples of adult subjects.

Emergency Physician Perceptions of Medically Unnecessary Advanced Diagnostic Imaging

Abstract: Objectives The objective was to determine emergency physician (EP) perceptions regarding 1) the extent to which they order medically unnecessary advanced diagnostic imaging, 2) factors that contribute to this behavior, and 3) proposed solutions for curbing this practice. Methods As part of a larger study to engage physicians in the delivery of high-value health care, two multispecialty focus groups were conducted to explore the topic of decision-making around resource utilization, after which qualitative analysis was used to generate survey questions. The survey was extensively pilot-tested and refined for emergency medicine (EM) to focus on advanced diagnostic imaging (i.e., computed tomography [CT] or magnetic resonance imaging [MRI]). The survey was then administered to a national, purposive sample of EPs and EM trainees. Simple descriptive statistics to summarize physician responses are presented. Results In this study, 478 EPs were approached, of whom 435 (91%) completed the survey; 68% of respondents were board-certified, and roughly half worked in academic emergency departments (EDs). Over 85% of respondents believe too many diagnostic tests are ordered in their own EDs, and 97% said at least some (mean = 22%) of the advanced imaging studies they personally order are medically unnecessary. The main perceived contributors were fear of missing a low-probability diagnosis and fear of litigation. Solutions most commonly felt to be “extremely” or “very” helpful for reducing unnecessary imaging included malpractice reform (79%), increased patient involvement through education (70%) and shared decision-making (56%), feedback to physicians on test-ordering metrics (55%), and improved education of physicians on diagnostic testing (50%). Conclusions Overordering of advanced imaging may be a systemic problem, as many EPs believe a substantial proportion of such studies, including some they personally order, are medically unnecessary. Respondents cited multiple complex factors with several potential high-yield solutions that must be addressed simultaneously to curb overimaging.

Sexual Minorities in England Have Poorer Health and Worse Health Care Experiences: A National Survey

Abstract: The health and healthcare of sexual minorities have recently been identified as priorities for health research and policy To compare the health and healthcare experiences of sexual minorities with heterosexual people of the same gender, adjusting for age, race/ethnicity, and socioeconomic status Multivariate analyses of observational data from the 2009/2010 English General Practice Patient Survey The survey was mailed to 556 million randomly sampled adults registered with a National Health Service general practice (representing 99 % of England’s adult population) In all, 2,169,718 people responded (39 % response rate), including 27,497 people who described themselves as gay, lesbian, or bisexual Two measures of health status (fair/poor overall self-rated health and self-reported presence of a longstanding psychological condition) and four measures of poor patient experiences (no trust or confidence in the doctor, poor/very poor doctor communication, poor/very poor nurse communication, fairly/very dissatisfied with care overall) Sexual minorities were two to three times more likely to report having a longstanding psychological or emotional problem than heterosexual counterparts (age-adjusted for 52 % heterosexual, 109 % gay, 150 % bisexual for men; 60 % heterosexual, 123 % lesbian and 188 % bisexual for women; p < 0001 for each) Sexual minorities were also more likely to report fair/poor health (adjusted 196 % heterosexual, 218 % gay, 264 % bisexual for men; 205 % heterosexual, 249 % lesbian and 316 % bisexual for women; p < 0001 for each) Adjusted for sociodemographic characteristics and health status, sexual minorities were about one and one-half times more likely than heterosexual people to report unfavorable experiences with each of four aspects of primary care Little of the overall disparity reflected concentration of sexual minorities in low-performing practices Sexual minorities suffer both poorer health and worse healthcare experiences Efforts should be made to recognize the needs and improve the experiences of sexual minorities Examining patient experience disparities by sexual orientation can inform such efforts

Group motivational interviewing for adolescents: change talk and alcohol and marijuana outcomes.

