Design and accrual of S1417CD: Development of a prospective financial impact assessment tool in patients with metastatic colorectal cancer (mCRC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6652-TPS6652 ◽  
Author(s):  
Veena Shankaran ◽  
Joseph M. Unger ◽  
Amy K. Darke ◽  
Jennifer Marie Suga ◽  
James Lloyd Wade ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Assessment Tool ◽  
Randomized Study ◽  
Financial Impact ◽  
Research Network ◽  
Security Measures ◽  
Financial Outcomes ◽  
Oncology Research ◽  
Credit Data ◽  
The Impact

TPS6652 Background: Few studies have assessed the financial impact of cancer diagnosis (dx) in diverse patients (pts) and caregivers (cgs) using objective and standard financial measures. S1417CD, led by the SWOG Cancer Research Network, is the first prospective cohort study assessing financial outcomes to be conducted in the NCI Community Oncology Research Program (NCORP). We present our experience with design and accrual. Methods: Pts age ≥ 18 within 120 days of mCRC dx were considered eligible and asked to identify a caregiver (cg) who could participate concurrently. The primary endpoint is incidence of treatment-related financial hardship, defined as ≥ 1 of the following: debt accrual, selling/refinancing home, ≥ 20% income decline, or borrowing money. Measures include 1) pt and cg surveys (baseline (BL), 3, 6, 9 and 12 months (mo)) assessing out-of-pocket spending, financial impacts, cg burden, and quality of life and 2) pt credit reports (BL, 6, and 12 mo). Linkage to records from TransUnion, a national credit agency, required pt social security number (SSN) and processes for batched credit report transfer via secure web portal. The accrual goal was n = 374 pts in 3 years. The study activated on Apr 1, 2016 and closed on Feb 1, 2019 after reaching its accrual goal. A total of 380 pts (median age 59.7 years) and 155 cgs enrolled (41% cg participation). Enrollment steadily increased during the study period; 56% enrolled in the last 12 mo. Credit data were not obtainable for 76 (20%) pts due to early death, lack of credit, or inability to match records. S1417CD, the first cooperative group led study assessing financial outcomes in the community setting, completed enrollment faster than anticipated. Required SSN collection was not a barrier to enrollment, which improved as sites became familiar with data security measures. Robust accrual to S1417CD demonstrates pts’ and cgs’ desire to improve understanding of financial toxicity and its solutions. Follow-up will conclude in 12 mo with results to follow. SWOG plans to launch a randomized study (S1912) assessing the impact of financial navigation on household finances, using credit data for primary endpoint assessment. Clinical Trials Registry Identifier NCI-2015-01885. Clinical trial information: NCT02728804.

A phase III randomized study of apremilast, an oral phosphodiesterase 4 inhibitor, for active ankylosing spondylitis

2021 ◽  
pp. jrheum.201088
Author(s):  
Peter C. Taylor ◽  
Désirée van der Heijde ◽  
Robert Landewé ◽  
Shannon McCue ◽  
Sue Cheng ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Primary Endpoint ◽  
Randomized Study ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Upper Respiratory Infection ◽  
Phosphodiesterase 4 ◽  
The Impact ◽  
Phosphodiesterase 4 Inhibitor

Objective To evaluate the efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with active ankylosing spondylitis (AS). Methods This phase III, multicenter, double-blind, placebo-controlled study (NCT01583374) randomized patients with active AS (1:1:1) to placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily for 24 weeks, followed by a long-term extension phase (up to 5 years). The primary endpoint was assessment of the SpondyloArthritis International Society 20 (ASAS 20) response at Week 16. The impact of treatment on radiographic outcomes after 104 weeks was assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Results In total, 490 patients with active AS were randomized in the study (placebo: n=164; apremilast 20 mg twice daily: n=163; apremilast 30 mg twice daily: n=163). The primary endpoint of ASAS 20 response at Week 16 was not met (placebo: 37%; apremilast 20 mg twice daily: 35%; apremilast 30 mg twice daily: 33%; p=0.44 vs placebo). At Week 104, mean (SD) changes from baseline in mSASSS were 0.83 (3.6), 0.98 (2.2), and 0.57 (1.9) in patients initially randomized to placebo, apremilast 20 mg twice daily, and apremilast 30 mg twice daily, respectively. The most frequently reported adverse events through Week 104 were diarrhea, nasopharyngitis, upper respiratory infection, and nausea. Conclusion No clinical benefit was observed with apremilast treatment in patients with active AS. The safety and tolerability of apremilast were consistent with its known profile.

scholarly journals Twitter promotion predicts citation rates of cardiovascular articles: a preliminary analysis from the ESC Journals Randomized Study

