Proceedings of the 54th Hawaii International Conference on System Sciences | 2021

Patient Pathways for Comprehensive Care Networks – A Development Method and Lessons from its Application in Oncology Care

Peggy Richter Hannes Schlieter TU Dresden, Germany TU Dresden, Germany [email protected] [email protected]

Abstract based medical guideline recommendations as well as to Patient pathways are recognized as a valuable tool support seamless, optimal care in a comprehensive to support standardization, comparability, quality, and network of different health service providers [7]. transparency of care processes in comprehensive care However, uniform and standardized practical support networks. Still, existing development approaches lack for the development of patient pathways is not given yet. real practical guidance as well as an integration of the There are different procedural frameworks for the network and patient perspectives. Therefore, a user- development and implementation of pathways (e.g. [8]– centered and requirements-based approach was chosen [13]), but they are rather generic and not described in to design a patient pathway development method. It such detail as to provide practical guidance and support defines a role model and procedural steps. The method’s for the users. Also, pathway development is mostly innovative character lies in the development of generic addressed for single institutions, not the patient pathway templates to be adapted to national, entire care network involved in the care process of regional, and local conditions of specific patients. Also, the clinical rather than the patient comprehensive care networks. The method was perspective is the focus so far (e.g. [1], [14]). positively assessed in terms of demonstrating its To centrally support network governance, e.g. by applicability and the fulfilment of user requirements national or international non-profit organizations, and to with a use case from oncology care – the development increase the quality of care across care networks, a of a colorectal patient pathway template. This template-based patient pathway development approach work drives the standardization of patient pathway is called for [9]. Patient pathway templates for particular development and their large-scale implementation in patient types can function as guiding blueprints for the comprehensive care networks, supporting the analysis, development of network-specific ones by adapting them design, and optimization of healthcare processes. to national, regional, and local specifics (e.g. availability of technologies or national guidelines on follow-up timeframes). This approach would allow for better comparability, consistency, and increased uniformity of 1. Introduction care provision across different comprehensive care networks [9]. Also, similar to the general advantages of Patient pathways are used to plan and manage the reference models [15], an increase of safety for patients whole process of care for a specific patient type, and health service providers, the reduction of risks and especially for patients with complex, long-term costs during pathway development (e.g. by shortening conditions, by defining goals and milestones while also the development time), and an increase of pathway supporting mutual decision-making by the patient and quality can be expected. Still, the potentials of reusable her/his multidisciplinary care team collaborating in a patient pathway templates are not exploited yet. comprehensive network of care providers [1]–[3]. Addressing these gaps and elaborating on the Against the background of an increasing demand for template-based patient pathway approach, this paper integrated care delivery in a coordinated network of aims to provide practical guidance with a method for the health service providers [4], [5], the concept of patient development of patient pathways in comprehensive care pathways becomes even more important. For example, networks. The focus is on the construction and design of in cancer care - with cancer being one of the most patient pathway templates and on highlighting the common and costly diseases in western countries [6] - network and patient view. Therefore, a user-centered patient pathways are regarded as important tools to and use-case-driven approach is chosen. improve patient information, to implement evidence-

URI: https://hdl.handle.net/10125/71071 978-0-9981331-4-0 Page 3753 (CC BY-NC-ND 4.0) The remainder of the paper is structured as follows. requirements were used to develop the Pa2D-method. In section 2, the used methods are described. The We demonstrate its applicability with the development requirements analysis for practical guidance of patient of a colorectal cancer patient pathway template for pathway development is conducted in section 3. Based comprehensive cancer care networks. The experiences on this and to practically guide the development of during the application were used to assess the method patient pathways, a procedural model and a role model and to derive lessons for improvement. The for a patient pathway development method, hereafter development team of the colorectal cancer template was abbreviated with Pa2D-method, are described in section asked to answer an online questionnaire. It addressed the 4. In section 5, the method is assessed in terms of degree of fulfilling the defined requirements with the demonstrating its applicability and demonstrating the Pa2D-method as well as for the personal (positive and fulfillment of user requirements with an example use negative) perception of the application of the method. case in oncology care. The paper closes with a discussion and a conclusion in sections 6 and 7. 3. Requirements analysis

