scholarly journals A161 PREVALENCE OF FINANCIAL CONFLICTS OF INTEREST (FCOI) AMONG PROPENSITY-SCORE MATCHED RETROSPECTIVE STUDIES EVALUATING BIOLOGIC THERAPEUTICS FOR IBD

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 168-170
Author(s):  
K Elsolh ◽  
D Tham ◽  
M A Scaffidi ◽  
R Bansal ◽  
J Li ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Retrospective Studies ◽  
Conflicts Of Interest ◽  
Cochrane Library ◽  
High Burden ◽  
Real World Evidence ◽  
Full Text Retrieval ◽  
Financial Conflicts Of Interest ◽  
Matched Comparison

Abstract Background Inflammatory Bowel Disease (IBD) studies have commonly relied on real-world evidence to evaluate different therapies. An emerging idea has been the use of propensity score matching as a statistical method to account for baseline characteristics in IBD patients. In retrospective studies, propensity score matching of patients helps reduce treatment assignment bias and mimic the effects of randomization. Recently, propensity-score matching has become an important tool in IBD studies comparing biologic therapeutics. Biologic medications are among the highest-grossing drugs worldwide, and their pharmaceutical producers make considerable payments to physicians to market them. In spite of this, there is a lack of evidence examining the role of undue industry influence among propensity-score matched comparative studies evaluating biologic therapeutics for IBD. Aims Given the documented association between IBD biologics and FCOI, we hypothesize a high burden of FCOI in propensity-score matched studies. The aim of this study was to evaluate the prevalence of disclosed & undisclosed financial conflicts of Interest (FCOI) in propensity-score matched comparison studies evaluating biologics for IBD. Methods We developed & ran a librarian-reviewed systematic search on EMBASE, MEDLINE, and Cochrane Library databases for all propensity-score matched retrospective studies comparing biologics for the treatment of IBD. Full-text retrieval & screening was performed on all studies in duplicate. 16 articles were identified. Industry payments to authors were only considered FCOI if they were made by a company producing a biologic that was included in the comparison study. Disclosed FCOI were identified by authors’ interests disclosures in full-texts. Any undisclosed FCOI among US authors were identified using the Centre for Medicare and Medicaid Services (CMS) Open Payments Database, which collects industry payments to physicians. Results Based on a preliminary analysis of 16 studies, there was at least one author with a relevant FCOI in 14 (88%) of the 16 studies. 14 studies (88%) had at least one disclosed FCOI, while 6 studies (37.5%) had at least one undisclosed FCOI. Among studies with disclosed FCOI, a mean of 40.2% (SD = 23.4%) of authors/study reported FCOI. Among studies with undisclosed FCOI, a mean of 18.8% (SD = 7.0%) of authors/study reported FCOI. The total dollar value of FCOIs was $1,974,328.3. The median conflict dollar value was $5,576.6 (IQR: $321.6 to $36,394.9). Conclusions We found a high burden of undisclosed FCOI (37.5%) among authors of propensity-score matched studies evaluating IBD biologics. Given the potential for undue industry influence stemming from such payments, authors should ensure better transparency with industry relationships. Funding Agencies None

Fr528 FINANCIAL CONFLICTS OF INTEREST AMONG PROPENSITY-SCORE MATCHED RETROSPECTIVE STUDIES EVALUATING BIOLOGIC THERAPEUTICS FOR IBD

2021 ◽  
Vol 160 (6) ◽  
pp. S-349
Author(s):  
Karam Elsolh ◽  
Daniel Tham ◽  
Michael A. Scaffidi ◽  
Rishi Bansal ◽  
Juana Li ◽  
...  
Keyword(s):  
Propensity Score ◽  
Retrospective Studies ◽  
Conflicts Of Interest ◽  
Financial Conflicts Of Interest

scholarly journals Assessing the Effectiveness of Quantway®: A Multilevel Model With Propensity Score Matching

2018 ◽  
Vol 46 (3) ◽  
pp. 257-287 ◽  
Author(s):  
Hiroyuki Yamada ◽  
Angel X. Bohannon ◽  
Alicia Grunow ◽  
Christopher A. Thorn
Keyword(s):  
Propensity Score ◽  
Student Success ◽  
Propensity Score Matching ◽  
Hierarchical Linear Modeling ◽  
Developmental Mathematics ◽  
College Level ◽  
Linear Modeling ◽  
Mathematics Courses ◽  
Matched Comparison ◽  
Mathematics Course