2020 ◽  
Vol 41 (34) ◽  
pp. 3222-3225 ◽  
Author(s):  
Ricardo Ladeiras-Lopes ◽  
Sarah Clarke ◽  
Rafael Vidal-Perez ◽  
Michael Alexander ◽  
Thomas F Lüscher
Keyword(s):  
Social Media ◽  
Primary Endpoint ◽  
Preliminary Analysis ◽  
Citation Rate ◽  
Randomized Study ◽  
Final Analysis ◽  
Cardiovascular Medicine ◽  
Number Of Citations ◽  
The Impact ◽  
Social Media Strategy

Abstract Aims The association between the dissemination of scientific articles on Twitter and online visibility (including Altmetric score) is still controversial and the impact on citation rates has never been addressed for cardiovascular medicine journals. Methods and Results The ESC Journals Study randomized 696 papers published in the ESC Journals family (March 2018–May 2019) for promotion on Twitter or to a control arm (with no active tweeting from ESC channels) and aimed to assess if Twitter promotion was associated with an increase in citation rate (primary endpoint) and Altmetric score. This is a preliminary analysis of 536 articles (77% of total) published until December 2018 (therefore, papers published at least 6 months before collecting citation and Altmetrics data). In the analysis of the primary endpoint, Twitter promotion of articles was associated with a 1.43 (95% confidence interval 1.29–1.58) higher rate of citations, and this effect was independent of the type of article. Both Altmetric score and number of users tweeting were positively associated with the number of citations in both arms, with evidence of a stronger association (interaction) in the Twitter arm. Conclusion Therefore, a social media strategy of Twitter promotion for cardiovascular medicine papers seems to be associated with increased online visibility and higher number of citations. The final analysis will include 696 papers and 2-year scientific citation rate and is estimated to be concluded in March 2021.

Bevacizumab (BEV) plus chemotherapy (CT) continued beyond first progression in patients with metastatic colorectal cancer (mCRC) previously treated with BEV plus CT: Results of a randomized phase III intergroup study (TML study).

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. CRA3503-CRA3503 ◽  
Author(s):  
Dirk Arnold ◽  
Thierry Andre ◽  
Jaafar Bennouna ◽  
Javier Sastre ◽  
Pia J. Osterlund ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Response Rate ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Rank Test ◽  
Chi Square ◽  
Log Rank Test ◽  
Reported Data ◽  
The Impact

CRA3503 Background: BEV in combination with fluoropyrimidine-based CT is standard treatment for mCRC in the first-line (1L) and BEV-naïve second-line (2L) settings. This is the first randomized study evaluating the benefit of continuing BEV in combination with standard CT as 2L treatment for patients with mCRC who progressed after receiving a standard BEV-containing regimen in the 1L setting. Methods: Patients with unresectable, histologically confirmed mCRC who progressed within 3 months after discontinuation of 1L BEV + CT were randomised to 2L fluoropyrimidine-based CT ± BEV (2.5 mg/kg/wk equivalent). Choice of oxaliplatin- or irinotecan-based 2L CT was dependent on the regimen used in 1L (crossover) and included as a stratification variable. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), response rate and safety. Results: 820 patients were randomized from February 2006 to June 2010 (409 to BEV + CT and 411 to CT alone). Baseline patient and disease characteristics were well balanced between arms. The study met its primary endpoint; median OS was 11.2 months for BEV + CT and 9.8 months for CT (HR=0.81; 95% CI 0.69–0.94; unstratified log-rank test, p=0.0062). Median PFS was 5.7 months for BEV + CT and 4.1 months for CT (HR=0.68; 95% CI 0.59–0.78; unstratified log-rank test, p<0.0001). The response rate was 5.4% for BEV + CT and 3.9% for CT (unstratified Chi-Square Test, p=0.3113). The adverse event profile was consistent with previously reported data for BEV + CT. Compared with historical data from BEV treatment in 1L or 2L mCRC, BEV-related adverse events were not increased when continuing BEV beyond progression. Conclusions: This is the first randomized study to prospectively investigate the impact of continuing BEV treatment in 2L mCRC for patients who progressed after receiving a BEV-containing regimen in 1L. Our findings demonstrate that BEV + CT (crossed over from 1L regimen) continued beyond progression significantly prolongs OS and PFS in 2L mCRC. Additional analysis (including biomarker evaluation) is ongoing.