2. Method The analysis of the user stories resulted in the identification of functional and non-functional For the design and testing of a patient pathway requirements which cover both general procedural development method for comprehensive care networks, issues as well as the representation of patient pathways. the design science paradigm was followed [16]. With Functional requirements describe the desired functions the aim to provide a user-centered and practical method, of the intended patient pathway development method. we used a qualitative data collection approach by We identified seven functional requirements R1 to R7. defining user requirements based on user stories. A user They are described in the following. An exemplary user story is a statement written from the end user’s story for each requirement is given in Table 1. perspective [17]. It represents a short, informal R1 - Patient pathways for comprehensive care description of a requirement in the format “As a networks should have uniform template character and I want so that .” We set up a provide adaptation notes for their implementation to workshop and asked 25 people to describe user stories particular care networks. The development method from their own or a chosen perspective, i.e. role. The should produce generic patient pathway templates, i.e. workshop included international participants who are standard pathway patterns, which are not specific for a part of an international project consortium in the domain particular care network but provide a framing of of cancer care. The group consisted of health care essential building blocks for each phase of care for a providers (e. g., oncologists, nurses), managers of health specific disease. The templates function as guidance for care organizations, methodologists (e. g., medical the development of network-specific patient pathways guideline developers), representatives of national and provide adaptation notes for implementation, e.g. authorities and international and national health required/optional parts or adaptation instructions organizations, patient representatives as well as considering national, regional, or local conditions. researchers. The participants were given the example R2 - Patient pathways should be disease-specific. user story “As a physician in a patient pathway They should be designed for a specific patient type, e.g. development board I want to use an agreed upon patients with a specific tumor entity, and thus describe pathway representation format so that all colleagues in in- and exclusion criteria for entering the pathway. [comprehensive cancer care networks] can exchange R3 - Patient pathways should be developed by a pathways across networks”. Altogether, 33 user stories1 multi-stakeholder working group. This means, they were collected. They were analyzed using a qualitative should be developed by a working group consisting of content analysis according to Mayring [18] with a people representing the roles and organizations involved coding scheme derived from a previous systematic in care provision along the whole pathway. This should literature review of existing pathway methods also include the patient perspective. conducted by the authors [9]. Therewith, we derived R4 - A patient pathway development method should requirements for the intended patient pathway define the group processes. This includes for example development method. We focused on construction- and the definition of group composition, roles, consensus design-related requirements which specify the finding, decision-, prioritization- and review processes. development phase for patient pathways. The roles R5 - Patient pathways should be developed based on specified in the user stories together with the derived scientific evidence, especially medical guideline

1 The full list of user stories can be provided by the authors.

Page 3754 recommendations. The link of the patient pathway Additionally, non-functional requirements were content to its evidence base should be maintained. identified. These specify criteria that can be used to Therefore, patient pathways should provide concepts to evaluate the method’s performance in terms of quality describe the evidence level of a recommendation (e.g. criteria. A method to develop patient pathways for pathway step/decision) and to link the evidence source. comprehensive care networks should be generic, easy- R6 - A patient pathway should sequence obligatory to-manage (workable), inclusive, and easy-to- and optional steps and the relevant information along understand (e.g. “As a […] network advisor I want an all phases of care in a comprehensive care network for inspiring, workable, generic method for designing and the involved care providers and the patient. Relevant implementing patient pathways […]”). A standardized, information are tasks, decisions, roles, process flows, clear and easy-to-analyze representation format of time restrictions, information objects, quality aspects. patient pathways should be used (e.g. “As a (healthcare) R7 - Patient pathways should provide a patient view researcher I want conceptually clear and ‘easy to to support shared decision-making and analyze’ […] representation so that it facilitates individualization. They should represent steps the efficient, transparent and reproducible research”). patient is directly involved in (e.g. consultation, consent) or has to perform him-/herself. They should 4. Patient pathway development method allow for individualization to patient-specific situations, e.g. patient preferences or comorbidities. According to Brinkkemper (1996), “[a] method is an approach to perform a systems development project, Table 1. Functional requirements based on a specific way of thinking, consisting of No. Example user story directions and rules, structured in a systematic way in R1 “As a manager I want the methodology to development activities with corresponding development provide guidelines on the pathway development products” [19]. Patient pathways are a processual view and identify the essential building blocks of a of a comprehensive care network which is a socio- pathway so that pathways can be developed and technical system [20]. To systematically guide and adopted to the local healthcare context of the support their development, the Pa2D-method is [comprehensive care network].” proposed. In the following, its role model and the R2 “As a medical doctor in training I want patient procedural model are described. pathways to be tumor-specific so that I can provide quality of care.” 4.1. Roles R3 “As a patient I want patient views and perspectives to be integrated in the [pathway To specify the tasks and expected qualifications of development] process in order to integrate people applying the Pa2D-method, the involved roles are shared (informed) decision-making in patient summarized in Table 2. pathway development.” To meet the requirement of template-based pathway R4 “As a methodologist in a [patient pathway development (see R1, sec. 3), the roles patient pathway development] board I want to have template designer and patient pathway designer are information/agreement on consensus finding distinguished. The former develops the template and process so that bias in [patient pathway prepares it for reuse whereas the latter adapts the patient development] is controlled.” pathway template to national, regional, or local specifics R5 “As a methodologist in a [patient pathway of a comprehensive care network. Both roles should be development] board I want to have a description modelling experts and experienced in the application of of the evidence base and the strength of process (pathway) modelling languages. The patient certainty in order to get transparent and pathway template designer additionally needs to be reproducible results.” familiar with reference modelling techniques, especially R6 “As national authority I want to have a mean to pathway templates. Depending on the organizational define obligatory tasks within the pathway.” context, both roles can be assigned to one person. R7 “As a patient I want a patient pathway that I can For the development of a patient pathway template, understand and that helps me make decisions the knowledge input from domain experts of the specific together with my doctor and my family so that I health care phenomenon, e.g. a health condition or can be in control of what is happening and to disease for which the patient pathway (template) shall check if everything is going according to my be developed, is necessary. The content of the patient expectations […].” pathway template, e.g. activities, process-, information-

