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Background Healthcare experiences associated with perceived racial/ethnic discrimination among patients are poorly understood. Objective Identify domains of patient dissatisfaction associated with perceived racial/ethnic discrimination among patients with pain. Design Semi-structured telephone surveys completed in 2013–2015. Participants White, African American, and Latino participants who reported receiving pain management from 25 Veterans Affairs (VA) Medical Centers. Main measures Surveys included open-ended questions about healthcare satisfaction/dissatisfaction and a measure of perceived racial/ethnic-based discrimination while seeking VA healthcare. Binary indicators for ten qualitative domains of dissatisfaction were derived from open-ended questions. We used multilevel models to identify dissatisfaction domains associated with perceived discrimination, adjusting for patient characteristics and site. Within domains associated with discrimination, we identified the most frequent codes and examined whether patients primarily referenced clinical or non-clinical staff in their experiences. Key results Overall, 622 participants (30.4% White, 37.8% African American, 31.8% Latino; 57.4% female; mean age = 53.4) reported a median discrimination score of 1.0 (IQR: 1.0–1.3) on a scale of 1 to 5; 233 (37.5%) perceived any racial/ethnic discrimination in healthcare. Individually, 7 of 10 qualitative domains were significantly associated with perceived discrimination: dissatisfaction with care quality, facilities, continuity of care, interactions with staff, staff demeanor, unresolved pain, and pharmacy services (ps<0.005). In combined models stratified by racial/ethnic group, 3 domains remained statistically significant: poor interactions for Latinos (adjOR = 5.24, 95% CI = 2.28–12.06), negative demeanor for African Americans (adjOR = 2.82, 95% CI = 1.45–5.50), and unresolved pain for Whites (adjOR = 6.23, 95% CI = 2.39–16.28). Clinical staff were referenced more often than non-clinical staff for all domains (interactions: 51% vs. 30%; demeanor: 46% vs. 15%; unresolved pain: 18% vs. 1%, respectively). Conclusion Negative interpersonal experiences and unresolved pain are strong correlates of perceived racial/ethnic discrimination among patients with pain. Future studies should test whether interventions targeting these domains reduce patient perceptions of racial/ethnic discrimination in healthcare.

Background Women in the postpartum period are at greater risk of intimate partner violence (IPV), which may cause physical, sexual, or psychological harm and have a long-lasting negative impact on mother and child. Seeking help in case of IPV in the postpartum period can be difficult. Objective The purpose of this study was to examine service preferences among postpartum women in Germany (non-)affected by IPV. Methods In the cross-sectional study INVITE, postpartum mothers ( n  = 3,509) were interviewed via telephone. Using the WHO-Violence Against Women Instrument (WHO-VAWI), women were divided into groups: non-affected women and women affected by psychological, physical, and/or sexual IPV. Using analyses of variance, group differences regarding preferred services and modes of service provision were assessed. Examined service domains were psychosocial services (e.g., women´s shelter or self-help groups), medical services (e.g., gynecologist or emergency room), and midwives. Modes of service provision included direct communication (e.g., in person or video conference) and indirect communication (e.g., chat or e-mail). Results People from the women's social environment (e.g., family, friends) and specialized IPV services, such as women's shelters, were the most preferred support. Regarding service categories, women who experienced any type of IPV rated all three service domains less likely to be used than non-affected women. Most preferred provision mode was “in person”. Women affected by physical and/or sexual IPV rated direct modes more negatively than non-affected women. However, there were no differences between (non-)affected women regarding indirect modes, such as e-mails or apps. Discussion The present results indicate that services were rated less likely to be used by postpartum women affected by IPV. Potential barriers which lead to these ratings need to be investigated. Efforts should be made to increase awareness of IPV and the beneficial effects of support.

