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Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines |

Methodology for Development of Guidelines for Lung CancerMethodology for Developing Lung Cancer Guideline: Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines FREE TO VIEW

Sandra Zelman Lewis, PhD; Rebecca Diekemper, MPH; Doreen J. Addrizzo-Harris, MD, FCCP
Author and Funding Information

From the American College of Chest Physicians (Dr Lewis and Ms Diekemper), Northbrook, IL; and the Pulmonary Division (Dr Addrizzo-Harris), New York University School of Medicine, New York, NY.

Correspondence to: Sandra Zelman Lewis, PhD, American College of Chest Physicians, 3300 Dundee Rd, Northbrook, IL 60062; e-mail: slewis@chestnet.org


Funding/Sponsors: The development of this guideline was supported primarily by the American College of Chest Physicians. The lung cancer guidelines conference was supported in part by a grant from the Lung Cancer Research Foundation. The publication and dissemination of the guidelines was supported in part by a 2009 independent educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.

COI grids reflecting the conflicts of interest that were current as of the date of the conference and voting are posted in the online supplementary materials.

Disclaimer: American College of Chest Physician guidelines are intended for general information only, are not medical advice, and do not replace professional medical care and physician advice, which always should be sought for any medical condition. The complete disclaimer for this guideline can be accessed at http://dx.doi.org/10.1378/chest.1435S1.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2013;143(5_suppl):41S-50S. doi:10.1378/chest.12-2344
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Background:  The objective was to develop high-quality and comprehensive evidence-based guidelines on the diagnosis and management of lung cancer.

Methods:  A carefully crafted panel of lung cancer experts, methodologists, and other specialists was assembled and reviewed for relevant conflicts of interest. The American College of Chest Physicians guideline methodology was used. Population, intervention, comparator, outcome (PICO)-based key questions and defined criteria for eligible studies were developed to inform the search strategies, subsequent evidence summaries, and recommendations. Research studies, systematic reviews, and meta-analyses, where they existed, were assessed for quality and summarized to inform the recommendations.

Results:  Each recommendation was developed with supporting evidence and the consensus of the writing committees. Controversial recommendations were identified for further consultation by the entire panel, with anonymous voting to achieve consensus.

Conclusions:  The final recommendations can be trusted by health-care providers, patients, and other stakeholders since they are based on the current evidence in these areas and were developed with trustworthy processes for guideline development.

Figures in this Article

The American College of Chest Physicians (ACCP) strives to develop the most trustworthy clinical practice guidelines in chest medicine, following widely endorsed standards.1,2 Thus, this third edition of the Diagnosis and Management of Lung Cancer: ACCP Evidence-Based Clinical Practice Guidelines (LC III) improves upon the methodology and brings additional enhancements over past iterations.35

Target Audience

The main objective of these guidelines is to inform the clinical decisions that must be jointly made by physicians and patients in developing diagnostic, treatment, and management plans so that they can enhance the benefits and reduce the harms associated with various options. Thus, the main audiences for these guidelines include both patients and physicians. Comprehensive guidelines such as these are intended for a multidisciplinary readership, including primary care, medical, and surgical specialists, plus nursing and allied health professionals. Additional audiences include researchers from basic scientists to clinical investigators and the funders of that research, so the topic editors have included sections in each article that point out the evidence gaps where forthcoming research is greatly requisite to provide evidence-based guidance in the future.

Scope

The breadth of these guidelines has also evolved over the three editions. With increasingly greater success in tobacco treatment approaches, the LC III Executive Committee determined that an entire article should be dedicated to helping physicians, nurses, and treatment counselors help their patients with lung cancer stop using tobacco.6 Staging lung cancer has become increasingly complex, so the previous differentiation between invasive and noninvasive staging, now more closely integrated, permitted the merging of these into one article.7 The distinction between stage IIIA and stage IIIB disease remains, but the treatment approaches overlap such that these two articles in the second edition are now combined into one for this third edition.8 An area of increased focus this time is bronchial intraepithelial neoplasia or early central airway tumors. Bronchioloalveolar carcinoma, on the other hand, is now recognized to be a problematic term because it has been used to refer to many different entities. Therefore, this has been dropped as a separate article, and entities previously included as bronchioloalveolar carcinoma are discussed in several different articles (staging,9 bronchial intraepithelial neoplasia,10 and stage I and II articles11).