Page 3755 Table 2. Role model of the Pa2D-method2 professionals). To also explicitly include the patient Task Qualification perspective (see R7, sec. 3), representatives of patient Patient pathway template designer organizations should be involved in the patient pathway Ensures adequate use of the Modelling expert: template development. modelling language; excerpts the computer Patient pathway templates are applied to specific knowledge of the domain scientist, comprehensive care networks. The adaptation of the experts and transfers it into the information template is supported by patient pathway users, who are PP template; prepares PP systems engineer familiar with the specific characteristics of the own templates for reuse comprehensive care network. Also, they implement the Patient pathway designer approved patient pathway. The patient pathway users Ensures the correct application Modelling expert: primarily are medical, , and supportive care of the PP template; adapts the PP computer professionals. Also, administrative staff and the patient template model to CCN scientist, him-/herself are relevant representatives. Thus, patient specifics; models the PP information pathway users are a subgroup of patient pathway elements systems engineer template stakeholders and people could be assigned both Patient pathway template stakeholder roles at the same time. Gives domain input for PP Domain expert: The quality and progress of the patient pathway template development; reviews representative of development process should be assured and monitored and approves PP template interest group by a method expert. This role also includes the responsibility for the training and guidance of the contents and representation 2 Patient pathway user project team members in terms of the Pa D-method. Uses the developed, approved Domain expert: PP and implements it in the representatives of 4.2. Procedural model accounted CCN unit; supports involved CCN with the adaptation of the PP units along the PP A typical project flow for the development and template, e.g. to CCN specifics; implementation of template-based patient pathways in participates in approving the PP comprehensive care networks consists of the main for the CCN phases as shown in Figure 1. The process consists of two Method expert major parts, which are first, the development of a Is particularly familiar with Method expert: generic patient pathway template for a specific disease template-based pathway design; business (see upper part of Figure 1) and second, the template- leads the execution of the economist, based development of patient pathways for a particular method and conducts necessary information comprehensive care network by adapting the template to trainings on the method; systems engineer national, regional, and local context (see lower part of recognizes and implements Figure 1). This distinction is in particular due to change requests to the method; requirement R1 (see sec. 3). involves in the continuous The project institution for template development optimization of the method comprises the establishment of the multidisciplinary patient pathway template development team (working or resource flows, involved roles, obligatory and group) [8], [10], [13], [21]. In detail, this team shall optional parts, should be provided by a team of consist of patient pathway template designer(s), patient representatives of different interest groups (see R3, sec. pathway template stakeholders including patient 3). These patient pathway template stakeholders should pathway users, and method expert(s) as described in the 2 involve representatives (e.g. national Pa D-method’s role model in section 4.1. Also, the team authorities, health policy developers, or advisors), shall be trained and educated about the development representatives of national or international health care process [8], [13] and the consensus finding process shall organizations or associations (e.g. representatives of be defined [9] (see R3 and R4, sec. 3). The project plan, accreditation organizations or medical guideline e.g. timetables, tasks, responsibilities, and resources, development), researchers, and representatives of should be set up [10], [13]. The definition of the involved units of comprehensive care networks (e.g. addressed patient population is necessary. network managers, quality managers, healthcare

2 “Patient pathway” is abbreviated with PP and “comprehensive care network” with CCN in Tables and Figures of this article.

