Overview of caBIG’s ™ for the Nursing Community

1. Overview of caBIG’s™ for the Nursing Community Session Length:Approximate two hours Target Audience:Oncology nurses, nurse scientists, clinical trials nurses and nurse clinicians. Trainer:Self-Led Nursing Matter Experts: Mollie R. Poynton, PhD, APRN, BC, College of Nursing, University of Utah Katherine Sward, PhD, RN, MS, College of Nursing, University of Utah caBIG™ Matter Expert, Doc & Training WS Contact: Lewis Frey, PhD (Lewis.Frey@HSC.Utah.edu), Biomedical Informatics, University of Utah School of Medicine Creation Date:February, 2008

2. Session Details • Training Topic Statement:Overview of the National Cancer Institute’s (NCI) Cancer Biomedical Informatics Grid (caBIG™) for the nursing community. • Target Audience:Oncology nurses, nurse scientists, clinical trials nurses and nurse clinicians that are interested in using caBIG™ applications and sharing data across institutions. • Prerequisites:This training does not assume prior knowledge of caBIG™. Those familiar with caBIG™ may want to focus on lessons 2 and 3.

3. Session Details: Session Goals • By the end of this training, you will be able to: • Describe caBIG™ • Explain caBIG’s™ relevance for the nursing community • List reasons for nursing community to use caBIG™ infrastructure • Use caBIG™ resources • Participate in caBIG™

4. Session Details:Lesson Plan • Lesson 1: Introduction to caBIG™ • Lesson 2: Nursing and caBIG™ • Lesson 3: Reasons for Nurses to use caBIG™ • Lesson 4: Accessing caBIG™ Resources • Lesson 5: Participating in caBIG™

5. Lesson 1: Introduction to caBIG™ Lesson Overview • This lesson provides a broad overview of caBIG™ • By the end of this lesson, you will be able to: • State what caBIG™ stands for and indicate who funds caBIG™ • Describe the problems that caBIG™ addresses • Describe the mission and goals of caBIG™ • Explain the foundation that caBIG™ is built upon • List the results that the caBIG™ initiative will produce • List the caBIG™ workspaces

6. Lesson 1: Introduction to caBIG™ Introduction caBIG™ is the acronym for cancer Biomedical Informatics Grid is an innovative infrastructure initiative led by the National Institutes of Health (NIH)’s National Cancer Institute (NCI). Material from: https://cabig.nci.nih.gov/overview/

7. Lesson 1: Introduction to caBIG™ Purpose caBIG™ was initiated to address 1. The Information Tsunami • The ever increasing and overwhelming volume of data • Multitude of data sources (clinical, genetic, epidemiologic, etc…) • 2. A Research Tower of Babel • Each cancer research community speaks its own scientific “dialect” resulting in a confusion of tongues • Integration is critical to achieve understanding & synthesizing • findings for discovery Material adapted from: https://cabig.nci.nih.gov/

8. Lesson 1: Introduction to caBIG™ Mission The mission of caBIG™ is to develop a truly collaborative information network that accelerates the discovery of new approaches for the • detection, • diagnosis, • treatment, and • prevention of cancer, • ultimately improving patient outcomes. Material from: https://cabig.nci.nih.gov/overview/

9. Lesson 1: Introduction to caBIG™ Goals • Develop standard rules and a common language to more easily share information • Connectscientists and practitioners through a shareable and interoperable infrastructure • Build or adapt tools for collecting, analyzing, integrating, and disseminating information associated with cancer research and care Material adapted from: https://cabig.nci.nih.gov/overview/

10. Lesson 1: Introduction to caBIG™ Foundation caBIG™ is built on the foundation of federation, open-development, open-access and open-source. • Federated: caBIG™ software and resources are widely distributed, interlinked, and available to everyone. caBIG™is setup so that institutions maintain local control over their own resources and data. • Open-development: caBIG™ tools and infrastructure are being developed through an open, participatory process. When possible, caBIG™ adopts existing tools and resources rather than creating new ones. • Open-access: To encourage broad data-sharing and collaboration, caBIG™ resources are freely obtainable and the caBIG™ website serves as a central repository for accessing the resources. • Open-source: The caBIG™ source code is available to view, alter, and redistribute. Material adapted from: https://cabig.nci.nih.gov/overview/

