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Article: Disorders of coagulation in stroke.

Waddy, Salina P

2006 Volume 26, Issue 1, Page(s) 57–64

Abstract: The roles of the coagulopathies in thrombosis have been well established; however, the role in ischemic stroke is poorly understood. This article reviews the recent advances in the genetics of coagulation, the recently identified interactive roles of the ...

Abstract	The roles of the coagulopathies in thrombosis have been well established; however, the role in ischemic stroke is poorly understood. This article reviews the recent advances in the genetics of coagulation, the recently identified interactive roles of the coagulation and anticoagulation proteins, and the literature supporting protein dysregulation as a causative agent in cerebral venous thrombosis and ischemic stroke.
MeSH term(s)	Blood Coagulation Disorders/blood ; Blood Coagulation Disorders/complications ; Blood Coagulation Disorders/diagnosis ; Blood Proteins/physiology ; Humans ; Stroke/blood ; Stroke/diagnosis ; Stroke/etiology
Chemical Substances	Blood Proteins
Language	English
Publishing date	2006-02
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	603165-1
ISSN	1098-9021 ; 0271-8235
ISSN (online)	1098-9021
ISSN	0271-8235
DOI	10.1055/s-2006-933309
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Article ; Online: Concomitant Use of Gabapentinoids with Opioids Is Associated with Increased Mortality and Morbidity among Dialysis Patients.

Waddy, Salina P / Becerra, Adan Z / Ward, Julia B / Chan, Kevin E / Fwu, Chyng-Wen / Eggers, Paul W / Abbott, Kevin C / Kimmel, Paul L

American journal of nephrology

2020 Volume 51, Issue 6, Page(s) 424–432

Abstract: Background: The opioid epidemic is a public health emergency and appropriate medication prescription for pain remains challenging. Physicians have increasingly prescribed gabapentinoids for pain despite limited evidence supporting their use. We ... ...

Abstract	Background: The opioid epidemic is a public health emergency and appropriate medication prescription for pain remains challenging. Physicians have increasingly prescribed gabapentinoids for pain despite limited evidence supporting their use. We determined the prevalence of concomitant gabapentinoid and opioid prescriptions and evaluated their associations with outcomes among dialysis patients. Methods: We used the United States Renal Data System to identify patients treated with dialysis with Part A, B, and D coverage for all of 2010. Patients were grouped into 4 categories of drugs exposure status in 2010: (1) no prescriptions of either an opioid or gabapentinoid, (2) ≥1 prescription of an opioid and no prescriptions of gabapentinoids, (3) no prescriptions of an opioid and ≥1 prescription of gabapenbtinoids, (4) ≥1 prescription of both an opioid and gabapentinoid. Outcomes included 2-year all-cause death, dialysis discontinuation, and hospitalizations assessed in 2011 and 2012. Results: The study population included 153,758 dialysis patients. Concomitant prescription of an opioid and gabapentin (15%) was more common than concomitant prescription of an opioid and pregabalin (4%). In adjusted analyses, concomitant prescription of an opioid and gabapentin compared to no prescription of either was associated with increased risk of death (hazard ratio [HR] 1.16, 95% CI 1.12-1.19), dialysis discontinuation (HR 1.14, 95% CI 1.03-1.27), and hospitalization (HR 1.33, 95% CI 1.31-1.36). Concomitant prescription of an opioid and pregabalin compared to no prescription of either was associated with increased mortality (HR 1.22, 95% CI 1.16-1.28) and hospitalization (HR 1.37, 95% CI 1.33-1.41), but not dialysis discontinuation (HR 1.13, 95% CI 0.95-1.35). Prescription of opioids and gabepentinoids compared to only being prescribed opioids was associated with higher risk of hospitalizations, but not mortality, or dialysis discontinuation. Conclusions: Concomitant prescription of opioids and gabapentinoids among US dialysis patients is common, and both drugs have independent effects on outcomes. Future research should prospectively investigate the potential harms of such drugs and identify safer alternatives for treatment of pain in end-stage renal disease patients.
MeSH term(s)	Adult ; Aged ; Analgesics, Opioid/therapeutic use ; Cause of Death ; Drug Prescriptions/statistics & numerical data ; Female ; Gabapentin/analogs & derivatives ; Gabapentin/therapeutic use ; Hospitalization/statistics & numerical data ; Humans ; Kidney Failure, Chronic/complications ; Kidney Failure, Chronic/mortality ; Kidney Failure, Chronic/therapy ; Male ; Middle Aged ; Pain/drug therapy ; Pain/etiology ; Polypharmacy ; Pregabalin/therapeutic use ; Registries/statistics & numerical data ; Renal Dialysis/adverse effects ; Retrospective Studies ; Risk Assessment/statistics & numerical data ; United States/epidemiology ; Young Adult
Chemical Substances	Analgesics, Opioid ; Pregabalin (55JG375S6M) ; Gabapentin (6CW7F3G59X)
Language	English
Publishing date	2020-05-19
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	604540-6
ISSN	1421-9670 ; 0250-8095
ISSN (online)	1421-9670
ISSN	0250-8095
DOI	10.1159/000507725
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Zs.A 1635: Show issues

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Article ; Online: Improving Kidney Disease Research in the Black Community: The Essential Role of Black Voices in the APOLLO Study.

