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01.12.2012 | Research article | Ausgabe 1/2012 Open Access

BMC Medical Informatics and Decision Making 1/2012

Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools

Zeitschrift:
BMC Medical Informatics and Decision Making > Ausgabe 1/2012
Autoren:
Taylor R Pressler, Po-Yin Yen, Jing Ding, Jianhua Liu, Peter J Embi, Philip R O Payne
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1472-6947-12-47) contains supplementary material, which is available to authorized users.
Po-Yin Yen, Peter J Embi and Philip R O Payne contributed equally to this work.

Competing interests

There are no competing interests to report.

Authors’ contributions

TP designed and carried out the evaluation study. PY assisted in the design and analysis of the heuristic evaluation. JL and JD designed the software presented in this manuscript and provided the data for the validation study. PE and PP conceived the study, participated in its design and coordination, and helped to revise the final manuscript. All authors have read and approved the final manuscript.

Abstract

Background

Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW) store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment.

Methods

The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use.

Results

Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV) of 54.12% and 0.7%, respectively, and a negative predictive value (NPV) of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation.

Conclusions

This software is intended to provide an initial list of eligible patients to a clinical study coordinators, which provides a starting point for further eligibility screening by the coordinator. Because this software has a high “rule in” ability, meaning that it is able to remove patients who are not eligible for the study, the use of an automated tool built to leverage an existing enterprise DW can be beneficial to determining eligibility and facilitating clinical trial recruitment through pre-screening. While the results of this study are promising, further refinement and study of this and related approaches to automated eligibility screening, including comparison to other approaches and stakeholder perceptions, are needed and future studies are planned to address these needs.
Zusatzmaterial
Additional file 1: Supplemental Material. The task list and survey presented to the users during the usability testing portion of the study. (DOC 28 KB)
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Authors’ original file for figure 1
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