11. Lesson 1: Introduction to caBIG™ The caBIG™ initiative will produce these results: • A collaborative research environment through an interoperable infrastructure. • Interoperability addresses the “Information Tsunami” and the “Tower of Babel”. It is the ability of two or more systems to exchange information and to use the data that have been exchanged. • There are two parts to interoperability: • 1) accessing information from a system ('syntactic interoperability') and • 2) using/understanding the data that have been received ('semantic interoperability'). • Tools for analyzing information associated with cancer research and care. • Better data sharing by providing: common data elements, data models, and standards. • Data elements provide a detailed description of the meaning of the information that is recorded, in addition to its value (often called semantic metadata). • For example, with a patient's temperature, the semantic metadata describes what is meant by a 'patient' and 'temperature' in addition to what constitutes a valid value for a patient temperature. caBIG™ Glossary of Acronyms and Terms: https://cabig.nci.nih.gov/glossary Material from: https://cabig.nci.nih.gov/overview/cabig-primer/html/primer.html

12. Strategic Workspace caBIG Strategic Planning Cross-cutting Workspace Architecture DOMAIN WORKSPACE 2 Integrative Cancer Research DOMAIN WORKSPACE 1 Clinical Trial Management Systems Cross-cutting Workspace Vocabularies & Common Data Elements DOMAIN WORKSPACE 4 Imaging DOMAIN WORKSPACE 3 Tissue Banks & Pathology Tools Strategic Workspace Data Sharing & Intellectual Capital Strategic Workspace Documentation & Training Lesson 1: Introduction to caBIG™ caBIG™: Organizational Overview caBIG™ is organized around workspaces. Domain workspaces focus on specific areas of cancer research. Cross-cutting and Strategic workspaces support these groups by developing standards and infrastructure. Material adapted from: caBIG-Newcomers-3June07.PPT Located at: https://cabig.nci.nih.gov/overview/Presentations_About_caBIG/

13. Lesson 1: Introduction to caBIG™ Review • The cancer Biomedical Informatics Grid (caBIG™) is funded by the NCI to develop a collaborative information network to improve patient outcomes through accelerating the discovery of new approaches for the detection, treatment and prevention of cancer. • caBIG™ is build on the foundation of federation, open-development, open-access and open-source. • The caBIG™ initiative will produce these results: • A collaborative research environment • Improved data sharing • Tools for cancer research and care • caBIG™ is organized around nine workspaces that address infrastructure and specific areas of research.

14. Lesson 2: Nursing and caBIG™ Lesson Overview • This lesson discusses caBIG’s™ relevance for the nursing community. • By the end of this lesson, you will be able to: • Discuss challenges in oncology nursing research • Describe similarities between ONS and caBIG™ agendas • Describe recent collaborations between ONS and caBIG™ • Compare the PROMIS initiative with caBIG™

15. Lesson 2: Nursing and caBIG™ Challenges in Oncology Nursing Research There are limited methods for integrating across related research. Opportunities for integration: • An intervention to decrease pain experienced by oncology patients is effective for some patients, but not for others. • Behavioral oncology research examines the effectiveness of nursing interventions for tobacco use cessation. • Research indicates genetic factors may influence patient response to pain. • Genetic research describes heritability of propensity to smoke, and propensity for smoking cessation.

16. Lesson 2: Nursing and caBIG™ Challenges in Oncology Nursing Research • There is a need to • Increased sample sizes and data quality for detection of small effects and for using analyses methods that require large data sets. • Improve and increase the identification of nurse sensitive patient outcomes in oncology. • Develop and expand the infrastructure and processes for multi-site oncology nursing research.

