Clinical Practice Guidelines
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Clinical Practice Guidelines, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-draft built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/cqf-recommendations/ and changes regularly. See the Directory of published versions

Separating and Defining Case, Plan, and Workflow

This section provides an overview of the specific separations of concerns in the CPG implementation guide as well as some details of their respective boundary issues. An overview of each separation is covered here and in more detail in individual sections that include:

  • Case
  • Plan
  • Workflow
  • Boundary Issues between Separations (covered below)
FIG. 69. Illustrating the separation of the Case (patient clinicopathophysiological processes and their manifestations and qualifications thereof), the Plan (the approach to the patient’s current, historical, and potential future state of disease and well-being including medical decision-making), and the Workflow (how the Plan is implemented either through interactions with clinical information systems or through real-world human tasks and activities). Separation of Concerns

Case

From the domain perspective, a case is conceptualized as the contextually relevant information oriented to clinically meaningful descriptions of an individual patient’s current and historical state of health, disease, and risks. The case includes a comprehensive, detailed description of the current and relevant historical clinicopathological presentation of the patient. Key information to sufficiently summarize the case for the purpose of making appropriate and timely medical decisions in a given situation are often referred to as pertinents (e.g., positive and negative pertinents). Details for the CPGCase are covered in this linked section.

Plan

Within the healthcare domain, the providers formulate an approach, or plan, for how they intend to address the health, well-being, and active clinical concerns of the patient, taking into account the patient’s goals and preferences. The plan includes current interventions, takes into account prior and current response to those interventions, and formulates an approach to assess and address all elements of the patient’s state of health and disease. A plan consists of requesting (e.g., ordering, prescribing, scheduling) medications, procedures, diagnostics (e.g., laboratory and imaging, and other tests), and appointments (e.g., referrals and consults).

A plan takes into consideration existing or potential complications, side effects or adverse events for various interventions, and worsening signs and symptoms to watch for, as well as the means to mitigate and/or address potential adverse events. The plan typically addresses each item in a differential diagnosis, and since many patients have multiple conditions, a plan is developed for each problem, including considerations for the severity and urgency needed to be addressed as well as interactions between conditions and/or their existing and planned interventions. A plan often mentions next steps and/or expectations for information (e.g., a pending lab result) and expected/possible/likely decisions to be made.

Plan, Planning, and Care Plan

There exists a fine distinction between and relationship among a plan for best practice care across a population and/or subpopulations; the working care plan for a specific patient by a care team and the care team's cognitive, collaborative, and often poorly coordinated processes of formulating a patient-specific care plan. This latter planning process utilizes, in part, best practice guideline recommendations in the context of patient-specific goals and preferences as well as other conditions and considerations, and awareness of the situational factors of the patient’s current and historical state in the context of their real-world setting.

The patient-specific plan (i.e., Care Plan ) in most healthcare settings can be found across the plan section of current and recent instances of clinician documentation, but must be aggregated across all care team members (e.g., primary team, consulting teams, and documentation from various healthcare professionals), as well as recent, active, and initiated orders or prescriptions or the resulting fulfillment (e.g., medication administration record).

In the CPG, the concept of a plan as a separated concern is further divided into the abstracted, more generalized reasoning and rationale for determining the best course of action for a patient (e.g., recommendations, strategies, pathways) formalized as logic in the Plan and the patient-specific past, current, and likely course of action (e.g., proposals, requests, and fulfillments of those requests) called a Care Plan (described further below) formalized as data elements in the Care Plan. Though there are use cases where have both in context is of considerable value as is described in the CPGCasePlanSummeryView.

Workflow

Workflow, an often overloaded term in the healthcare domain, refers to the activities in real-world healthcare delivery settings, the human-computer interaction activities which are carried out in the context of clinical information systems (e.g., EHRs), and even some of the interaction within and between those systems. This often refers to human task flow, information flow, and patient flow. Clinical workflow is the description, abstraction, or depiction of clinical work that includes the physical, cognitive, coordination, and computational tasks or activities carried out by individual and teams of clinicians along with other staff and various resources using specialized knowledge, vast amounts and varieties of information, and numerous tools or artifacts collectively to achieve the goal of delivering the safest and highest quality care to individual patients as well as populations of patients or the broader public. Clinical work occurs in a broader system, social, legal, regulatory, and professional context that can greatly influence how this work is carried out.

