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34 © 2012 IMIA and Schattauer GmbH

Business Process Modelling is an Essential Part of a Contribution of EFMI Primary Care Working Group

S. de Lusignan1,3, P. Krause2, G. Michalakidis2, M. Tristan Vicente3, S. Thompson1, M. McGilchrist4, F. Sullivan4, P. van Royen5, L. Agreus6, T. Desombre1, A. Taweel7, B. Delaney8 1 Department of Health Care Management and Policy, University of Surrey, Guildford, Surrey, UK 2 Department of , University of Surrey, Guildford, Surrey, UK 3 Primary Care Informatics, Division of Population Health Sciences and Education, St. George’s – University of London, London, UK 4 Division of Clinical & Population Sciences and Education, The Mackenzie Building, Dundee, Scotland 5 Dept of Primary and interdisciplinary care, University of Antwerp, Antwerpen (Wilrijk), Belgium 6 Dept of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Stockholm, Sweden 7 Department of Informatics and Public Health, King’s College London, London, UK 8 Department of Primary Care and Public Health Sciences, London, UK

[11, 12]. Cancer registries are also well Summary Introduction established [13, 14] and more recently Objectives: To perform a requirements analysis of the barriers to con- Requirements analyses are part of soft- have become international and used to

ducting research linking of primary care, genetic and cancer data. ware engineering with the purpose of study of a wide range of conditions Methods: We extended our initial data-centric approach to include reducing the chances of failure or the [15], and the effectiveness of treat- socio-cultural and . We created reference models need for frequent expensive changes ments [16]. Primary care data are also of core data requirements common to most studies using unified mod- further along the development path- widely used in research. These data are elling language (UML), dataflow diagrams (DFD) and business proc- way. A requirements analysis is the rich, collected longitudinally and in ess modelling notation (BPMN). We conducted a stakeholder analysis process of determining what a countries with registration pro- and constructed DFD and UML diagrams for use cases based on simu- must do, acknowledging the at times vide a population denominator [17, 18]. lated research studies. We used research output as a sensitivity analysis. conflicting needs of the various Research networks have been devel- Results: Differences between the reference model and use cases iden- stakeholders [1, 2]. Conventionally oped within primary care, at regional tified study specific data requirements. The stakeholder analysis conducting a requirements analysis was and national level and have improved identified: tensions, changes in specification, some indifference from an early step in the waterfall approach the capability and capacity for research data providers and enthusiastic informaticians urging inclusion of to development [3, 4, 5]. in primary care; including recruitment socio-cultural context. We identified requirements to collect informa- However, "agile" approaches which in- into trials [19, 20]. There are many tion at three levels: micro- data items, which need to be semantically clude user and stakeholder involvement models, sometimes they are part of interoperable, meso- the medical record and data extraction, and throughout development [6] and recog- National or regional sentinel networks macro- the health system and socio-cultural issues. BPMN clarified nise the need for flexibility and change [21], or of single vendor linked data complex business requirements among data providers and vendors; [7] have been used more and also com- collection schemes [15]. and additional geographical requirements for patients to be repre- bined with the waterfall approach. There have been a number of at- sented in both linked datasets. High research output was the Medical research is a complex proc- tempts to link these different types of norm for most repositories. ess and although there are many com- data for research [22, 23, 24, 25], but Conclusions: Reference models provide high-level schemata of the puterised data repositories, they are not the successes have largely been lim- core data requirements. However, business requirements’ modelling commonly linked in research studies ited to the use of specific methods in identifies stakeholder issues and identifies what needs to be ad- [8]. These data repositories include: [26, 27]. dressed to enable participation. genetic , disease registries, and, routinely collected primary care Keywords data. Genetic data has been collected General practice; medical records systems, computerized; research into biobanks since the completion of Objective design; registry; records as topic the mapping of the human genome [9, 10], though biological specimens have We carried out this requirements analy- Yearb Med Inform 2012:34-43 been used in forensic science for longer sis to identify how to maximise the use

