Committee Presentation

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Committee on Credible Practice of Modeling & Simulation in Healthcare

prepared by

Committee Co-Chairs

Interagency Modeling and Analysis Group

Multiscale Modeling Consortium

April 12, 2013

https://simtk.org/home/cpms

DEFINITIONS

Credible Practice of Modeling & Simulation in Healthcare

dependable with a desired certainty level to guide research or support decision making within a prescribed application domain and intended use; establishing reproducibility & accountability

DEFINITIONS

Credible Practice of Modeling & Simulation in Healthcare

any activity involving development, solution, interpretation and application of computational representation of biological, environmental and man-made systems and their interaction thereof

DEFINITIONS

Credible Practice of Modeling & Simulation in Healthcare

specifically computational modeling; virtual representation of system(s) of interest in a usable form in order to provide descriptive and predictive metrics for timely and systematic exploration of the system(s)

DEFINITIONS

Credible Practice of Modeling & Simulation in Healthcare

computational solution of models to quantify descriptive and predictive metrics of system(s) of interest; including related post-processing efforts to calculate these metrics from raw analysis results

DEFINITIONS

Credible Practice of Modeling & Simulation in Healthcare

any activity involving development, maintenance, advancement, or administration of medical care; including research, diagnosis, risk assessment, prevention, therapy, rehabilitation, surgery, intervention design, and regulation

NEED

* Clinical urgency

- There is a pressing need to utilize computational modeling & simulation to support clinical research and decision making in healthcare.

- There is a gap in mechanisms or processes for translating computational models to the clinical practice.

* Research diversity

- Within and across mathematical and biological disciplines, subject matter experts tend to have their own interpretation of credibility assessment.

- Tools and good practice recommendations do not readily transfer across disciplines or are not adopted by different fields.

NEED

* Challenges of multiscale analysis - Multiscale simulations require re-use of subsidiary models, which may have varying (or unknown) credibility. - Propagation of uncertainties of a given scale for multiscale analysis can be complicated. * Scattered activities - In modeling & simulation (M&S) world, a plethora of commendable yet unconnected scientific and community activities exist for - verification & validation - uncertainty estimation - error propagation - evidence based assessment - reporting recommendations - model exchange and dissemination - standards and mark-up development - documentation

NEED None of us are experts in everything. We need to learn from each other. Credible practice of modeling and simulation in healthcare requires ongoing inclusive communications to establish adaptive workflows that can be utilized broadly.

CHARGE * Adopt a consistent terminology * Propose guidelines and procedures for credible practice * Demonstrate workflows for credible practice * Promote good practice

CHARGE Adopt a consistent terminology * Clearly describe committee's understanding of modeling and simulation vocabulary, e.g., - model - simulation - multiscale - verification - validation - uncertainty - sensitivity - credibility - accreditation

* Consistently use appropriate vocabulary for communication * Unify discipline-specific appreciation of modeling and simulation vocabulary

Propose guidelines and procedures for credible practice * Identify translational research directions to leverage readily available techniques to increase credibility of modeling and simulation in healthcare, e.g., - verification and validation - uncertainty quantification ? Establish guidelines to implement readily available model evaluation techniques which are aware of the constraints of clinical practice ? Define novel translational workflows to enhance credibility of models and simulation processes

CHARGE Demonstrate workflows for credible practice * Summarize state-of-the-art by identifying examples in literature and in field practice for the development of model credibility assessment procedures * Conduct studies, ideally with proposed guidelines and procedures, for the implementation of credibility assessment procedures in modeling and simulation in healthcare * Disseminate examples of credibility assessment by providing a repository of case studies on the implementation of proposed guidelines and procedures for different types of M&S

CHARGE Promote good practice * Bridge synergistic activities of establishing confidence in simulation-based medicine conducted by - modeling and simulation communities - scientific societies - clinical practitioners - regulatory agencies * Outreach to advocate credible practice of modeling and simulation through increased awareness and training; by providing - webinars - lectures - guidelines

ORGANIZATION

COMMITTEE Co-Chairs & Members: EXECUTE & CHARGE

ADVISORY COUNCIL: REVIEW & ADVISE

Interagency Modeling and Analysis Group (IMAG)