17. Lesson 2: Nursing and caBIG™ Challenges in Oncology Nursing Research • Address the “Tower of Babel”: Communication and collaboration with the larger community of cancer researchers who need to speak the same language. • The oncology nursing community recognizes the barrier posed by the current “Tower of Babel”. • 2006: Institutes of Learning and the Advanced Practice Nursing Conference identified issues and barriers/facilitators related to assessing and documenting nursing sensitive patient outcomes (NSPOs), the use of common data elements, and data sharing.¹ • 2007: A consensus-building conference was held to finalize selection of priority NSPOs and corresponding measures, and a model for implementation was developed.¹ 1 Berry DL. Oncology Nursing Society 2005-2009 Research Agenda: Oncology Nursing Society; 2007.

18. Lesson 2: Nursing and caBIG™ Similarities between ONS and caBIG™ The caBIG™ initiative is consistent with Oncology Nursing Society (ONS) strategic planning priorities. ONS Multi-Site Research Strategic Plan Priorities: • Clarify Oncology Nursing Society (ONS)’s role in multisite research, such as education and training/mentorship. • Increase ONS presence in national research agenda initiatives and facilitate development of/participation in research networks (advocacy and partnership). • Accelerate translation of research findings into practice (data sharing and marketing). Material adapted from: http://www.ons.org/research/documents/pdfs/MSRStrategicPlan.pdf

19. Lesson 2: Nursing and caBIG™ Similarities between ONS and caBIG™ ONS Core Data Set Project Team • Team’s Charge: Develop core set of common data elements to promote quality cancer care. • Develop system that uses Common Data Elements • Build upon existing ONS Evidence-Based Measurement for Nursing Sensitive Patient Outcomes (NSPO’s) • caBIG™ infrastructure is being to be used to meet metadata needs for the ONS multi-site research charge. Material from the MSR Core Data Set Project Team Charge Summary 1-07-07.doc

20. Lesson 2: Nursing and caBIG™ Collaborations between ONS and caBIG™ ONS and caBIG™ have been meeting to build the partnership between the two communities. These recent collaborations have lead to ONS multi-site studies data elements being loaded into caBIG™. These can be viewed via the Common Data Element (CDE) Browser. Screen shot from caBIG’s™ CDE Browser

21. Lesson 2: Nursing and caBIG™ Consistency of PROMIS initiative and caBIG™ • Patient-Reported Outcomes Measurement Information System (PROMIS)2 • Develop ways to measure patient-reported symptoms, such as pain and fatigue, which can be used to develop a set of publicly available computerized adaptive tests for the clinical research community. • Part of the NIH Roadmap. • Individual items need to be stored as metadata. • In the same way the caBIG™ infrastructure maintains ONS Multisite Research Study data elements, it can be used to store the metadata for PROMIS tests. • develop a consistent measurement of pain using the same scale, with same range of values. 2 PROMIS. (2008, January 14, 2008). PROMIS - Home. from http://www.nihpromis.org/default.aspx

22. Lesson 2: Nursing and caBIG™ Review • Cancer researchers need to speak the same language and reduce the confusion of tongues resulting from the “Tower of Babel” problem. • The Oncology Nursing Society wants to clarify its role in multi-site research and connect with national research initiatives. • The partnership between ONS and caBIG™ has led to metadata for the ONS multi-site research studies project being loaded into caBIG™. • Measurement of patient-reported symptoms is a goal of PROMIS which aligns with both ONS and the caBIG™ initiative.

23. Lesson 3: Reasons for Nurses to use caBIG™Lesson Overview • This lesson provides reasons for the nursing community to use caBIG™. • By the end of this lesson, you will be able to: • Explain how caBIG™ helps nurses share data • Discuss the ethics of data stewardship for nursing • Describe how caBIG™ facilitates data stewardship • State the security mechanisms caBIG™ uses to protect data • Describe how caBIG™ can empower nurses

24. Lesson 3: Reasons for Nurses to use caBIG™caBIG™ Supports Data Sharing Consistent Data Description • Use of common information building blocks or core data elements for data capture and reporting facilitates the understanding and sharing of cancer research information. • Variation in data descriptors (metadata) makes it nearly impossible to aggregate and manage even modest-sized data sets in order to ask basic questions and obtain meaningful answers. • One approach to this challenge is to use terminology driven metadata to create consistent data descriptions.

