Journal:Improving data quality in clinical research informatics tools - Revision history

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	Lastly, data loss could be present in the ETL process, a significant challenge in ETL processes because of the nature of the source systems. Data losses arise from the disparities among the source operational systems. Source systems are diverse and disparate because of the increased amount of data, modification of data formats, and modification and derivation of new data elements.		Lastly, data loss could be present in the ETL process, a significant challenge in ETL processes because of the nature of the source systems. Data losses arise from the disparities among the source operational systems. Source systems are diverse and disparate because of the increased amount of data, modification of data formats, and modification and derivation of new data elements.

	n general, data integration with heterogeneous systems is not an easy task. This is mainly due to the fact that many data exchange channels must be developed in order to allow an exchange of data between the systems<ref>{{Cite book \|last=Berkhoff, K.; Ebeling, B.; Lübbe, S. \|year=2012 \|editor-last=Jeffery, K.G.; Dvořák, J. \|title=e-Infrastructures for Research and Innovation Linking Information Systems to Improve Scientific Knowledge Production \|url=http://hdl.handle.net/11366/92 \|chapter=Integrating Research Information into a Software for Higher Education Administration – Benefits for Data Quality and Accessibility \|series=Proceedings of the 11th International Conference on Current Research Information Systems \|publisher=euroCRIS \|pages=167-176 \|isbn=9788086742335}}</ref> and to solve problems related to the provision of interoperability between systems on the level of data.<ref>{{Cite journal \|last=Marek \|first=Macura \|date=2014 \|title=Integration Of Data From Heterogeneous Sources Using ETL Technology \|url=http://journals.agh.edu.pl/csci/article/view/275 \|journal=Computer Science \|language=en \|volume=15 \|issue=2 \|pages=109 \|doi=10.7494/csci.2014.15.2.109 \|issn=1508-2806}}</ref>		In general, data integration with heterogeneous systems is not an easy task. This is mainly due to the fact that many data exchange channels must be developed in order to allow an exchange of data between the systems<ref>{{Cite book \|last=Berkhoff, K.; Ebeling, B.; Lübbe, S. \|year=2012 \|editor-last=Jeffery, K.G.; Dvořák, J. \|title=e-Infrastructures for Research and Innovation Linking Information Systems to Improve Scientific Knowledge Production \|url=http://hdl.handle.net/11366/92 \|chapter=Integrating Research Information into a Software for Higher Education Administration – Benefits for Data Quality and Accessibility \|series=Proceedings of the 11th International Conference on Current Research Information Systems \|publisher=euroCRIS \|pages=167-176 \|isbn=9788086742335}}</ref> and to solve problems related to the provision of interoperability between systems on the level of data.<ref>{{Cite journal \|last=Marek \|first=Macura \|date=2014 \|title=Integration Of Data From Heterogeneous Sources Using ETL Technology \|url=http://journals.agh.edu.pl/csci/article/view/275 \|journal=Computer Science \|language=en \|volume=15 \|issue=2 \|pages=109 \|doi=10.7494/csci.2014.15.2.109 \|issn=1508-2806}}</ref>

	==Steps to ensure informatics quality==		==Steps to ensure informatics quality==

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	==Discussion==		==Discussion==
			The revealed discrepancies lead to major information quality measures such as data inconsistency and data accuracy, which both affect the believability and the validity of the data. The discrepancies noted above are likely due to several factors. First, SlicerDicer counts patients for every race selected, whereas i2b2 only takes the first race field. This is because two data models were used to pattern race and ethnicity variables in i2b2 to both the 1997 OMB race categories and the 2003 OMB variables, the latter containing a more granular set of race and ethnicity categories. The mapping then was done to "bundle" the other races to a more general set of categories. This could be the reason why there is a reduction of concepts because perhaps the mapping is incomplete.

			Secondly, the purpose of the ETL process is to load the warehouse with integrated and cleansed data. Data quality focuses on the contents of the individual records to ensure the data loaded into the target destination is accurate, reliable, and consistent. As such, the ETL code should be evaluated to ensure the data extracted generally matches what researchers expect. In our case, this means understanding what diagnosis most researchers are interested in: they are expecting encounter diagnosis instead of data that includes problem lists and medical history. Thirdly, a leading cause for data quality issues is formatting differences or conversion errors (Azeroual et al., 2019; Souibgui et al., 2019), which was also the case with this dataset.