Multiscale Modeling Consortium (MSM)

ACTIVITY CYCLE: *** TBD IMAGE should go here

ROLES & EXPECTATIONS Committee Co-Chairs (2) * Provide leadership and guidance to the Committee * Assign tasks to Committee Members to realize charge of the Committee and incorporate their work to reach Committee end-products - Serve as Committee Members, i.e., take on and fulfill assigned tasks to realize charge of the Committee - Report to Advisory Council and implement their feedback - Report to IMAG/MSM and implement their feedback - Evaluate performance of Committee Members - Evaluate performance of Advisory Council - Share authority and responsibilities equally

ROLES & EXPECTATIONS * Committee Members (10 including Co-Chairs) - Complete assigned tasks (on schedule) to realize charge of the Committee and prepare Committee end-products - Report to the Committee and implement their feedback - Represent a particular discipline and an area of practice to diversify Committee interests and reach out - Evaluate performance of Committee Co-Chairs - Evaluate performance of Advisory Council - Expect to invest 8 hours of effort per month

ROLES & EXPECTATIONS * Advisory Council - Review Committee activities (on schedule) and provide feedback on the pathway for realization of the charge of the Committee and for preparation of Committee end-products - Represent a particular discipline and an area of practice to broaden Committee affairs and reach out - Evaluate performance of Committee Co-Chairs - Evaluate performance of Committee Members - Expect to invest 1 hour of effort per month

PARTICIPATION Committee Co-Chairs (2) * Nominated and elected by the Committee Members and the Advisory Council * 2 year term with possibility of reappointment * Elections 6 months prior to end of term * Continuing post subject to commitment to leadership * Ideally, one from IMAG and the other from MSM * First-term (04/2013- 04/2015) appointed via IMAG consensus - Lealem Mulugeta (NASA, IMAG representative) - Ahmet Erdemir (Cleveland Clinic, MSM-WG representative)

PARTICIPATION Committee Members (10 including Co-Chairs) * Participation through nomination and invitation * 2 year term with possibility of reappointment * Continuing membership subject to commitment to timely completion of tasks * Multidisciplinary background - clinicians - mathematicians - biologists - engineers - statisticians - computer scientists - product developers

PARTICIPATION Committee Members (10 including Co-Chairs) * Wide variety of groups - IMAG representatives - MSM working groups - External representatives - Professional Societies - Regulatory Agencies - Funding Agencies

PARTICIPATION Advisory Council * Participation through nomination and invitation - 2 year term with possibility of reappointment - Continuing membership subject to commitment to providing feedback in a timely manner - Substantial experience and expertise in respective areas of interest

FIRST-TERM (2013-2015) GOALS * Form the Committee and the Advisory Council * Establish infrastructure for communications between Committee Co-Chairs and Members, and Advisory Council * Establish a web-based framework for development, community interactions, and dissemination * Develop a guidance document on establishing credible practice of modeling and simulation in healthcare * Draft a proposed model certification process

FIRST-TERM (2013-2015) TIMELINE by April 30, 2013 * Establish communication infrastructure * Establish web-based framework * Appoint Committee Members * Introductory meeting with Committee Members * Discuss objectives, roles & assign tasks by May 31, 2013 * Meeting with Committee Member to review first set of tasks * Appoint Advisory Council * Introductory meeting with Advisory Council * Discuss objectives, roles & summarize progress by June 30, 2013 * Working outline of guidance document by MSM 2013 meeting * Community outreach to summarize progress and plans by April 30, 2014 * First draft of guidance document for external review by October 31, 2014 * Release of guidance document by November 30, 2014 * Journal article/white paper based on guidance document * Outline of model certification process * Co-Chairs; nominations and election through December 2014 – April 2015 * Co-Chairs; transition * First draft of proposed model certification process

CONTACT

CHECK https://simtk.org/home/cpms

Lealem Mulugeta Committee Co-Chair mulugeta@dsls.usra.edu lealem.mulugeta@nasa.gov

Ahmet Erdemir Committee Co-Chair erdemira@ccf.org