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OBJECTIVE Efficacy and safety of the glucagon-like peptide 1 (GLP-1) analog oral semaglutide and the sodium–glucose cotransporter 2 inhibitor empagliflozin were compared in patients with type 2 diabetes uncontrolled on metformin. RESEARCH DESIGN AND METHODS Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial. Key end points were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two estimands addressed efficacy-related questions: treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized patients. RESULTS Four hundred (97.1%) patients in the oral semaglutide group and 387 (94.4%) in the empagliflozin group completed the trial. Oral semaglutide provided superior reductions in HbA1c versus empagliflozin at week 26 (treatment policy –1.3% vs. –0.9% [–14 vs. –9 mmol/mol], estimated treatment difference [ETD] –0.4% [95% CI –0.6, –0.3] [–5 mmol/mol (–6, –3)]; P < 0.0001). The treatment difference in HbA1c significantly favored oral semaglutide at week 26 for the trial product estimand (–1.4% vs. –0.9% [–15 vs. –9 mmol/mol], ETD –0.5% [95% CI –0.7, –0.4] [–6 mmol/mol (–7, –5)]; P < 0.0001) and at week 52 for both estimands (P < 0.0001). Superior weight loss was not confirmed at week 26 (treatment policy), but oral semaglutide was significantly better than empagliflozin at week 52 (trial product −4.7 vs. −3.8 kg; P = 0.0114). Gastrointestinal adverse events were more common with oral semaglutide. CONCLUSIONS Oral semaglutide was superior to empagliflozin in reducing HbA1c but not body weight at 26 weeks in patients with type 2 diabetes uncontrolled on metformin. At week 52, HbA1c and body weight (trial product estimand) were significantly reduced versus empagliflozin. Oral semaglutide was well tolerated within the established safety profile of GLP-1 receptor agonists.

Recent analysis of clinical Computer-Interpretable Guideline (CIG) modelling languages from the perspective of the control-flow patterns has revealed limited capabilities of these languages to provide flexibility for encoding and executing clinical guidelines. The concept of flexibility is of major importance in the medical-care domain since no guarantee can be given on predicting the state of patients at the point of care. In this paper, we illustrate how the flexibility of CIG modelling languages can be improved by describing clinical guidelines using a declarative approach. We propose a CIGDec language for modelling and enacting clinical guidelines.

During the design of any information system, it is important to balance between flexibility and support. This is of particular importance when designing process-aware information systems. On the one hand, userswant to have support from the system to conduct their daily activities in a more efficient and effective manner. On the other hand, the same users want to have flexibility, that is, the freedom to do whatever they want and without being "bothered" by the system. Sometimes it is impossible to provide both flexibility and support because of conflicting requirements. The continuous struggle between flexibility and support is illustrated by Fig. 6.1. The right-hand-side of Fig. 6.1 shows the part of the spectrum covered by classical workflow management systems. These systems focus on processes that are repeatedly executed in some predefined manner and are driven by procedural languages. Note that in procedural workflow models there may be alternative paths controlled by (X)OR-splits/joins. However, the basic idea is that the completion of one task triggers other tasks. The YAWL nets described in earlier chapters provide such a procedural language. Although the YAWL language is highly expressive, its token-based semantics is most suitable for repetitive processes with tight control. The left-hand-side of Fig. 6.1 shows the other end of the spectrum. Here processes are less repetitive and the emphasis is on flexibility and user empowerment. Here it is difficult to envision all possible paths and the process is driven by user decisions rather than system decisions. Groupware systems (e.g., "enhanced" electronic mail, group conferencing systems, etc.) support such processes and focus on supporting human collaboration and co-decision. Groupware systems do not offer supportwhen it comes to ordering and coordination of tasks. Instead, the high degree of flexibility of these systems allows users to control the ordering and coordination of tasks while executing the process (i.e., "on the fly").

Traditionally, process mining has been used to extract models from event logs and to check or extend existing models. This has shown to be useful for improving processes and their IT support. Process mining techniques analyze historic information hidden in event logs to provide surprising insights for managers, system developers, auditors, and end users. However, thus far, process mining is mainly used in an offline fashion and not for operational decision support. While existing process mining techniques focus on the process as a whole, this paper focuses on individual process instances (cases) that have not yet completed. For these running cases, process mining can used to check conformance, predict the future, and recommend appropriate actions. This paper presents a framework for operational support using process mining and details a coherent set of approaches that focuses on time information. Time-based operational support can be used to detect deadline violations, predict the remaining processing time, and recommend activities that minimize flow times. All of this has been implemented in ProM and initial experiences using this toolset are reported in this paper.