			Lastly, data loss could be present in the ETL process, a significant challenge in ETL processes because of the nature of the source systems. Data losses arise from the disparities among the source operational systems. Source systems are diverse and disparate because of the increased amount of data, modification of data formats, and modification and derivation of new data elements.

			n general, data integration with heterogeneous systems is not an easy task. This is mainly due to the fact that many data exchange channels must be developed in order to allow an exchange of data between the systems (Berkhoff et al., 2012) and to solve problems related to the provision of interoperability between systems on the level of data. (Macura, 2014)

			==Steps to ensure informatics quality==
			To improve the data quality generated from de-identified systems, which mainly contains counts, and to solve any data quality issues related to the provision of interoperability between the used tools on the level of data, we propose the following steps to better ensure quality results:

			# '''Make data “fit for use.”''' In order to do this, data governance bodies must clearly define major data concepts/variables included in the de-identified systems and standardize their collection and monitoring processes; this can increase clinical data reliability and reduce the inconsistency of data quality among systems involved. (Halimeh, 2011; AbuHalimeh and Tudoreanu, 2014)
			# '''Define data elements by developing a data dictionary.''' This is a fundamental part of any data quality plans; the lack of clear definitions of source data and controlled data collection procedures often raises concerns about the quality of data provided in such environments and, consequently, about the evidence level of related findings. (Spengler et al., 2020) Developing a data dictionary is essential to ensuring data quality, especially in de-identified systems where all data elements are aggregated in a specific way, and there are not enough details about each concept. A data dictionary will serve as a guidebook to define the major data concepts. To do this, organizations must determine what [[metadata]] is helpful to the researchers when they use the de-identified data systems. In addition, identifying more targeted data concepts and process workflows can help reduce some of the time and effort for researchers when working with large amounts of data, ultimately improving overall data quality.
			# '''Apply strong ETL practices.''' Applying good ETL practices such as data cleansing mechanisms to get the data to a place that acts well with data from other sources is also essential.
			# '''Choose smart ETL architecture.''' Choose an architecture that allows you to update components of your ETL process when data and systems change or are updated to prevent any data loss and to ensure [[data integrity]] and consistency.
			# '''Apply data lineage techniques.''' This will help in understanding where data originated from, when it was loaded, how it was transformed, and how it is essential for the integrity of the downstream data and the process that moves it to any of the de-identified systems.
			# '''Establish rigorous processes for monitoring and cleansing data.''' Discovering and acting upon suspicious data and taking the appropriate cleansing action is preventative and useful.
			# '''Evaluate and revise queries regularly.''' Users need to revise their queries and refine results as they combine data variables.
			# '''Have critical knowledge support available in-house or on-demand.''' Having a clinical informaticist available can be beneficial to the process. They can ensure that your data reflects what is seen in clinical practice or help explain questionable data with their knowledge of clinical [[workflow]]s and how that data is collected, especially if your analyst has no clinical background.

			==Conclusion==
			The success of any de-identified data tool depends largely on the quality of the data used and the mapping process which is intertwined with the ETL components. By extension, the ETL process is a crucial component in determining the quality of the data generated by an information system.

			This case study proved that the discrepancies in the data used in the data pull process led to major information quality issues, such as data inconsistency and data accuracy, which in turn affects the believability and the validity of the data, which are also major data quality measures.

			From this case study, our biggest contribution is a proposed set of steps that together form guidelines for a methodology of manual and automated procedures and tools used to manage data quality and data governance in a multifaceted, diverse information environment such as healthcare organizations, as well as to enhance data quality among data housed in de-identified data systems.

			Future work will focus on more clinical informatics tools such as TriNetX, and other types of medical data, to assess the quality of the counts obtained from those tools.

			==Acknowledgements==
			===Author contributions===
			The author confirms being the sole contributor of this work and has approved it for publication.

			===Conflict of interest===
			The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

	==References==		==References==
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	==Notes==		==Notes==
	This presentation is faithful to the original, with only a few minor changes to presentation, grammar, and punctuation. In some cases important information was missing from the references, and that information was added. ~~Numerous links that were originally posted inline~~ in ~~the text were turned into full citations for this version, adding significantly to the total citation count~~.		This presentation is faithful to the original, with only a few minor changes to presentation, grammar, and punctuation. In some cases important information was missing from the references, and that information was added. The original article lists references alphabetically, but this version—by design—lists them in order of appearance.

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	''V''<sub>1</sub> = i2b2 counts and ''V''<sub>2</sub> = SlicerDicer counts; these counts are plugged into the below formula:		''V''<sub>1</sub> = i2b2 counts and ''V''<sub>2</sub> = SlicerDicer counts; these counts are plugged into the below formula:


			:<math>Percentage{~~}difference =\| V1 - V2 \|/[{{({V1\ + \ V2})}/2}] \times \ 100</math>


			A paired ''t''-test is used to investigate the difference between two counts from i2b2 and SlicerDicer for the same query.