Cumulative incidence of financial hardship in metastatic colorectal cancer patients: Primary endpoint results for SWOG S1417CD.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7010-7010 ◽  
Author(s):  
Veena Shankaran ◽  
Joseph M. Unger ◽  
Amy Darke ◽  
Jennifer Marie Suga ◽  
James Lloyd Wade ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Cumulative Incidence ◽  
Insurance Coverage ◽  
Secondary Analysis ◽  
Health Insurance Coverage ◽  
National Sample ◽  
Financial Hardship ◽  
Research Network ◽  
Risk Of Death ◽  
Oncology Research

7010 Background: Despite evidence that rising cancer care costs are contributing to “financial toxicity” in cancer pts, no studies, to our knowledge, have prospectively assessed the financial impact of cancer diagnosis (dx) using both self-reported and objective financial measures. S1417CD, led by the SWOG Cancer Research Network and conducted in the NCI Community Oncology Research Program (NCORP), was the first national prospective cohort study to evaluate time-to-first evidence of major financial hardship (MFH) in pts with newly diagnosed mCRC. We present results of the primary endpoint analysis. Methods: Pts age ≥ 18 within 120 days of mCRC dx receiving systemic treatment completed surveys every 3 months (mo) for 12 mo. MFH was defined as ≥ 1 occurrence of self-reported increase in debt, new loans, selling home, refinancing home, or ≥ 20% income decline during the 12 mo study period. Cumulative incidence (CI) of MFH was estimated to account for competing risk of death. Additional endpoints, not reported here, included quality of life, caregiver strain, and changes in credit status over 12 mo. Results: In total, 380 pts (median age 59.9) across 126 clinic sites were enrolled, with 377 eligible and evaluable for the primary endpoint (reached 12 mo assessment, death, or MFH endpoint); complete data were available for 92% of pts as of Jan 23, 2020. Most pts were white (78%), male (61%), and insured (98%), with annual income ≤ $50,000 (56%). Cumulative incidence of MFH at 12 mo was 71.5% (95% CI: 65.9%-76.3%), with 24.6%, 52.4%, and 61.8% at 3, 6, and 9 mo. The dominant components of MFH were new debt (12-mo CI, 56.7%) and >20% decline in income (26.7%); 104 (41%) pts reported ≥ 2 elements of MFH. In a secondary analysis excluding new debt, 12 mo cumulative incidence of MFH was 42.9% (95% CI: 37.2%-48.5%), with 10.3%, 24.4%, and 31.9% at 3, 6, and 9 mo. Conclusions: In a national sample of mCRC pts on systemic tx, financial hardship, most commonly in the form of increased debt, accumulates progressively over time. Nearly 3 out of 4 pts experiencing MFH at 12 mo despite access to health insurance coverage. These findings underscore the need for clinic and policy solutions such as early financial navigation and elimination of cost sharing to protect pts from financial devastation as they continue with tx. Clinical trial information: NCI-2015-01885 . [Table: see text]

Cumulative incidence of financial hardship in metastatic colorectal cancer (mCRC) patients (pts): Primary endpoint results for SWOG S1417CD.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 137-137
Author(s):  
Veena Shankaran ◽  
Joseph M. Unger ◽  
Amy Darke ◽  
Jennifer Marie Suga ◽  
James Lloyd Wade ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Cumulative Incidence ◽  
Insurance Coverage ◽  
National Sample ◽  
Financial Hardship ◽  
Research Network ◽  
Annual Income ◽  
Risk Of Death ◽  
Oncology Research ◽  
Increased Risk

137 Background: Despite evidence that rising cancer care costs contribute to “financial toxicity” in cancer pts, no studies, to our knowledge, have prospectively assessed the financial impact of cancer diagnosis (dx) using both self-reported and objective financial measures. S1417CD, led by the SWOG Cancer Research Network and conducted in the NCI Community Oncology Research Program (NCORP), was the first national prospective cohort study to evaluate time-to-first evidence of major financial hardship (MFH) in pts with newly diagnosed mCRC. We present results of the primary endpoint analysis. Methods: Pts age ≥ 18 within 120 days of mCRC dx receiving systemic treatment completed surveys every 3 months (mo) for 12 mo. MFH was defined as ≥ 1 occurrence of self-reported increase in debt, new loans, selling home, refinancing home, or ≥ 20% income decline during the 12 mo study period. Cumulative incidence (CI) of MFH was estimated to account for competing risk of death. Multivariate logistic regression was used to evaluate the association between pt characteristics with development of MFH. Results: 380 pts (median age 59.9) across 126 clinic sites were enrolled. Most pts were white (78%), male (61%), and insured (98%), with annual income ≤ $50,000 (56%). Cumulative incidence of MFH at 12 mo was 71.5% (95% CI: 65.9%-76.3%), with 24.6%, 52.4%, and 61.8% at 3, 6, and 9 mo; 104 (41%) pts reported ≥ 2 elements of MFH. Age, race, marital status, employment, and annual income (≤ vs. > $50K) were not significantly associated with MFH. In a post hoc analysis, income <$100,000 and total assets <$100,000 were both adversely associated with MFH. Each increase in number of these 2 risk factors from 0 to 1 and 1 to 2 was associated with a 49% increased risk of MFH (p<.001). Conclusions: In a national sample of mCRC pts on systemic tx, financial hardship, most commonly in the form of increased debt, accumulates progressively over time. Nearly 3 out of 4 pts experiencing MFH at 12 mo despite access to health insurance coverage. These findings underscore the need for clinic and policy solutions such as early financial navigation and elimination of cost sharing to protect pts from financial devastation as they continue with tx. [Table: see text]

