scholarly journals THU0585 ONLINE EDUCATION YIELDS SIGNIFICANT GAINS IN RHEUMATOLOGISTS’ KNOWLEDGE OF THE JAK INHIBITORS MODE OF ACTION AND CLINICAL TRIAL DATA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 534.2-534
Author(s):  
A. Stan ◽  
M. Calle ◽  
C. Scot-Smith ◽  
R. Van Vollenhoven
Keyword(s):  
Clinical Trial ◽  
Online Education ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Janus Kinase ◽  
Jak Inhibitors ◽  
Research Support ◽  
Educational Grant ◽  
Trial Outcomes ◽  
Post Assessment

Background:Physicians face challenges staying up-to-date with the latest research and accessing the ever-growing field of knowledge is time-consuming. Online education can make these clinician’s tasks more efficient and less time-consuming.Objectives:This study assessed whether the online CME accredited round-table-discussion with title “Meet the JAKs: Understanding the Role of Janus Kinase Inhibition in RA” improves physicians’ understanding mechanism of action (MOA) of current and emerging Janus kinase (JAK) inhibitors and rationale for their development in rheumatoid arthritis (RA).Methods:Rheumatologists participated in an online CME activity (https://www.medscape.org/viewarticle/913625) consisting of a 30-minute video discussion between 2 experts with accompanying slides. Educational effect was assessed using a 4-question repeated pairs, pre-/post-assessment. A chi-square test was used to determine if a statistically significant improvement (P<.05 significance level) existed in the number of correct responses from the pretest and posttest scores. Cramer’s V was used to estimate the level of impact of the education. The CME activity launched on June 4, 2019, and the data were collected through September 3, 2019.Results:A total of 107 rheumatologists completed the pre- and post activity assessments. Overall the activity had a signficiant impact (P<.001) on rheumatologists’ knowledge of JAK inhibitors and relatedclinical trial data with a Cramer’s V value of 0.319 indicating an extensive educational impact. The average percentage of correct responses rose from 47% pre-activity to 78% post-activity. The repeated pairs analysis (each individual learner tracked pre- and post-education) showed that 34% of learners improved their knowledge and 44% reinforced their knowledge. The change in percentage of correct responses from pre- to post-assessment achieved statistical significance for all 3 questions presented: (1) understanding the MOA of JAK inhibitors vs biologics (64% at baseline rising to 82% post acivity;P<0.01), (2) understanding the specificity of different JAK inhibitors (49% at baseline rising to 85% post acivity;P<.001), (3) knowledge of clinical trial outcomes with JAK inhibitors (29% at baseline rising to 67% post acivity;P<.001) and (4) 60% of rheumatologists gained confidence in their ability to describe the MOA of current and emerging JAK inhibitors.Conclusion:This online CME activity significantly improved rheumatologists’ understanding of JAK inhibitors mode of action. However, there is clearly room for further improving physicians’ knowledge of clinical trial outcomes with these agents, since one third of rheumatologists provided incorrect answers to question 3 post-activity) and this topic can be further addressed in future education.Acknowledgments:This CME-certified activity was supported by anindependent educational grant from AbbVie.Disclosure of Interests:Adriana Stan Grant/research support from: The CME-certified activity was supported by anindependent educational grant from Sandoz., Marinella Calle Grant/research support from: This CME-certified activity was supported by anindependent educational grant from Novartis AG, Camille Scot-Smith Grant/research support from: This CME-certified activity was supported by anindependent educational grant from AbbVie, Ronald van Vollenhoven Grant/research support from: BMS, GSK, Lilly, UCB, Pfizer, Roche, Consultant of: AbbVie, AstraZeneca, Biogen, Biotest, Celgene, Gilead, Janssen, Pfizer, Servier, UCB, Speakers bureau: AbbVie, Pfizer, UCB

scholarly journals THU0651-HPR ONLINE EDUCATION YIELDS SIGNIFICANT GAINS IN RHEUMATOLOGISTS’ KNOWLEDGE OF THE ROLE OF ENTHESITIS IN THE DIAGNOSIS AND MANAGEMENT OF PSA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 570.1-570
Author(s):  
A. Stan ◽  
M. Calle ◽  
P. Schoonheim ◽  
P. J. Mease
Keyword(s):  
Clinical Trial ◽  
Psoriatic Arthritis ◽  
Online Education ◽  
Correct Answer ◽  
Research Support ◽  
Diagnosis And Management ◽  
Educational Grant ◽  
Trial Outcomes ◽  
Post Assessment

