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)
Dec 22, 2015
NCCN and NCCN Clinical Practice
Guidelines in Oncology™
Joan S. McClure, MSSenior Vice President of Clinical Information and Publications National Comprehensive Cancer Network (NCCN)
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
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
Two Types of Evidence-Based Guidelines
• Process map of integrated interventions over time
• Exhaustive review of single decision point
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
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
Evidence-based Consensus Allows Comprehensive Guideline
Continuum of disease and patient care
High-level evidence exists
Gaps in evidence filled with expert consensus
Evidence-based guideline
Evidence-based consensus guideline
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.
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
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)
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
NCCN Oncology Outcomes Database Project Update*
Project Start Patients Institutions
Breast Cancer 7/1997 54,82018 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 8
Ovarian Cancer 1/2004 558 6
* Number of patients abstracted as of October 29, 2009.
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