Abstract: OBJECTIVE: Little is known about what may distinguish effective and ineffective group interventions. Group motivational interviewing (MI) is a promising intervention for adolescent alcohol and other drug use; however, the mechanisms of change for group MI are unknown. One potential mechanism is change talk, which is client speech arguing for change. The present study describes the group process in adolescent group MI and effects of group-level change talk on individual alcohol and marijuana outcomes. METHOD: We analyzed 129 group session audio recordings from a randomized clinical trial of adolescent group MI. Sequential coding was performed with the Motivational Interviewing Skill Code (MISC) and the CASAA Application for Coding Treatment Interactions software application. Outcomes included past-month intentions, frequency, and consequences of alcohol and marijuana use; motivation to change; and positive expectancies. RESULTS: Sequential analysis indicated that facilitator open-ended questions and reflections of change talk increased group change talk. Group change talk was then followed by more change talk. Multilevel models accounting for rolling group enrollment revealed group change talk was associated with decreased alcohol intentions, alcohol use, and heavy drinking 3 months later; group sustain talk was associated with decreased motivation to change, increased intentions to use marijuana, and increased positive alcohol and marijuana expectancies. CONCLUSIONS: Facilitator speech and peer responses each had effects on change and sustain talk in the group setting, which were then associated with individual changes. Selective reflection of change talk in adolescent group MI is suggested as a strategy to manage group dynamics and increase behavioral change. (PsycINFO Database Record (c) 2014 APA, all rights reserved). Language: en

Growth In Buprenorphine Waivers For Physicians Increased Potential Access To Opioid Agonist Treatment, 2002–11

Abstract: Opioid use disorders are a significant public health problem, affecting two million people in the United States. Treatment with buprenorphine, methadone, or both is predominantly offered in methadone clinics, yet many people do not receive the treatment they need. In 2002 the Food and Drug Administration approved buprenorphine for prescription by physicians who completed a course and received a waiver from the Drug Enforcement Administration, exempting them from requirements in the Controlled Substances Act. To determine the waiver program’s impact on the availability of opioid agonist treatment, we analyzed data for the period 2002–11 to identify counties with opioid treatment shortages. We found that the percentage of counties with a shortage of waivered physicians fell sharply, from 98.9 percent in 2002 to 46.8 percent in 2011. As a result, the percentage of the US population residing in what we classified as opioid treatment shortage counties declined from 48.6 percent in 2002 to 10.4 percent in 2011....

From Subject to Participant: Ethics and the Evolving Role of Community in Health Research

Abstract: Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research.

What is the evidence base for public involvement in health-care policy?: results of a systematic scoping review.

Abstract: Background Public involvement in health-care policy has been advocated as a means to enhance health system responsiveness, yet evidence for its impact has been difficult to ascertain. Objectives To review the peer-reviewed empirical evidence on outcomes of public involvement in health-care policy. Methods We systematically searched PsychINFO and PubMed from November 2000 to April 2010 for empirical studies that reported on original research only; studies in languages other than English, German or French were excluded. Data were extracted using a standardized evidence table with a priori determined headings. Main results Nineteen studies were identified as eligible for inclusion in our review. We found that sound empirical evidence of the outcomes of public involvement activities in health care remains underdeveloped. The concept and the indicators used to examine and determine outcomes remain poorly specified and inconsistent, as does the reporting of the evidence. There was some evidence for the developmental role of public involvement, such as enhancing awareness, understanding and competencies among lay participants. Evidence for instrumental benefits of public involvement initiatives was less well documented. Conclusions Despite the growing body of work on public involvement in health-care policy, evidence of its impact remains scarce; thus, firm conclusions about involvement activities that are appropriate and effective for policy development are difficult to draw. However, focus on outcomes risks missing the normative argument that involving the public in the health-care policy process may be seen to be of intrinsic value.

Breast implant-associated anaplastic large cell lymphoma: a systematic review.

Abstract: Background:There is substantial evidence that a type of anaplastic large cell lymphoma (ALCL) is associated with breast implants. However, the course in patients with breast implants seems to be unusually benign compared with other systemic ALCL. The purpose of this study was to identify and analyze

Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN)