Background:Physicians face challenges staying up-to-date with the latest research and accessing the ever-growing field of knowledge is time-consuming. Online education can make these clinician’s tasks more efficient and less time-consuming.Objectives:As part of a larger curriculum, we developed an online CME activity titled: “Enthesitis in Psoriatic Arthritis: Disease, Diagnosis and Decisions”. The goal of this study was to assess whether this online CME accredited video discussion improves physicians’ understanding of the role of enthesitis in the diagnosis and management of patients with psoriatic arthritis (PsA) in clinical practice.Methods:Rheumatologists participated in an online CME activity (https://www.medscape.org/viewarticle/910671) consisting of a 30-minute video discussion between 2 experts with accompanying slides. Educational effect was assessed using a 4-question repeated pairs, pre-/post-assessment. A chi-square test was used to determine if a statistically significant improvement (P<.05 significance level) existed in the number of correct responses from the pretest and posttest scores. Cramer’s V was used to estimate the level of impact of the education. The CME activity launched on March 28, 2019, and the data were collected through June 7, 2019.Results:A total of 145 rheumatologists completed the pre- and post activity assessments. Overall the activity had a signficiant impact (P<.0001) on rheumatologists’ knowledge of the role of enthesitis in the diagnosis and management of PsA, with a Cramer’s V value of 0.153 indicating a noticeble educational impact. The average percentage of correct responses rose from 54% pre-activity to 69% post-activity. A repeated pairs analysis showed that 22% of rheumatologists improved their knowledge and 47% reinforced their knowledge, respectively. The change in percentage of correct responses from pre- to post-assessment for all questions are shown in table. Almost 40% of rheumatologists had a measurable improvement in confidence in their ability to evaluate the presence of enthesitis according to a clinical exam or ultrasound.Table.Impact of education on rheumatologists’ knowledge of enthesitisQuestion #Question topicAggregated dataLinked Learner ResultsaAverage % of correct responses Pre- vs. Post-educationP-value% ImprovedblearnersPre- vs. Post-education% ReinforcedclearnersPre- vs. Post-education1.Immunopathology of PsA75% vs 84%.057912%72%2.Prevalence of enthesitis in patients with PsA44% vs 68%<.000133%34%3.Clinical trial outcomes in patients with enthesitis43% vs 56%.034522%34%aEach individual learner tracked pre and post-educationbIncorrect answer pre-education, Correct answer post-educationcCorrect answer pre-education, Correct answer post-educationConclusion:This online CME activity significantly improved rheumatologists’ understanding of role of enthesitis in the diagnosis and management of PsA. However, there is clearly room for further improving physicians’ knowledge of clinical trial outcomes with biologics in patients with enthesitis, since 44% of rheumatologists provided incorrect answers to question 3 post-education. This topic can be addressed in future education.Acknowledgments:This CME-certified activity was supported by independent funding from Novartis AG.Disclosure of Interests:Adriana Stan Grant/research support from: The CME-certified activity was supported by an independent educational grant from Sandoz., Marinella Calle Grant/research support from: This CME-certified activity was supported by an independent educational grant from Novartis AG, Peter Schoonheim Grant/research support from: This CME-certified activity was supported by independent funding from Sandoz., Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau

scholarly journals A Case of Disseminated Cutaneous Mycobacterium chelonae Infection During Treatment With Tofacitinib

2021 ◽  
pp. jrheum.200730
Author(s):  
Vinit Joseph Gilvaz ◽  
Elinor Mody ◽  
Saud Abaalkhail
Keyword(s):  
Clinical Trial ◽  
Opportunistic Infection ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Janus Kinase ◽  
Jak Inhibitors ◽  
Mycobacterium Chelonae ◽  
Increased Risk ◽  
Common Opportunistic Infection

Janus kinase ( JAK) inhibitors, like other immunomodulators, are known to be associated with an increased risk of infections.1 An analysis of long-term clinical trial data has shown tuberculosis to be the most common opportunistic infection associated with tofacitinib use.2

scholarly journals AB0882-HPR ANCA-ASSOCIATED VASCULITIS: A CLINICAL PRACTICE ASSESSMENT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1464.2-1465
Author(s):  
S. Mendly ◽  
G. Boutsalis
Keyword(s):  
Clinical Practice ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Remission Induction ◽  
Refractory Disease ◽  
Maintenance Strategy ◽  
Combination Therapies ◽  
Research Support ◽  
Educational Grant ◽  
Anca Associated Vasculitis