Page 3756 scope definition (1) includes the specification of the

Project institution Systematic Patient Pathway phases along the continuum of care which are to be for template collection and template Dissemination development review of evidence construction covered by the patient pathway template. Such phases are typically the network entry, prevention, diagnosis, Development of generic generic of Development patient pathway template pathway patient treatment planning, treatment, follow-up, rehabilitation, Patient Pathway template supportive care, end-of-life care, and end of network repository care. The patient population as well as in- and exclusion criteria for patients entering the patient pathway need to

patient pathway patient Project institution Adaptation of the Implementation for pathway template to CCN and evaluation of be defined. Also, the modeling language and tool need based development of based development - development context pathway in CCN specific - to be selected [12]. The systematic literature review of CCN Template standard languages and notations for the graphical Figure 1. Main phases of the Pa2D-method for modeling of patient care processes conducted by the development of generic templates and Mincarone et al. [22] showed, that the Business Process their adaptation in CCNs Model and Notation (BPMN) as well as the Unified Modeling Language (UML), especially its activity and The systematic collection and review of evidence use case diagrams, are well known and used approaches should use literature reviews to analyze and assess the in health care practice. Domain-specific modeling current state of existing evidence for the whole language extensions such as BPMN4CP, a BPMN continuum of care covered by the patient pathway [8], extension for care pathway modeling [23], could be used [10], [11], [21] (see R2 and R3, sec. 3). This step should as well. Using this modeling language, the evidence also include a review of existing patient pathways for level and evidence source can easily be represented and the addressed patient type in the scientific and grey maintained within the pathway (template) model (see literature, e.g. published by healthcare organizations. In R5, sec. 3) by the patient pathway (template) designer. this context, similar concepts such as care pathway, 3 clinical pathway, or patient journey should be included Detailing each in the search as well since they are often used process candidate input sheet synonymously [2], [9]. The collection of evidence 1 should be carried out by the patient pathway template Scope definition [process candidates] [detailed process candidates] stakeholders and methodologically supported by the method expert. The collected literature and existing 2 4 Identification process landscape template modeling Designing the pathways are input for the following template of process patient pathway construction phase. candidates template model The patient pathway template construction is the 2 [patient pathway template internal and [patient pathway template] core phase of the Pa D-method and for this reason under revision] external review highlighted in yellow in Figure 1. In Table 3, the Evaluation of the essential information of this phase is represented. patient pathway template [template without 5 need for revision] Table 3. External view on the phase “patient pathway template construction” 6 Final approval Attribute Description Objective Development of a reference PP template Figure 2. Inner view of the phase “patient in CCNs for specific patient population pathway template construction” Input Current evidence (medical guidelines, systematic reviews), existing pathways, The next step is the identification of process defined target patient population candidates (2), i.e. the identification of important Output Approved and agreed upon PP template patient pathway steps (process candidates) and linking Roles PP template designer(s), PP template them to the phases of care as defined in step (1). The involved stakeholders, PP users, method experts result is called the process landscape. Therefore, the Customers CCNs applying the template contents of existing pathways for the addressed patient population – identified with the previously conducted To practically guide the patient pathway template literature review – should be analyzed and mapped to construction, a more detailed procedural description is structure the patient pathway landscape. If there are provided. It consists of six steps, with the steps 2 to 5 none available, this step can be solely performed in being performed in an iterative manner (see Fig. 2). The

