### MISSION STATEMENT 

Population sciences are an integral component of cancer research and
represent key elements in the bridge between clinical/basic research and
cancer control. These studies often collect specialized information on
large numbers of study subjects (from hundreds to tens of thousands) and
often employ representative sampling, cohort, case-control, case-cohort,
cross-sectional, family-based or randomized intervention designs. The
Population Sciences Special Interest Group (PS SIG) aims to advance the
various disciplines of population sciences including Epidemiology,
Surveillance, Behavior Science, Chemoprevention, Cancer Control, Cancer
Survivorship, Biostatistics, Economics, and Health Outcomes Research by
developing tools and creating data standards that operate within caBIG™
to address the common needs of these disciplines.

The SIG will identify priority areas for data standardization to provide
a unified set of data elements. These common data elements will be
constructed from a common vocabulary base that is suggested by the SIG
to the caBIG™ VCDE Workspace, that is maintained at the NCI, and that
possibly incorporates industry standard vocabularies.

The SIG will use models to develop or adopt tools for creating,
deploying, and administering applications for: data collection and
retrieval; study administration and execution; data sharing and
transmission; and communication with cancer registries and other data
resources. The SIG participants will use relevant applications in other
caBIG™ SIGs and Workspaces and utilize interoperable data elements to
identify new characteristics of cancer, design intervention strategies,
and ultimately reduce the suffering and death due to cancer.

### WHO WE ARE

The Population Sciences SIG is part of the Integrative Cancer Research
Workspace and the larger caBIG™ initiative (cancer Biomedical
Informatics Grid) that was announced in July 2003 under the coordinating
supervision of the National Cancer Institute (NCI). caBIG™ is being
developed in partnership with the Cancer Center community to create a
voluntary virtual network (or grid) that links individuals and
institutions both nationally and internationally, effectively creating a
World Wide Web of cancer research. Researchers will be able to develop
and share tools and data on the caBIG™ network according to agreed-upon,
common standards. This initiative will allow biomedical researchers to
answer research questions more rapidly and efficiently, thereby
promising to accelerate progress in all aspects of cancer research.

Key to the success of caBIG™ is the development of solutions that are
both semantically and syntactically interoperable. This includes
solutions newly developed for caBIG™ as well as existing commercial and
locally developed applications. This involves the development of common
models for population sciences areas of interest, agreement on a robust
set of computable data types and terminology standards, and the
development and/or adoption of messaging standards, interchange formats
and common Application Programming Interfaces (APIs). By providing a set
of semantically and syntactically interoperable tools, the PS SIG will
ultimately provide the cancer research community with more choices, and
move towards modular and interoperable software architecture.
Development of these solutions will be based on key needs and priorities
identified by the community and will be developed, tested and validated
by participants of the caBIG™ initiative.

As part of the Integrative Cancer Research Workspace, the Population
Sciences SIG will draw upon the resources of the other members of the
workspace, and of the caBIG™ community as a whole, to utilize best of
breed solutions to common issues and to further complete the caBIG™
health informatics community.

### PROGRESS TO DATE

The PS SIG was officially announced at the caBIG™ Annual Meeting on
April 12^th^ 2005. The SIG had its kick-off conference call on May
19^th^ 2005 and scheduled bi-weekly future meetings. After the first
conference call, members of the community completed capabilities and
needs assessments. The resulting gap analysis identified two main areas
of needs: data standards, and tools to facilitate electronic data
acquisition and study management. These two areas were used to structure
targeted break-out calls to further define the research priorities of
the group. This mission statement results from the surveys, group calls,
and break-out calls.

### PROJECTED ACTIVITIES

The scope of work for the Population Sciences SIG is anticipated to
include the following areas:

-   Data modeling and standardization is a key effort for the SIG. The
    SIG will explore existing domain models, create new standards, and
    explore new ways of modeling data within caBIG™ (such as using UML).

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-   Potential Areas for creating priority data elements, either from
    scratch or by extension of an existing standard, for use within
    caBIG™ include, but are not limited to:

    -   Demographics

    -   Census data fields

    -   Quality of patient care

    -   Patient care experiences and health care system characteristics

    -   Patient decision making

    -   Psychosocial measures

    -   Geographical Information Systems objects

    -   Family histories and trees

    -   Cancer related behaviors such as tobacco usage, dietary and
        nutritional profile, physical activity, pharmaceutical use, sun
        exposure, etc...

    -   Quality of life

    -   Reproductive and gynecologic history

    -   Clinical measurements (e.g. anthropoemetric, BMI, blood
        pressure, etc.)