1.1 Panel Composition and Responsibilities

A call for applications to serve on the LC III guidelines panel was put forth to the ACCP membership, to past panelists, and to other organizations that have previously endorsed earlier editions of these guidelines or appointed representatives to serve on those panels. Guiding the team was the LC III Executive Committee, composed of a Panel Chair, Vice Chair, Liaison to the Guidelines Oversight Committee (GOC), and two staff members, one serving as an adviser and the other as the lead methodologist. The GOC appointed the Liaison and the Chair, who was required to be free of conflicts of interest (COI). This Executive Committee provided general oversight and guidance; multiple reviews of research questions, article outlines, manuscripts, evidence tables, and other supporting documents; and facilitation of the final conference discussions and voting.

As the scope was defined, content experts in each major area were identified to serve as topic editors and nominated by the Panel Chair to be advanced to the GOC for the requisite qualifications and COI review and approval process. These topic editors organized their research and writing teams, oversaw the work of the individual members, edited separate contributions into synthesized manuscripts, presented evidence at the final conference, and managed any of their committee members who were approved with management stipulations relevant to their COIs.

Each topic editor was initially charged with proposing individuals to support their topic committees with expertise in the content area and/or methodology. With the Chair’s approval, these individuals were nominated for GOC reviews for COI and expertise. In some cases, GOC staff helped to locate additional methodologic support when it was determined to be necessary for various article committees. This resulted in an international panel of > 100 multidisciplinary experts across 24 articles representing the fields of pulmonary medicine, critical care medicine, thoracic surgery, medical and radiation oncology, pathology, integrative medicine, primary care, health-care research, guidelines methodology, and epidemiology.

Nineteen international organizations that are also dedicated to advancing research and practice in the area of lung cancer were invited to appoint representatives to this guideline project as adjunct participants. These individuals, unless already approved panelists, were not considered full voting members of the panel, since they had not been through the same ACCP COI review, but were included at the final conference, participated fully in the discussions, and provided external review and feedback on the manuscripts and supporting documentation.

1.2 COI Review and Approvals

Guidelines are an important foundation for clinical decision-making and quality improvement efforts in health care. However, evaluation of the underlying evidence can be subject to interpretation and judgment. Even the perception of bias, whether real or not, can undermine the careful work of the panel if it causes the end users to have less trust in the guidelines. Therefore, a careful screening, evaluation, and resolution of nominees’ COIs is important to assure readers of the trustworthiness of the final product.1,12

Nominees were required to provide curriculum vitae, statements of interest, and completed COI disclosure forms. Nominees were required to disclose the following types of conflicts:

  • All research grants (regardless of funding source, restricted or unrestricted)

  • Remunerations for patient enrollment in clinical trials or other aspects of research

  • Royalties or in-kind benefits from industry (eg, travel)

  • Stock or share ownerships

  • Paid employment or officer positions

  • Consultancies

  • Speakers bureau participation

  • Advisory board service

  • Patent rights or pending applications

  • Testimony as a legal expert

  • Public statements relevant to the assigned topic

  • Anything else that could affect the perception by others of one’s objectivity or independence