IMIA Yearbook of Medical Informatics 2012 35 Modelling is an Essential Part of a Requirements Analysis

of IT in conducting complex research with elsewhere within the project [34]. (1) End users of the linked datasets; spe- projects linking aggregated primary We developed a schema of the proc- cifically those looking to run the use care data to a disease registry or a ge- esses associated with a linked data re- case defined linked-data studies. netic data repository. search project as a reference model (2) Direct and indirect providers of these (Figure 1) [35] based on our experi- data. Direct suppliers include da- ence of extracting, aggregating and tabase owners or other direct data processing routinely collected data [36, providers to a study. We spoke in Methods 37]. Additionally we recognised that depth to ten. Indirect data providers linked research required the same in- include those recording or aggregat- 1 Overview dividuals to be represented in both ing data earlier in the process. linked databases; as cases present in (3) The TRANSFoRm study team and We adopted an agile approach to al- only one could not be used their funders, and low for any alterations in the require- for linked research. We called this link (4) External experts, principally from ments as other parts of the project de- a "geographical " (Figure the International Medical Infor- veloped [28]. We simultaneously 2) and included it within our business matics Association (IMIA) and Eu- conducted a literature review and held requirements. ropean Federation for Medical expert consensus workshops [29, 30]. We created UML and data flow dia- Informatics (EFMI) primary care We developed a reference model and grams (DFD) for the reference model informatics working groups. models for data flow and of the busi- at a high level of abstraction, so we ness process involved. We conducted could contrast them with individual a stakeholder analysis that included study use cases [38, 39, 40]. interacting with potential data provid- 5 Testing ers and electronic health record (EHR) We analysed the TRANSFoRm use cases system vendors. 4 Stakeholder Analysis to define the data requirements and the

integrity of the use cases, constructing a We identified the following stakeholder DFD and UML models for each. The 2 TRANSFoRm Research groups and summarised our findings in use cases were in two clinical domains, a mind map and stakeholder analysis type-2 diabetes and acid-reflux related Programme grid (Figure 3, Table 2): oesophageal disease. The type-2 diabe- This investigation was part of the TRANSFoRm (Translational Research and Patient Safety In Europe) research programme [31]. TRANSFoRm is de- signed to reduce the barriers to con- ducting research using routine health data and promote interoperability be- tween different health computer sys- tems so that international data can be collected about the quality of care and for research [32]. One element of TRANSFoRm was a requirements analysis to assess the feasibility of con- ducting research studies set out in the form or use cases.

3 Creating a Reference Model for the Research Process and Studies We separately modelled the use case defined research studies, using the Unified Modelling Language (UML) [33]. We excluded consent and data privacy issues as they were being dealt Fig. 1 Schema of the process involved in conducting a linked data research study

IMIA Yearbook of Medical Informatics 2012 36 de Lusignan et al.

(Table 2). There were challenges in getting direct data providers to engage with the process. We made 316 con- tacts with data providers we thought might participate and only 56 (17.7%) supplied the comprehensive informa- tion defined by the requirements analysis. The proportion of valid re- sponses from primary care data pro- viders was 26.4% (29/110); from can- cer registries 16.9% (15/89); and from genetic data bases 10.3% (12/117). Many of the data repositories were re- gional not national and already sus- tained by a viable programme of re- search; most were producing high grade research output. Their data Fig. 2 BPMN schema of the key business decisions which inform whether a data repository is likely to participate in a TRANSFoRm research study processing systems had grown or- ganically as EHR systems had be- come more sophisticated. They were tes cohort study explored the risk of com- The stakeholder analysis informed us generally proprietary, not using plications and response to oral medica- these were important and they were ne- standard metadata, and functioning tion, a cohort study linking primary care glected in our initial programme design. as "black boxes" between data entry and genetic data. The second domain, and export for research. However, all gastro-oesophageal reflux disease could output data in a range of stand- (GORD), included two use cases link- 8 Sensitivity Analysis ard formats. ing primary care and cancer registry We identified and contacted 17 data. One was a randomised control- We collected data about peer review pub- EHR vendors identified through our led trial of on-demand compared with lications produced by data repositories initial searches and a further nine continuous use of proton pump inhibi- being considered for inclusion in the flagged by stakeholders. EHR ven- tors (PPIs) a class of anti-indigestion TRANSFoRm research studies. We did dors were reluctant to engage unless medicine. The other was a nested case- this because that track record may be there were some chance of benefits control study to explore the association predictive of future success. Finally, we realisation including a priori publica- of GORD symptoms and the use of PPIs conducted a review of what elements of tion of criteria for inclusion in future with developing Barrett’s disease and our requirements analysis contributed to TRANSFoRm studies. One primary cancer of the oesophagus. our final specifications. care EHR system reported it has an open application programme interface (API). The lack of open APIs makes 6 Defining the Scope of the 9 Ethical Considerations this approach to interaction with EHRs more challenging as it might require This investigation did not involve any Information Needed from separate licenced APIs to be developed direct contacts with patients or access Candidate Databases with each vendor. to medical records. No specific ethical TRANSFoRm investigators had We defined the scope of the informa- consent was deemed necessary. tion we would need to collect from can- different perspectives reflecting their didate data providers; though asking varying backgrounds; they were stakeholders to define what they con- largely clinical or information sys- sidered to be essential requirements. tems researchers. These differences Results were nuanced, but the former gener- ally described the project as a com- 1 Stakeholder Analysis plex clinical process, while the lat- 7 Business Process Modelling We identified key stakeholders and ter looked to rationalise things into Late on in our process we introduced used a mind map to capture key con- machine processable activities. The Business Process Modelling Notation cepts (Figure 3) and summarised their TRANSFoRm senior investigators (BPMN) to define business requirements. views in a stakeholder analysis grid were trying to co-ordinate the "big