Objective: Quantway is a Carnegie Math Pathways initiative, which redesigns the content, pedagogy, and structure of traditional developmental mathematics courses to simultaneously tackle traditional barriers to student success and support a broad range of developmental students in achieving their mathematics potential. Specifically, Quantway is a quantitative reasoning sequence that is comprised of a single term accelerated developmental mathematics course called Quantway 1 and a college-level mathematics course called Quantway 2. This study assesses the effectiveness of the developmental mathematics course, Quantway 1, during its first six semesters of implementation. Method: We used a hierarchical linear modeling technique to conduct propensity score matching across 37 student characteristics to compare the course performance of Quantway 1 students with matched comparison students from traditional developmental mathematics courses. Results: Quantway 1 students demonstrated significantly higher odds of success in fulfilling developmental mathematics course requirements and enrolling in college mathematics courses in the following year than matched comparison students. In addition, Quantway 1 effects were positive across all sex and race/ethnicity subgroups as well as in nearly all classrooms and colleges. Contributions: This study provides robust evidence that Quantway 1 increases student success in fulfilling developmental mathematics requirements and advances equity in student outcomes. Implications of and future directions for the Pathways are discussed.

scholarly journals Efficacy of Newer Combinations and Fibril-Targeting for AL Amyloidosis: A Systematic Review of Transplant and Innovative Non-Transplant Therapies

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5763-5763
Author(s):  
Shaunak Pandya ◽  
Nadia Carenina Nunes Cavalcante Parr ◽  
Muhammad Sardar ◽  
Christine Chiu ◽  
Maria Serafini ◽  
...  
Keyword(s):  
Stem Cell ◽  
Retrospective Studies ◽  
Stem Cell Transplant ◽  
Conflicts Of Interest ◽  
Progression Free Survival ◽  
Cochrane Library ◽  
Al Amyloidosis ◽  
Cell Transplant ◽  
Amyloid Protein ◽  
Novel Drugs

Abstract Background Light-chain (AL) amyloidosis is a multi-organ amyloid deposition disease caused by misfolded protein aggregation. Current treatments have improved overall (OS) and progression-free survival (PFS) but challenges remain in improving therapy with newer agents and targeting amyloid protein deposits with novel immunotherapy. We review the literature regarding efficacy of existing chemotherapy in AL amyloidosis and summarize non-FDA approved novel drugs and monoclonal antibodies (mAbs) in early phase clinical development. Methods We searched databases including Cochrane library, PubMed and ClinicalTrials.gov for all prospective and retrospective studies (As of 4/15/2018) with measured hematologic response rate (HR) in patients with AL amyloidosis since 2000. Inclusion criteria included all prospective and retrospective studies with melphalan-based treatments, bortezomib combinations including bortezomib, cyclophosphamide and dexamethasone (VCD), bortezomib and dexamethasone (VD) and immunotherapies. We included all studies with at least 5 or more patients and reported HR. Results From 918 studies, we selected 57 studies (2640 patients) evaluating HR with melphalan-based stem cell transplant (SCT) treatments and non-stem cell transplant treatments including melphalan and bortezomib combinations. Other agents included daratumumab (anti-CD38 mAb), and ixazomib (proteasome inhibitor). Mean aggregate HR reported from studies with melphalan-based SCT treatment (17 studies, n=587) was 67%. Mean aggregate HR from all non-transplant treatments (40 studies, n=2053) was 64%. Of the non-transplant treatments, HR for melphalan-based treatments (21 studies, n=1148) was 59% and varied as follows: melphalan + lenalidomide + dexamethasone (57%) and melphalan + dexamethasone (52%). Mean aggregated HR for non-transplant bortezomib-based treatment (17 studies, n=859) was 72% consisting of VD (69%) and VCD (76%). HR with Ixazomib (1 study) and Daratumumab (1 study) was 52% and 76% respectively. Other novel drugs currently being studied include 11-1F4 (chimeric fibril-reactive mAb), GSK2398852 and GSK2315698 (anti-serum amyloid protein mAbs), and NEOD001 (anti-circulating soluble and deposited aggregated amyloid mAb). Conclusion For AL amyloidosis, melphalan-based SCT has shown effectiveness while VD and VCD demonstrate effectiveness in non-transplant patients. Further studies are warranted to evaluate novel proteasome inhibitors (Ixazomib) and emerging immunotherapy with daratumumab. Current trials including amyloid protein and fibril targeting (circulating and tissue-fixed) with novel immunotherapy are innovative and may have higher clinical efficacy, but need further testing. Disclosures No relevant conflicts of interest to declare.

