Methods for developing and analyzing clinically rich data for patient‐centered outcomes research: an overview

Schneeweiß, Sebastian; Seeger, John D.; Smith, Scott

doi:10.1002/pds.3270

Cited by 9 publications

(5 citation statements)

References 19 publications

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“…An incident cohort design was used for assessing the effectiveness and safety of dabigatran in comparison with warfarin [12]. The database was searched for adults (age 18 years) with NVAF (ICD-10 code I48) who had been newly started on dabigatran or warfarin in either the in-or out-patient setting between 14 March 2011 and 30 June 2016.…”

Section: Methodsmentioning

confidence: 99%

Comparative effectiveness and safety of warfarin and dabigatran in patients with non-valvular atrial fibrillation in Japan: A claims database analysis

Koretsune

Yamashita

Yasaka

et al. 2019

Journal of Cardiology

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Background: Antithrombotic therapy, including direct oral anticoagulants, is recommended in patients with non-valvular atrial fibrillation (NVAF) who are at intermediate-to-high risk of stroke. The aims of this study were to assess the patterns of oral anticoagulant (OAC) prescription in Japanese patients with NVAF and compare the effectiveness and safety of dabigatran and warfarin. Methods: This was a retrospective observational study of adults with NVAF who initiated dabigatran or warfarin between March 14, 2011 and June 30, 2016, using electronic claims data of approximately 12.94 million patients from 230 hospitals. Propensity score matching was used to derive equal patient cohorts. Outcomes included the combined incidence of stroke, systemic embolism, and intracranial bleeding (primary endpoint) and the incidence of major bleeding (secondary endpoint). Results: Overall, 400,884 patients were included. Among those prescribed an OAC, warfarin was the most common (34.3%). For the comparison of dabigatran and warfarin, 4606 patients were propensity-score matched in each cohort. Dabigatran recipients had lower incidences of stroke, systemic embolism, and intracranial bleeding [29.0 vs. 35.6 per 1000 patient-years; hazard ratio (HR), 0.72; 95% confidence interval (CI): 0.53-0.97; p = 0.031] and major bleeding (6.4 vs. 11.3 per 1000 patient-years; HR, 0.55; 95% CI: 0.30-0.99; p = 0.048). The most common type of bleeding in both groups was gastrointestinal and the incidence was lower in dabigatran recipients (1.6 vs. 6.4 per 1000 patient-years; HR, 0.24; 95% CI: 0.08-0.69; p = 0.009). Conclusions: In Japan, dabigatran was associated with a lower risk of stroke, systemic embolism, and intracranial bleeding and major bleeding compared with warfarin in patients with NVAF.

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Section: Methodsmentioning

confidence: 99%

Comparative effectiveness and safety of warfarin and dabigatran in patients with non-valvular atrial fibrillation in Japan: A claims database analysis

Koretsune

Yamashita

Yasaka

et al. 2019

Journal of Cardiology

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“…The addition of other time-stamped data from the EHR such as medications and procedures could also add value, 13 as this can provide patient-level clinical details that are not present in administrative datasets. 37 One study even linked clinical phenotypic data from questionnaires to patients' genomes. 10 Demographic data including race, gender, and age could also be useful.…”

Section: Discussionmentioning

confidence: 99%

Modeling temporal relationships in large scale clinical associations

Hanauer

Ramakrishnan

2013

J Am Med Inform Assoc

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“…Because patient-centered outcomes research can include a variety of research designs and specific techniques, PCORI's Methodology Standards do not attempt to address all possible issues in clinical research. Rather, the topics for the standards were chosen to reflect areas where there were either (1) substantial deficiencies or inconsistencies in how available methods were applied in practice, despite specialized knowledge about how best to conduct research; or (2) threats to the validity of research results that diminished the value and potential use of those results (Helfand et al 2011;Lohr 2007;Schneeweiss, Seeger, and Smith 2012).…”

Section: Introductionmentioning

confidence: 99%

The PCORI Methodology Report

Newhouse¹

2017

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Authorized by the Patient Protection and Affordable Care Act (PPACA) of 2010, the Patient-Centered Outcomes Research Institute (PCORI) was established to help people make better informed healthcare decisions and improve healthcare delivery and outcomes by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community. PCORI has developed a program of patientcentered outcomes research (PCOR) that meets this goal by emphasizing scientifically rigorous comparative clinical effectiveness research (CER) that examines choices and clinical outcomes that are meaningful to patients and generates evidence that patients and other stakeholders need to improve health and healthcare outcomes. The PCORI Methodology Committee provides guidance to the institute in advancing this mission and to the research community more broadly. The committee was established by the PPACA to "develop and improve the science and methods of comparative clinical effectiveness research." This report summarizes the committee's work to date in meeting that charge; it is a revised, updated version of the Methodology Report and Methodology Standards adopted by PCORI's Board of Governors in 2017. This report first addresses the need to take a more systematic approach to prioritizing research topics and determining which research designs can provide information that is both useful and timely to patients, caregivers, clinicians, and other healthcare system stakeholders. PCORI emphasizes the importance of taking a deliberative approach in the translation framework for choosing study designs for specific research questions and considering concerns about the quality of the resulting evidence, appropriate use of scarce research resources, and timeliness of results. The report then presents the PCORI Methodology Standards. Departures from good research practices are partially responsible for mismatches between the quality and relevance of the information research provides and the information needed to make informed health decisions. The PCORI Methodology Standards help ensure that PCOR studies are designed and conducted to generate the evidence needed to address patients' and clinicians' questions about what works best, for whom, and under what circumstances. These standards do not represent a complete, comprehensive set of all requirements for high-quality PCOR; rather, they address a group of topics that are likely to contribute to improvements in PCOR quality and value. Specifically, the standards focus on selected methodologies and issues that reflect either areas where there are substantial deficiencies or inconsistencies in how available methods are applied in practice or areas where there is evidence that supports the recommended practices. Building on the work of the National Academy of Medicine (formerly the Institute of Medicine [2011]), the PCORI Methodology Committee starts with the following definition of a standard: A process, action, or procedure for ...

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Methods for developing and analyzing clinically rich data for patient‐centered outcomes research: an overview

Cited by 9 publications

References 19 publications

Comparative effectiveness and safety of warfarin and dabigatran in patients with non-valvular atrial fibrillation in Japan: A claims database analysis

Comparative effectiveness and safety of warfarin and dabigatran in patients with non-valvular atrial fibrillation in Japan: A claims database analysis

Modeling temporal relationships in large scale clinical associations

The PCORI Methodology Report

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