    -   Access to health care

    -   Cancer Pathology and Histology

    -   Environmental Exposure

    -   Complementary and alternative medicine use

-   To build the elements, the group will use a standard vocabulary set
    defined in EVS. To aid in adding new entries the group will explore
    the use of industry standard vocabularies such as SNOMED, Logical
    Observation Identifiers Names and Codes (LOINC), or the National
    Library of Medicine's Unified Medical Language System (UMLS).

-   To utilize the data elements in online data collection tools, the
    group will explore creating a standard for describing data
    collection instruments. The standard would need to:

-   Fully describe the grouping and order of instruments, forms, and
    questions.

-   Describe all skip-pattern and branching logic.

-   Describe data quality assurance measures including variable type,
    range, permissible values, and logical consistency checks, etc.

-   Be developed in a fully modular fashion that separates the questions
    from their flow and presentation on a form or screen.

-   To investigate possible integration models for future electronic
    health records implementations.

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-   To create models to describe study design specifications and
    conceptual frameworks.

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-   With standards for both data elements and a structure to represent
    them in data collection instruments, the group will be able to
    develop or adopt tools for online data collection and study
    administration. Examples of activities in this area are:

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-   To develop a flexible, modular data collection instrument
    administration toolset that provides the ability to dynamically
    generate data collection instruments based on a SIG adopted data
    model.

-   To explore methods for creating interface and backend agnostic
    systems for collecting data:

    -   Over the web

        -   With or without a mouse

        -   Using thin clients such as web browsers

        -   Using thick clients such as java applets or flash
            applications.

    -   Using a a personal digital assistant (PDA) or other hand held
        device.

    -   For people with disabilities

    -   via Computer Aided Telephone Interviews (CATI); Computer aided
        personal interviews (CAPI)

    -   Through printed Data Collection Instruments

-   Investigate implementation approaches for the following aspects of a
    web based data collection instrument development tool:

    -   Skip patterns

    -   Question library/picker support that will permit reuse of
        previously created questions, instruments and questionnaires.

    -   Data entry quality assurance (e.g., variable type, range,
        permissible values, logical consistency checks, double key data
        entry)

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-   To investigate methods for using harmonized data models and the
    capabilities of caGRID to share data between institutions and
    establish data repositories for Population Sciences data on the
    grid.

-   To utilize the works of the Data Sharing and Information Capital
    Working Group to ensure that all published data is properly
    de-identified.

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-   To investigate implementation models and tools for advanced features
    for study administration such as:

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-   Comprehensive patient notification and communication systems
    enabling communications through email, postal mail, or scheduled
    phone calls.

    -   Also a creation of scheduling and tracking system for these
        communications.

-   Help modules (possibly derived from the metadata of study data)

-   To create comprehensive security modules that encompasse the NCI CSM
    (Common Security Model), suggestions from the caBIG™ Architecture
    workspace, and the needs of the Population Sciences Community.

-   Implementations of the caCORE Security Framework to support the role

-   Data collection instrument metadata import/export facilities

-   Text search

-   Enabling different types of web-site presentation techniques to
    represent an array of different intervention strategies

-   Generation of analytic datasets and related documentation

-   Specialized data structures (e.g., Family studies) capabilities

-   Standard approaches for importing and exporting data to allow forms
    to be completed off-line and then submitted and validated once
    connected to the web.

-   Other enhanced study management tools such as recruitment management
    & tracking, randomization, scheduling, expectations, receipt
    control, inventory control, shipping, and document management.

-   To facilitate assembling and evaluating patient health data for
    enrolling patients into studies and for surveillance purposes.

-   To Facilitate the use of multi-level data, where multi-level data
    can represent communities all the way down to molecules that can
    effect patient health.

### SUPPORTING ACTIVITIES

The SIG holds bi-weekly conference calls that are open to the public.
These calls are used to discuss the strategic direction of the SIG and
identify potential opportunities for development or data modeling
efforts within caBIG™ that would benefit the population sciences
community. In addition to the bi-weekly group calls, the SIG will be
supported by a minimum of a data standards sub-group and an electronic
data acquisition and study management tools development sub-group.

### FURTHER INFORMATION

ICR Workspace Website:

<http://caBIG.nci.nih.gov/workspaces/ICR/>

PS SIG website:
<http://cabig.nci.nih.gov/workspaces/ICR/Meetings/SIGs/PopulationSciencesAndCancerControl/>

SIG Administration -- Joseph Hanauer:

<hanauer_joseph@bah.com>