Background:Detection of various relevant autoantibodies plays an important role in the identification of connective tissue diseases (CTD); however, there is currently a limited offer of automated multi-analyte tests, and many currently available methods are either single tests and/or manual or semi-automated. The development of fully automated multiplexed devices remains a need.Objectives:To assess the analytical performance of a novel, single-use, multiplexed microarray immunoassay prototype (MosaiQ AiPlex CTDplus) when used with the fully automated MosaiQ® system, for the simultaneous detection of fifteen autoantibodies associated with connective tissue diseases (CTD), compared with selected CE-marked devices.Methods:Microarray prototypes (AliveDx, Eysins, Switzerland) (Figure 1) have two separate sides of functionalized glass of which one was printed with antigens (Figure 1). Microarrays are assembled into magazines for processing on the MosaiQ 125 instrument. Human serum samples in primary tubes, buffers and reagents are loaded on the instrument, then microarrays are automatically processed, generating immunoassay spot signals that are interpreted by the instrument using a proprietary algorithm for image analysis. The system includes security features such as radiofrequency identification (RFID) and when magazines and reagents are loaded on the instrument, key information (i.e., lot number, expiry date and volume) is transmitted to it to assess whether resources loaded are adequate to perform the required test order. In addition to antigens, every microarray contains internal positive and negative controls to identify the location of the printed antigen probes to enable processing of the image, addition of reagents and to demonstrate that no non-specific results occur due to the print matrix. Banked human serum samples, characterized as reactive to ≥1 autoantibody or non-reactive were included. Reactive samples were characterized with FIDISTM Connective Profile (Theradiag, France) for CENP B, Jo-1, Ribosomal P, Scl-70, Sm, Sm/RNP, SS-A 60, TRIM21 (SS-A 52), SS-B and U1RNP; EliA CCP (Phadia, Germany) for CCP2, QUANTA Lite® Chromatin (Werfen, Spain) for Chromatin, QUANTA Flash® DFS70* (Werfen, Spain) for DFS70, Anti-dsDNA-IgG-ELISA (DRG, Germany) for dsDNA, and Immunodot (Euroimmun, Germany) for RNA polymerase III (RNAP III). For CCP2, only reactive samples were included. For the remaining analytes, non-reactive samples were characterized using both immunofluorescence (ANA-Ro IgG FLUORESCENT HEp-2000®; Immuno Concepts, Germany) and ANAscreen ELISA (ORGENTEC-Diagnostika-GmbH, Germany). Each individual non-reactive sample was tested with the investigational device once and reactive samples were tested in duplicates. Positive percent agreement (PPA) and negative percent agreement (NPA) for individual analytes were calculated. For CCP2 only PPA is presented as no negative samples were included.Figure 1.Results:Compared with relevant devices, the investigational prototype showed positive percentage agreement (PPA) ranging from 75% for chromatin to 99% for SS-A 60 and TRIM21. Negative percentage agreement (NPA) ranged from 95% for chromatin, RNAP III, Scl-70 and Sm to 100% for DFS70, SS-A 60 and TRIM21. Performance of individual analytes is shown in the Table 1.Table 1.Conclusion:The investigational prototype showed preliminary results demonstrating substantial agreement with the compared CE-marked devices for the detection of the autoantibodies included in the assay. Further analytical studies with the final prototype and evaluation of samples with clinical diagnosis will allow for expanded performance assessment of the investigational device. This fully automated multiplexed platform has the potential to contribute to optimizing CTD evaluation by simplifying complex testing pathways and analyzing large number of samples per day.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:Daphne Bijlsma AliveDx, Ewa Lukasik AliveDx, Michael Hausmann AliveDx, Gerber Gomez AliveDx, Christian Fischer AliveDx, Pascale Ghillani-Dalbin: None declared, Makoto Miyara participation in Scientific Advisory Board Meetings for AliveDx, Emmanuel Moreau AliveDx.

Background Mitigating the risks of adverse outcomes from opioids is critical. Thus, the Veterans Affairs (VA) Healthcare System developed the Stratification Tool for Opioid Risk Management (STORM), a dashboard to assist clinicians with opioid risk evaluation and mitigation. Updated daily, STORM calculates a “risk score” of adverse outcomes (e.g., suicide-related events, overdoses, overdose death) from variables in the VA medical record for all patients with an opioid prescription and displays this information along with documentation of recommended risk mitigation strategies and non-opioid pain treatments. In March 2018, the VA issued a policy notice requiring VA Medical Centers (VAMCs) to complete case reviews for patients whom STORM identifies as very high-risk (i.e., top 1% of STORM risk scores). Half of VAMCs were randomly assigned notices that also stated that additional support and oversight would be required for VAMCs that failed to meet an established percentage of case reviews. Using a stepped-wedge cluster randomized design, VAMCs will be further randomized to conduct case reviews for an expanded pool of patients (top 5% of STORM risk scores vs. 1%) starting either 9 or 15 months after the notice was released, creating four natural arms. VA commissioned an evaluation to understand the implementation strategies and factors associated with case review completion rates, whose protocol is described in this report. Methods This mixed-method study will include an online survey of all VAMCs to identify implementation strategies and interviews at a subset of facilities to identify implementation barriers and facilitators. The survey is based on the Expert Recommendations for Implementing Change (ERIC) project, which engaged experts to create consensus on 73 implementation strategies. We will use regression models to compare the number and types of implementation strategies across arms and their association with case review completion rates. Using questions from the Consolidated Framework for Implementation Research, we will interview stakeholders at 40 VAMCs with the highest and lowest adherence to opioid therapy guidelines. Discussion By identifying which implementation strategies, barriers, and facilitators influence case reviews to reduce opioid-related adverse outcomes, this unique implementation evaluation will enable the VA to improve the design of future opioid safety initiatives. Trial registration This project is registered at the ISRCTN Registry with number ISRCTN16012111 . The trial was first registered on 5/3/2017.