In our earlier work we proposed using the declarative language DecSerFlow for modeling, analysis and enactment of processes in autonomous web services. DecSerFlow uses constraints specified with Linear Temporal Logic (LTL) to implicitly define possible executions of a model: any execution that satisfies all constraints is possible. Hence, a finite representation of all possible executions is retrieved as an automaton generated from LTL-based constraints. Standard model-checking algorithms for creating Büchi automata from LTL formulas are not applicable because of the requirements posed by the proper execution of DecSerFlow (and LTL-based process engines). On the one hand, LTL handles infinite words where each element of the word can refer to zero or more propositions. On the other hand, each execution of a DecSerFlow model is a finite sequence of single events. In this paper we adopt an existing approach to finite-word semantics of LTL and propose the modifications of LTL and automata generation algorithm needed to handle occurrences of single events. Besides eliminating errors caused by the ‘multiple properties - single events’ mismatch, the proposed adjustments also improve the performance of the automata generation algorithms dramatically.

The Declare Service is a YAWL Custom Service that enables decomposing YAWL tasks into DECLARE workflows, that is, workflows supported by the workflow management system (WfMS) called DECLARE. The goal of this service is to enable a particular kind of flexibility. Chapter 6 describes a constraint-based approach to workflow models and the ConDec language. This approach, supported by the DECLARE WfMS, allows for more flexibility, that is, execution of tasks is allowed if it is not explicitly forbidden by some constraint. This chapter describes DECLARE and the Declare Service for YAWL. Sometimes it is easier to express a process in a procedural language (e.g., the native workflow language of YAWL) and sometimes a declarative approach is more suitable. Moreover, in a larger process it may be useful to express parts of the process in a procedural language and specify other parts in terms of constraints. Using the service-oriented architecture of YAWL, this can easily be realized. A YAWL task may decompose into a DECLARE process and a task in DECLARE can be decomposed into a YAWL process. Arbitrary decompositions of DECLARE and YAWL models allow for the integration of declarative and YAWL workflows on different abstraction levels.1 This way the designer is not forced to make a binary choice between a declarative and a procedural way of modeling. Hence, a seamless integration can be achieved, where parts of the workflow that need a high degree of flexibility are supported by declarative DECLARE models, and parts of the processes that need centralized control of the system are supported by YAWL models.

Mainstream workflow management systems are using procedural languages ranging from BPMN and EPCs to BPEL and YAWL. By demonstrating DECLARE, we will show that it is also possible to use a fundamentally different approach based on constraints. DECLARE allows for multiple constraint-based languages whose semantics are grounded in Linear Temporal Logic (LTL). The DECLARE system provides a broad range of functionalities ranging from design, enactment and dynamic change to verification, discovery and recommendation. This demo presents the main functionalities of DECLARE and is intended for both researchers and practitioners interested in innovative BPM solutions for processes that require flexibility.

In our earlier work we have proposed using the declarative language DecSerFlow for modeling, analysis and enactment of web service processes. DecSerFlow uses constraints, which are formally specified as Linear Temporal Logic (LTL) formulas, to implicitly define possible executions of a model: any execution that satisfies all constraints is possible. A finite representation of all possible executions is retrieved as an automaton generated from LTL-based constraints. Standard algorithms for creating B¨uchi automata from LTL formulas cause errors when be applied to DecSerFlow due to important semantical differences. On the one hand, LTL handles infinite traces where each element of the trace can refer to zero or more propositions. On the other hand, executions of DecSerFlow models are finite sequences of single events. In this paper we describe how both LTL and automata generation algorithms can be adjusted to fit two properties of DecSerFlow. Since adjustments for finite traces have already been proposed by other researchers, this paper focuses on the modifications needed to handle occurrences of single events. Besides eliminating errors caused by the described mismatch, the proposed adjustments also improve the performance of the model checking algorithms dramatically. This is important as for the enactment of declarative languages like DecSerFlow new problems related to model checking techniques are generated after each step in the process.

The lack of flexibility is often seen as an inhibitor for the successful application of workflow technology. Many researchers have proposed different ways of addressing this problem and some of these ideas have been implemented in commercial systems. However, a "one size fits all" approach is likely to fail because, depending on the situation (i.e., characteristics of processes and people involved), different types of flexibility are needed. In fact within a single process/organisation varying degrees of flexibility may be required, e.g., the front-office part of the process may require more flexibility while the back-office part requires more control. This triggers the question whether different styles of flexibility can be mixed and integrated into one system. This paper proposes the Flexibility as a Service (FAAS) approach which is inspired by the Service Oriented Architecture (SOA) and our taxonomy of flexibility. Activities in the process are linked to services. Different services may implement the corresponding activities using different workflow languages. This way different styles of modelling may be mixed and nested in any way appropriate. This paper demonstrates the FAAS approach using the Yawl, Declare, and Worklet services.

Recent analysis of clinical Computer-Interpretable Guideline (CIG) modelling languages from the perspective of the control-flow patterns has revealed limited capabilities of these languages to provide flexibility for encoding and executing clinical guidelines [15]. The concept of flexibility is of major importance in the medical-care domain since no guarantee can be given on predicting the state of patients at the point of care. In this paper, we illustrate how the flexibility of CIG modelling languages can be improved by describing clinical guidelines using a declarative approach. We propose a CIGDec language for modelling and enacting clinical guidelines.

