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Complete Summary
GUIDELINE TITLE
Lung cancer prevention: the guidelines.
BIBLIOGRAPHIC SOURCE(S)
· Dragnev KH, Stover D, Dmitrovsky E. Lung cancer
prevention: the guidelines. Chest 2003 Jan;123(1 Suppl):60S-71S.
[81 references] PubMed
GUIDELINE STATUS
This is the current release of the guideline.
COMPLETE SUMMARY CONTENT
SCOPE
METHODOLOGY - including Rating Scheme and Cost Analysis
RECOMMENDATIONS
EVIDENCE SUPPORTING THE RECOMMENDATIONS
BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
IMPLEMENTATION OF THE GUIDELINE
INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY
REPORT CATEGORIES
IDENTIFYING INFORMATION AND AVAILABILITY
DISCLAIMER
SCOPE
DISEASE/CONDITION(S)
Lung cancer
GUIDELINE CATEGORY
Prevention
CLINICAL SPECIALTY
Family Practice
Internal Medicine
Oncology
Pulmonary Medicine
INTENDED USERS
Physicians
GUIDELINE OBJECTIVE(S)
To provide clinically relevant, evidence-based guidelines
for lung cancer prevention
TARGET POPULATION
· General population (for smoking prevention)
· Individuals at risk for the development of lung
cancer
INTERVENTIONS AND PRACTICES CONSIDERED
School-based and community-based smoking prevention
1. "Life skills training"
2. Antismoking campaigns
3. Tobacco excise taxes
4. Restrictions on smoking in the workplace
Smoking cessation
1. Smokers identified and advised to quit smoking
2. Current smokers provided with pharmacotherapy, psychosocial
treatment, and behavioral modification therapies as indicated
Chemoprevention (Note: all of these chemopreventive agents
are considered but none are recommended outside of a clinical
trial)
1. Beta-carotene
2. Alpha-tocopherol (vitamin E)
3. Retinol (vitamin A)
4. Aspirin
5. Retinoids (i.e., oral isotretinoin)
6. Retinol palmitate
7. N-acetylcysteine
8. Selenium
MAJOR OUTCOMES CONSIDERED
· Lung cancer incidence
· Smoking rates
METHODOLOGY
METHODS USED TO COLLECT/SELECT EVIDENCE
Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases
DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE
EVIDENCE
Overview
As a first step in identifying the evidence for each topic,
the guideline developers sought existing evidence syntheses
including guidelines, systematic reviews, and meta-analyses.
They searched computerized bibliographic databases including
MEDLINE, Cancerlit, CINAHL and HealthStar, the Cochrane
Collaboration Database of Abstracts of Reviews of Effectiveness,
the National Guideline Clearinghouse, and the National Cancer
Institute Physician Data Query database. Computerized searches
through July 2001 used the MeSH terms lung neoplasms (exploded)
and bronchial neoplasms or text searches for lung cancer
combined with review articles, practice guidelines, guidelines,
and meta-analyses. They also searched and included studies
from the reference lists of review articles, and queried
experts in the field. An international search was conducted
of Web sites of provider organizations that were likely
to have developed guidelines. Abstracts of candidate English
language articles were reviewed by two physicians (one with
methodological expertise and one with content area expertise)
and a subset was selected for review in full text. Full-text
articles were reviewed again by two physicians to determine
whether they were original publications of a synthesis and
were pertinent to at least one of the topics of the guideline.
Articles described as practice guidelines, systematic reviews,
or meta-analyses were included, as were review articles
that included a "Methods" section. Included articles
were classified according to topic.
Strategy specific for lung cancer prevention
Duke University, supported by a contract from the American
College of Chest Physicians, searched for phase III studies
of putative chemopreventive agents used for primary, secondary,
or tertiary prevention in which the primary end point was
lung cancer incidence. Duke researchers conducted computerized
searches of the MEDLINE bibliographic database from 1966
to July 2001, the HealthStar database, and the Cochrane
Library. They searched using the terms lung neoplasm, prevention
and control and smoking, prevention and control, along with
terms to identify randomized controlled trials (RCTs), systematic
reviews, meta-analyses, and practice guidelines. In addition,
the reference lists of included studies, practice guidelines,
systematic reviews, and meta-analyses were searched.