The CPG-IG explicitly does not address, local workflows due to their significant variation, complexity, and need for consideration for local factors (e.g., specific resources and resource type, policies, customized or localized tooling), as well as to avoid conflating detailed clinical workflow descriptions/definitions with the flow of abstract clinical activities often necessary to describe as part of the care process in guideline recommendations. This topic is addressed in further detail in the subsection on Workflow and the Common Pathway.

Boundary Issues at the Separation of Domain Concerns

As discussed in the section on Knowledge Architecture, it is critical in knowledge-driven approaches to identify accurate, representative, unambiguous, and useful domain knowledge abstractions and for these abstractions themselves to respect domain-oriented separations of concerns. These separations of concerns must be respected within and across the domain conceptualizations, as well as between knowledge formalizations and across the translations or transformations thereof. A related principle is fidelity to domain conceptualizations, where oversimplification leads to unwieldy and value-diminishing complexity to correct for gaps in fidelity, while appropriate complexity to align with the domain yields optimal formalizations.

One of the most critical principles in dealing with these boundary issues is to identify them, recognize that they exist, and then formulate a plan to explicitly address them. There are several best practices for addressing these boundary issues once they have been identified. One such best practice is to use “Layers of Abstraction”. Creating abstraction layers is a means of hiding much of the working details of a component, allowing the separation of concerns to facilitate both interoperability within the knowledge architecture and across implementations thereof. In fact, the “concerns” themselves can be thought of as creating abstraction layers. Often when modeling or architecting a “concern”, one creates fit-for-purpose features for that concern that themselves may be abstracted, which specifically address boundary issues with ‘adjacent’ concerns with which it must interact.

Examples of Boundary Issues in the CPG

  • Workflow: The CPG implementation guide addresses generalized or abstract workflow, not real-world local workflow, and the work done within and across clinical information systems (e.g., EHRs, etc.). More on this separation may be found, in part, in the subsection on Workflow and the Common Pathway. Workflow may be further addressed through shared information (e.g., CPGCaseFeatures) and reuse of the same standards for clinical information system activities (e.g., FHIR Requests and their lifecycle, task, and workflow status) and workflow enablements (e.g., Adaptive Forms, CDSHooks, etc.).
  • Clinical Assessment: is it part of the Case or the Care Plan? Clinical Assessments may be referenced by each. In clinical practice, the Assessment (i.e., the “A” from the SOAP note), called the ClinicalImpression in FHIR (FHIR ClinicalImpression Resource), provides the clinician’s highest level summation of the state of the patient’s clinical course including what problem(s) may be affecting the patient just before planning the treatments or management strategies are best to address the patient's condition (clinicopathophysiological state) as part of the Plan (or patient-specific Care Plan). As such, there is a succinct clinical summarization of the Case from a clinicians perspective. Furthermore, it typically has significant clinician-formulated implications (stated or implied) for their judgement on both what needs done for the patient and/or how the patient is responding to interventions and thus is very relevant to the Care Plan.
  • Proposals: Proposals (patient-specific recommendations), resulting or related requests (orders, prescriptions), and their resulting event (administrations, results, encounters))- are they part of the Case or the Care Plan? Requests and their ‘resulting’ and/or related Events go into both. Proposals are scoped to the Care Plan in the CPG.. However, indicators (i.e., CPGMetrics) may qualify patient-specific guideline recommendations (i.e., CPGProposal) compliance or adherence or how the Case is ‘performing’ with respect to the ‘Plan’. As discussed elsewhere (see CPGMetric in subsection on Derived & Related Assets ), these patient-specific indicators may be treated as CPGCaseFeatures and thus part of the Case.
  • Plan or Workflow: the CPGPlan is focused on what to do for the patient, while issues of how to specifically implement that plan within local workflows and clinical information systems is outside the scope of this implementation guide though some implications are addressed in the section of Knowledge Implementation. However, as described above, some implications of clinical information system workflow and abstract workflow are addressed as described in the subsection on Common Pathway.
  • Case and Workflow: while much patient-level information (i.e., Case Features) contains information or metadata about local clinical workflow (e.g. performer, timing) and some aspects of local clinical workflow impact certain aspects of patient-level Requests and Events (e.g. timing and availability), for the scope of this implementation guide, such information is expressed within the data elements or resources as scoped by FHIR Resources, while relevant inferences about such information are addressed within their appropriate concerns.