MODELING TASK FORCE LEADERSHIP

	J. Jaime Caro MDCM, FRCPC, FACP, Chair, ISPOR-SMDM Modeling Good Research Practices Task Force ISPOR and SMDM Member, and  Senior Vice President, Research, United BioSource Corporation, Lexington, MA, USA, and Adjunct Professor of Medicine & Epidemiology & Biostatistics, McGill University, Montreal, QC, Canada
	Andrew Briggs, DPhil, Co-Chair, ISPOR-SMDM Modeling Good Research Practices Task Force ISPOR and SMDM Member, and William R. Lindsay Chair of Health Economics, Health Economics & Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, Scotland UK
	Karen Kuntz ScD, Co-Chair, ISPOR-SMDM Modeling Good Research Practices Task Force SMDM Member, SMDM Issues in Methodology Working Group Chair, and Professor, University of Minnesota School of Public Health Minneapolis, MN USA
	Uwe Siebert, MD, MPH, MSc, ScD, Co-Chair ISPOR-SMDM Modeling Good Research Practices Task Force ISPOR and SMDM Member, SMDM Board representative-Issues in Methodology Working Group  and Professor of Public Health, UMIT – Univ. of Health Sciences, Medical Informatics & Technology Hall i.T, Austria

Goal:
To ensure that good research practices on modeling techniques remain useful for all current modeling techniques as well as to foster the use of model-based results to inform health care decisions, a Modeling Good Research Practices Task Force was created to address (1) advances in modeling, (2) approaches to evaluating variability in models, and (3) transparency in reporting of models. The development of these modeling good research practices is in collaboration with The Society for Medical Decision Making (SMDM). The ISPOR Board of Directors approved this initiative March 25, 2010 and the SMDM Board approved May 1, 2010.

Background:
The first International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Research Practices Task Force on Modeling (2000-2003), chaired by Milton Weinstein, published its report in 2003. See Principles of Good Practice for Decision Analytic Modeling in Health-Care Evaluation: Report of the ISPOR Task Force on Good Research Practices—Modeling Studies (pdf format) [1].  This ISPOR Task Force Report began by defining a model and its purposes, presented an approach to evaluating a model, and then described the consensus of the Task Force regarding the attributes that define a good model, in terms of structure, data and validation. 

Developments in three aspects of modeling created a need for a new examination of several issues addressed by the previous Task Force. First, the recommendations were focused on the kinds of models that were in most widespread use in our field at the time, namely state-transition (Markov) and decision-analytic models.  Consideration was given to both deterministic and probabilistic (i.e., individual-level Monte Carlo simulation) approaches to such models.  In the intervening years, with advances in computing capabilities, experience with other types of models has grown in our research community, among these being models that focus on the timing of events rather than transitions between health states.  The roles of deterministic cohort models, as well as individual micro-simulations and other techniques such as SEIR transmission models need to be re-examined. Second, analysis of uncertainty surrounding model results has also advanced with computing capabilities, with new approaches to probabilistic sensitivity analysis becoming available.  Still, deterministic sensitivity analyses have an important role to play because of their transparency for decision makers. Finally, while the U.S. Panel on Cost-Effectiveness in Health and Medicine [2] recommended that models be transparent, with detailed technical reports publicly available, this practice has been followed inconsistently.

Work Product:
This ISPOR-SMDM Joint Modeling Good Research Practices Task Force will provide a guidance for: a) delineating the approach and design of modeling studies and the identification and preparation of required data, b) selecting a modeling technique, c) implementing and validating the model, d) addressing uncertainty around model results, e) reporting the modeling study results to assure transparency, and f) using model-based study results to inform decision-making. Since there are multiple issues to be addressed by this Modeling Task Force, and to assure each issue is adequately addressed including defining preferred practices for different modeling techniques, this Task Force will produce several papers (parts) to this Modeling Task Force Report, similar to the papers published in Medical Decision Making, Primer on Medical Decision Analysis Part 1 – Part 5 [8-12].

• Modeling Good Research Practices - Overview: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-1
  This paper will cover the goals of the Modeling Good Research Practices Task Force and issues addressed, as well as a summary of the preferred practices from each of the tutorial papers included in the Task Force Report
• Conceptualizing a Model: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-2
  This paper will address the issue that the approach to modeling should be based on how the disease works, rather than designed to show the cost-effectiveness of a technology. This paper will develop the conceptual phase of modeling to show the hypothesized linkages between the disease, its impact on the patient and the link with the measures used to capture that impact. In addition, this paper will address good research practices for assembling best evidence for inputs, which may require some degree of statistical modelling of randomized controlled trial or observational datasets. Development of functional relationships and how data availability influences granularity and heterogeneity of a model will be discussed.
• State-Transition Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3
  This paper will review current modeling techniques for state-transition-based modeling (Markov models and others) for both cohort and individual-level (Monte Carlo) state-transition models. It will address issues concerning state-transition modeling and address the key principles of the implementation of cohort simulation and microsimulation in state-transition modeling.
• Modeling using Discrete Event Simulation: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-4
  This paper will review techniques for discrete event simulation and address issues around event-based versus state-based technique as well as agent-based modeling.
• Dynamic Transmission Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-5
  This paper will review modeling techniques for dynamic transmission modeling, and address issues relevant to these modeling techniques.
• Model Parameter Estimation and Uncertainty Analysis: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-6
  This paper will present methods for assessing and reporting parameter estimation (including calibration) and uncertainty in models. In addition to uni-or muli-variate sensitivity analyses, the correlation of input variables will be addressed. In this paper, the use of Bayesian approaches to integrate prior knowledge will be discussed.
• Model Transparency and Validation: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-7
  This paper will address external model validation [versus verification], analyses, documentation, and transparency in reporting of model results. The importance of conceptualization (up front scoping) to ensure that the model addresses the problem will be emphasized. In addition, this paper will describe how results should be presented to be useful to the user.

Activities:
Modeling Good Research Practices - Everything You Need To Know
May 2011 – ISPOR 16th Annual International Meeting, Third Plenary Session, Baltimore, MD, USA

Modeling Good Research Practices (The Good, The Bad, and The Ambiguous)
November 2010 - ISPOR 13th Annual European Congress, Forum Presentation Prague, Czech Republic
2010 - 32nd Annual Meeting of the Society for Medical Decision Making, Toronto, Canada

ISPOR-SMDM Joint Modeling Good Research Practices Task Force Face to Face Meeting March 3-6, 2011 in Boston, MA, USA

Task Forces Index

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