			===Findings and hypotheses===
			All the results obtained from comparing the counts between i2b2 and SlicerDicer are listed in Tables 2 and 3.

			However, when diagnoses were explored, larger discrepancies were noted. There are two diagnosis fields in i2b2: one for diagnosis and one for billing diagnosis. Using <tt>J45</tt> as the ICD-10 code for asthma resulted in 22,265 patients when using the billing diagnosis code in SlicerDicer but only 20,429 in i2b2. The discrepancy using diagnosis was even larger. Patient count results for type 1 diabetes diagnosis code <tt>E10</tt> using both diagnosis and billing diagnosis are also shown in Table 3.

			The best approach to understanding the reasons for this discrepancy was by looking at the diagnosis options in SlicerDicer to build a hypothesis on where this discrepancy might come from. Next, the SQL code for the Caboodle-to-i2b2 ETL process was examined. From these examinations, the following hypotheses were considered:

			H0: There is no discrepancy in the data elements used to pull the data.

			H1: There is a discrepancy in the data elements used to pull the data.

			A paired sample ''t''-test was implemented on the counts obtained from ib2b and SlicerDicer using different data points. The ''p''-value was equal to 0, [''P''(x ≤ –Infinity) = 0]; in all cases that means that the chance of type I error (rejecting a correct H0) is small: 0 (0%). The smaller the ''p''-value the more it supports H1. For example, results of the paired ''t''-test indicated that there is a significant medium difference between i2b2 (''M'' = 14,500, ''SD'' = 0) and SlicerDicer (''M'' = 23,958, ''SD'' = 0), t(0) = Infinity, ''p'' < 0.001; results of the paired ''t''-test indicated that there is a significant medium difference between i2b2 (''M'' = 155,434, ''SD'' = 0) and Slicerdicer (''M'' = 1,579, ''SD'' = 0), t(0) = Infinity, ''p'' < 0.001.

			Since the ''p''-value < α, H0 is rejected and the i2b2 population's average is considered to be not equal to the SlicerDicer population's average. In other words, the difference between the averages of i2b2 and SlicerDicer is big enough to be statistically significant.

			The paired ''t''-test results supported the alternative hypothesis and revealed that there is a discrepancy in the data elements used to pull the data.

			Also, the percentage difference calculator results, which were used to estimate the quality of the counts coming from the two tools, showed that a majority exceeded the threshold for accepted quality in this study (below 2%), as shown in Tables 2 and 3. The percentage difference results showed and provided strong evidence for a crucial quality issue in the counts obtained.

			When examining the SQL code for the Caboodle-to-i2b2 ETL process, the SQL code results showed the code only looked at billing and encounter diagnosis, and everything that was not a billing diagnosis was simply labeled "diagnosis." SlicerDicer, and even Caboodle, include other diagnosis sources such as "medical history," "hospital problem," and "problem list." This was included in the data dictionary so that researchers would understand what sources i2b2 was using and that if they wanted data beyond that, they would have to request data from Caboodle.

			==Discussion==


	==References==		==References==

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Method description

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	{\|		{\|
	\| style="vertical-align:top;" \|		\| style="vertical-align:top;" \|
	{\| class="wikitable" border="1" cellpadding="5" cellspacing="0" width="80%"		{\| class="wikitable" border="1" cellpadding="5" cellspacing="0" width="100%"
	\|-		\|-
	\| colspan="4" style="background-color:white; padding-left:10px; padding-right:10px;" \|'''Table 3.''' Patients count based on diagnosis codes.		\| colspan="4" style="background-color:white; padding-left:10px; padding-right:10px;" \|'''Table 3.''' Patients count based on diagnosis codes.
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	''V''<sub>1</sub> = i2b2 counts and ''V''<sub>2</sub> = SlicerDicer counts; these counts are plugged into the below formula:		''V''<sub>1</sub> = i2b2 counts and ''V''<sub>2</sub> = SlicerDicer counts; these counts are plugged into the below formula:




	==References==		==References==

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	==Introduction==		==Introduction==
			Data is the building block in all research, as research results are only as good as the data upon which the conclusions were formed. However, researchers may receive minimal training on how to use the de-identified data systems and methods common to [[wikipedia:Clinical research\|clinical research]] today for achieving, assessing, or controlling the [[Quality (business)\|quality]] of research data. (Nahm, 2012; Zozus et al., 2019) De-identified data systems are defined as systems or tools that allow users to drag and drop search terms from a hierarchical [[Ontology (information science)\|ontology]] into a Venn diagram-like interface. Investigators can then perform an initial analysis on the de-identified cohort. However, de-identified data systems have no features to indicate or assist in identifying the [[Data quality\|quality of data]] in the system; these systems only provide counts.