Abstract: Objectives The ALIGN study (NCT01061723) evaluated the efficacy and safety of sarilumab, the first fully human monoclonal antibody against interleukin-6 receptor-α (IL-6Rα), in patients with ankylosing spondylitis (AS). Methods Patients with active AS despite conventional treatment were randomised to placebo, or one of five subcutaneous dose regimens of sarilumab (100, 150 or 200 mg every other week, or 100 or 150 mg every week), for 12 weeks. The primary efficacy end point was the percentage of patients achieving the Axial SpondyloArthritis international Society (ASAS) 20 response criteria at week 12. Secondary endpoints included ASAS40 response, ASAS partial remission, AS Disease Activity Score, high-sensitivity C-reactive protein (hs-CRP) value, and safety. Results Baseline demographic and disease characteristics of the 301 patients enrolled were similar across treatment groups. At week 12, there was no statistically significant difference in ASAS20 response rate between placebo (ASAS20 = 24.0%) and any sarilumab dose group. A significantly greater reduction in hs-CRP value was achieved with the higher sarilumab doses versus placebo. No other statistically significant differences were evident for secondary efficacy endpoints. The most common treatment-emergent adverse events reported for sarilumab included infections (non-serious), neutropenia, and increase in alanine aminotransferase. No cases of tuberculosis, opportunistic, or fungal infections, or bowel perforations were reported. Seven patients experienced a treatment-emergent serious adverse event (all in sarilumab treatment groups). No deaths occurred. Conclusions The ALIGN study shows that IL-6Rα blockade with sarilumab was not an effective treatment for AS. Sarilumab was generally well tolerated with a manageable safety profile.

A multicentre comparison of quantitative 90Y PET/CT for dosimetric purposes after radioembolization with resin microspheres: the QUEST Phantom Study

Abstract: Purpose To investigate and compare the quantitative accuracy of 90Y imaging across different generation PET/CT scanners, for the purpose of dosimetry after radioembolization with resin microspheres.

US Prevalence and Predictors of Informal Caregiving for Dementia

Abstract: In 2010, 5.5 million US adults ages seventy and older received informal care, including 3.6 million with cognitive impairment or probable dementia. Adults with probable dementia received 171 hours of monthly informal care, versus 89 hours for cognitively impaired adults without dementia and 66 hours for cognitively normal adults.

Propensity Score Analysis with Survey Weighted Data.

Abstract: Propensity score analysis (PSA) is a common method for estimating treatment effects, but researchers dealing with data from survey designs are generally not properly accounting for the sampling weights in their analyses. Moreover, recommendations given in the few existing methodological articles on this subject are susceptible to bias. We show in this article through derivation, simulation, and a real data example that using sampling weights in the propensity score estimation stage and the outcome model stage results in an estimator that is robust to a variety of conditions that lead to bias for estimators currently recommended in the statistical literature. We highly recommend researchers use the more robust approach described here. This article provides much needed rigorous statistical guidance for researchers working with survey designs involving sampling weights and using PSAs.

Wrong-Site Surgery, Retained Surgical Items, and Surgical Fires : A Systematic Review of Surgical Never Events

Abstract: Importance Serious, preventable surgical events, termed never events , continue to occur despite considerable patient safety efforts. Objective To examine the incidence and root causes of and interventions to prevent wrong-site surgery, retained surgical items, and surgical fires in the era after the implementation of the Universal Protocol in 2004. Data Sources We searched 9 electronic databases for entries from 2004 through June 30, 2014, screened references, and consulted experts. Study Selection Two independent reviewers identified relevant publications in June 2014. Data Extraction and Synthesis One reviewer used a standardized form to extract data and a second reviewer checked the data. Strength of evidence was established by the review team. Data extraction was completed in January 2015. Main Outcomes and Measures Incidence of wrong-site surgery, retained surgical items, and surgical fires. Results We found 138 empirical studies that met our inclusion criteria. Incidence estimates for wrong-site surgery in US settings varied by data source and procedure (median estimate, 0.09 events per 10 000 surgical procedures). The median estimate for retained surgical items was 1.32 events per 10 000 procedures, but estimates varied by item and procedure. The per-procedure surgical fire incidence is unknown. A frequently reported root cause was inadequate communication. Methodologic challenges associated with investigating changes in rare events limit the conclusions of 78 intervention evaluations. Limited evidence supported the Universal Protocol (5 studies), education (4 studies), and team training (4 studies) interventions to prevent wrong-site surgery. Limited evidence exists to prevent retained surgical items by using data-matrix–coded sponge-counting systems (5 pertinent studies). Evidence for preventing surgical fires was insufficient, and intervention effects were not estimable. Conclusions and Relevance Current estimates for wrong-site surgery and retained surgical items are 1 event per 100 000 and 1 event per 10 000 procedures, respectively, but the precision is uncertain, and the per-procedure prevalence of surgical fires is not known. Root-cause analyses suggest the need for improved communication. Despite promising approaches and global Universal Protocol evaluations, empirical evidence for interventions is limited.