scholarly journals Assessing the Long-Term Role of Vaccination against HPV after Loop Electrosurgical Excision Procedure (LEEP): A Propensity-Score Matched Comparison

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 717
Author(s):  
Giorgio Bogani ◽  
Francesco Raspagliesi ◽  
Francesco Sopracordevole ◽  
Andrea Ciavattini ◽  
Alessandro Ghelardi ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Cervical Dysplasia ◽  
The Cost ◽  
Matched Comparison ◽  
Term Data ◽  
Loop Electrosurgical Excision

Background: Primary prevention through vaccination is a prophylactic approach aiming to reduce the risk of developing human papillomavirus (HPV)-related lesions. No mature and long-term data supported the adoption of vaccination in women undergoing conization. Methods: This is a retrospective multi-institutional study. Charts of consecutive patients undergoing conization between 2010 and 2014 were collected. All patients included had at least 5 years of follow-up. We compared outcomes of patients undergoing conization plus vaccination and conization alone. A propensity-score matching algorithm was applied in order to reduce allocation biases. The risk of developing recurrence was estimated using Kaplan-Meir and Cox hazard models. Results: Overall, charts of 1914 women were analyzed. The study group included 116 (6.1%) and 1798 (93.9%) women undergoing conization plus vaccination and conization alone, respectively. Five-year recurrence rate was 1.7% (n = 2) and 5.7% (n = 102) after conization plus vaccination and conization alone, respectively (p = 0.068). After the application of a propensity-score matching, we selected 100 patients undergoing conization plus vaccination and 200 patients undergoing conization alone. The crude number of recurrences was 2 (2%) and 11 (5.5%) for patients undergoing conization plus vaccination and conization alone, respectively (p = 0.231). Vaccination had no impact on persistent lesions (no negative examination between conization and new cervical dysplasia; p = 0.603), but reduced the risk of recurrent disease (patients who had at least one negative examination between conization and the diagnosis of recurrent cervical dysplasia; p = 0.031). Conclusions: Patients having vaccination experience a slightly lower risk of recurrence than women who had not, although not statistically significantly different. Further evidence is needed to assess the cost effectiveness of adopting vaccination in this setting.

scholarly journals Risk of Venous Thromboembolism in Hospitalized Patients with Acute Ischemic Stroke Versus Other Neurological Conditions

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3212-3212
Author(s):  
Nirav Dhanesha ◽  
Aayushi Garg ◽  
Amir Shaban ◽  
Edgar Samaniego ◽  
Anil K Chauhan ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Venous Thromboembolism ◽  
Propensity Score ◽  
Acute Ischemic Stroke ◽  
Propensity Score Matching ◽  
Conflicts Of Interest ◽  
Intravenous Thrombolysis ◽  
Study Data ◽  
Increased Risk ◽  
Neurological Conditions

Abstract Background The mechanism of increased risk of venous thromboembolism (VTE) after acute ischemic stroke (AIS) is unclear. In this study, we aimed to evaluate the risk of VTE in hospitalizations due to AIS as compared to those due to non-vascular neurological conditions. We also aimed to assess any potential association between VTE risk and the use of intravenous thrombolysis (rtPA) among hospitalizations with AIS. Methods In this case-control study, data were obtained from the Nationwide Inpatient Sample 2016-2018. Propensity score matching was used to adjust for the baseline differences between the groups. Logistic regression analysis was used to compare the risk of VTE. Results We identified 1,541,685 hospitalizations due to AIS and 1,453,520 hospitalizations due to non-vascular neurological diagnoses that served as controls. After propensity score matching, 640,560 cases with AIS and corresponding well-matched controls were obtained. Hospitalizations due to AIS had higher odds of VTE as compared to the controls [odds ratio (OR) 1.50, 95% confidence interval (CI) 1.40-1.60, P<0.001]. Among hospitalizations with AIS, 184,065 (11.9%) got rtPA. The odds of VTE were lower among the AIS hospitalizations that received rtPA as compared to those that did not (OR 0.89, 95% CI 0.79-0.99, P0.035). Conclusion Hospitalizations due to AIS have a higher risk of VTE as compared to the non-vascular neurological controls. Among AIS cases, the risk of VTE is lower among patients treated with rtPA. These epidemiological findings support the hypothesis that the risk of VTE after AIS might be partly mediated by an intrinsic pro-coagulant state. Disclosures No relevant conflicts of interest to declare.

