Community Updates

CDISC

The Clinical Data Interchange Standards Consortium (CDISC) has been diligently working toward a new ‘era’ of standards development---one that requires an accelerated process and new tools. In a prior column, I wrote about the publication of a standard for Alzheimer’s Disease; the use of this standard by a CDISC partner, the Critical Path Institute (C-Path), enabled the development of a groundbreaking database that is open for researchers around the world to do modeling and other analyses in search of a new therapy for this debilitating disease. Through another project, CDISC helped in developing a standard for data from patients with Polycystic Kidney Disease; this has led to the qualification of a biomarker for a new endpoint, enabling earlier detection of this disease to increase chances that therapies can be effective.

Other CDISC and C-Path partnerships include the Bill and Melinda Gates Foundation, the Michael J. Fox Foundation, the PKD Foundation, Tufts University, Duke University, Rochester University, the National Institutes of Health (NIH). Standards development is ongoing in disease areas such as Parkinson’s Disease, Virology, Oncology, and Cardiovascular Disease.

Just recently, CDISC and C-Path announced the signing of a partnership agreement to establish the Coalition for Accelerating Standards and Therapies (CFAST), an initiative to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health. Key areas of activity over the next few months will be: a) to take what we have learned from the initial projects to formulate a new process that will be significantly more efficient, while retaining the rigor that is essential to this work, and b) to develop an electronic metadata repository environment.

To do this work properly will require broad collaboration with the research community, biopharmaceutical companies, academia, FDA (see PDUFA V and the list of priorities FDA has posted), the Innovative Medicines Initiative (IMI), the Translational Research Informatics Institute (TRI) in Japan and others who are interested in participating. We are excited to augment the existing open and free foundational CDISC clinical research standards with these new ones focused on supporting specific disease areas. Mark your calendars! The official launch of CFAST will be on 24 October at the CDISC International Interchange in Baltimore, MD. We hope you will all participate in any way you can.

CEN TC /251

CEN TC251 (Health Informatics) has been considering its strategic direction for the future contribution to Health Informatics standardisation. In March the Technical Committee consulted with its National Member Bodies, and has concluded that it needs to become much more customer focused and to widen its scope to consider the 'delivery' of standards, not solely the 'development' of its standards. One small step towards the customer focus objective is to issue a newsletter to improve communication with its stakeholders.

CEN's strategy has been to progress it's standards to ISO whenever possible. TC251 has been particularly good at doing this with its flag-ship projects, e.g. ISO EN 13606 (EHR Communication), ISO EN 13940 (Systems of concepts to support continuity of care) and ISO EN 12967 (Health Informatics Service Architecture). In Rome in July, a timely workshop is to be held to consider how these 3 projects are taken forward as they mature and are revised.
It is appropriate to acknowledge the role of Alessandra Pastorino who helped to make the workshop a reality even while she was very ill. Alessandra passed away in June. We will miss her, but will make sure the workshop succeeds to honour her efforts.

As part of its new strategy too, CEN TC251 will also endeavour to better support the wide ranging EU directives and the interoperability agenda in accord with its value proposition.

You may find out more about recent developments in CEN TC 251 via their newsletter

ISO TC /215

ISO TC 215 on Health Informatics advanced its reorganization during the Vancouver meeting last spring, and anticipates to bring this to close at its plenary in Vienna next September. The question of criteria for accepting new work, centered around the goals of standard coherence (with other work) and alignment (with member countries’ real needs and requirements) was made more operational by the introduction of new-work-item review metrics. Consistent with the goals of alignment, an extended presentation by the Clinical Informatics Modeling Initiative (CIMI) was made to the Joint Initiative Council hosted by ISO TC215, comprising CEN, CDISC, HL7, GS1, and ISO. TC215 is also exploring collaborative HIT standards development with the ITU (International Telephone Union) in Geneva, who deal with health telecommunications and Health Information Exchange. In parallel with these organizational activities, TC215 has continued to mature and publish several standards, most recently in cooperation with the medical device community on safety issues.

HL7

In this issue HL7 has provided a detailed update via its feature article.

LOINC

LOINC Version 2.40 and RELMA 5.8 Released

In June 2012, Regenstrief Institute, Inc and the LOINC Committee released the 49th edition of the LOINC terminology, version 2.40 that contained more than 70,000 terms. We are excited by the growing interest in LOINC from the instrument and test kit vendor community. This latest release includes terms requested directly by many of these companies. By making it easy for laboratories to identify the LOINC codes for the measurements they perform, the mapping work of data exchange becomes much more straightforward. In this latest LOINC release we have continued expanding coverage of standardized survey instruments and patient assessments, including the FACIT (Functional Assessment of Chronic Illness Therapy), FACT (Functional Assessment of Cancer Therapy), and more.

The RELMA program now features an answer list browser, a revamped tool for correcting idiosyncratic local spellings, and support for the new SI Edition of the Top 2000+ Laboratory Observations. It also includes a new French translation of LOINC produced by ASIP Santé and updates to the French (Canada), Italian (Italy), and Spanish (Spain) translations. Our web-based search application (search.loinc.org) also got an updated theme, performance enhancements, and can be used in English, Italian, and Chinese with more languages to come.

New SI Edition of the LOINC Top 2000+ Lab Observations Released

Regenstrief is pleased to announce the availability of a new SI edition of the user-favorite LOINC Top 2000+ Lab Observations list and mapper's guide. The original Top 2000+ was based on the reporting patterns of three large organizations in the United States. These laboratories commonly report in mass units, e.g. mg/dL, rather than molar units, e.g. mmol/L. Since LOINC codes are in use by many countries that report various tests in molar units, this list was created to help users in that environment too. We are indebted to Dr. Gilbert Hill at The Hospital for Sick Children, Toronto, Ontario, Canada, for helping us create this SI version. For measurements from the US edition of the Top 2000+ that are commonly reported in molar units, the equivalent mass term was replaced. For those tests that are reported in either mass or molar units, the mass term remained and the molar term was added. You can read more about development of both the US and SI versions in the Introduction document, which is available along with both the SI and US editions at http://loinc.org/usage/obs.

MedBiquitous

MedBiquitous continues to make progress on a suite of standards related to competency-based learning and assessment. Public review is underway for the Competency Framework specification, which defines the relationships among a set of interrelated competencies. The Competency Framework serves as the backbone for MedBiquitous’ competency-related standards. The MedBiquitous Standards Committee is currently reviewing the Curriculum Inventory specification, a common format for core data about health professions curricula, enabling the dissemination of curricular innovations and best practices. There has been a great deal of interest in the standard vocabularies for assessment methods, instructional methods, and resources developed for describing curricular events.

The Educational Trajectory Working Group has produced a draft specification for Educational Achievement data, a specification for documenting learner competency and making that data portable across the continuum of health professions education. The Educational Achievement specification includes a standard format for describing entrustment decisions, allowing learners to show the full range of their responsibilities. As a compliment to this work, the Competencies working group is undertaking the development of a Performance Framework standard, which will provide a standard format for documenting performance levels in relation to specific competencies. Residency training milestones are one example of the kind of frameworks that the Performance Framework specification will encode. By having milestones available in a machine readable format, milestones can be referenced from assessment and curriculum data in a consistent manner, allowing for research into their implementation and achievement.

For more information on any of these standards development efforts, visit the MedBiquitous website: www.medbiq.org