Background In 2018, the Department of Veterans Affairs (VA) issued Notice 2018-08 requiring facilities to complete “case reviews” for Veterans identified in the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard as high risk for adverse outcomes among patients prescribed opioids. Half of the facilities were randomly assigned to a Notice version including additional oversight. We evaluated implementation strategies used, whether strategies differed by randomization arm, and which strategies were associated with case review completion rates. Methods Facility points of contact completed a survey assessing their facility’s use of 68 implementation strategies based on the Expert Recommendations for Implementing Change taxonomy. We collected respondent demographic information, facility-level characteristics, and case review completion rates (percentage of high-risk patients who received a case review). We used Kruskal-Wallis tests and negative binomial regression to assess strategy use and factors associated with case reviews. Results Contacts at 89 of 140 facilities completed the survey (64%) and reported using a median of 23 (IQR 16–31) strategies. The median case review completion rate was 71% (IQR 48–95%). Neither the number or types of strategies nor completion rates differed by randomization arm. The most common strategies were using the STORM dashboard (97%), working with local opinion leaders (80%), and recruiting local partners (80%). Characteristics associated with case review completion rates included respondents being ≤ 35 years old (incidence rate ratio, IRR 1.35, 95% CI 1.09–1.67) and having < 5 years in their primary role (IRR 1.23; 95% CI 1.01–1.51), and facilities having more prior academic detailing around pain and opioid safety (IRR 1.40, 95% CI 1.12–1.75). Controlling for these characteristics, implementation strategies associated with higher completion rates included (1) monitoring and adjusting practices (adjusted IRR (AIRR) 1.40, 95% CI 1.11–1.77), (2) identifying adaptations while maintaining core components (AIRR 1.28, 95% CI 1.03–1.60), (3) conducting initial training (AIRR 1.16, 95% CI 1.02–1.50), and (4) regularly sharing lessons learned (AIRR 1.32, 95% CI 1.09–1.59). Conclusions In this national evaluation of strategies used to implement case reviews of patients at high risk of opioid-related adverse events, point of contact age and tenure in the current role, prior pain-related academic detailing at the facility, and four specific implementation strategies were associated with case review completion rates, while randomization to additional centralized oversight was not. Trial registration This project is registered at the ISRCTN Registry with number ISRCTN16012111 . The trial was first registered on May 3, 2017.

BACKGROUND The extent to which treatment recommendations in the orthopedic setting contribute to well-established racial disparities in the utilization of total joint replacement (TJR) in the treatment of advanced knee/hip osteoarthritis has not been explored. OBJECTIVE To examine whether orthopedic surgeons are less likely to recommend TJR to African-American patients compared to white patients with similar clinical indications, and whether there are racial differences in the receipt of TJR within six months of study enrollment. DESIGN Prospective, observational study. PARTICIPANTS African-American (AA; n = 120) and white (n = 337) patients seeking treatment for knee or hip osteoarthritis in Veterans Affairs orthopedic clinics. MAIN MEASURES Patients completed surveys that assessed socio-demographic and clinical variables that could influence osteoarthritis treatment. Orthopedic surgeons’ notes were reviewed to determine whether patients had been recommended for TJR and whether they underwent the procedure within 6 months of study enrollment. RESULTS Rate of TJR recommendation was 19.5%. Odds of receiving a TJR recommendation were lower for AA than white patients of similar age and disease severity (OR = 0.46, 95% CI = 0.26–0.83; P = 0.01). However, this difference was not significant after adjusting for patient preference for TJR (OR = 0.69, 95% CI = 0.36–1.31, P = 0.25). Overall, 10.3% of patients underwent TJR within 6 months. TJR was less likely for AA patients than for white patients of similar age and disease severity (OR = 0.41, 95% CI = 0.16–1.05, P = 0.06), but this difference was reduced after adjusting for whether patients had received a recommendation for the procedure at the index visit (OR = 0.57, 95% CI = 0.21–1.54, P = 0.27). CONCLUSIONS In this study, race differences in patient preferences for TJR appeared to underlie race differences in TJR recommendations, which led to race differences in utilization of the procedure. Our findings suggest that patient treatment preferences play an important role in racial disparities in TJR utilization in the orthopedic setting.