Background:AAV (ANCA-associated vasculitis) is a group of progressive, rare, severe autoimmune diseases1,2. AAV can affect blood vessels in different parts of the body resulting in damage to vital organs such as the lungs, kidneys, nervous system, gastrointestinal system, skin, eyes, and heart.2 There are currently no approved therapies for remission-induction in patients with AAV. The current treatment armamentarium for AAV is comprised of various immunosuppressive therapies in combination with steroid treatment. Understanding clinical practice gaps in the management of AAV, can inform development of tools to improve physician practices.Objectives:This medical education activity aims to assess physicians’ knowledge on the various manifestations of antineutrophil cytoplasmic antibody-associated vasculitis (AAV), current guideline-recommended treatment strategies for remission induction in patients with AAV, as well as recent clinical trial data for combination therapies used for remission induction.Methods:A 24-question survey consisting of multiple-choice knowledge and case-based questions was made available to nephrologists and rheumatologists without monetary compensation or charge. The questions were designed to evaluate knowledge regarding the various manifestations of AAV and the results from clinical trials that have compared the efficacy of combination therapies used for remission induction in patients with AAV. As well as application of guideline-recommended therapies and clinical trial data for remission induction in patients with AAV within clinical practice. The survey launched online on a website dedicated to continuous professional development. (www.medscape.org/viewarticle/920320) on July 15, 2020. Data were collected until October 1, 2020.Results:363 nephrologists and 190 rheumatologists completed the survey. Physicians demonstrated gaps in the following areas:TopicIncorrect Responses to Knowledge and Clinical Decision-Making Questions (%)NephrologistsRheumatologistsSystemic diseases associated with AAV59%45%How to confirm diagnosis of AAV42%25%Therapy selection to induce remission that would be consistent with guidelines recommendations71%51%Guideline-recommended therapy for patients that do not respond to the induction regimen32%34%Definition of refractory disease95%94%Most effective maintenance strategy for a patient once remission is achieved80%64%Where would an emerging therapy such as a C5a receptor inhibitor fit into the therapeutic armamentarium of AAV?62%47%What are the guideline-recommended therapies to reduce remission in patients without organ-threatening disease?71%51%Most effective maintenance strategy for a patient once remission is achieved80%64%Guideline-recommendations on length of time to continue maintenance therapy31%35%Conclusion:This educational research on assessment of physicians’ (nephrologists and rheumatologists) clinical practices yielded important insights into clinical gaps related to understanding of the disease pathophysiology and progression of AAV, guideline recommendations on diagnosing and managing AAV with guideline-directed medical therapies (GDMTs), strategies for the management of relapsing and refractory disease in AAV and positioning of emerging therapies in the treatment paradigm.References:[1]www.medscape.org/viewarticle/920320.[2]Hutton HL, et al. Semin Nephrol 2017;37(5):418–35.[3]Al-Hussain T, et al. Adv Anat Pathol 2017;24(4):226–34.Disclosure of Interests:Sarah Mendly Grant/research support from: Supported by an independent educational grant from Vifor Pharma, George Boutsalis Grant/research support from: Supported by an independent educational grant from Vifor Pharma

scholarly journals 488 The impact of education on novel concepts in metastatic melanoma: triplet therapy

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A524-A524
Author(s):  
Kinjal Parikh ◽  
Sara Fagerlie ◽  
Patrick Kugel ◽  
Richard Caracio ◽  
Ryan Sullivan
Keyword(s):  
Clinical Trial ◽  
Checkpoint Inhibitors ◽  
Panel Discussion ◽  
Clinical Trial Data ◽  
Advanced Melanoma ◽  
Trial Data ◽  
Educational Activity ◽  
List Type ◽  
The Impact ◽  
Post Assessment

