Following the ACA, millions of people gained Medicaid insurance. Most electronic health record (EHR) tools to date provide clinical-decision support and tracking of clinical biomarkers, we developed ...an EHR tool to support community health center (CHC) staff in assisting patients with health insurance enrollment documents and tracking insurance application steps. The objective of this study was to test the effectiveness of the health insurance support tool in (1) assisting uninsured patients gaining insurance coverage, (2) ensuring insurance continuity for patients with Medicaid insurance (preventing coverage gaps between visits); and (3) improving receipt of cancer preventive care.
In this quasi-experimental study, twenty-three clinics received the intervention (EHR-based insurance support tool) and were matched to 23 comparison clinics. CHCs were recruited from the OCHIN network. EHR data were linked to Medicaid enrollment data. The primary outcomes were rates of uninsured and Medicaid visits. The secondary outcomes were receipt of recommended breast, cervical, and colorectal cancer screenings. A comparative interrupted time-series using Poisson generalized estimated equation (GEE) modeling was performed to evaluate the effectiveness of the EHR-based tool on the primary and secondary outcomes.
Immediately following implementation of the enrollment tool, the uninsured visit rate decreased by 21.0% (Adjusted Rate Ratio RR = 0.790, 95% CI = 0.621-1.005, p = .055) while Medicaid-insured visits increased by 4.5% (ARR = 1.045, 95% CI = 1.013-1.079) in the intervention group relative to comparison group. Cervical cancer preventive ratio increased 5.0% (ARR = 1.050, 95% CI = 1.009-1.093) immediately following implementation of the enrollment tool in the intervention group relative to comparison group. Among patients with a tool use, 81% were enrolled in Medicaid 12 months after tool use. For the 19% who were never enrolled in Medicaid following tool use, most were uninsured (44%) at the time of tool use.
A health insurance support tool embedded within the EHR can effectively support clinic staff in assisting patients in maintaining their Medicaid coverage. Such tools may also have an indirect impact on evidence-based practice interventions, such as cancer screening.
This study was retrospectively registered on February 4th, 2015 with Clinicaltrials.gov (#NCT02355262). The registry record can be found at https://www.clinicaltrials.gov/ct2/show/NCT02355262 .
Celotno besedilo
Dostopno za:
CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The use of implementation strategies is an active and purposive approach to translate research findings into routine clinical care. The Expert Recommendations for Implementing Change (ERIC) ...identified and defined discrete implementation strategies, and Proctor and colleagues have made recommendations for specifying operationalization of each strategy. We use empirical data to test how the ERIC taxonomy applies to a large dissemination and implementation initiative aimed at taking cardiac prevention to scale in primary care practice.
EvidenceNOW is an Agency for Healthcare Research and Quality initiative that funded seven cooperatives across seven regions in the USA. Cooperatives implemented multi-component interventions to improve heart health and build quality improvement capacity, and used a range of implementation strategies to foster practice change. We used ERIC to identify cooperatives' implementation strategies and specified the actor, action, target, dose, temporality, justification, and expected outcome for each. We mapped and compiled a matrix of the specified ERIC strategies across the cooperatives, and used consensus to resolve mapping differences. We then grouped implementation strategies by outcomes and justifications, which led to insights regarding the use of and linkages between ERIC strategies in real-world scale-up efforts.
Thirty-three ERIC strategies were used by cooperatives. We identified a range of revisions to the ERIC taxonomy to improve the practical application of these strategies. These proposed changes include revisions to four strategy names and 12 definitions. We suggest adding three new strategies because they encapsulate distinct actions that were not described in the existing ERIC taxonomy. In addition, we organized ERIC implementation strategies into four functional groupings based on the way we observed them being applied in practice. These groupings show how ERIC strategies are, out of necessity, interconnected, to achieve the work involved in rapidly taking evidence to scale.
Findings of our work suggest revisions to the ERIC implementation strategies to reflect their utilization in real-work dissemination and implementation efforts. The functional groupings of the ERIC implementation strategies that emerged from on-the-ground implementers will help guide others in choosing among and linking multiple implementation strategies when planning small- and large-scale implementation efforts.
Registered as Observational Study at www.clinicaltrials.gov ( NCT02560428 ).