IMIA Yearbook of Medical Informatics 2012 37 Business Process Modelling is an Essential Part of a Requirements Analysis

Fig. 3 Mind map of stakeholders and issues

Table 1 Summary stakeholder analysis

Project Stakeholder Specific Information Needs Best Source of Information Planned Method of Delivery Timing Considerations Needed

1 End users / researchers Will data deliver study? 1. Own study protocol Require a third party to link data Want to avoid any delays in

1. Unique linked patient records; 2. Relevant use case research process 2. Case definition (Coding); 3. Track record of provider 3. Outcome variables; 4. Inclusion & exclusion criteria 5. Study specific - controls, randomisation, patient link 2 Direct Data providers 1. Return on investment of time - Who will get a funded study? Engage once benefits Have standard processable (Data repositories and studies, funding Track record of researcher outputs readily available networks) 2. Strategic interest Network / repository owner Indirect Data providers 1. About use of their data Largely via network / repository Challenging to change (Citizens, Patients, GPs) 2. Maintenance of confidentiality/privacy arrangement 3 Study team & funders 1. Progress towards achieving milestones 1. TRANSFoRm study protocol 1. Connecting data via TRANSFoRm Critical nature of dependencies in project 2. Work package outputs engine from previous work packages 2. Requirements of next steps in project 2. Provenance engine 3. Meeting own institutions objectives 4 External experts Academic interest in how and whether Simulations & studies - proof of Informal input / advice re: projects Variable this can be done concept

picture" and focused on project mile- in scope of provenance extended be- and socio-cultural factors all influence stones and reports to funders. There yond what is defined within the use the process and should be included were also inevitable changes in cases as it included influences prior in the requirements analysis [23, 24]. project scope. Important changes for to recording. Their view was that contextual prov- the requirements analysis were the in- The Informatics working group enance whilst important could only clusion of cancer registries and adop- members also broadened the scope apply to data that were recorded and tion of contextual provenance with of the requirements. They argued that a broader contextual overview the requirement to describe "How that human factors and the wider might better explain why data were that data came to be." This change context of the health system, legal present or not.

IMIA Yearbook of Medical Informatics 2012 38 de Lusignan et al.