With facilitation by staff, the GOC Policies and Procedures Subcommittee carefully reviewed each individual for both qualifications and COIs. Following the GOC Policy for Authorship, each nominee was evaluated for their expertise and ability to meaningfully contribute to the role for which they were nominated. Although the subcommittee members were not asked to become COI investigators, the primary reviewer and chair searched the curriculum vitae, institutional websites, and ProPublica.org for conflicts not disclosed on the COI form. The subcommittee then made a recommendation on each nominee to the full GOC body, which had the final authority to approve, disapprove, or approve the individuals with management. Individuals accepted with management were allowed to participate at various levels. These caveats often included disallowing drafting and voting on recommendations and grading for recommendations related to the COIs, quarterly reporting and preauthorization of any future activities that might be deemed to have COI consequences, and review of all written work on these guidelines by the topic editors and members of the Executive Committee to ensure no biases were introduced. All panelists, with and without management, were required to sign Panel Member Agreement Forms, which among other obligations require the panelists to refrain from any marketing talks or activities funded by marketing budgets (as opposed to research and development budgets, which is allowed) for the duration of the guideline project and 1 year postpublication. In LC III, 119 individuals were nominated, 112 were approved, nine of those with management (one of whom preferred to step down rather than refrain from promotional talks), and seven were disallowed participation on the project.

All panelists were required to update their COIs before each meeting (Executive Committee members before each biweekly call) and at the time of submission for publication. The COI grids that illustrated each panelist’s conflict status relative to each recommendation were used at the time of the conference and are published along with the supplementary materials, as they reflect COI status at the time of the voting.

Although there was not explicit management of intellectual conflicts, as in some ACCP guidelines,13 the idea was considered by the GOC. Based on the Executive Committee’s input, consideration of intellectual conflicts was not considered as necessary for this particular set of guidelines.

1.3 Funding

No honoraria were paid to any members of the panel for their work on these guidelines. There was, however, one contracted methodologist who reviewed the literature in the surgical pathology, diagnosis, and stage IV articles, reviewed early drafts, and participated in the conference online to help ensure the recommendations followed the evidence.

The ACCP no longer accepts funding from industry, but at the time this project began, the policy was different. One private foundation and one pharmaceutical company contributed to the development and dissemination of these guidelines. The vast majority of the funding was from the ACCP Board of Regents. This was the last of the ACCP guidelines to accept any industry funding, but secure firewalls were maintained. The sponsoring companies were not allowed to participate in the guideline process in any way. They could not know the scope, who served on the panel, or the research questions being investigated. Sponsors could not attend any calls or meetings (nor did they know anything about when, where, or even that they took place) and were not permitted to see any minutes, notes, or drafts of the manuscripts except the final published version. The panelists and members of the GOC did not know who the sponsors were until it was printed in the final publication. The only communication between the sponsoring companies and the ACCP took place within the Division of Business Development, on the opposite side of the firewall from the Clinical Education, Informatics, and Research Division, in which the guidelines staff work.

No other organizations provided any funding for development or dissemination purposes. There were, as noted above, representatives appointed by other organizations to serve as conference participants and external reviewers, whose travel and accommodations were funded by their own organizations. The only exception was if these representatives were already GOC-approved panelists for these guidelines, in which case ACCP paid travel expenses for them to attend the conference.

1.4 Organization of the Guidelines

There are several changes from the second edition of these guidelines. The ACCP guideline methodology has changed considerably with a more robust population, intervention, comparator, and outcome (PICO)-based systematic review process, more rigorous assessment of both the individual study quality and that of the complete body of literature relative to a given outcome, standardization of tables where evidence and resources existed, and a more rigorous COI approach, as described previously.

Using the systematic evidence review methodology resulted in one or more recommendations for each PICO question, which is associated with a defined body of evidence. In this third edition of the ACCP Lung Cancer Guidelines, the sections of text, recommendations, and supporting tables are numbered to help the reader follow the specific background information that relates to each recommendation. This system, used in other ACCP guidelines,14 helps readers drill down to find more detail about how the panelists derived the recommendations. So a recommendation numbered 3.4.1 would relate to the narrative section labeled 3.4.1 and a figure will reference that section in the caption. In the table of PICO questions, the PICO question numbered 3.4.1 would be the question that ultimately resulted in recommendation 3.4.1. There are some recommendations for which the PICO-based approach was not applicable, but these recommendations and their associated section of text are also linked by the numbering system.

