Clinical templates registries and terminologies
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Clinical templates, registries and terminologies. Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 / WG II. Contents. what is a clinical template ? batteries, data sets, reusable fragments of messages

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Clinical templates registries and terminologies l.jpg

Clinical templates, registries and terminologies

Angelo Rossi Mori

National Research Council, Rome - Italy

HL7 / Clinical Templates SIG & CEN / TC251 / WG II


Contents l.jpg
Contents

  • what is a clinical template ?

    batteries, data sets,

    reusable fragments of messages

  • 3 pillars for semantic interoperability

    repositories, templates, value domains

  • “HL7 light”: a complementary approach

    • decentralisation of a registration process

    • involvement of professionals and agencies

    • a common strategy for HL7 and CEN ?


What is a template l.jpg

what is a template ?

too many legitimate

perspectives and options


Typology of templates 1 2 l.jpg
typology of templates 1/2

  • USAM tables

    • e.g. role-link-role

  • ENCAPSULATION (terminology vs RIM)

    • e.g. to describe style in messages

  • BATTERY = set of “Acts”

    • sets of observations (i.e. battery)

      (precise description for orders and payments)

    • goals, outcomes

    • sets of procedures (e.g. clinical guidelines)

    • data sets (e.g. from regulatory agencies)


Typology of templates 2 2 l.jpg
typology of templates 2/2

  • CDA-L2 = set of sections

    • Clinical Document Architecture - level 2

    • expected shape of a document

  • DICOM SR = set of sections, acts, materials, devices, …

  • MESSAGES = profiles, new messages ?

    • internal needs of an organization

    • needs of a specialty (e.g. cancer network)

    • needs of agencies (e.g. Public Health reporting)

    • needs of a region / country (e.g. xDT Germany)


Sharing templates l.jpg

sharing templates

need for registries ?


Emerging needs in hl7 l.jpg
emerging needs in HL7 ?

  • refine standard messages and documents with “local” detailed constraints or refinements, e.g. to satisfy the needs of

    • sub-communities (diabetes, cancer, ESRD)

    • ad-hoc information flows (e.g. CDC, HCFA)

    • regional or national information flows

  • management of pathology networks

  • registries, clinical trials, sharing records

  • secondary uses

  • reporting to authorities, statistics


Clinical templates a real need l.jpg
clinical templates: a real need ?

  • is there a need to reduce combinatorial alternatives and impose a common “style” ?

  • what is better achieved by

  • a-posteriori transformations ?

  • is there a need for control over the processthrough registration and support databases ?

  • (i.e. decentralise but avoid the chaos)

  • if communication is local, why HL7 should

  • introduce international rules or registries ?


My vision need for registries l.jpg
my vision: need for registries

  • if we want to share clinical templates

  • across organizations,

  • components of templates must be registered.

  • all names and labels used in templates

  • should be stored in a registry

  • should be mapped to the RIM classes

  • should have a well defined “value set”

  • (how can we decentralize the register ?)


3 pillars for real interoperability l.jpg
3 pillars for real interoperability

  • The optimal strategy is based on 3 pillars:

  • 1. data dictionaries and metadata registries,

  • including appropriate “LOINC codes”

  • 2. clinical templates

  • 3. tables with enumerated value domains

  • they are complementary

  • all 3 pillars are needed to assure a real semantic interoperability


1 metadata registries 1 2 l.jpg
1. Metadata registries 1/2

  • A registry of data elements, between

  • one thousand robust data elements i.e. the attributes in the RIM

  • millions of user-created XML labels

  • Specializations of the RIM:

  • each data element should be explicitly

  • registered as a child/refinement of a RIM class,

  • under control of the respective HL7-TC


1 metadata registries 2 2 l.jpg
1. Metadata registries 2/2

  • Quick solution:

  • Collection of data sets and lists of XML tags

  • with either answer-list or ranges of values

  • (e.g. see “names for observations” in LOINC;

  • see also xDT/Germany, ASTM E1384)

  • Optimal solution:

  • Integrated repository (e.g. ISO 11179)

  • with uniform and comparative representation

  • of data elements from all the sources


2 clinical templates l.jpg
2. Clinical templates

  • to aggregate data elements from the repository

  • (including the RIM) into meaningful fragments

  • i.e. building blocks, from predefined data elements,

  • to produce more detailed messages, between

  • hundreds of balloted standard messages

  • millions of user-created DTD/schemas

  • Templates (and the related data elements)

  • need a process for (local) registration

  • under the control of HL7 TCs

  • a neutral language to represent templates ?