scholarly journals Development of a Rapid Risk and Impact Assessment Tool to Enhance Response to Environmental Emergencies in the Early Stages of a Disaster: A Tool Developed by the European Multiple Environmental Threats Emergency NETwork (EMETNET) Project

2021 ◽  
Author(s):  
Emma-Jane Goode ◽  
Eirian Thomas ◽  
Owen Landeg ◽  
Raquel Duarte-Davidson ◽  
Lisbeth Hall ◽  
...  
Keyword(s):  
Public Health ◽  
Impact Assessment ◽  
Assessment Tool ◽  
The European Union ◽  
Protection Mechanism ◽  
Environmental Threats ◽  
Environmental Disasters ◽  
Early Stages ◽  
Potential Risks ◽  
The Impact

AbstractEvery year, numerous environmental disasters and emergencies occur across the globe with far-reaching impacts on human health and the environment. The ability to rapidly assess an environmental emergency to mitigate potential risks and impacts is paramount. However, collating the necessary evidence in the early stages of an emergency to conduct a robust risk assessment is a major challenge. This article presents a methodology developed to help assess the risks and impacts during the early stages of such incidents, primarily to support the European Union Civil Protection Mechanism but also the wider global community in the response to environmental emergencies. An online rapid risk and impact assessment tool has also been developed to promote enhanced collaboration between experts who are working remotely, considering the impact of a disaster on the environment and public health in the short, medium, and long terms. The methodology developed can support the appropriate selection of experts and assets to be deployed to affected regions to ensure that potential public health and environmental risks and impacts are mitigated whenever possible. This methodology will aid defensible decision making, communication, planning, and risk management, and presents a harmonized understanding of the associated impacts of an environmental emergency.

scholarly journals A Randomized Study of the Impact of a Corneal Pre-Cut During Cataract Surgery on Wound Architecture and Corneal Astigmatism

2021 ◽  
Author(s):  
Birgit Doeller ◽  
Nino Hirnschall ◽  
Maria Fichtenbaum ◽  
Phuong-Mai Nguyen ◽  
Ralph Varsits ◽  
...  
Keyword(s):  
Cataract Surgery ◽  
Randomized Study ◽  
Corneal Astigmatism ◽  
The Impact

scholarly journals The Role of Digital Maturity Assessment in Technology Interventions with Industrial Internet Playground

Electronics ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. 1134
Author(s):  
Annabeth Aagaard ◽  
Mirko Presser ◽  
Tom Collins ◽  
Michail Beliatis ◽  
Anita Krogsøe Skou ◽  
...  
Keyword(s):  
Assessment Tool ◽  
Digital Transformation ◽  
Assessment Tools ◽  
Manufacturing Companies ◽  
Digital Interventions ◽  
Maturity Assessment ◽  
Industrial Internet ◽  
Digital Development ◽  
Key Dimensions ◽  
The Impact

The use of digital technologies such as Internet of Things and advanced data analytics are central in digitally transforming manufacturing companies towards Industry 4.0. Success cases are frequently reported, and there is clear evidence of technology interventions conducted by industry. However, measuring the impact and effect of such interventions on digital maturity and on the organizational adoption can be challenging. Therefore, the research aim of this paper is to explore how the combination of the different methods of Industrial Internet Playground (IIP) pilots, Shadow Infrastructure (SI) and digital maturity assessment can assist in conducting and documenting the technical, as well as organisational, impact of digital interventions. Through an elaborate literature review of existing digital maturity assessment tools and key dimensions in digital transformation, we have developed a digital maturity assessment tool (DMAT), which is presented and applied in the paper to identify digital development areas and to evaluate and document the effects of digital interventions. Thus, the paper contributes with new knowledge of how the IIP pilot and SI combined with digital maturity assessment can support effective, transparent and documented digital transformation throughout an organisation, as explored through theory and a practice case.

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