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Showing 1 to 8 of 8 entries
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Building internal capacity in pragmatic trials: a workshop for program scientists at the US National Cancer Institute.

Trials

Norton WE, Zwarenstein M, Czajkowski S, Kato E, O'Mara A, Shelburne N, Chambers DA, Loudon K.
PMID: 31881919
Trials. 2019 Dec 27;20(1):779. doi: 10.1186/s13063-019-3934-y.

BACKGROUND: Building capacity in research funding organizations to support the conduct of pragmatic clinical trials is an essential component of advancing biomedical and public health research. To date, efforts to increase the ability to design and carry out pragmatic...

Pragmatic Clinical Trials in CKD: Opportunities and Challenges.

Journal of the American Society of Nephrology : JASN

de Boer IH, Kovesdy CP, Navaneethan SD, Peralta CA, Tuot DS, Vazquez MA, Crews DC.
PMID: 27283497
J Am Soc Nephrol. 2016 Oct;27(10):2948-2954. doi: 10.1681/ASN.2015111264. Epub 2016 Jun 09.

Randomized controlled trials in CKD lag in number behind those of other chronic diseases, despite the high morbidity and mortality experienced by patients with kidney disease and the exorbitant costs of their health care. Observational studies of CKD frequently...

Series: Pragmatic trials and real world evidence: Paper 4. Informed consent.

Journal of clinical epidemiology

Kalkman S, van Thiel GJMW, Zuidgeest MGP, Goetz I, Pfeiffer BM, Grobbee DE, van Delden JJM.
PMID: 28502809
J Clin Epidemiol. 2017 Sep;89:181-187. doi: 10.1016/j.jclinepi.2017.03.019. Epub 2017 May 11.

The GetReal consortium of the Innovative Medicines Initiative aims to develop strategies to incorporate real-world evidence earlier into the drug life cycle to better inform health care decision makers on the comparative risks and benefits of new drugs. Pragmatic...

Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems.

Healthcare (Amsterdam, Netherlands)

Larson EB, Tachibana C, Thompson E, Coronado GD, DeBar L, Dember LM, Honda S, Huang SS, Jarvik JG, Nelson C, Septimus E, Simon G, Johnson KE.
PMID: 27637816
Healthc (Amst). 2016 Sep;4(3):138-41. doi: 10.1016/j.hjdsi.2015.07.005. Epub 2015 Jul 29.

Pragmatic clinical trials are increasingly common because they have the potential to yield findings that are directly translatable to real-world healthcare settings. Pragmatic clinical trials need to integrate research into clinical workflow without placing an undue burden on the...

How pragmatic is it? Lessons learned using PRECIS and RE-AIM for determining pragmatic characteristics of research.

Implementation science : IS

Gaglio B, Phillips SM, Heurtin-Roberts S, Sanchez MA, Glasgow RE.
PMID: 25163664
Implement Sci. 2014 Aug 28;9:96. doi: 10.1186/s13012-014-0096-x.

BACKGROUND: The need for high-quality evidence that is applicable in real-world, routine settings continues to increase. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-world settings, whereas explanatory trials aim to test whether an intervention works...

Pragmatic surgical studies: are they the New Gold Standard.

The bone & joint journal

Simpson AHRW, Frost H, Norrie J.
PMID: 30418050
Bone Joint J. 2018 Nov;100(11):1407-1408. doi: 10.1302/0301-620X.100B11.BJJ-2018-0947.

No abstract available.

Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.

Clinical pharmacology and therapeutics

Eichler HG, Koenig F, Arlett P, Enzmann H, Humphreys A, Pétavy F, Schwarzer-Daum B, Sepodes B, Vamvakas S, Rasi G.
PMID: 31574163
Clin Pharmacol Ther. 2020 Apr;107(4):773-779. doi: 10.1002/cpt.1638. Epub 2019 Oct 01.

Real-world data and patient-level data from completed randomized controlled trials are becoming available for secondary analysis on an unprecedented scale. A range of novel methodologies and study designs have been proposed for their analysis or combination. However, to make...

Series: Pragmatic trials and real world evidence: Paper 8. Data collection and management.

Journal of clinical epidemiology

Meinecke AK, Welsing P, Kafatos G, Burke D, Trelle S, Kubin M, Nachbaur G, Egger M, Zuidgeest M.
PMID: 28716504
J Clin Epidemiol. 2017 Nov;91:13-22. doi: 10.1016/j.jclinepi.2017.07.003. Epub 2017 Jul 14.

Pragmatic trials can improve our understanding of how treatments will perform in routine practice. In a series of eight papers, the GetReal Consortium has evaluated the challenges in designing and conducting pragmatic trials and their specific methodological, operational, regulatory,...

Showing 1 to 8 of 8 entries