3 value domains l.jpg
3. Value domains

  • Thousands of explicit tables

  • with enumerated value domains

  • or numeric ranges

    admitted values for each data element

    in the context of a clinical template

  • "terminologies in context"

  • coordinated by HL7 vocabulary TC

    (see the “context groups” in DICOM-SR)


Hl7 light open hl7 l.jpg

HL7 light ?Open HL7 ?

a registration process

in addition to normal ballots


Hl7 light l.jpg
“HL7 light” ?

  • fix by ballot the common framework (ISO ?), i.e.

    • basic rules and development processes

    • RIM and common templates

    • rules for registration

  • my vision: two different speeds + legacy

  • ballot the general standards (as usual)

  • control decentralisation of detail

    • a registration process driven by HL7 users

  • 3. legacy systems (Z-segment and adaptations)


1 unified development process l.jpg
1. Unified development process

  • Uniform process, according toHDF (HL7, CEN)

  • the development framework allows to define

  • the standard for a type of messages/documents

    • uniform measures for a vendor (level 7 !) to create, transport, parse, and visualizethe instances of messages and documents

      • general methods

      • same software

      • common skills

      • basic manuals and training


2 sharing pre defined building blocks l.jpg
2. Sharing pre-defined building blocks

  • 1. usual ballots in HL7 (RIM, messages, CMETs)

    • the RIM (and the CEN-RIM)

    • general-purpose messages

    • basic clinical templates and CMETs

  • 2. HL7 Committees registerdata elements and “shared” clinical templates (LOINC + ?)

    • data elements registered wrt the RIM

    • related value domains

    • useful clinical templates


Not just a list l.jpg
( Not just a list … )

  • harmonise data elements / XML tags across different systems/organisations

  • facilitate users’ feedback into the process by uniform collection of legacy usages

  • facilitate mappingfrom legacy data elements of end-users to registered data elements [similarly to RELMA for LOINC]


3 decentralise detailed content l.jpg
3. Decentralise detailed content

  • HL7 members register "local" clinical templates

  • define the content of their typical messages and documents (i.e. all and only the detailed data elements needed and adequate for a task)

    • National affiliates (and CEN/TC251 ?)

    • US government agencies

    • disease networks (e.g. cancer registries, ESRD)

    • member organisations

    • professional bodies


The new sig l.jpg

the new SIG

a forum for discussion

and harmonization


A new sig on clinical templates l.jpg
A new SIG on Clinical Templates

  • to coordinate discussion across TC/SIGs

  • and with external bodies

  • CEN, ASTM, DICOM, GEHR.org, ...

  • XML schemas, bizTalk, ebXML, …

  • compare perspectives on:

    • real needs

    • use cases, purposes, target groups

    • potential solutions

  • no production activities within the template SIG


  • Role of hl7 groups vs templates sig l.jpg
    role of HL7 groups vs templates SIG

    • The SIG is made of members from other groups

    • each TC/SIG should produce its vision

    • real user needs, use cases, kind of templates,

    • examples and the future “production” activities.

    • Role of the new SIG:

    • clarify the perspective of each group

    • discover similarities and differences

    • comparative review of TCs’ visions

    • strategic proposals to the HL7 Board


    Who has a real need for templates l.jpg
    who has a “real need” for templates ?

    • e.g. professional societies

    • (see cardiologists in DICOM …)

    • quality of reports (check list)

    • (complete, understandable, processable)

    • clinical databases

    • uniform data collection

    • (clinical trials, clinical registries)

    • are they aware ?

    • what is the limit of “promotion” ?


    Perceived by professional groups l.jpg
    perceived by professional groups ?

    • groups that are currently working

    • on clinical data sets include:

    • DEEDS (CDC)

    • Am. Dental Association

    • Am. Ophtalmology Association

    • Am. Coll. Obstetrics and Gynecology

    • Am. College of Pediatrics

    • (consistent structure across specialties

    • would be in the best interest of medicine)


    Filling in the gap l.jpg
    filling in the gap

    • “clinical templates” as a keyword:

    • everything filling in the gap between

    • (slow) ballot-based process

    • Z-segments and local adaptations

    • including registry of data elements (LOINC+)

    • and related vocabularies

    • “now that XML is available

    • we don’t need HL7 anymore, right ?”


    Issues l.jpg
    Issues

    • what is a clinical template ?

      batteries, reusable fragments of messages,

      data sets, messages,

      internal structure of documents

    • 3 pillars for semantic interoperability

      repositories, templates, value domains

    • HL7 light ?

      • decentralisation of a registration process

      • neutral representation of templates

      • involvement of professionals and agencies

    • concrete needs, use cases, solutions

    • volunteers to prepare the January meeting


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