Feasibility Platform for Stroke Studies

Abstract

Randomized controlled trials are necessary to evaluate the effectiveness of new stroke therapies. 1 The patient population included in a randomized controlled trial is defined by its eligibility criteria. 2 Restrictive inclusion criteria provide a homogeneous study population but also lead to difficulties in enrolling patients and thus increasing the trial's duration and costs. Less stringent inclusion criteria improve patient accrual and the generalizability of the study results, but at the expense of study population homogeneity and statistical power. Eligibility criteria are therefore a key factor for the feasibility and validity of acute stroke trials as well as for demonstrating treatment effects. However, methods to optimize eligibility criteria and to reliably estimate the proportion of eligible patients are not available to date.Our aim was to develop an open access online tool to assess the effect of inclusion and exclusion criteria on the proportion of patients eligible for a clinical stroke trial. Such resource could help to estimate the recruitment rate for a specific stroke study and could be used to improve stroke trial design with respect to optimizing eligibility criteria. At its initiation, the feasibility platform for stroke studies (FePASS) is based on a large cohort of acute stroke patients from 3 stroke centers. For 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.

Prevalence of Imaging Biomarkers to Guide the Planning of Acute Stroke Reperfusion Trials

“…To compute accurate feasibility estimates of sample size, number needed to screen, and power, it is crucial to know the prevalence of both the clinical variables and imaging biomarkers in each of the time windows after symptom onset. Although there are existing databases that describe the prevalence of clinical variables, 9 the community lacks a similar database that describes the prevalence of imaging Background and Purpose-Imaging biomarkers are increasingly used as selection criteria for stroke clinical trials. The goal of our study was to determine the prevalence of commonly studied imaging biomarkers in different time windows after acute ischemic stroke onset to better facilitate the design of stroke clinical trials using such biomarkers for patient selection.…”

Clinical Trial Recruiters’ Experiences Working With Trial Eligibility Criteria: Results of an Exploratory, Cross-sectional, Online Survey

“…62,63 The latter group includes methods for using criteria in automated electronic health record data searching, either for nding potentially eligible trial participants 64,65 or assessing trial feasibility. [66][67][68] There is relatively little prior evidence from a quality perspective, i.e. how to ensure criteria are wellselected, well-written, and not liable to misinterpretation or classi cation error.…”

User Satisfaction Evaluation of the EHR4CR Query Builder: A Multisite Patient Count Cohort System

“…For example, the Shared Health Research Information Network (SHRINE) provides a query tool for open source Informatics for Integrating Biology and the Bedside (i2b2) clinical data repositories [ 6 ]. Other examples of the reuse of clinical data to support clinical research include the feasibility platform for stroke studies (FePASS), an open access online web-system that allows users to obtain eligible patient counts for stroke trials based on user-defined eligibility criteria (EC) [ 7 ] and the Feasibility Assessment and Recruitment System for Improving Trial Efficiency (FARSITE) tool [ 8 ]. These systems often have limitations such as reduced number of temporal constraints available or single source compatibility [ 9 ].…”