24th International Conference of the European Federation for Medical Informatics

Quality of Life through Quality of Information J. Mantas et al. (Eds.)

MIE2012 / CD / Short Communications (Poster)

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 webbased 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

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
Query text
Variable
number
name
1
Please check for missing value in variable Date of laboratory analysis Blodat
[dd.mm.yyyy].
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 > blasts baso
100 %.
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.
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