2 Use Case Analysis We compared the use cases developed for the TRANFoRm project with the reference model schema we constructed for a generic research study to identify specific data requirements. The diabetes use case varied little from the reference model schema other than we needed to add a prescribing database. The UML model reflected that this was a cohort study where a subset of the population is identified (Figure 4(a)). The GORD use cases were more complex, also reflecting the study type (Figures 4(b) and 4(c)). 4(a) In this use case genetic and primary care data about type-2 dia- betes (T2D) are linked; <> des- ignates that the information is required at least once. 4(b) Case-control study to exploring the associate of GORD, use of PPIs, and oesophageal adeno- carcinoma. 4(c) GORD RCT compar- ing on-demand and regular PPI The diabetes study has an almost iden- tical DFD to that in the reference model schema (Figure 5(a)). The GORD case- control study DFD (Figure 5(b)) only differed from the diabetes study DFD as a result of the addition of randomisation. The data flows in the RCT were much more complex and reflected a different approach to collecting data (Figure 5(c)). In this use case, the GP or the researcher mined their EHR data to identify and Fig. 4 UML use case model giving an overview research process for: (a) Diabetes (cohort study), (b) GORD (case control) and (c) GORD (randomised consent patients to participate at the be- controlled trial) use cases ginning of the study, whereas in the other studies there is no GP-patient interaction. (2) Meso-level requirements included 4 Scope of the Business reporting methods of data ex- 3. Scope of the Information traction [43, 44], details of the Requirements Required to Link Candidate EHR systems used and their ar- We identified and integrated into our chitecture [45], audit trails that requirements analysis a number of busi- Databases: might provide information about ness requirements that went beyond the We identified three levels of granular- data provenance, and the size of data requirements for conducting a ity of information required to assess if the database; study (Figure 6). Most of what we a data source could be used to partici- (3) Macro-level issues related to the framed as business requirements fit pate in a research project (Table 2): nature of the health system and within the scope of a research network. (1) Micro-level requirements were a de- socio-cultural issues. The business process modelling was tailed description of the type data source, critical in developing an understanding the data itself, the potential for linkage Study specific requirements were de- of the lack of engagement, and how and achieving semantic interoperability fined by differences between the ref- concentration on the ignored between data sources [42]; erence model and use cases. the need for a business case.

IMIA Yearbook of Medical Informatics 2012 39 Business Process Modelling is an Essential Part of a Requirements Analysis

Discussion 1 Principal Findings The requirements for linking com- plex heterogeneous databases are ex- tensive, and failure to foresee the business requirements resulted in stake-holder disengagement. In ad- dition to the anticipated core data re- quirements we have identified geo- graphical and socio-cultural requirements. The use case, data driven model, helped define whether a database was suitable to conduct a particular research study. However, we also required information about the geographical overlap between data repositories and readiness to par- ticipate. We used a reference model to identify generic as well as study specific requirements. Local lan- guage and the regional nature of some data repositories are additional challenges to conducting interna-

tional research. Many of the success- ful data collection systems were pro- prietary and saw no reason to move to more open methods and systems; they believed this entailed risk and expense but with no obvious benefit. Only after we included BMPN in our approach did we manage to ration- alise and frame these requirements.

Fig. 5 DFD for the TRANSFoRm use cases 2 Implications of the Findings The data requirements from the use case analysis identified most data needed to conduct research, but may 5 Sensitivity Analysis maining four, two estimated 11 to 20 miss important business issues which and two estimated 2 to 5 publications. may constrain involvement. Whilst We used publication of peer-reviewed generic reference models for re- studies as an index of a functional busi- search studies make sense of the ness process. Eight of the ten data 6 Contributions to the Requirements processes and data flows; the busi- providing stakeholders who provided ness requirements of the data reposi- full information could provide evi- Analysis tory owners and EHR vendors also dence of work produced from their Finally, we report how the different need to be modelled and met. Re- data and indexed in the bibliographic inputs contributed to the final require- searchers who design data projects database Medline. Four data providers ments analysis (Table 2). With the ex- that involve linking databases need estimated between 30 and 100 peer- ception of socio-cultural issues, all the to make sure that they include in- reviewed publications had been pub- requirements were identified by more centives for participation otherwise lished in the last five years. Of the re- than one source. they risk low levels of engagement.

IMIA Yearbook of Medical Informatics 2012 40 de Lusignan et al.

Fig. 6 Detailed BPMN diagram to demonstrate the steps in ascertaining if a data source meets the business requirements

Table 2 Scope of data collection defined by the requirements analysis

Micro- Meso- Macro- Study level level level specific

Dara source / Data Method & Record system Organisational Socio-cultural Use-Case Data type Interoperability control of data & information level factors compatibility level extraction model

