Feasibility platform for stroke studies: an online tool to improve eligibility criteria for clinical trials.
OBJECTIVE
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.
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.). minnerup@uni-muenster.de.
Jens
J
Minnerup
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Benjamin
B
Trinczek
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Michael
M
Storck
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Maria
M
Hohenberger
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Simon
S
Wilpsbäumer
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Azmil H
AH
Abdul-Rahim
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Kai Timo
KT
Liesirova
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Anne
A
Broeg-Morvay
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Julia
J
Meisterernst
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Kennedy R
KR
Lees
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Heinrich P
HP
Mattle
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Heike
H
Wersching
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Rainer
R
Dziewas
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Wolf-Rüdiger
WR
Schäbitz
From the Department of Neurology (J. Minnerup, M.H., R.D., M. Schilling), Institute of Medical Informatics (B.T., M. Storck, S.W.), Institute of Epidemiology and Social Medicine (H.W.), University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (A.H.A.-R., K.R.L.); Department of Neurology, Inselspital, University of Bern, Bern, Switzerland (K.T.L., A.B.-M., J. Meisterernst, H.P.M.); and Department of Neurology, Bethel, Bielefeld, Germany (W.-R.S.).
Matthias
M
Schilling
D002986:Clinical Trials as Topic / Q000379:methods*; D004608:Eligibility Determination; D005240:Feasibility Studies; D006801:Humans; D020407:Internet; D018579:Patient Selection; D020521:Stroke
clinical science; clinical trial; ischemic; stroke