Pembrolizumab (PD-1 inhibitor) and cetuximab (EGFR inhibitor) are active as single agents and in combination with cytotoxic chemotherapy for recurrent or metastatic head and neck squamous cell ...carcinoma (HNSCC). Given each drug's single agent activity and unique mechanism of action, we aimed to evaluate the anti-tumour activity of PD-1 blockade with EGFR inhibition in recurrent or metastatic HNSCC.
This study is an open-label, non-randomised, multi-arm, phase 2 trial done at four academic centres in the USA. Participants were required to have platinum-resistant or platinum-ineligible, recurrent or metastatic HNSCC, be at least 18 years old, have an Eastern Cooperative Oncology Group performance status 0–1, have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and to have received no previous immunotherapy or EGFR inhibition. All participants received pembrolizumab 200 mg intravenously every 3 weeks, combined with an initial loading dose of cetuximab 400 mg/m2 intravenously followed by 250 mg/m2 intravenously weekly (21 day cycle). The primary endpoint was overall response rate defined as the proportion of participants with a partial or complete responses (per RECIST version 1.1) by 6 months in the intention-to-treat population. The safety population included all participants who received at least one dose of pembrolizumab. Herein, the final analysis of cohort 1 (no previous PD-1, PD-L1, or EGFR inhibition for recurrent or metastatic HNSCC) is reported. Three additional cohorts (two for participants with a previous response to immunotherapy followed by relapse or progression, with or without previous cetuximab exposure, and one for cutaneous HNSCC) will be reported separately once fully accrued. This study is registered with ClinicalTrials.gov, NCT03082534, and remains open as the three additional cohorts are actively accruing participants.
Between March 22, 2017, and July 16, 2019, 33 participants were enrolled to cohort 1. All 33 participants received at least one dose of pembrolizumab. Median follow-up duration was 7·3 months (IQR 3·9–10·9). By 6 months, the overall response rate was 45% (95% CI 28–62), with 15 of 33 participants achieving a partial response. The most common grade 3–4 treatment-related adverse event was oral mucositis (three 9% of 33 participants), and serious treatment-related adverse events occurred in five (15%) participants. No treatment-related deaths occurred.
Pembrolizumab combined with cetuximab shows promising clinical activity for recurrent or metastatic HNSCC, and merits further investigation.
Merck Sharp & Dohme.
Emergency department (ED) crowding and patient boarding are associated with increased mortality and decreased patient satisfaction. This study uses a positive deviance methodology to identify ...strategies among high-performing, low-performing, and high-performance improving hospitals to reduce ED crowding.
In this mixed-methods comparative case study, we purposively selected and recruited hospitals that were within the top and bottom 5% of Centers for Medicare & Medicaid Services case-mix-adjusted ED length of stay and boarding times for admitted patients for 2012. We also recruited hospitals that showed the highest performance improvement in metrics between 2012 and 2013. Interviews were conducted with 60 key leaders (physicians, nurses, quality improvement specialists, and administrators).
We engaged 4 high-performing, 4 low-performing, and 4 high-performing improving hospitals, matched on hospital characteristics including geographic designation (urban versus rural), region, hospital occupancy, and ED volume. Across all hospitals, ED crowding was recognized as a hospitalwide issue. The strategies for addressing ED crowding varied widely. No specific interventions were associated with performance in length-of-stay metrics. The presence of 4 organizational domains was associated with hospital performance: executive leadership involvement, hospitalwide coordinated strategies, data-driven management, and performance accountability.
There are organizational characteristics associated with ED decreased length of stay. Specific interventions targeted to reduce ED crowding were more likely to be successfully executed at hospitals with these characteristics. These organizational domains represent identifiable and actionable changes that other hospitals may incorporate to build awareness of ED crowding.