Page 3757 workshops with the domain experts and by including the (5) are performed in development cycles, detailing the recommendations from medical guidelines. template in each iteration. When the patient pathway After the process landscape of the patient pathway template is evaluated with no need for further revisions, template is defined, the detailing of each process it gets final approval (6) from the working group. candidate (3) follows. Therefore, a standardized input After final approval, the patient pathway template sheet is provided with the Pa2D-method. It roots in the for the specific disease should be disseminated and information collected for care pathway building as published, i.e. made available to the comprehensive care described with the 3-blackboard method by Vanhaecht networks of interest. Therefore, a messaging and et al. [24] but additionally includes perspectives to be dissemination strategy needs to be developed and covered in order to meet the patient pathway specific implemented [10], [11], [21]. With this regard, a requirements from section 3. The sheets should be filled common patient pathway template repository, provided in by the involved domain experts from the working and managed by a governing agency of the addressed group and with the results of analyzing the comprehensive care networks or an international health recommendations of medical guidelines and the articles care society, would be beneficial [9]. identified with the conducted review on current An approved patient pathway template can then be evidence. To reduce the risk of distortion of included implemented in comprehensive care networks. When a studies, the level of evidence must be paid attention to network decides to develop a patient pathway based on [25]. The input sheet is filled for each process candidate such template, it first needs to establish a project and requires the following information: (a) process institution for pathway development. This multi- name, (b) patient inclusion criteria (e.g. a subgroup of disciplinary project team should involve the patient the generally addressed patient population), (c) pathway users of the network, patient pathway responsible/ involved units of the comprehensive care designer(s), and development method expert(s) as network, (d) resources (e.g. medical technology, described in the Pa2D-method’s role model in section infrastructure), (e) process inputs (e.g. information, lab 4.1. The task of the working group is the adaptation of results), (f) detailed process description (i.e. the template to the context of the comprehensive care interventions, decisions, consultations, tasks related to network, i.e. to national, regional, and local specificities medical, nursing, and supportive care (i.e. which are not part of the evidence base used for pathway psychological, physical, emotional, practical/ template development (medical guidelines). Therefore, organizational, informational, spiritual, social support the adaptation notes specified with the template should [26]), as well as to administration and activities the be used. Reasons for adaptation could for example be patient is responsible for), (g) times (i.e. time national disease management programs or follow-up criticalities, time recommendations, iterations), (h) plans defining timeframes of a follow-up routine. The process outputs, (i) measures/ evaluation criteria (e.g. pathway also needs to be adapted in case of unavailable quality indicators to be assessed), (j) adaptation notes technologies or care professionals (e.g. the role of nurse (i.e. required and optional steps; national, regional, local specialists might differ between countries). After its conditions to be considered for the implementation in a development, the patient pathway needs to be piloted, specific comprehensive care network). implemented and continuously evaluated in the Using the information from the filled input sheets, comprehensive care network (see [9] for a detailed list the next step is designing the patient pathway template of steps necessary for this purpose, e.g. checking for model (4) by the patient pathway template designer. new evidence). Therefore, the process landscape view is detailed by specifying the process candidates, their order and 5. Demonstration and assessment relations. This step can be supported by also including methods for the derivation of pathways from medical 2 guideline recommendations (e.g. [27]). The template For the evaluation of the Pa D-method, focusing on designer might identify information gaps, which need to the template construction phase, we first, demonstrate its applicability using the example use case of integrated be closed by getting feedback from the involved domain 2 experts. This can happen either on short notice or during cancer care in section 5.1 and second, assess the Pa D- the following evaluation of the patient pathway template method in section 5.2. (5). With this step, feedback from the working group is collected and need for improvements of the template is 5.1. Demonstration - the oncology use case identified. Furthermore, the template should also be reviewed by external domain experts, who were not The Pa2D-method was tested by applying it in the involved in its development. As long as there is need for context the large-scale European Joint Action iPAAC revision of the patient pathway template, the steps (2) to (Innovative Partnership for Action Against Cancer)

Page 3758 Modell: CRC Patient Pathway Template/Landkarte/CRC_Prozesslandkarte Stand: Mittwoch, 15. Juli 2020 Bearbeiter:

aiming to develop innovative approaches to advances in CCCN Entry Diagnosis Treatment planning cancer control. One focus is to improve the governance histological pre-therapeutic staging diagnostics of integrated cancer care, e.g. by the development and confirmation MDT meeting implementation of patient pathways in comprehensive preparation of MDT patient consultation patient consultation cancer care networks (CCCNs). “A CCCN consists of meeting after diagnosis multiple units belonging to different institutions referral to other information processing dedicated to research, prevention, diagnosis, treatment, discipline and discussion (patient) follow-up, supportive and and shared rehabilitation for the benefit of cancer patients and decision-making cancer survivors” [7]. The Pa2D-method was applied to develop a Treatment Follow-up Rehabilitation colorectal cancer patient pathway template for CCCNs neoadjuvant follow-up planning rehabilitation in Europe. The working group for the development of radio(chemo)therapy the template comprised all three roles as specified in follow-up care, Figuresurgery 3. Process landscape defined for CCCN surveillance section 4.2. The patient pathway template stakeholders care for colorectal cancer patients (excerpt) built an interdisciplinary and international group of Supportive care adjuvant organise patient life chemotherapy during follow-up experts in the colorectal cancer domain. The group For each process, the input sheets were filled in by the comprised people from national and international health supportive care domainother experts therapy of the working group and based on the authorities and societies, national care providers current evidence as identified with the evidence review (medical and nursing care) from different CCCN units, processpalliation. This information was then used to detail the as well as representatives from a European colorectal single processes if Endnecessary of CCCN care and to developEnd-of-life carea process post-operative/ mid-/ cancer patient organization. Therewith, the stakeholders end of follow-up post-therapeutic MDT model of the patient pathwayconsultation template using a BPMN.io also included a subgroup of future patient pathway modelingmeeting environment adapted to patientend-of-life pathway care users. The roles of the patient pathway template organisation of patient specificlife during requirements treatment [23], [28] as presented in Figure designers and the method experts were taken by the 4. Quality indicators were included as blue circles and authors and colleagues, i.e. information systems experts. adaptation notes as comments to the corresponding In a systematic review process, existing colorectal pathway concepts. The working groupSeite regarded 1 von 1 cancer pathways and the evidence base (esp. medical comments as sufficient, practical solution for the 3 guidelines such as ESMO clinical practice guidelines) purpose of adaptation notes. A draft of the template was for colorectal cancer care were identified. Additionally, continuously reviewed by the members of the working pathways used in the countries and cancer centers of the group as well as by external domain experts not working group members were collected. involved in the development process with background For the main phase of the patient pathway template in medical guideline development for the addressed construction (as described in Figure 2), the scope of the tumor entity until no further revisions were necessary. pathway template was defined. It should cover all Then, the template was finally approved. It will be phases of CCCN care for patients with a suspicion of implemented in two pilot CCCNs in Germany and colorectal cancer and for patients with a histologically Poland. The implementation and adaptation process will confirmed diagnosis. Screening recommendations and be evaluated and changes to the method might be activities of primary prevention should not be necessary. After this, the template will function as integrated. The scope definition also included the recommended patient pathway for colorectal cancer decision to use BPMN and its domain-specific patients in European CCCNs. extensions [23] for pathway template modeling. With this, also quality indicators can be added along the 5.2. Assessment of the Pa2D-method patient pathway. The working progress was organized remotely for most of the time, having physical meetings After the demonstration of the Pa2D-method’s in-between with the whole or part of the working group. feasibility by using the colorectal cancer use case in In the next step, the important steps of the patient section 5.1, we assess its procedure and its results (the pathway template - the process candidates - were patient pathway template) regarding the fulfillment of identified and the process landscape was defined (see the initially defined requirements R1 to R7 (see section Figure 3). It maps the important processes to the 3). Reflecting on the experiences from the application of different phases of colorectal cancer care in a CCCN but the method, we argue the completeness of fulfilling each does not describe relationships between them. requirement in Table 4. Additionally, the assessment

