1. NCCN and NCCN Clinical Practice Guidelines in Oncology™
Joan S. McClure, MS
Senior Vice President of Clinical Information and Publications
National Comprehensive Cancer Network (NCCN)

3. What is the NCCN?
An Alliance of 21 Academic Cancer Centers in the United States
A National Developer and Communicator of:
Programs to support member institution missions in education, research, and patient care
Scientific/evaluative information to inform and improve the decision-making between patients and physicians to improve quality and effectiveness of care
Developer of benchmarking data regarding quality of cancer care

4. Oncology Complex group of about 200 different diseases
Managed by multidisciplinary teams
Rapidly evolving standard of care based on large volume of research
Share-care models across disparate settings of care
Coordination of care a significant challenge

5. Two Types of Evidence-Based Guidelines
Process map of integrated interventions over time
Exhaustive review of single decision point

6. NCCN Guidelines
Comprehensive across all stages, modalities and continuum of care
44 multidisciplinary expert panels
Cancer screening, diagnosis, treatment and supportive care
Updated at least annually and up to 4 times per year since 1995
Category of evidence and consensus designated for each recommendation
Transparent processes
Centerpiece of suite of tools to support quality oncology care

7. NCCN Clinical
Practice Guidelines
in Oncology™

8. Components of NCCN Guidelines
Title
Panel List
Names, affiliations, specialties
Algorithm
Step by step clinical decision making map
Staging
Identification of patient subsets
Discussion
Data supporting recommendations and
Issues identified by panel
References
Disclosures
Individual
Organizational

9. Evidence-based Consensus Allows Comprehensive Guideline
Evidence-based guideline
Continuum of disease and patient care
Evidence-based consensus guideline
High-level evidence exists
Gaps in evidence filled with expert consensus

10. NCCN Levels of Evidence
Category 1: Based upon high-level evidence and uniform NCCN consensus that intervention is appropriate
Category 2A: Based on lower-level evidence and uniform NCCN consensus that it constitutes appropriate care
Category 2B: Based upon lower-level evidence and NCCN consensus that it constitutes appropriate care
Category 3: Any level of evidence but major NCCN disagreement that the recommendation is appropriate. 10

11. Selecting Recommendations
The amount of data available differs across disease sites and across clinical decisions within a disease site
Major change in standard of care supported by consistent, convincing studies which have major impact on outcomes – e.g., Adjuvant trastuzumab in breast cancer
Less dramatic, but significant change in standard of care supported by lower level evidence – e.g., bevacizumab in Glioblastoma
New studies WILL change the standard of care over time
Data from multiple studies
Expert evaluation
Distill appropriate
recommendations

12. Examples from Breast Cancer Guideline

13. Disclosure
No industry or any other interest group funds are used to support panel meetings
No industry representatives allowed at meetings
Individual panel members disclose conflicts of interest at each panel meeting and in writing
Potential conflicts of interest published individually
Members are excused from deliberations when degree of conflict warrants
Most panel members have some conflict(s)

14. Implementation of Guidelines
Measure concordance with guidelines
evaluate the quality of care
examine patterns and outcomes of care
evaluate treatments and other interventions
provide feedback to providers
provide feedback to guidelines developers

15. NCCN Oncology Outcomes Database Project Update*
Start
Patients
Institutions
Breast Cancer
7/1997
54,820
18 NCCN
18 community
Non-Hodgkin’s Lymphoma
7/2000
4,344 7
Colon/Rectal Cancer
9/2005
5,419 8
Non-Small Cell Lung Cancer
1/2007
2,528
Ovarian Cancer
1/2004
558 6
This is clinical trials quality data, abstracted from patient charts by data managers largely funded by NCCN.
Numbers reflect table counts of the number of records contained in each database
We collect 305 separate data elements, demographic information, treatments (e.g., drugs, surgeries, radiation), etc.
Patients from each NCCN institution (in the Lung Database), as of 11/10/2009:
Center N Column %
MD Anderson
Roswell Park
Duke
Johns Hopkins
Dana-Farber
U Michigan
City of Hope
Ohio State University 171 7
Total
* Number of patients abstracted as of October 29, 2009. 15

16. Standards for Guidelines Development
Provide latitude for both types of guideline development
Permit both evidence and consensus as criteria for inclusion
Accommodate rapid update cycles
Foster transparency and consistency of process
Disclosure of developers potential conflicts
Encourage assessment of implementation