			Another issue involves the level of knowledge a clinician has about informatics in general and clinical informatics in particular. Without knowledge of informatics concepts, clinicians may not be able to identify quality issues in informatics systems. This requires some background in [[Informatics (academic field)\|informatics]], the science of how to use data, information, and knowledge to improve human health and the delivery of healthcare services (American Medical Informatics Association, 2022), as well as clinical informatics, the the application of informatics and information technology to deliver healthcare services. For example, clinicians increasingly need to turn to patient portals, [[electronic medical record]]s (EMRs), [[telehealth]] tools, healthcare apps, and a variety of data reporting tools (American Medical Informatics Association, 2022) as part of achieving higher-quality health outcomes.

			The case presented in this paper focuses on the quality of data obtained from two de-identified systems: TranSMART Foundation's i2b2 and Epic's SlicerDicer. The purpose of this paper is to discuss the quality of the data (counts) generated from the two systems, understand the potential causes of data quality issues, and propose steps to improve the quality and increase the trust of the generated counts by comparing the accuracy, consistency, validity, and understandability of the outcomes from the two systems. The proposed quality improvement steps are broadly applicable and contribute towards adding generic and essential steps to automate data curation and data governance to tackle various data quality problem. These steps should help data managers, information systems teams, and informaticists at a healthcare organization monitor and sustain data quality as part of their business intelligence, data governance, and data democratization processes.

			The remainder of this paper is organized as follows. In the following section, we introduce the importance of data quality to clinical research informatics, followed by details of the case study, study method, and materials used. Afterwards, findings are presented and the proposed steps to ensure data quality are discussed. At the end, conclusions are drawn and future work discussed.

			==Importance of data quality to clinical research informatics==
			Data quality refers to the degree data meets the expectations of data consumers and their intended use of the data. (Pipino et al., 2002; Halimeh, 2011; AbuHalimeh and Tudoreanu, 2014). In clinical research informatics, this depends on the parameters of the study conducted. (Nahm, 2012; Zozus et al., 2019)

			The significance of data quality lies in how the data is perceived and used by its consumer. Identifying data quality involves two stages: first, highlighting which characteristics (i.e., dimensions) are important (Figure 1) and second, determining how these dimensions affect the population in question. (Halimeh, 2011; AbuHalimeh and Tudoreanu, 2014)


			[[File:Fig1 AbuHalimeh FrontBigData2022 5.jpg\|536px]]
			{{clear}}
			{\|
			\| style="vertical-align:top;" \|
			{\| border="0" cellpadding="5" cellspacing="0" width="536px"
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|<blockquote>'''Fig. 1''' De-identified data quality dimensions (DDQD)</blockquote>
			\|-
			\|}
			\|}

			This paper focuses on a subset of data quality dimensions, which we term "de-identified data quality dimensions" (DDQD). We think these dimensions, described in Table 1, are critical to maintaining data quality in de-identified systems.

			{\|
			\| style="vertical-align:top;" \|
			{\| class="wikitable" border="1" cellpadding="5" cellspacing="0" width="70%"
			\|-
			\| colspan="2" style="background-color:white; padding-left:10px; padding-right:10px;" \|'''Table 1.''' Definitions of de-identified data quality dimensions (DDQD)
			\|-
			\|-
			! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" \|Quality dimension
			! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" \|Definition
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Accuracy
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Refers to the degree to which information accurately reflects an event or object described, i.e., how well does a piece of information reflect reality?
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Completeness
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Refers to the extent to which data is not missing and of sufficient amount for the task at hand, i.e., does it fulfill data consumers' expectations and is the needed amount known?
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Consistency
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Refers to the extent to which data is applicable and helpful to the task at hand, i.e., does information stored in one place match relevant data stored elsewhere?
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Timeliness
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Refers to the extent to which data is sufficiently relevant for the task at hand, i.e., is the most up-to-data available when you need it?
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Validity
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Refers to information that doesn't conform to a specific format or doesn't follow business rules, i.e., is the information in a specific format, does it follow business rules, or is it in a usable format?
			\|-
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Understandability
			\| style="background-color:white; padding-left:10px; padding-right:10px;" \|Refers to the degree the data can be comprehended, i.e., can the user understand the data easily?
			\|-
			\|}
			\|}

			The impact of quality data and management is in performance and efficiency gains and the ability to extract new understanding. On the other hand, poor clinical research informatics data quality can cause inefficiencies and other problems throughout an organization. This impact includes the quality of research outcomes, healthcare services, and decision-making.