Data extracted Diabetes study Demographics ID Use case/protocol and Primary Health Wider social Genetic data HL7 Health Level Primary care & Coded Data EPR architecture Care System influences Seven - www.hl7.org Free-text genetic data Data quality On data availability Fragmentation / consent & access of care Primary Care / CDISC Clinical Data Taxonomy of errors PCROM to data Cancer Registry Exchange Consortium associated with data Primary Care Separate providers data - www.cdisc.org extraction Research Model Coverage Socio-cultural Barrets Univesal/limited dimensio to what is oesophagus & disease & presented BRIDG Biomedical medicatoin ISO 11179 OpenEHR to primary care Research Integrated Management of All types of data Metadata Archetypes Domain Group - http//metadata- www.openehr.org Ambulatory care www.bridg.org standards.org/11179 sensitive conditions

One strategy to overcome this might 3 Comparison with the Literature is a working example of the use of be creating a research network infra- ontologically driven systems [49]. Such to register researchers and Linking heterogeneous data is challeng- ontologically driven systems might best data providers wishing to conduct ing [46]. Use cases and UML have used be developed using object-orientated ap- linked data studies that might pro- in research reporting adverse events in proaches as has been used in specialist vide a forum to facilitate and broker clinical trials [47] and medical image cancer management [50] and for check- solutions. analysis pilots [48]. The OntoRAT toolkit ing healthcare domain models [51].

IMIA Yearbook of Medical Informatics 2012 41 Business Process Modelling is an Essential Part of a Requirements Analysis

Although widely used in software to the life sciences to help generate engineering, the modelling tools we UML models [59]; and other tailored Conclusions propose to be used have been little packages have been used to generate We defined generic user requirements used in the health domain; despite UML diagrams for bioinformatics for research studies linking health calls that they should be made more research [60] and to generate genotype- data based on a reference model, accessible to health researchers [52]. phenotype maps [61]. which can be extended for specific DFD have been used little in health Our requirements analysis pro- studies; using UML use case dia- care though they have been proposed duced a non-executable set of mod- grams and DFD. Additionally we as a component of object orientated els and methods for sorting candi- have identified geographical require- health information management system date databases into those potentially ments and the importance of socio- [53]. UML has been used the most. It useable in linked data research. We cultural context. However, the key has been proposed as a tool for avoid- did not define these steps in suffi- learning from this exercise is the im- ing integration problems [54] and for cient detail to be able to set them out portance of modelling the business modelling research studies [55], but using business process executable process and including this within a re- thus far with little evidence of ben- language (BPEL) specifications [62], quirements analysis. Failure to include efit [56]. BPMN is now considered BPEL has been used within health- and recognise the importance of mod- an appropriate tool for modelling care [63], and might help reduce elling the business process as part of digital pathology and care pathways barriers to potential researchers and requirements analysis risks lack of en- but has not been proposed for mod- data providers. gagement by intended participants and elling health research [57, 58]. increases the risk of project failure.

Acknowledgements 4 Limitations of the Method 5 Call for Further Research IMIA and EFMI for supporting their primary care informatics working

We could have just used UML. The The user requirements developed need groups. Elena Crecan for her contribu- UML alternatives are either to de- to be tested prospectively. Where the tion to the research. TRANSFoRm is velop a domain model or use UML required activities can be published with part-financed by the European Com- state-machine or finite state machine clearly defined interfaces it will be mission - DG INFSO (FP7 2477). diagrams [26-8]. Business architec- possible to produce an executable model Antonis Ntasioudis for assistance with ture models (BAM) have been applied such as BPEL. the diagrams and modelling.

Data sharing agreement Table 3 Contribution of use cases and stakeholder analysis to final requirements The limited quantitative data collected as part of this study have been placed on a database at University of Dundee Micro Meso Macro Study Specific Sensitivity Data level analysis with the Work Package lead (FS); ini- / type tially for further analysis within the Patient Coding Metadata Record Health Socio- Diabetes Non- Track record TRANFoRm project. The generic mod- level system & & system & service cultural & GORD use peer review els developed as part of this study are data Interoper- Extraction information organisa- & legal studies case publications freely available for use from this pa- ability model tional per or from the clinical informatics Use cases x xx x xx website:http://www.clininf.eu/

Stakeholder refmodel/ - users are requested to cite

analysis: this paper.

End users xx xx x x xx xx xx Data xx xx xx x Providers References

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IMIA Yearbook of Medical Informatics 2012 43 Business Process Modelling is an Essential Part of a Requirements Analysis

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IMIA Yearbook of Medical Informatics 2012