A Query Tool for an Electronic Data Capture Patient Registry Software System

Doris LINDRFER,1 and Thomas H. MLLER Institut fr medizinische Informationsverarbeitung, Biometrie und Epidemiologie,

Ludwig-Maximilians Universitt Mnchen; Germany

Abstract. Query processing is an important tool for data quality control in clinical research. As an alternative to classical paper processing, an existing electronic data capture tool was supplemented with an online query processing module. This module accepts queries in a simple tabular format that can be generated from SAS or any similar statistic software package. Once uploaded into the EDC system, the queries can be answered online in a very efficient manner based on a work list. The query response and eventual correction of prior eCRF data can be performed in a single step, saving both, the query response and the corrected data.

Keywords. Electronic data capture, EDC, patient registry software system, query tool

Introduction

One important element of data quality assurance in clinical research projects is the generation and processing of queries by the central study coordinator [1]. Unfortunately, extensive paper-based query management often places a significant burden on the resources of investigator-initiated projects. In this respect, the European Treatment and Outcome Study (EUTOS) Population-based Registry [2], a European registry project which is active with 27 study groups in 25 European countries, is not different. A preliminary account of this project, its objectives, and the developed web-based electronic data capture (EDC) tool has appeared [3].

While some validation checks can be incorporated into an EDC tool, it can be desirable to have more complex queries generated by external software, such as SAS macros, possibly for the sole reason of using a tool data managers are already familiar with. For this purpose we developed an extension module for the EDC tool that imports queries formatted in an appropriate, but very simple fashion. Once the data manager has happily concluded this task, this query module provides a web dialog for trial site users to efficiently process the queries from a filtered work list. Although the implementation is, of course, specific for the EDC tool used here, we do not only focus on user functionality, but provide also the necessary logical details of input format and internal processing to allow porting to other EDC tools.

1 Corresponding Author. Doris Lindrfer, Dipl.-Inf.; Institut fr medizinische Informationsverarbeitung,

Biometrie und Epidemiologie, Ludwig-Maximilians Universitt Mnchen, Marchioninistrasse 15, 81377 Mnchen, Germany; Email: lindoerf@ibe.med.uni-muenchen.de

24th International Conference of the European Federation for Medical InformaticsQuality of Life through Quality of Information J. Mantas et al. (Eds.)

MIE2012 / CD / Short Communications (Poster)

1. Methods

The EDC tool for the EUTOS Population-based Registry uses a generic implementation of EDC functionality that consists essentially of a generic configurable web forms generator "dbform" and a form compiler that derives the appropriate configuration data from a tabulated data dictionary. The system was originally described in 2002 [4] and has been refined in many aspects. The form generator runs on a platform providing a webserver and database management system (DBMS) environment. Our current choices are Linux, Apache [5], and PostgreSQL [6], respectively, but other environments are possible. The major implementation programming language is Perl [7].

The system is not monolithic, so enabling the adaptation to multiple types of database clients. It provides an application programming interface (API) suitable for many kinds of extensions. This API was used to implement the query processing extension module.

2. Results

In our EDC patient registry software system, the data are organized in panels such as Demographic data, Hematology data, Cytogenetic data, etc. To check the data for missing values and implausibility, we programmed SAS macros. We checked the patient data using those macros and created the query information, as listed in Table 1 for some variables in the panel Hematology data. is. Each query consists of a unique number, a query text with a question about the variable and the unit in which the variable is needed. It is possible to add new queries during the project time.

In order to generate a set of queries, the captured data is extracted from the database and checked offline with SAS or a similar software system. The query information is stored in a simple tabular format in text files. These are uploaded into the query tool of the EDC patient registry software system.

Each single query is identified per patient data by the triplet consisting of the panel name, the query number and the query creation date. In this way it can be guaranteed that queries are not contrived twice.

Table 1. Queries for some variables in panel Hematology data with unique query numbers.Query number

Query text Variable name

1 Please check for missing value in variable Date of laboratory analysis [dd.mm.yyyy].

Blodat

2 Please check for missing value in variable Hemoglobin [g/dl]. Hb 3 Please check for missing value in variable WBC [109/L]. Wbc 4 Please check for missing value in variable Platelets [109/L] Platelets .. 8 Please check value for Hemoglobin, since it is < 1. Hb 9 Please check value for Hemoglobin, since it is > 25. Hb .. 20 Please check implausibility, The sum of the percentage values is >

100 %. blasts baso eosino

The work list containing some queries for a study group is shown in Figure 1. The

work list can be filtered by panel, by visit and by region for each study group. A query can be selected by clicking at the blue arrow at the left side.

The screenshot after a query selection is shown in Figure 2. The screen is divided into two parts: on the right side the user can see the values currently stored in the database. The variable field in question is highlighted so that the missing or incorrect value can easily be filled in or corrected. On the left side the query needs to be answered. After clicking the button save data and send reply the answer and the value are stored automatically in the database and the query is removed from the work list.

Figure 1. Some queries for hematology data. Figure 2. A selected query with answer and reason.

3. Discussion

The described online query module is an efficient tool to communicate a large number of queries at low cost. Due to the integrated work list query processing by the sites is also very efficient. In the European registry project about 1600 queries were answered within a two months period, demonstrating good acceptance.

References

[1] Gassman JJ, Owen WW, Kuntz TE, Martin JP, Amoroso WP: Data Quality Assurance, Monitoring, and Reporting. Control Clin Trials 1995; 16:104S-136S.

[2] http://www.eutos.org/content/registry/ (last accessed 13 April 2012) [3] Lindrfer D, Mller TH: Integration und Analyse von Patienten mit Chronischer Myeloischer

Leukmie (CML) in 25 Europischen Lndern mit webbasierter elektronischer Datenerfassung. In: Schmcker P, Elssser K-H, Hayna S (Hrsg.): Tagungsband der 55. GMDS Jahrestagung 2010. Mannheim, 2010.

[4] Mller TH, Adelhard K: A web-based central diagnostic data repository. Stud Health Technol Inform. 2002; 90: 246-250.

[5] http://httpd.apache.org (last accessed 13 April 2012) [6] http://www.postgresql.org (last accessed 13 April 2012) [7] http://www.perl.org (last accessed 13 April 2012)