Background:There is a limited offer of fully-automated multiplexed devices for testing autoantibodies associated with connective tissue diseases (CTD).Objectives:To assess the performance characteristics of the novel MosaiQ® AiPlex CTD microarray immunoassay (AiPlex-CTD) when used with the fully-automated MosaiQ system, for simultaneous qualitative detection of eleven autoantibodies commonly found in CTD.Methods:A comparator study was conducted at Hôpital Pitié-Salpêtrière (Paris, France), using anonymized human serum samples, characterized as non-reactive for all analytes (n= 445) or reactive for ≥1 analytes included in the assay (n= 466) with a composite of CE-marked devices used in routine laboratory practice, as part of AiPlex-CTD evaluations towards CE mark under IVDR. For dsDNA, samples were reactive by HEp-2000®-IgG-FLUORESCENT-ANA-Ro, (ANA-IFA) (ImmunoConcepts, USA) and Anti-dsDNA-IgG-ELISA (DRG, Germany). For other analytes, samples were reactive by ANA-IFA and FIDIS™-Connective-Profile (FIDIS) (Theradiag, France) or were reactive by ANA-IFA and/or ANAscreen (ANA-ELISA) (ORGENTEC-Diagnostika-GmbH, Germany) but FIDIS non-reactive or equivocal. Non-reactive samples were characterized with both ANA-IFA and ANA-ELISA.Results:Information on clinical diagnosis was available for 381 of the 466 enrolled reactive samples (Table 1). The most frequent diagnosis was lupus, followed by Sjögren’s syndrome, systemic sclerosis, idiopathic inflammatory myopathies (IIM), and mixed connective tissue disease (MCTD). In 43 samples (11.29%) the diagnosis featured more than 1 CTD. Other diseases included a range of conditions ranging from various autoimmune disorders to malignancies. After discordant analysis, compared with composite comparator results, AiPlex-CTD showed Positive Percentage Agreement (PPA) ranging from 78.4% for SCL-70 to 100% for SS-A 60. Negative Percentage Agreement (NPA) ranged from 97.2% for dsDNA to 100% for Jo-1, SS-B and Sm/RNP. Performance details for each individual analyte are shown in Table 2.Conclusion:MosaiQ AiPlex-CTD demonstrated high concordance with compared CE-marked devices for the automated qualitative detection of the eleven autoantibodies included in the assay. This platform has the potential to contribute to the advancement of CTD testing. Further ongoing steps include expanding the number of printed antigens and semi-quantification.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:Pascale Ghillani-Dalbin: None declared, Christel Daubrosse: None declared, Valerie Mercier: None declared, Daphne Bijlsma AliveDx, Ewa Lukasik AliveDx, Rocio Pasion Galvan AliveDx, Valeria Botti AliveDx, Gerber Gomez AliveDx, Emmanuel Moreau AliveDx, Michael Hausmann AliveDx, Christine C Ginocchio Dr. Ginocchio was employee of AliveDx at the time the study was conducted, Makoto Miyara participation in Scientific Advisory Board meetings for AliveDx.

Despite a large body of evidence describing care processes known to reduce the incidence of surgical site infections, many are underutilized in practice. Fifty-six hospitals volunteered to redesign their systems as part of the National Surgical Infection Prevention Collaborative, a 1-year demonstration project sponsored by the Centers for Medicare & Medicaid Services. Each facility selected quality improvement objectives for a select group of surgical procedures and reported monthly clinical process measure data. Forty-four hospitals reported data on 35,543 surgical cases. Hospitals improved in measures related to appropriate antimicrobial agent selection, timing, and duration; normothermia; oxygenation; euglycemia; and appropriate hair removal. The infection rate decreased 27%, from 2.3% to 1.7% in the first versus last 3 months. The Collaborative demonstrated improvement in processes known to be associated with reduced risk of surgical site infections. Quality improvement organizations can be effective resources for quality improvement in the surgical arena.

New sensor solutions are under development in the context of digitalization in order to integrate sensory functions into systems. When integrating sensors, the three domains of mechanical, electrical and information engineering must be considered. This results in complex development processes that require suitable procedure models. However, specific procedure models for sensor selection and integration are missing. This contribution proposes a procedure model for sensor selection and integration on the basis of the Munich Procedure Model (MPM) and gives an outlook on open research questions.

This study investigates the role of students' sense of belonging to their university in college student retention. Using individual growth curve modeling, we examined (a) whether sense of belonging predicts intentions to persist, and (b) the effects of an intervention designed to enhance students' sense of belonging. African American and white first-year students completed surveys three times throughout the academic year. Students were randomly assigned to a group that received an intervention to enhance students' sense of belonging or to one of two control groups. Sense of belonging was found to predict intentions to persist, controlling for background variables and other predictors of persistence. Overall, sense of belonging and intentions to persist declined over the academic year. However, the decline in sense of belonging was smaller for students in the intervention group. Implications for the development of college retention programs and for existing models of student persistence are discussed.