Abstract Purpose We wanted to review and synthesize published criteria for good qualitative research and develop a cogent set of evaluative criteria. Methods We identified published journal articles ...discussing criteria for rigorous research using standard search strategies then examined reference sections of relevant journal articles to identify books and book chapters on this topic. A cross-publication content analysis allowed us to identify criteria and understand the beliefs that shape them. Results Seven criteria for good qualitative research emerged: (1) carrying out ethical research; (2) importance of the research; (3) clarity and coherence of the research report; (4) use of appropriate and rigorous methods; (5) importance of reflexivity or attending to researcher bias; (6) importance of establishing validity or credibility; and (7) importance of verification or reliability. General agreement was observed across publications on the first 4 quality dimensions. On the last 3, important divergent perspectives were observed in how these criteria should be applied to qualitative research, with differences based on the paradigm embraced by the authors. Conclusion Qualitative research is not a unified field. Most manuscript and grant reviewers are not qualitative experts and are likely to embrace a generic set of criteria rather than those relevant to the particular qualitative approach proposed or reported. Reviewers and researchers need to be aware of this tendency and educate health care researchers about the criteria appropriate for evaluating qualitative research from within the theoretical and methodological framework from which it emerges.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Two phase 2 trials assessed the efficacy and safety of intravenous infusions of a broadly neutralizing antibody, VRCO1, to prevent HIV-1 infection. VRC01 did not cause adverse events and did not ...prevent overall HIV-1 acquisition significantly more effectively than placebo. In secondary analyses, VRC01 prevented transmission of VRC01-sensitive HIV-1 isolates.
Background
To the authors' knowledge, there are no approved therapies for recurrent, metastatic (R/M) salivary gland carcinoma (SGC), but molecularly targeted therapies warrant ongoing investigation. ...In the current study, the authors have reported on the efficacy of tipifarnib in patients with aggressive HRAS‐mutant, R/M SGC.
Methods
The current prospective, nonrandomized, multicenter, international cohort study involved 8 centers and was conducted from May 2015 to June 2019. The median follow‐up was 22 months (range, 6‐55 months). Subjects with HRAS‐mutant R/M SGC (any histology) and disease progression within the last 6 months were enrolled. Tipifarnib was dosed orally twice daily. The authors determined the objective response rate using Response Evaluation Criteria in Solid Tumors (version 1.1), duration of response, and molecular predictors of response.
Results
A total of 13 patients with R/M SGC were enrolled; all had received prior systemic therapy (1‐3 regimens). One objective response was observed; an additional 7 of 12 evaluable patients (58%) had stable disease as their best response with a median duration of 9 months (range, 3‐14 months). Five of 7 patients had >10% tumor regression and 6 of 7 had stable disease lasting >6 months. Q61R was the most frequent activating HRAS mutation noted (7 of 13 patients; 54%), but gene variant and allele frequency did not correlate with outcomes. The median progression‐free survival was 7 months (95% confidence interval, 5.9‐10.1 months), and the median overall survival was 18 months (95% confidence interval, 9.6‐22.4 months) with approximately 58.6% of patients alive at 1 year. Survival was similar regardless of HRAS mutant variant or co‐occurring PIK3CA alterations. No participant discontinued treatment because of toxicity.
Conclusions
Tipifarnib resulted in modest clinical activity with a promising disease control rate among patients with HRAS‐mutant, R/M SGC who developed disease progression within the last 6 months.
In this prospective, multicenter cohort study that includes 13 adults, 1 patient (8%) is found to achieve a partial response to therapy, and an additional 58% of patients demonstrate stable disease (the majority with >10% tumor regression), with responses often found to last >6 months. Tipifarnib demonstrates a meaningful and often durable disease control rate among patients with a more aggressive subgroup of HRAS‐mutant salivary gland cancers, with evidence of a potential benefit across several variant HRAS mutational genotypes and allele frequencies.
Oxidation of biogenic volatile organic compounds (BVOC) by the nitrate radical (NO
) represents one of the important interactions between anthropogenic emissions related to combustion and natural ...emissions from the biosphere. This interaction has been recognized for more than 3 decades, during which time a large body of research has emerged from laboratory, field, and modeling studies. NO
-BVOC reactions influence air quality, climate and visibility through regional and global budgets for reactive nitrogen (particularly organic nitrates), ozone, and organic aerosol. Despite its long history of research and the significance of this topic in atmospheric chemistry, a number of important uncertainties remain. These include an incomplete understanding of the rates, mechanisms, and organic aerosol yields for NO
-BVOC reactions, lack of constraints on the role of heterogeneous oxidative processes associated with the NO
radical, the difficulty of characterizing the spatial distributions of BVOC and NO
within the poorly mixed nocturnal atmosphere, and the challenge of constructing appropriate boundary layer schemes and non-photochemical mechanisms for use in state-of-the-art chemical transport and chemistry-climate models. This review is the result of a workshop of the same title held at the Georgia Institute of Technology in June 2015. The first half of the review summarizes the current literature on NO
-BVOC chemistry, with a particular focus on recent advances in instrumentation and models, and in organic nitrate and secondary organic aerosol (SOA) formation chemistry. Building on this current understanding, the second half of the review outlines impacts of NO
-BVOC chemistry on air quality and climate, and suggests critical research needs to better constrain this interaction to improve the predictive capabilities of atmospheric models.