3 ESMO: European Society for Medical Oncology

Page 3759 Figure 4. Detail of the colorectal cancer patient pathway template for CCCNs results of the six completed questionnaires received “openness to engage with patient organizations” as well from the working group are included in Table 4. as the “international, inter-disciplinary and multi-level In terms of meeting the initially defined consultations”, “compris[ing] multi-sectoral and multi- requirements, most of them are strongly positive. The national experience” were highly appreciated. It was results regarding R4 and R5 indicate potentials for highlighted that the Pa2D-method template development stronger implementation in the Pa2D-method. The group procedure is a “positive interactive process which processes could be guided in more detail (relating to should assist in creating a clear template for different R4). For example, the consensus procedures could be countries to adapt according to their specific needs but pre-defined in the method or examples for how to handle which is at the same time based on evidence”. The different opinions in the working group could be given. process was rated “rigorous and well thought-through”. In the demonstration case, this was not necessary and The template-based approach was in general well the Pa2D-method in its current version assigns the accepted and is expected to have a positive impact responsibility for defining the consensus procedure to especially on creating a uniformly high level of quality the users. The results regarding R5 show that the care, on reducing the risks and difficulties of patient inclusion of the evidence base could be improved. The pathway development for comprehensive care Pa2D-method uses the existing evidence base as a major networks, on improving the quality of patient pathways input and complements it with expert knowledge and implemented in comprehensive care networks, as well experiences. In the demonstration case, there were no as on improving benchmarking of comprehensive care contradictions identified. However, it is important to networks for the same patient populations. Potentials for keep in mind, that the patient pathway template contents improvement of the method were stated in terms of should be developed based on best available evidence. increasing the number of meetings (physical or online) This is not possible for all steps and phases in the to discuss intermediate results. The transparent pathway, since scientific studies and medical guidelines communication of the planned development procedure are rather available for the medical perspective. The in the beginning of the project is said to be of high specification of the nursing, supportive care or patient importance. “[P]iloting [the template] will show perspective is largely based on good practice bottlenecks” of the method. Then, other possible experiences from the domain experts. improvements might become apparent. In summary, the procedure of the Pa2D-method for the development of patient pathway templates was well 6. Discussion accepted and rated positively. We asked the members of the working group for their opinion on both what they We used a user-centered and requirements-driven liked about the procedure for patient pathway template approach to design the Pa2D-method to practically construction and how it could be further improved. The support the development and implementation of patient