BackgroundAdvanced melanoma treatment selection is guided by BRAF-mutation status and patient and disease-specific factors. Historically, oncologists decided between targeted therapy or immune checkpoint inhibitors (ICI). However, given the differences in onset of activity, response durability, and adverse events combination BRAF/MEK inhibitors and ICI (triplet therapy) are being evaluated to optimize outcomes. With several trials due to report, oncologists need education to stay up-to-date on the available data and contextualize this potential treatment option.MethodsAn online continuing education (CME) activity consisting of a multi-media 30-minute video panel discussion explored the rationale, available clinical trial data, and future directions of triplet therapy for the treatment of advanced BRAF-mutated melanoma. Educational effect was assessed using a repeated pairs pre-assessment/post-assessment study design and compared the pre- and post-assessment responses. A chi-square test was used to identify differences between pre- and post-assessment responses. Effect size was calculated using Cramer’s V test by determining the strength of the association between the activity and the outcomes (V = 0.16–0.26 is considerable and V > 0.26 is extensive). P values were calculated and those < 0.05 were considered statistically significant. Data from oncologist participants were collected between 12/23/2019 through 2/26/20.ResultsParticipation in education resulted in statistically significant improvements and noticeable educational effect for oncologists (n=49; p < 0.05, V =0.136). • 39% of pre-assessment questions were correctly answered increasing to 52% post-assessment • 15% of oncologists had a measurable improvement in confidence regarding the rationale for use of triplet therapy in advanced melanoma• Significant improvement in knowledge regarding clinical trial data in triplet therapy was observed (35% vs. 55%; p < 0.05, V = 0.205)ConclusionsThis online, interactive, expert-led, CME-certified educational activity resulted in significant gains in oncologist knowledge and confidence regarding triplet therapy in the management of melanoma. These results demonstrate the effectiveness of on-demand education but also highlight an ongoing need for education on this topic as further data becomes available.AcknowledgementsThis educational initiative was supported through educational grants from Novartis Pharmaceuticals Corporation and GenentechReferenceSullivan RJ, Salama AKS. Managing Melanoma: Emerging Concepts of Triplet Therapy. https://www.medscape.org/viewarticle/923003

Keeping oncologists current with CDK4/6 inhibitors in HR+ breast cancer: The impact of online education.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13044-e13044
Author(s):  
Kinjal Parikh ◽  
Mindy Tanzola ◽  
Pamela M. Peters ◽  
Massimo Cristofanilli
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Online Education ◽  
Clinical Trial Data ◽  
Educational Approach ◽  
Chi Square ◽  
Her2 Breast Cancer ◽  
The Impact ◽  
Post Assessment ◽  
Selection Of

e13044 Background: CDK4/6 inhibitors have revolutionized the care of patients with hormone receptor positive (HR+), HER2-negative breast cancer, improving survival outcomes. There are multiple CDK4/6 inhibitors available that differ in their pharmacologic features, reported outcomes, therapeutic indications, and adverse event profiles. Education is needed to empower clinicians to optimally use these agents in practice and personalize breast cancer treatment. The goal of this educational initiative was to increase the knowledge, competence, and confidence of oncologists regarding clinical trial data and factors for selection of CDK4/6 inhibitor. Methods: This educational approach included a 30-minute online video discussion among 3 expert faculty, synchronized with slides to support the discussion. Educational effectiveness was assessed with repeated paired pre/post assessment in which learners served as their own controls. A chi-square test assessed differences from pre- to post-assessment. P values < .05 are statistically significant. Effect size was calculated using Cramer’s V test by determining the strength of the association between CME and the outcomes (V = .16-.26 is considerable and V > .26 is extensive). The activity launched 11/25/2019 and data are reported through 2/4/2020. Results: A total of 889 learners, including 513 physician learners, participated in the activity from 11/2019 through 2/2020. Participation in the education resulted in significant improvements in knowledge among oncologists (n = 81; p < .001; V = 0.16). On average, the proportion of learners who responded correctly to knowledge-based questions about CDK4/6 inhibitors increased from 51% at the pre-assessment to 67% at the post-assessment. Moreover, 41% of oncologists had a measurable positive change in confidence in their ability to incorporate CDK4/6 inhibitors into the treatment of HR+, HER2- advanced breast cancer. Significant improvements in knowledge were observed in the following areas: The clinical trial safety and efficacy data evaluating CDK4/6 inhibitors in the management of patients with HR+/HER2-negative breast cancer (32% vs. 51%, p < .05, V = 0.19). The potential role of patient- and tumor- specific prognostic factors in selection of individual CDK4/6 inhibitors (56% vs. 72%, p < .05, V = 0.17). Conclusions: This CME-certified online discussion resulted in statistically significant gains in oncologists’ knowledge and improved confidence surrounding the personalization of CDK4/6 inhibitor therapy in HR+/HER2- breast cancer.

Clinical Trial Data Management Software: A Review of the Technical Features

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Management Systems ◽  
Data Management Systems ◽  
Technical Features

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

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