25. Lesson 3: Reasons for Nurses to use caBIG™caBIG™ Supports Data Sharing • In order to combine data collected at different sites, care settings, you need data with identical definitions and ranges of values. • The sharing of data without clear concept definitions and identical measurements results in inconsistent data sets. • There is a danger of incorrect conclusions and the publication of incorrect results. • The caBIG™ metadata infrastructure helps protect nurse scientists from the danger of inconsistent data. • caBIG™ establishes data standards to maintain consistency. • This establishes consistencies WITHIN a multi-site study and potentially ACROSS studies when the same data elements are consistently used.

26. Lesson 3: Reasons for Nurses to use caBIG™caBIG™ Supports Data Sharing How Data Standards are Adopted by caBIG™ • A proposed data standard is reviewed in detail by the Vocabularies and Common Data Elements (VCDE) Workspace. • The VCDE may ask the submitter to clarify the proposal or to expand the scope of the proposed data standard to meet additional business needs or use cases uncovered during the review. • When the final proposal is voted on and approved by the VCDE membership, the candidate data standard is submitted to the caBIG™ community for review. Any comments received during the review period are addressed by the VCDE and may result in modifications to the proposal. • At the end of the review period, if no further action is required the candidate standard is promoted to a caBIG™ data standard. • The VCDE governance process for data standards is described in more detailed at the following link: https://caBIG.nci.nih.gov/workspaces/VCDE/Data_Standards/

27. Lesson 3: Reasons to use caBIG™Data Stewardship Data stewardship is essentially managing, using and protecting data. Data Stewardship in the Information Age • Innovation in information technology has fundamentally changed the nature of health care data, including data used in cancer research. • Electronic health information: • More easily shared, distributed. This can lead to substantial security/ privacy concerns. • Better structured for secondary analysis/use. The value of data itself has increased through the potential secondary reuse of data. In this challenging landscape, ethical data stewardship is crucial.

28. Lesson 3: Reasons to use caBIG™Ethics of Data Stewardship Fundamental ethical principle of beneficence: “All persons have a duty to advance the good of others where the nature of this good is in keeping with the fundamental and ethically defensible values of the affected party”.2 Application of this principle to data stewardship: • Collect data in a way that enables future use and re-use, for the greater good of society. • Do not collect data in such a way that its use is limited to the original study. 2 Kluge, E. W. (2002). IMIA Code of Ethics for Health Information Professionals. Retrieved December 1, 2007, from http://www.imia.org/code_of_ethics.html

29. Lesson 3: Reasons to use caBIG™Ethics of Data Stewardship Fundamental ethical principle of integrity: “Whoever has an obligation, has a duty to fulfill that obligation to the best of his or her ability”.² Application of this principle to data stewardship: • When we collect data from human subjects, we become stewards of that data. • We have a duty and an obligation to steward patient data to the best of our ability. • We should faithfully protect patient data, providing for security and privacy. • The patient’s contribution to research should be collected, managed and used in ways that best enable knowledge generation over time. 2 Kluge, E. W. (2002). IMIA Code of Ethics for Health Information Professionals. Retrieved December 1, 2007, from http://www.imia.org/code_of_ethics.html

30. Lesson 3: Reasons to use caBIG™caBIG™ Facilitates Data Stewardship caBIG™ facilitates ethical data stewardship • Data collected and shared using caBIG™ has much greater potential for contribution to scientific discovery, improvements in cancer treatment and to society. • caBIG™facilitates our fulfillment of this responsibility through the use of semantically and syntactically interoperable common data elements and a secure grid infrastructure.