			Quality is not a simple scalar measure but can be defined on multiple dimensions, with each dimension yielding different meanings to different information consumers and processes. (Halimeh, 2011; AbuHalimeh and Tudoreanu, 2014) Each dimension can be measured and assessed differently. Data quality assessment implies providing a value for each dimension that clearly says something about how much of the dimension or quality feature is achieved to enable adequate understanding and management. Data quality and the discipline of informatics are undoubtedly interconnected. Data quality depends on how data are collected, processed, and presented; this is what makes data quality important and sometimes complicated because data collection and processing varies from one study to another. Clinical informatics data can include different data formats and types and can come from different resources.

			==Case study goals==

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{{Infobox journal article
|name =
|image =
|alt = 
|caption =
|title_full = Improving data quality in clinical research informatics tools
|journal = ''Frontiers in Big Data''
|authors = AbuHalimeh, Ahmed
|affiliations = University of Arkansas at Little Rock
|contact = Email: aaabuhalime at ualr dot edu
|editors = Ehrlinger, Lisa
|pub_year = 2022
|vol_iss = '''5'''
|at = 871897
|doi = [http://dx.doi.org/10.3389/fdata.2022.871897 10.3389/fdata.2022.871897]
|issn = 2624-909X
|license = [http://creativecommons.org/licenses/by/4.0/ Creative Commons Attribution 4.0 International]
|website = [https://www.frontiersin.org/articles/10.3389/fdata.2022.871897/full https://www.frontiersin.org/articles/10.3389/fdata.2022.871897/full]
|download = [https://www.frontiersin.org/articles/10.3389/fdata.2022.871897/pdf https://www.frontiersin.org/articles/10.3389/fdata.2022.871897/pdf] (PDF)
}}

{{Ombox math}}
{{ombox
| type = notice
| image = [[Image:Emblem-important-yellow.svg|40px]]
| style = width: 500px;
| text = This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed.
}}
==Abstract==
Maintaining [[data quality]] is a fundamental requirement for any successful and long-term [[Information management|data management]] project. Providing high-quality, reliable, and statistically sound data is a primary goal for [[wikipedia:Clinical research|clinical research]] [[Informatics (academic field)|informatics]]. In addition, effective data governance and management are essential to ensuring accurate data counts, reports, and validation. As a crucial step of the clinical research process, it is important to establish and maintain organization-wide standards for data quality management to ensure consistency across all systems designed primarily for cohort identification, allowing users to perform an enterprise-wide search on a clinical research data repository to determine the existence of a set of patients meeting certain inclusion or exclusion criteria. Some of the clinical research tools are referred to as de-identified data tools.

Assessing and improving the quality of data used by clinical research informatics tools are both important and difficult tasks. For an increasing number of users who rely on [[information]] as one of their most important assets, enforcing high data quality levels represents a strategic investment to preserve the value of the data. In clinical research informatics, better data quality translates into better research results and better patient care. However, achieving high-quality data standards is a major task because of the variety of ways that errors might be introduced in a system and the difficulty of correcting them systematically. Problems with data quality tend to fall into two categories. The first category is related to inconsistency among data resources such as format, syntax, and semantic inconsistencies. The second category is related to poor extract, transform, and load (ETL) and data mapping processes.

In this paper, we describe a real-life case study on assessing and improving the data quality within a healthcare organization. This paper compares between the results obtained from two de-identified data systems—TranSMART Foundation's i2b2 and Epic's SlicerDicer—and discuss the data quality dimensions specific to the clinical research informatics context, and the possible data quality issues between the de-identified systems. This work closes by proposing steps or rules for maintaining data quality among different systems to help data managers, information systems teams, and informaticists at any healthcare organization to monitor and sustain data quality as part of their business intelligence, data governance, and data democratization processes.

'''Keywords''': clinical research data, data quality, research informatics, informatics, management of clinical data

==Introduction==

==References==
{{Reflist|colwidth=30em}}

==Notes==
This presentation is faithful to the original, with only a few minor changes to presentation, grammar, and punctuation. In some cases important information was missing from the references, and that information was added. Numerous links that were originally posted inline in the text were turned into full citations for this version, adding significantly to the total citation count.


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[[Category:LIMSwiki journal articles on clinical research]]
[[Category:LIMSwiki journal articles on data quality]]