For chemoprevention studies, the Duke researchers considered
only RCTs with lung cancer incidence as an end point. For
studies of smoking avoidance or cessation, they selected
systematic reviews and meta-analyses, and they searched
for individual RCTs only where high-quality and current
reviews and meta-analyses were not available.
NUMBER OF SOURCE DOCUMENTS
Not stated
METHODS USED TO ASSESS THE QUALITY AND STRENGTH
OF THE EVIDENCE
Expert Consensus
Weighting According to a Rating Scheme (Scheme Given)
RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE
The USPSTF scheme offers general guidelines to assign one
of the following grades of evidence: good, fair, or poor.
In general, good evidence included prospective, controlled,
randomized clinical trials, and poor evidence included case
series and clinical experience. Trials with fair quality
of evidence, for instance, historically controlled trials
or retrospective analyses, were somewhere in between. In
addition to the strength of the study design, however, study
quality also was considered. The USPSTF approach considers
well-recognized criteria in rating the quality of individual
studies for a variety of different types of study design
(e.g., diagnostic accuracy studies and case-control studies).
The thresholds for distinguishing good vs fair and fair
vs poor evidence are not explicit but are left to the judgment
of panelists, reviewers, and members of the executive committee.
Assessment of the Scope and Quality of Clinical
Practice Guidelines
Clinical practice guidelines identified from the systematic
search were evaluated by at least four reviewers using the
Appraisal of Guidelines for Research and Evaluation (AGREE)
instrument.
METHODS USED TO ANALYZE THE EVIDENCE
Review of Published Meta-Analyses
Systematic Review
DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE
Not stated
METHODS USED TO FORMULATE THE RECOMMENDATIONS
Informal Consensus
DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS
Each writing committee received a comprehensive list of
existing systematic reviews and meta-analyses as well as
guidelines published by other groups. In addition, for five
key topics (prevention, screening, diagnosis, and staging
[invasive and noninvasive], new systematic reviews were
undertaken [see "Description of Methods Used to Collect
the Evidence" and "Description of Methods Used
to Analyze the Evidence" fields]). For all other topics,
writing committees were responsible for identifying and
interpreting studies that were not otherwise covered in
existing syntheses or guidelines.
The guidelines developed by the writing committee were distributed
to the entire expert panel, and comments were solicited
in advance of a meeting. During the meeting, proposed recommendations
were reviewed, discussed, and voted on by the entire panel.
Approval required consensus, which was defined as an overwhelming
majority approval. Differences of opinion were accommodated
by revising the proposed recommendation, the rationale,
or the grade until consensus could be reached. The evidence
supporting each recommendation was summarized, and recommendations
were graded as described. The assessments of level of evidence,
net benefit, and grade of recommendation were reviewed by
the executive committee.
Values
The panel considered data on functional status, quality
and length of life, tolerability of treatment, and relief
of symptoms in formulating guideline recommendations. Cost
was not explicitly considered in the guideline development
process. Data on these outcomes were informally weighted,
without the use of explicit decision analysis or other modeling.
The values placed on types of outcomes varied with clinical
scenarios. For example, in some situations they considered
life expectancy, such as the effects of early detection.
In other situations they weighed quality of life more heavily,
such as in palliative care and in interpreting small increases
in life expectancy with chemotherapy for stage IV disease.
RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS
The guideline developer’s grading scheme is a modification
of the US Preventive Services Task Force (USPSTF) grades
to allow recommendations for a service when
(1) evidence is poor, (2) the assessment of the net benefit
is moderate to high, and (3) there is consensus among the
expert panel to recommend it. This change was necessary
because, unlike preventive services (i.e., the routine offering
of tests or treatments to well people) in which the burden
of proof is high, clinical decisions about the treatment
of patients with lung cancer often must be based on an interpretation
of the available evidence, even if it is of poor quality.
This adaptation distinguished between interventions with
poor evidence for which there is consensus (grade C) and
interventions with poor evidence for which there is not
consensus (grade I).
