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

NCCN Clinical Practice Guidelines

in Oncology™

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

Examples from Breast Cancer Guideline

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