Feasibility platform for stroke studies: an online tool to improve eligibility criteria for clinical trials

Minnerup, Jens; Trinczek, Benjamin; Storck, Michael; Hohenberger, Maria; Wilpsbäumer, Simon; Abdul-Rahim, Azmil H; Liesirova, Kai Timo; Broeg-Morvay, Anne; Meisterernst, Julia Anne; Lees, Kennedy R; Mattle, Heinrich P; Wersching, Heike; Dziewas, Rainer; Schäbitz, Wolf-Rüdiger; Schilling, Matthias (2015). Feasibility platform for stroke studies: an online tool to improve eligibility criteria for clinical trials. Stroke, 46(1), pp. 137-142. Lippincott Williams & Wilkins 10.1161/STROKEAHA.114.007124

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BACKGROUND AND PURPOSE Eligibility criteria are a key factor for the feasibility and validity of clinical trials. We aimed to develop an online tool to assess the potential effect of inclusion and exclusion criteria on the proportion of patients eligible for an acute stroke trial. METHODS We identified relevant inclusion and exclusion criteria of acute stroke trials. Based on these criteria and using a cohort of 1537 consecutive patients with acute ischemic stroke from 3 stroke centers, we developed a web portal feasibility platform for stroke studies (FePASS) to estimate proportions of eligible patients for acute stroke trials. We applied the FePASS resource to calculate the proportion of patients eligible for 4 recent stroke studies. RESULTS Sixty-one eligibility criteria were derived from 30 trials on acute ischemic stroke. FePASS, publicly available at http://fepass.uni-muenster.de, displays the proportion of patients in percent to assess the effect of varying values of relevant eligibility criteria, for example, age, symptom onset time, National Institutes of Health Stroke Scale, and prestroke modified Rankin Scale, on this proportion. The proportion of eligible patients for 4 recent stroke studies ranged from 2.1% to 11.3%. Slight variations of the inclusion criteria could substantially increase the proportion of eligible patients. CONCLUSIONS FePASS is an open access online resource to assess the effect of inclusion and exclusion criteria on the proportion of eligible patients for a stroke trial. FePASS can help to design stroke studies, optimize eligibility criteria, and to estimate the potential recruitment rate.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology

UniBE Contributor:

Liesirova, Kai Timo; Broeg-Morvay, Anne; Meisterernst, Julia Anne and Mattle, Heinrich

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0039-2499

Publisher:

Lippincott Williams & Wilkins

Language:

English

Submitter:

Valentina Rossetti

Date Deposited:

06 Mar 2015 13:01

Last Modified:

29 Oct 2015 11:58

Publisher DOI:

10.1161/STROKEAHA.114.007124

PubMed ID:

25395412

Uncontrolled Keywords:

clinical science, clinical trial, ischemic, stroke

BORIS DOI:

10.7892/boris.64141

URI:

https://boris.unibe.ch/id/eprint/64141

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