Grades of Recommendations and Estimates of Net Benefit
The grade of the strength of recommendations is based on
both the quality of the evidence and the net benefit of
the service (i.e., test, procedure, etc).
Grade A The panel strongly recommends that
clinicians routinely provide [the service] to eligible patients.
An "A" recommendation indicates good evidence
that [the service] improves important health outcomes and
that benefits substantially outweigh harms.
Grade B The panel recommends that clinicians
routinely provide [the service] to eligible patients. A
"B" recommendation indicates at least fair evidence
that [the service] improves important health outcomes and
concludes that benefits outweigh harms.
Grade C The panel recommends that clinicians
routinely provide [the service] to eligible patients. A
"C" recommendation indicates that there was consensus
among the panel to recommend [the service] but that the
evidence that [the service] is effective is lacking, of
poor quality, or conflicting, or the balance of benefits
and harms cannot be reliably determined from available evidence.
Grade D The panel recommends against clinicians
routinely providing [the service]. A "D" recommendation
indicates at least fair evidence that [the service] is ineffective
or that harm outweighs benefit.
Grade I The panel concludes that the evidence
is insufficient to recommend for or against [the service].
An "I" recommendation indicates that evidence
that [the service] is effective is lacking, of poor quality,
or conflicting, and the balance of benefits and harms cannot
be determined, and that the panel lacked a consensus to
recommend it.
Net Benefit
The levels of net benefit are based on clinical assessment.
Estimated net benefit may be downgraded based on uncertainty
in estimates of benefits and harms.
Substantial Benefit: Benefit greatly outweighs
harm
Moderate Benefit: Benefit outweighs harm
Small/weak Benefit: Benefit outweighs harm
to a minimally clinically important degree
None/negative Benefit: Harms equal or outweigh
benefit, less than clinically important.
COST ANALYSIS
A formal cost analysis was not performed and published cost
analyses were not reviewed.
METHOD OF GUIDELINE VALIDATION
Peer Review
DESCRIPTION OF METHOD OF GUIDELINE VALIDATION
After extensive review within the expert panel and executive
committee, the guidelines were reviewed and approved by
the American College of Chest Physicians (ACCP) Health and
Science Policy Committee and then by the American College
of Chest Physicians Board of Regents.
RECOMMENDATIONS
MAJOR RECOMMENDATIONS
Each recommendation is rated based on the levels of evidence
(good, fair, poor), net benefit (substantial, moderate,
small/weak, none/negative), and the grades of the recommendations
(A, B, C, D, I). Definitions are presented at the end of
the "Major Recommendations" field.
1. For all individuals, smoking prevention should be strongly
encouraged to decrease the risk of lung cancer. Level of
evidence, good; benefit, substantial; grade of recommendation,
A
2. For all individuals, school-based and community-based
interventions that are aimed at reducing tobacco exposure
should be recommended, including a "life skills training"
approach that is aimed at reducing tobacco, alcohol, and
illicit drug use, campaigns with brief recurring antismoking
messages, high tobacco excise taxes, and restrictions on
smoking in the workplace. Level of evidence, good; benefit,
substantial; grade of recommendation, A
3. Smokers should be identified as smoking cessation reduces
the risk of lung cancer. Level of evidence, good; benefit,
substantial; grade of recommendation, A
4. Current smokers should be advised to quit smoking, and,
when appropriate, clinicians should prescribe and monitor
pharmacotherapy. Individuals who smoke and want to quit
also should have access to psychosocial treatment and behavioral
modification therapies as indicated. There is sufficient-to-strong
evidence that indicates these practices will help to increase
long-term smoking abstinence rates. Level of evidence, good;
benefit, substantial; grade of recommendation, A
5. Individuals who are at risk for lung cancer and were
treated with beta-carotene, retinol, isotretinoin, or N-acetyl-cysteine
for lung cancer prevention did not experience clinical benefit.