Page 3760 Table 4. Requirements-based evaluation of the pathways in comprehensive care networks. The method Pa2D-method (1: strongly agree to 5: strongly provides the description of roles to be involved and disagree) describes a template-based patient pathway Working group development procedure. The method was assessed by No. Fulfillment assessment demonstrating its applicability with the use case of R1 Separation of template R1 oncology care. A patient pathway template for development and its im- 5 colorectal cancer was developed by in international, plementation (template- interdisciplinary multi-stakeholder working group, who positively assessed the method based on their based development of a 1 PP for specific CCN); 0 0 0 0 experiences with the development process. Critically reflecting on the limitations of our template construction 1 2 3 4 5 NA specified as main phase approach, the requirements used for the method R2 A PP template is R2 development might not be complete. Further 2 developed for a specific 4 requirements might lead to changes in the Pa D-method design. However, the requirements are supported by the disease, specified by in- 2 and exclusion criteria in findings of a former literature review on the topic of the scope definition of 0 0 0 0 methodological support for patient pathway development in [9]. Also, the Pa2D-method fits into the the template construc- 1 2 3 4 5 NA tion phase existing literature on methodological support for the R3 Interdisciplinary multi- R3 development and implementation of pathways in stakeholder group is 6 healthcare. It includes, combines and especially details defined in the role the necessary steps described in other literature (e.g. model; covers different referring to [8], [10]–[13]). Reflecting on the application 2 professions and know- 0 0 0 0 0 and evaluation of the Pa D-method, it needs to be applied for more cases than the one we demonstrated in ledge domains of all PP 1 2 3 4 5 NA stages and CCN units R4 section 5. It is currently also applied for the development of a pancreatic cancer patient pathway R4 The group composition 2 2 and consensus finding template but should also be used and tested outside of process are defined in 1 1 the oncology care domain in the future. Also, the implementation and adaptation of the template in the project institution 0 0 phase for the PP specific comprehensive care networks will be necessary template development 1 2 3 4 5 NA to demonstrate and evaluate the method in a more R5 Systematic collection of comprehensive manner. This will be conducted with evidence as separate R5 both the colorectal and pancreatic patient pathway phase; PP template con- 4 template in pilot CCCNs in Germany and Poland. A struction uses current long-term evaluation of implemented patient pathways is desirable as well. Currently, the evaluation of evidence base; recom- 1 1 mended modeling lan- 0 0 0 pathways and their impact is rather on outcomes such as time, resources and costs [29]. With the patient pathway guages provide concepts 1 2 3 4 5 NA for representation of approach, rather patient- and network-centered evidence in PP models evaluation approaches are needed - including outcome R6 measures concerning patient and disease progression R6 Obligatory and optional 5 concepts are defined (e.g. disease management, quality of life, patient with annotations in the empowerment), coordination, or communication, which 1 characterize integrated care [30]. PP template model; 0 0 0 0 adaptation notes are described 1 2 3 4 5 NA 7. Conclusion R7 Patient representatives R7 2 are explicitly included 3 3 With the Pa D-method, we provide practical as PP template guidance for the development and implementation of stakeholders; a patient patient pathways in comprehensive care networks. view with specific tasks 0 0 0 0 Designing the method, a user-driven and requirements- based procedure was followed. The template-based is included in the PP 1 2 3 4 5 NA template (BPMN lane) approach for patient pathway development aims to pathways in comprehensive care networks. The method support uniformly high quality for comprehensive care