The degree of flexibility of workflow management systems heavily influences the way business processes are executed. Constraint-based models are considered to be more flexible than traditional models because of their semantics: everything that does not violate constraints is allowed. Although constraint-based models are flexible, changes to process definitions might be needed to comply with evolving business domains and exceptional situations. Flexibility can be increased by run-time support for dynamic changes – transferring instances to a new model – and ad-hoc changes – changing the process definition for one instance. In this paper we propose a general framework for a constraint-based process modeling language and its implementation. Our approach supports both ad-hoc and dynamic change, and the transfer of instances can be done easier than in traditional approaches.

BPEL has emerged as the de-facto standard for implementing processes based on web services while formal languages like Petri nets have been proposed as an “academic response” allowing for all kinds of analysis. Although languages such as BPEL and Petri nets can be used to describe service flows, they both tend to “overspecify” the process and this does not fit well with the autonomous nature of services. Therefore, we propose DecSerFlow as a Declarative Service Flow Language. By using a more declarative style, there is no need to overspecify service flows. The declarative style also makes DecSerFlow an ideal language for monitoring web services, i.e., using process mining techniques it is possible to check the conformance of service flows by comparing the DecSerFlow specification with reality. This can be used to expose services that do not follow the rules of the game. This is highly relevant given the autonomous nature of services.

In today's fast changing business environment exible information systems are required to allow companies to rapidly adjust their business processes to changes in the environment. However, increasing exibility in large information system usually leads to less guidance for its users and consequently requires more experienced users. In order to allow for exible systems with a high degree of guidance, intelligent user assistance is required. In this paper we propose a recommendation service, which, when used in combination with exible information systems, can guide end users during process execution by giving recommendations on possible next steps. Recommendations are generated based on similar past process executions by considering the specific optimization goals. This paper also describes an implementation of the proposed recommendation service in the context of ProM and the declarative work ow management system DECLARE.

Traditional Workflow Management Systems (WFMSs) are not flexible enough to support loosely-structured pro- cesses. Furthermore, flexibility in contemporary WFMSs usually comes at a certain cost, such as lack of support for users, lack of methods for model analysis, lack of methods for analysis of past executions, etc. DECLARE is a proto- type of a WFMS that uses a constraint-based process mod- eling language for the development of declarative models describing loosely-structured processes. In this paper we show how DECLARE can support loosely-structured pro- cesses without sacrificing important WFMSs features like user support, model verification, analysis of past execu- tions, changing models at run-time, etc.

Management of dynamic processes in an important issue in rapidly changing organizations. Workflow management systems are systems that use detailed process models to drive the business processes. Current business process modelling languages and models are of imperative nature – they strictly prescribe how to work. Systems that allow users to maneuver within the process model or even change the model while working are considered to be the most suitable for dynamic processes management. However, in many companies it is not realistic to expect that end-users are able to change their processes. Moreover, the imperative nature of these languages forces designer to over-specify processes, which results in frequent changes. We propose a fundamental paradigm shift for flexible process management and propose a more declarative approach. Declarative models specify what should be done without specifying how it should be done. We propose the ConDec language for modelling and enacting dynamic business processes. ConDec is based on temporal logic rather than some imperative process modelling language.

The need for process support in the context of web services has triggered the development of many languages, systems, and standards. Industry has been developing software solutions and proposing standards such as BPEL, while researchers have been advocating the use of formal methods such as Petri nets and p-calculus. The languages developed for service flows, i.e., process specification languages for web services, have adopted many concepts from classical workflow management systems. As a result, these languages are rather procedural and this does not fit well with the autonomous nature of services. Therefore, we propose DecSerFlow as a Declarative Service Flow Language. DecSerFlow can be used to specify, enact, and monitor service flows. The language is extendible (i.e., constructs can be added without changing the engine or semantical basis) and can be used to enforce or to check the conformance of service flows. Although the language has an appealing graphical representation, it is grounded in temporal logic.

Work ow management systems support business processes and are driven by their models. These models cover different perspectives including the control- ow, resource, and data perspectives. This paper focuses on the resource perspective, i.e., the way the system distributes work based on the structure of the organization and capabilities/qualifications of people. Contemporary work ow management systems offer a wide variety of mechanisms to support the resource perspective. Because the resource perspective is essential for the applicability of such systems, it is important to better understand the mechanisms and their interactions. Our goal is not to evaluate and compare what different systems do, but to understand how they do it. We use Colored Petri Nets (CPNs) to model work distribution mechanisms. First, we provide a basic model that can be seen as the \greatest common denominator" of existing work ow management systems. This model is then extended for three specific systems (Staffware, FileNet, and FLOWer). Moreover, we show how more advanced work distribution mechanisms, referred to as resource patterns, can be modelled and analyzed.