There is also evidence that the use of beta-carotene and
isotretinoin for lung cancer chemoprevention in high-risk
individuals may increase the risk for lung cancer, especially
in individuals who continue to smoke. These agents should
not be used outside of a clinical trial for primary, secondary,
or tertiary lung cancer prevention. Level of evidence, good;
benefit, harmful; grade of recommendation, D
6. For individuals at risk for lung cancer and for patients
with a history of lung cancer there are not yet sufficient
data to recommend the use of any agent either alone or in
combination for primary, secondary, or tertiary lung cancer
chemoprevention outside of a clinical trial. Level of evidence,
insufficient; benefit, lacking data; grade of recommendation,
I
Definitions:
Levels of Evidence
In general, good evidence included prospective, controlled,
randomized clinical trials, and poor evidence included case
series and clinical experience. Trials with fair quality
of evidence, for instance, historically controlled trials
or retrospective analyses, were somewhere in between.
Grades of Recommendations
Grade A The panel strongly recommends that clinicians routinely
provide [the service] to eligible patients. An "A"
recommendation indicates good evidence that [the service]
improves important health outcomes and that benefits substantially
outweigh harms.
Grade B The panel recommends that clinicians routinely provide
[the service] to eligible patients. A "B" recommendation
indicates at least fair evidence that [the service] improves
important health outcomes and concludes that benefits outweigh
harms.
Grade C The panel recommends that clinicians routinely provide
[the service] to eligible patients. A "C" recommendation
indicates that there was consensus among the panel to recommend
[the service] but that the evidence that [the service] is
effective is lacking, of poor quality, or conflicting, or
the balance of benefits and harms cannot be reliably determined
from available evidence.
Grade D The panel recommends against clinicians routinely
providing [the service]. A "D" recommendation
indicates at least fair evidence that [the service] is ineffective
or that harm outweighs benefit.
Grade I The panel concludes that the evidence is insufficient
to recommend for or against [the service]. An "I"
recommendation indicates that evidence that [the service]
is effective is lacking, of poor quality, or conflicting,
and the balance of benefits and harms cannot be determined,
and that the panel lacked a consensus to recommend it.
Net Benefit
The levels of net benefit are based on clinical assessment.
Estimated net benefit may be downgraded based on uncertainty
in estimates of benefits and harms.
Substantial Benefit: Benefit greatly outweighs
harm
Moderate Benefit: Benefit outweighs harm
Small/weak Benefit: Benefit outweighs harm
to a minimally clinically important degree
None/negative Benefit: Harms equal or outweigh
benefit, less than clinically important.
CLINICAL ALGORITHM(S)
None provided
EVIDENCE SUPPORTING THE RECOMMENDATIONS
TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS
The type of supporting evidence is identified and graded
for each recommendation (see "Major Recommendations").
BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
POTENTIAL BENEFITS
Of the many strategies that might be considered for reducing
lung-specific cancer risks, only smoking prevention and
cessation has been shown to reduce lung cancer risk. Although
the focus of this guideline is on the chemoprevention of
lung cancer, it is primary prevention (i.e., smoking prevention)
that should be a major focus within our society including
local communities, schools from kindergarten through college,
and among persons in the medical profession. Strategies
that have been the most successful in preventing children
from starting to smoke include all-grade inclusive school
programs that emphasize a "life skills training approach,"
the use of brief recurring antismoking messages that point
out the positive aspects of being nicotine-free, and the
enforcement of high excise taxes on tobacco products. For
current smokers, there is strong evidence that brief recurring
physician advice significantly increases long-term smoking
abstinence rates. Clinician-based approaches should always
include the routine identification of tobacco users, which
in turn increases the rate of clinician intervention with
patients who smoke.
POTENTIAL HARMS
Not stated
IMPLEMENTATION OF THE GUIDELINE
DESCRIPTION OF IMPLEMENTATION STRATEGY
1. The American College of Chest Physicians (ACCP) is developing
a set of PowerPoint slide presentations for physicians to
download and use for physician and allied health practitioners
education programs.
2. The ACCP is developing a Quick Reference Guide (QRG)
in print and PDA formats for easy reference.
INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE
QUALITY REPORT CATEGORIES
IOM CARE NEED
Staying Healthy
IOM DOMAIN
Effectiveness
IDENTIFYING INFORMATION AND AVAILABILITY
BIBLIOGRAPHIC SOURCE(S)
· Dragnev KH, Stover D, Dmitrovsky E. Lung cancer
prevention: the guidelines. Chest 2003 Jan;123(1 Suppl):60S-71S.