31. Lesson 3: Reasons to use caBIG™Security and Privacy in caBIG™ • Security and privacy are important concerns for both patients and providers. The technical considerations related to security have been carefully considered in the caBIG™ initiative. • caBIG™ addresses security issues with state-of-the-art architecture and systems for user authentication and access control. You retain full control over data access. • caBIG™ provides a secure environment for data sharing. • caBIG™ provides a high quality framework for federated data sharing that allows investigators to manage access to data.

32. Lesson 3: Reasons to use caBIG™Security and Privacy in caBIG™ Security features in caBIG™: • caGrid, the underlying infrastructure of caBIG™, contains many security features that preserve user control over access and management of data: Grid Authentication and Authorization with Reliably Distributed Services (GAARDS). • caGrid provides the ability to issue and manage host credentials. • Security Working Group creates and implements security policies.

33. Lesson 3: Reasons to use caBIG™Empowering Nursing Community Potential of caBIG™ for Nurses • Increase sample size in oncology nursing studies, by facilitating multi-site studies and potentially, use of routinely collected clinical data. • Accelerate scientific discoveries in oncology nursing (eliminate tower of Babel, speak a common language of data elements, and channel the information tsunami to share data). • Empowerment of nurses: nurses become integral in translational research, greater collegiality, shared infrastructure for research.

34. Lesson 3: Reasons to use caBIG™Empowering Nursing Community • Nursing sensitive outcomes are important to the whole scientific community, not just for nurses. • Shared data can promote the demonstration of ways nursing makes a difference. • caBIG™ can make research more efficient to set up and conduct. • As a community represented within caBIG™, nurses become equal partners that participate in decision making related to the direction, software, standards, tools and strategies of the caBIG™ initiative. • The nursing community’s sphere of influence can widen with a seat at the caBIG™ table.

35. Lesson 3: Reasons to use caBIG™Review • Consistent data collection using common data elements with meaningful data definitions and permissible values is supported by caBIG™. • The information tsunami resulting from more powerfully connected technology exacerbated the need for ethical data stewardship. • Secure, semantically and syntactically interoperable systems enable proper data stewardship. • Technical considerations for the security of the caBIG™ grid have been thoughtfully integrated into the grid’s infrastructure. • With a seat at the caBIG™ table, nurses can actively steer the direction of the initiative to be more inclusive of a nursing focused agenda.

36. Lesson 4: Accessing caBIG™ Resources Lesson Overview • This lesson provides information on accessing some of caBIG’s™ resources that are relevant to the nursing community. • By the end of this lesson, you will be able to: • Find newcomer resources as well as other caBIG™ resources • Locate applications on the caBIG™ Website • Access metadata on the caBIG™ Website

37. Lesson 4: Accessing caBIG™ Resources caBIG™ Resources caBIG™ Community Website: https://cabig.nci.nih.gov/ Begin with the “Training Portal” and “Get Started” Other Links:https://cabig.nci.nih.gov/overview/ https://cabig.nci.nih.gov/overview/Presentations_About_caBIG/

38. Lesson 4: Accessing caBIG™ Resources caBIG™ Resources The caBIG™ Primer provides a next step overview of the program for Newcomers (https://cabig.nci.nih.gov/overview/cabig-primer/).

39. Lesson 4: Accessing caBIG™ Resources caBIG™ Resources Events & Calendar - Listing of caBIG™ events, particularly, the annual conference, teleconference, face-to-face meetings and town-hall meetings. Visit: https://cabig.nci.nih.gov/eventscalendar/

40. Lesson 4: Accessing caBIG™ Resources caBIG™ Resources GForge - Many workspaces post working documents in GForge, an online collaboration tool. Visit: http://gforge.nci.nih.gov/

41. Lesson 4: Accessing caBIG™ Resources caBIG™ Resources Additional resources: • Library - Repository for articles on caBIG™, scientific pulications, white papers, newsletters, presentations and other written documentation. Visit: https://cabig.nci.nih.gov/Library/ • Glossary - caBIG™ maintains a glossary of acronyms and terms located at: https://cabig.nci.nih.gov/glossary

42. Lesson 4: Accessing caBIG™ Resources caBIG™ Applications & Tools The Tools pages on caBIG™ website help connect you to caBIG™ tools and information to support the use of those tools.