It has been demonstrated that large numbers of tumor-specific T cells for adoptive cell transfer (ACT) can be manufactured by retroviral genetic engineering of autologous peripheral blood lymphocytes ...and expanding them over several weeks. In mouse models, this therapy is optimized when administered with dendritic cell (DC) vaccination. We developed a short 1-week manufacture protocol to determine the feasibility, safety, and antitumor efficacy of this double cell therapy.
A clinical trial (NCT00910650) adoptively transferring MART-1 T-cell receptor (TCR) transgenic lymphocytes together with MART-1 peptide-pulsed DC vaccination in HLA-A2.1 patients with metastatic melanoma. Autologous TCR transgenic cells were manufactured in 6 to 7 days using retroviral vector gene transfer, and reinfused with (n = 10) or without (n = 3) prior cryopreservation.
A total of 14 patients with metastatic melanoma were enrolled and 9 of 13 treated patients (69%) showed evidence of tumor regression. Peripheral blood reconstitution with MART-1-specific T cells peaked within 2 weeks of ACT, indicating rapid in vivo expansion. Administration of freshly manufactured TCR transgenic T cells resulted in a higher persistence of MART-1-specific T cells in the blood as compared with cryopreserved. Evidence that DC vaccination could cause further in vivo expansion was only observed with ACT using noncryopreserved T cells.
Double cell therapy with ACT of TCR-engineered T cells with a very short ex vivo manipulation and DC vaccines is feasible and results in antitumor activity, but improvements are needed to maintain tumor responses.
IMPORTANCE: Severely injured patients experiencing hemorrhagic shock often require massive transfusion. Earlier transfusion with higher blood product ratios (plasma, platelets, and red blood cells), ...defined as damage control resuscitation, has been associated with improved outcomes; however, there have been no large multicenter clinical trials. OBJECTIVE: To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, phase 3, multisite, randomized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013. INTERVENTIONS: Blood product ratios of 1:1:1 (338 patients) vs 1:1:2 (342 patients) during active resuscitation in addition to all local standard-of-care interventions (uncontrolled). MAIN OUTCOMES AND MEASURES: Primary outcomes were 24-hour and 30-day all-cause mortality. Prespecified ancillary outcomes included time to hemostasis, blood product volumes transfused, complications, incidence of surgical procedures, and functional status. RESULTS: No significant differences were detected in mortality at 24 hours (12.7% in 1:1:1 group vs 17.0% in 1:1:2 group; difference, −4.2% 95% CI, −9.6% to 1.1%; P = .12) or at 30 days (22.4% vs 26.1%, respectively; difference, −3.7% 95% CI, −10.2% to 2.7%; P = .26). Exsanguination, which was the predominant cause of death within the first 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6% in 1:1:2 group; difference, −5.4% 95% CI, −10.4% to −0.5%; P = .03). More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group (86% vs 78%, respectively; P = .006). Despite the 1:1:1 group receiving more plasma (median of 7 U vs 5 U, P < .001) and platelets (12 U vs 6 U, P < .001) and similar amounts of red blood cells (9 U) over the first 24 hours, no differences between the 2 groups were found for the 23 prespecified complications, including acute respiratory distress syndrome, multiple organ failure, venous thromboembolism, sepsis, and transfusion-related complications. CONCLUSIONS AND RELEVANCE: Among patients with severe trauma and major bleeding, early administration of plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days. However, more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours. Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group, no other safety differences were identified between the 2 groups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01545232
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