[81 references] PubMed
ADAPTATION
Not applicable: The guideline was not adapted from another
source.
DATE RELEASED
2003 Jan
GUIDELINE DEVELOPER(S)
American College of Chest Physicians - Medical Specialty
Society
GUIDELINE DEVELOPER COMMENT
The guideline development panel was composed of members
and nonmembers of the American College of Chest Physicians
(ACCP) who were known to have expertise in various areas
of lung cancer management and care, representing multiple
specialties from the following 13 national and international
medical associations:
· Alliance for Lung Cancer Advocacy, Support, and
Education (a patient support group)
· American Association for Bronchology
· American Cancer Society
· American College of Physicians
· American College of Surgeons Oncology Group
· American Society of Clinical Oncology
· American Society for Therapeutic Radiology and
Oncology
· American Thoracic Society
· Association of Community Cancer Centers
· Canadian Thoracic Society
· National Comprehensive Cancer Network
· Oncology Nursing Society
· Society of Thoracic Surgeons
The specialties included pulmonary/respiratory medicine,
critical care, medical oncology, thoracic surgery, radiation
oncology, epidemiology, law, and medical ethics.
SOURCE(S) OF FUNDING
Funding for both the evidence reviews and guideline development
was provided through an unrestricted educational grant from
Bristol-Myers Squibb, which had no other role in the evidence
review or guideline development process or content.
GUIDELINE COMMITTEE
American College of Chest Physicians (ACCP) Expert Panel
on Lung Cancer Guidelines
COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE
Primary Authors: Konstantin H. Dragnev, MD; Diane Stover,
MD, FCCP; Ethan Dmitrovsky, MD
FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST
Information about potential conflicts of interest were collected
from each member of the expert panel or writing committee
at the time of their nomination in accordance with the policy
of the American College of Chest Physicians. Information
on conflicts of interest for each panelist is listed in
the guideline.
GUIDELINE STATUS
This is the current release of the guideline.
GUIDELINE AVAILABILITY
Electronic copies: Available to subscribers of Chest - The
Cardiopulmonary and Critical Care Journal.
Print copies: Available from the American College of Chest
Physicians, Products and Registration Division, 3300 Dundee
Road, Northbrook IL 60062-2348.
AVAILABILITY OF COMPANION DOCUMENTS
The following are available:
Evidence Summary:
· Kelley MJ, McCrory DC. Prevention of lung cancer:
summary of published evidence. Chest 2003 Jan;123(1 Suppl):50S-59S.
Background Articles:
· Alberts WM. Lung cancer guidelines. Introduction.
Chest 2003 Jan;123(1 Suppl):1S-2S.
· McCrory DC, Colice GL, Lewis SZ, Alberts WM, Parker
S. Overview of methodology for lung cancer evidence review
and guideline development. Chest 2003 Jan;123(1 Suppl):3S-6S.
· Harpole LH, Kelley MJ, Schreiber G, Toloza EM,
Kolimaga J, McCrory DC. Assessment of the scope and quality
of clinical practice guidelines in lung cancer. Chest 2003
Jan;123(1 Suppl):7S-20S.
· Alberg AJ, Samet JM. Epidemiology of lung cancer.
Chest 2003 Jan;123(1 Suppl):21S-49S.
Electronic copies: Available to subscribers of Chest - The
Cardiopulmonary and Critical Care Journal.
Print copies: Available from the American College of Chest
Physicians, Products and Registration Division, 3300 Dundee
Road, Northbrook IL 60062-2348.
PATIENT RESOURCES
None available
NGC STATUS
This NGC summary was completed by ECRI on June 30, 2003.
The information was verified by the guideline developer
on July 25, 2003.
COPYRIGHT STATEMENT
This NGC summary is based on the original guideline, which
is subject to the guideline developer's copyright restrictions.
http://www.guideline.gov/
summary/summary.aspx?
ss=15&doc_id=3636&nbr=2862
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