Page 3761 networks and to simplify and standardize the [10] M. Gordon, “Steps to pathway development,” J Burn development process. The Pa2D-method was already Care Rehabil 16(2) Pt 2, pp. 197–202, 1995. tested in the field of oncology care by developing a [11] E. J. Flores et al., “Using a 10-step framework to support patient pathway template for colorectal cancer care in the implementation of an evidence-based clinical pathways programme,” BMJ Qual Saf, p. bmjqs-2018-008454, 2018. CCCNs. A template for pancreatic cancer is under [12] S. Ferranteet al., “A design methodology for medical development. After implementing the templates in two processes,” Appl Clin Inform 7(1), pp. 191–210, 2016. European pilot CCCNs and thus, further testing and [13] K. Vanhaecht et al., “The 7-phase method to design, potentially improving the method itself, the Pa2D- implement and evaluate care pathways,” Int J Pers Centered method will become part of the certification program in Med 2(3), pp. 341–351, 2012. European cancer care. This underlines its high [14] L. Kinsman et al., “What is a clinical pathway? innovation and dissemination potentials. The work Development of a definition to inform the debate,” BMC Med. pushes standardized patient pathway development and 8, pp. 31–33, 2010. the large-scale implementation in comprehensive care [15] P. Fettke and P. Loos, Reference Modeling for Business Systems Analysis. Hershey, PA: IGI Publishing, 2006. networks – thus, supporting the implementation of 2 [16] A. R. Hevner et al., “Design science in information integrated care. The Pa D-method can increase the systems research,” Manag Inf Syst Q 28(1), pp. 75–106, 2004. usage of patient pathways in care practice and serve as [17] S. W. Ambler, “Introduction to User Stories. Initial User basis for their evaluation. Stories (Formal),” Agile Modeling. http://www.agilemodeling.com/artifacts/userStory.htm#Initia Acknowledgment lFormal (accessed Feb. 08, 2019). The work for this article was funded by the European [18] P. Mayring, “Qualitative Content Analysis,” Forum Qual Soc Res 2(1), pp. 1–10, 2000. Union’s Health Programme (2014-2020). We thank the [19] S. Brinkkemper, “Method engineering: engineering of members of IPAAC WP10 for their fruitful feedback. information systems development methods and tools,” Inf Softw Technol 38(4), pp. 275–280, 1996. [20] E. Mumford, “The story of socio-technical design: reflections on its successes, failures and potential,” Inf Syst J., 16(4), pp. 317–342, 2006. References [21] C. Wicke et al., “Design and use of patient pathways in general surgery,” Chirurg 75(9), pp. 907–915, 2004. [1] European Pathway Association, “Care Pathways,” [22] P. Mincarone et al., “Standardized languages and European Pathway Association. http://e-p-a.org/care- notations for graphical modelling of patient care processes: a pathways/ (accessed June 15, 2020). systematic review.,” Int J Qual Health Care J Int Soc Qual [2] P. Richter and H. Schlieter, “Understanding Patient Health Care 30(3), pp. 169–177, 2018. Pathways in the Context of Integrated Health Care Services - [23] R. Braun et al., “BPMN4CP Revised - Extending BPMN Implications from a Scoping Review,” in Proc 14th Int Conf for Multiperspective Modeling of Clinical Pathways,” in Proc on Wirtschaftsinformatik, 2019, pp. 997–1011. 49th Hawaii International Conference on System Sciences [3] L. De Bleser et al. “Defining pathways.,” J Nurs Manag (HICSS), 2016, pp. 3249-3258. 14(7), pp. 553–563, 2006. [24] K. Vanhaecht et al., “The 3-blackboard method as [4] P. P. Valentijn et al., “Understanding integrated care: a consensus-development exercise for building care pathways,” comprehensive conceptual framework based on the integrative Int J Care Pathw 15(2), pp. 49–52, 2011. functions of ,” Int J Integr Care 13, p. e010, 2013. [25] OCEBM Levels of Evidence Working Group, “The [5] S. V. Lerum and J. C. Frich, “Normative assumptions in Oxford 2011 Levels of Evidence,” CEBM - Oxford Centre for integrated care: A conceptual discussion,” Int J Healthc Evidence-Based Medicine, 2011. https://www.cebm.net/ Manag 5(1), pp. 32–39, 2012. index.aspx?o=5653 (accessed Jul 07, 2020). [6] R. Busse, M. et al., Tackling chronic disease in Europe. [26] M. I. Fitch, “Supportive care framework,” Can Oncol Strategies, interventions and challenges. Kopenhagen, 2010. Nurs J Rev Can Nurs Oncol 18(1), pp. 6–24, 2008. [7] T. Albreht, R. Kiasuwa, and M. Van der Bulcke, Eds., [27] H. Schlieter et al., “Governance in - The Case EUROPEAN guide on quality improvement in comprehensive of Business Process Alignment,” in Proc Americas cancer control. Ljubljana: National Institute of Public Health; Conference on Information Systems (AMCIS) 2012. Brussels: Scientific Institute of Public Health, 2017. [28] P. Richter and H. Schlieter, “Process-Based Quality [8] S. McLachlan et al., “Clinical Caremap Development: Management in Care: Adding a Quality Perspective to How can caremaps standardise care when they are not Pathway Modelling,” in On the Move to Meaningful Internet standardised?,” in Proceedings of the 12th International Joint Systems: OTM 2019 Conferences, Cham, 2019, pp. 385–403, Conference on Biomedical Engineering Systems and [29] E. Aspland et al., “Clinical pathway modelling: a Technologies (BIOSTEC 2019), pp. 123-134. literature review,” Health Syst, pp. 1–23, 2019. [9] P. Richter and H. Schlieter, “Paving the Way for Patient [30] M. Minkman, “The Development Model for Integrated Pathways: Synthesizing a User-Centered Method Design with Care: a validated tool for evaluation and development,” J Results from a Systematic Literature Review,” in Proc 15th Int Integr Care 24(1), pp. 38–52, 2016. Conf on Wirtschaftsinformatik, 2020.

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