2.1 Defining the Research Questions and Search Strategies

Panelists received online training (R. L. Diekemper, MPH; J. Ornelas, PhD; S. Z. Lewis, PhD, Educational Program for Conducting an Evidence Review, unpublished data, 2011) in the more rigorous methodology used by the ACCP in recent years to conduct comprehensive and systematic evidence reviews, meta-analyses, and construction of evidence tables and evidence profiles. The topic editors and their committees then drafted the evidence questions using a PICO format whenever possible (patient population/intervention/comparator or control group/outcome). Outcomes were restricted to those that are patient important, not simply research focused. Methodologists and members of the Executive Committee reviewed each question and helped the content experts further develop and refine them. Then inclusion and exclusion criteria were produced to help guide the search for relevant clinical evidence, mostly in the form of original research or systematic reviews. Original research included all levels of evidence (randomized controlled trials [RCTs] as well as observational studies) as long as they appeared in peer-reviewed publications, the minimal threshold. These PICO questions can be accessed in the online supplementary materials for each content article.

The PICO questions then informed the search strategies. In addition to key terms from the PICO questions, synonyms and standardized subject headings (MeSH terms) were included. Topic panelists conducted their literature searches in at least two electronic databases, including Medline (PubMed or Ovid) and another database of their choice (Cochrane Library, Google Scholar, National Guidelines Clearinghouse, EMBASE, Scopus, Web of Science, and so forth). Searches were not limited by publication date unless it was determined by the article panelists that it was appropriate to do so (eg, because of a prior search that was used to inform the second edition of the ACCP Lung Cancer Guidelines). Any deviations from these details are noted in the methodology sections of the specific articles. Title and abstract screenings were performed by the content expert(s) and methodologists, as assigned. If additional studies were identified, they were retrieved for further consideration.

2.2 Assessment of Study Quality

Systematic reviews and meta-analyses were assessed using Documentation and Appraisal Review Tool (DART) DART (R. L. Diekemper; B. K. Ireland, MD; and L. R. Merz, PhD, MPH, Documentation and Appraisal Review Tool, unpublished data, 2012), which was developed as an improved alternative to the existing tools15,16 for use in a clinical setting. However, this tool has been adopted for use in ACCP guidelines and consensus statements since 2011.

Quality was assessed for each study as well as for the body of relevant evidence. Based on the PICO questions and volume of available literature, multiple study designs were included in the systematic reviews of the literature. RCTs primarily indicate benefits, but whenever observational studies met inclusion criteria they were often helpful in identifying harms. Observational studies were also examined when RCTs were not available to answer a particular PICO question. Allowing for multiple study designs resulted in the need for multiple quality assessment tools. Tools were chosen for assessing RCTs, observational studies, and diagnostic studies. The quality assessment tool for RCTs (R. L. Diekemper, B. K. Ireland, and L. R. Merz, unpublished data, 2012) was used for assessing the quality of RCTs, and a tool developed by the committee of the ninth edition of the Antithrombotics Guidelines was used for assessing the quality of observational studies.14 Diagnostic studies were assessed using the QUADAS tool.17

2.3 Meta-analyses

If a recently published good-quality meta-analysis was available, then it was used to inform the recommendations. When a good-quality meta-analysis was not available, guideline authors were encouraged to perform their own meta-analyses. Meta-analyses were performed when the data were fairly homogeneous. If a study was deemed poor quality, then it was not included in the pooled analysis. Heterogeneity of the pooled results was assessed using a χ2 test and Higgins I2, and a forest plot was examined for consistency of the results. The random effects model was chosen a priori as the appropriate model for pooling the data because it accounts for heterogeneity among the included studies. Results from the meta-analyses are available in the supplementary materials that can be downloaded from the Journal website under the corresponding article in the table of contents.