Iltis, Ana S / Conell, Alexis D / Cooper, Lori A / Gee, Patrick O / Jefferson, Nichole M / Johnson, Heather A / Kingston, Giftay Myah / Roberts, Glenda V / Scott, Norman / Smith, Angenetta / Waddy, Salina P / Woodard, Leslie / DuBois, James M

American journal of kidney diseases : the official journal of the National Kidney Foundation

2021 Volume 79, Issue 5, Page(s) 750–753

MeSH term(s)	Blacks ; Female ; Humans ; Kidney Diseases ; Male
Language	English
Publishing date	2021-10-12
Publishing country	United States
Document type	Editorial ; Research Support, N.I.H., Extramural
ZDB-ID	604539-x
ISSN	1523-6838 ; 0272-6386
ISSN (online)	1523-6838
ISSN	0272-6386
DOI	10.1053/j.ajkd.2021.09.006
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Zs.A 1669: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 468: Show issues

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Article ; Online: Toward solutions for minimizing disparities in stroke: National Institute of Neurological Disorders and Stroke update.

Pahigiannis, Katherine / Waddy, Salina P / Koroshetz, Walter

Stroke

2013 Volume 44, Issue 10, Page(s) e129–30

MeSH term(s)	Humans ; National Institute of Neurological Disorders and Stroke (U.S.) ; Stroke/diagnosis ; Stroke/epidemiology ; Stroke/therapy ; United States/epidemiology
Language	English
Publishing date	2013-09-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	80381-9
ISSN	1524-4628 ; 0039-2499 ; 0749-7954
ISSN (online)	1524-4628
ISSN	0039-2499 ; 0749-7954
DOI	10.1161/STROKEAHA.113.001418
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Zs.A 448: Show issues

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Article ; Online: Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

Lane, Karen / Palm, Marisha E / Marion, Eve / Kay, Marie T / Thompson, Dixie / Stroud, Mary / Boyle, Helen / Hillery, Shannon / Nanni, Angeline / Hildreth, Meghan / Nelson, Sarah / Burr, Jeri S / Edwards, Terri / Poole, Lori / Waddy, Salina P / Dunsmore, Sarah E / Harris, Paul / Wilkins, Consuelo / Bernard, Gordon R /

Dean, J Michael / Dwyer, Jamie / Benjamin, Daniel K / Selker, Harry P / Hanley, Daniel F / Ford, Daniel E

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e131

Abstract: One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but ...

Abstract	One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
Language	English
Publishing date	2023-05-25
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.560
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Article ; Online: The Trial Innovation Network Liaison Team: building a national clinical and translational community of practice.

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e249

Abstract: In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ ... ...

Abstract	In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers. Each HLT serves as an expert intermediary, connecting CTSA Hub investigators with TIN support, and connecting TIN research teams with potential multicenter trial site investigators. The cross-consortium Liaison Team network was developed during the first TIN funding cycle, and it is now a mature national network at the cutting edge of team science in clinical and translational research. The CTSA-based HLT structures and the external network structure have been developed in collaborative and iterative ways, with methods for shared learning and continuous process improvement. In this paper, we review the structure, function, and development of the Liaison Team network, discuss lessons learned during the first TIN funding cycle, and outline a path toward further network maturity.
Language	English
Publishing date	2023-11-06
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.675
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Article: Disorders of Coagulation in Stroke

Waddy, Salina P

Seminars in Neurology

2006 Volume 26, Issue 01, Page(s) 57–64

Abstract	The roles of the coagulopathies in thrombosis have been well established; however, the role in ischemic stroke is poorly understood. This article reviews the recent advances in the genetics of coagulation, the recently identified interactive roles of the coagulation and anticoagulation proteins, and the literature supporting protein dysregulation as a causative agent in cerebral venous thrombosis and ischemic stroke.
Keywords	Coagulation ; stroke ; protein
Language	English
Publishing date	2006-02-15
Publishing place	Stuttgart ; New York
Document type	Article
ZDB-ID	603165-1
ISSN	1098-9021 ; 0271-8235
ISSN (online)	1098-9021
ISSN	0271-8235
DOI	10.1055/s-2006-933309
Database	Thieme publisher's database

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Zs.A 1737: Show issues

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Article ; Online: Racial/Ethnic Disparities in Atrial Fibrillation Treatment and Outcomes among Dialysis Patients in the United States.

Waddy, Salina P / Solomon, Allen J / Becerra, Adan Z / Ward, Julia B / Chan, Kevin E / Fwu, Chyng-Wen / Norton, Jenna M / Eggers, Paul W / Abbott, Kevin C / Kimmel, Paul L

Journal of the American Society of Nephrology : JASN

2020 Volume 31, Issue 3, Page(s) 637–649

Abstract: Background: Because stroke prevention is a major goal in the management of ESKD hemodialysis patients with atrial fibrillation, investigating racial/ethnic disparities in stroke among such patients is important to those who could benefit from strategies ...