Zoledronic Acid Improves Overall Survival Compared To Pamidronate In Multiple Myeloma

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3182-3182
Author(s):  
Kristen M. Sanfilippo ◽  
Brian F Gage ◽  
Suhong Luo ◽  
Ravi Vij ◽  
Michael H. Tomasson ◽  
...  
Keyword(s):  
United States ◽  
Prognostic Factors ◽  
Propensity Score ◽  
Propensity Score Matching ◽  
Bone Disease ◽  
Conflicts Of Interest ◽  
The United States ◽  
Tumor Cell Adhesion ◽  
Multicenter Cohort Study ◽  
Anti Tumor Activity

Abstract Background Recent practice guideline changes suggest all patients with MM should receive bisphosphonates, regardless of the presence of bone disease. Nitrogen-containing bisphosphonates, ZA and PAM, inhibit protein prenylation, a process crucial for osteoclast survival. This inhibition also interferes with tumor cell adhesion, angiogenesis, and proliferation suggesting potential for anti-tumor activity of bisphosphonates. Morgan et al showed increased OS with use of ZA versus clodronate in MM. This increase was independent of the effect on bone disease, supporting anti-tumor activity of ZA. ZA and PAM are the two approved bisphosphonates for MM in the United States. In in-vitro studies, ZA has increased potency compared to PAM, a finding that may result in increased apoptosis of tumor cells. A meta-analysis by Mhaskar et al demonstrated an association between higher bisphosphonate potency and improved OS in MM. In an effort to clarify the effect of ZA versus PAM on OS in MM, we evaluated outcomes in a large cohort of United States Veterans with MM. Methods We identified 1,018 patients with newly diagnosed MM in the Veterans Administration Cancer Registry between 2002 and 2009, who were treated with either PAM or ZA, but not both. Data was collected on age, co-morbidities, date of diagnosis and death, myeloma specific and supportive medications, and baseline lab data. Cox proportional-hazards was used to assess association between bisphosphonate use and OS while controlling for other prognostic factors. Propensity score analyses were performed to reduce confounding by indication, using the inverse probability weighting (IPW) approach of Cole and Hernan and propensity score matching. The covariates for each propensity model were the same as those in the main analysis. Results Of the 1,018 patients in the cohort, 383 received ZA and 635 received PAM. The median follow-up was 26.9 months. After adjustment using propensity score groups, baseline characteristics were well balanced between the groups (Table 1). Kaplan-Meier curves showing OS of patients receiving ZA versus PAM are shown in Figure 1. After controlling for age, weight, comorbidity score, era of diagnosis (before or after 2006), baseline lab characteristics, and treatment, OS was significantly improved with ZA compare to PAM (HR 0.84; 95% CI, 0.72-0.98). In both the IPW and propensity score matching analyses, ZA significantly improved OS in MM (HR 0.84; 95% CI, 0.72-0.97) and (HR 0.83; 95% CI, 0.69-0.99) respectively. Conclusion In this large, multicenter cohort study, ZA improved OS compared to PAM in patients with MM. The benefit persisted even after controlling for known patient and treatment related prognostic factors, as well as controlling for differences in baseline patient characteristics. Bisphosphonates play a key role in the treatment of MM for the prevention of MM bone disease. Evidence suggests that bisphosphonates may also have a direct anti-tumor effect in MM. Our study adds to this growing body of evidence and provides rationale for selecting ZA over PAM in most patients with MM. Disclosures: No relevant conflicts of interest to declare.

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