43. Lesson 4: Accessing caBIG™ Resources caBIG™ Applications & Tools To search for tools, visit: https://caBIG.nci.nih.gov/tools/toolsearch_view As of February 2008, 42 tools were listed through the tool search. Below lists the areas of focus for the tools. Area of Focus (Number of applications) • Translational Research (3) • Microarray/Gene Expression (1) • Data Analysis and Statistical Tools (5) • Clinical Trials Management (9) • Genome Annotation (7) • Proteomics (4) • Vocabularies (0) • Biospecimens (3) • Data Sharing (3) • Infrastructure (1) • Imaging (2) • Pathways (3) • Other (1)

44. Lesson 4: Accessing caBIG™ Resources caBIG™ Applications & Tools Example Tool for Clinical Trials Management Patient Study Calendar (PSC) - Description: Standalone, web-based application providing the ability to create and edit study calendar templates, generate and view prospective calendars of patient activities, track activities as they occur, and manage calendars as they change during a study.

45. Lesson 4: Accessing caBIG™ Resources caBIG™ Applications & Tools Another Tool for Clinical Trials Management Cancer Adverse Event Reporting System (caAERS) - Description: Open source software tool used to collect, process and report adverse events that occur during clinical trials.

46. Lesson 4: Accessing caBIG™ Resources caBIG™ Applications & Tools Several other tools for Clinical Trials Management are: caMATCH - Description: caMATCH is a system for identifying patients who are potentially eligible for clinical trials. It is a middleware interface to accept patient data from electronic health records or other digital sources and match them to structured eligibility criteria is under development. A web-based application for breast cancer is available now at www.breastcancertrials.org Cancer Central Clinical Participant Registry (C3PR) - Description: Cancer Central Clinical Participant Registry (C3PR) is a web-based application for managing clinical trial data across multiple cancer clinical trials. The tool is used to improve clinical trials activation and execution by providing a large-scale and efficient web-based clinical trials information management system available for use by multiple cancer research centers across the country. Lab Integration Hub (caXchange) - Description: The Laboratory Integration Hub is an open source software tool used to collect, process and report laboratory data gathered during a clinical trial. Protocol Lifecycle Tracking Tool - Description: The Protocol Lifecycle Tracking Tool will assist in managing and documenting a protocol through the entire life cycle of the trial, starting at concept development and continuing through to the end of the cycle with submissions and publications.

47. Lesson 4: Accessing caBIG™ Resources Accessing caBIG™ Metadata Metadata are accessible through caBIG’s™ Common Data Element (CDE) Browser, see: http://cdebrowser.nci.nih.gov/CDEBrowser/ When you open the CDE Browser, on the left-hand side of the screen you will see a tree with “caDSR Contexts” at the root. Within the “caDSR Contexts” folder you will see a folder labeled, “caBIG (NCI cancer Biomedical Informatics Grid)”. If you click on the “+” in front of the caBIG folder, this will expand and show the contents of the caBIG folder. Next expand the folder labeled, “Classifications”. Scan down the listing for the “ONS (Oncology Nursing Society)” folder. To see the Common Data Elements for “Multisite Research Study” (within the ONS folder), click on the name of the folder “Multisite Research Study”.

48. Lesson 4: Accessing caBIG™ Resources Accessing caBIG™ Metadata Common Data Elements (CDE) for “Multisite Research Study” To see the Metadata, click on “Person Marital Status Category” and a new window will open.

49. Lesson 4: Accessing caBIG™ Resources Accessing caBIG™ Metadata Metadata for “Person Marital Status Category” Notice that information such as permissible values are located under different tabs.

50. Lesson 4: Accessing caBIG™ Resources Accessing caBIG™ Metadata Permissible Values for “Person Marital Status Category”