Abstract	Background: Because stroke prevention is a major goal in the management of ESKD hemodialysis patients with atrial fibrillation, investigating racial/ethnic disparities in stroke among such patients is important to those who could benefit from strategies to maximize preventive measures. Methods: We used the United States Renal Data System to identify ESKD patients who initiated hemodialysis from 2006 to 2013 and then identified those with a subsequent atrial fibrillation diagnosis and Medicare Part A/B/D. Patients were followed for 1 year for all-cause stroke, mortality, prescription medications, and cardiovascular disease procedures. The survival mediational g-formula quantified the percentage of excess strokes attributable to lower use of atrial fibrillation treatments by race/ethnicity. Results: The study included 56,587 ESKD hemodialysis patients with atrial fibrillation. Black, white, Hispanic, and Asian patients accounted for 19%, 69%, 8%, and 3% of the population, respectively. Compared with white patients, black, Hispanic, or Asian patients were more likely to experience stroke (13%, 15%, and 16%, respectively) but less likely to fill a warfarin prescription (10%, 17%, and 28%, respectively). Warfarin prescription was associated with decreased stroke rates. Analyses suggested that equalizing the warfarin distribution to that in the white population would prevent 7%, 10%, and 12% of excess strokes among black, Hispanic, and Asian patients, respectively. We found no racial/ethnic disparities in all-cause mortality or use of cardiovascular disease procedures. Conclusions: Racial/ethnic disparities in all-cause stroke among hemodialysis patients with atrial fibrillation are partially mediated by lower use of anticoagulants among black, Hispanic, and Asian patients. The reasons for these disparities are unknown, but strategies to maximize stroke prevention in minority hemodialysis populations should be further investigated.
MeSH term(s)	Aged ; Aged, 80 and over ; Anti-Arrhythmia Agents/administration & dosage ; Anticoagulants/administration & dosage ; Atrial Fibrillation/drug therapy ; Atrial Fibrillation/etiology ; Atrial Fibrillation/physiopathology ; Cohort Studies ; Databases, Factual ; Ethnicity/statistics & numerical data ; Female ; Healthcare Disparities/ethnology ; Humans ; Kidney Failure, Chronic/diagnosis ; Kidney Failure, Chronic/epidemiology ; Kidney Failure, Chronic/therapy ; Male ; Medicare/statistics & numerical data ; Racism ; Renal Dialysis/adverse effects ; Renal Dialysis/methods ; Retrospective Studies ; Stroke/prevention & control ; Treatment Outcome ; United States
Chemical Substances	Anti-Arrhythmia Agents ; Anticoagulants
Language	English
Publishing date	2020-02-20
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1085942-1
ISSN	1533-3450 ; 1046-6673
ISSN (online)	1533-3450
ISSN	1046-6673
DOI	10.1681/ASN.2019050543
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Article ; Online: A causal roadmap for generating high-quality real-world evidence.

Dang, Lauren E / Gruber, Susan / Lee, Hana / Dahabreh, Issa J / Stuart, Elizabeth A / Williamson, Brian D / Wyss, Richard / Díaz, Iván / Ghosh, Debashis / Kıcıman, Emre / Alemayehu, Demissie / Hoffman, Katherine L / Vossen, Carla Y / Huml, Raymond A / Ravn, Henrik / Kvist, Kajsa / Pratley, Richard / Shih, Mei-Chiung / Pennello, Gene /

Martin, David / Waddy, Salina P / Barr, Charles E / Akacha, Mouna / Buse, John B / van der Laan, Mark / Petersen, Maya

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e212

Abstract: Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and industry. ...

Abstract	Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and industry. A broad spectrum of studies use real-world data (RWD) to produce RWE, ranging from randomized trials with outcomes assessed using RWD to fully observational studies. Yet, many proposals for generating RWE lack sufficient detail, and many analyses of RWD suffer from implausible assumptions, other methodological flaws, or inappropriate interpretations. The
Language	English
Publishing date	2023-09-22
Publishing country	England
Document type	Journal Article ; Review
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.635
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

Hanley, Daniel F / Bernard, Gordon R / Wilkins, Consuelo H / Selker, Harry P / Dwyer, Jamie P / Dean, J Michael / Benjamin, Daniel Kelly / Dunsmore, Sarah E / Waddy, Salina P / Wiley, Kenneth L / Palm, Marisha E / Mould, W Andrew / Ford, Daniel F / Burr, Jeri S / Huvane, Jacqueline / Lane, Karen / Poole, Lori / Edwards, Terri L / Kennedy, Nan /

Boone, Leslie R / Bell, Jasmine / Serdoz, Emily / Byrne, Loretta M / Harris, Paul A

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e170

Abstract: New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by ... ...

Abstract	New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
Language	English
Publishing date	2023-07-25
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.597
Database	MEDical Literature Analysis and Retrieval System OnLINE

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