2.4 Summary Evidence Tables and Profiles

Guideline panelists were given the option of producing evidence tables or evidence profiles to present the data from the studies included in their reviews. Because of limited resources, it was not always possible to create evidence profiles for each PICO question. Evidence tables present data on individual studies, whereas evidence profiles present pooled data on each outcome examined and allow the reviewer to assess the quality of the body of evidence for each outcome. Evidence tables and evidence profiles are available in the supplementary materials that can be downloaded from the Journal website under the corresponding article in the table of contents.

Evidence table templates were produced a priori and given to the guideline panelists to tailor to their specific PICO questions. The evidence tables, designed to present data on each study included in the review, provide information about the study design, study setting, population, intervention, comparison group, outcomes measured, results, and overall quality assessment for each included study. Most of the articles used evidence tables to summarize the data from these studies.

Evidence profiles were produced using the GRADEpro (GRADEprofiler) software, which was modified by the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) working group specifically for the ACCP. The ACCP-modified GRADEpro software ranked the quality of the body of evidence using three categories (high, moderate, and low) as opposed to the four categories (high, moderate, low, and very low) used by the GRADEpro software. The body of evidence was summarized by outcome for each PICO question and was assessed based on risk of bias, precision, consistency, directness, and publication bias. Evidence profiles include a quality assessment table, which summarizes the quality of the body of evidence, and a summary of findings table, which includes the relative and absolute effect for each critically important outcome.

3.1 Formulating the Recommendations

In most cases the topic editors, along with the other completely nonconflicted members of the article committee, formulated the recommendations. The summarized evidence tables and profiles (where profiles existed) provided the foundation for the recommendations. In formulating the recommendations, panelists considered not only the body of evidence but also the balance between the benefits and harms and considerations of other factors, such as cost or resource availability considerations and patient values and preferences, which might vary widely for some recommendations. These additional considerations are described in a Remarks section, which appears just below the relevant recommendation in the publication, each time the recommendation appears.

3.2 Grading the Recommendations

Recommendations that are strong must be differentiated from those that are weak or weaker. Thus, the ACCP Grading System18,19 (Table 1) was used, and the wording of the recommendations is explicit. This grading system has been used since 2005 and is based on two dimensions: the balance of benefits to harms and the quality of the evidence base.

Table Graphic Jump Location
Table 1 —Strength of the Recommendations Grading System

If the benefits clearly outweigh the harms or the harms clearly outweigh the benefits, the strength of the recommendation is considered strong and graded as a 1. In most cases, when there is strong confidence that the benefits outweigh the harms, most patients would choose the intervention endorsed in that recommendation. However, when the tradeoffs between desirable and undesirable consequences are not as clear, variability in patient preferences and values often becomes germane to the decision-making conversation. Weak recommendations are those for which the benefits and harms are more equally balanced, and thus a clear choice is not as obvious; these are graded with a 2. Strong recommendations are phrased, “we recommend,” whereas weak recommendations are phrased “we suggest.”

Accompanying these indications of the strength of a recommendation is a letter score (A, B, or C) representing the grading of the body of relevant literature. In grading the quality of the evidence, RCTs start with a high score but might be downgraded to moderate or even low based on the following criteria: limitations in the study design or conduct of the trial, imprecision, indirectness relative to the specifics of the PICO question, inconsistency in the results, and risk of reporting bias. Observational studies, on the other hand, start off as low-level evidence but can be upgraded to moderate or even high if exceptionally large and consistent treatment effects increase confidence in the findings, especially if there is a strong dose-response gradient.

The final grades are combinations reflecting the strength of the recommendation and the quality of the evidence. Strong recommendations with high-quality evidence, grade of 1A, are less common than in past editions of these guidelines, since the evidence is assessed with greater rigor for most topics, and few studies without important limitations are available. However, recommendations that do attain this score are those for which the panel could state with confidence that new studies would be unlikely to change the direction of the effect. These recommendations apply to most patients in most circumstances. But as the grades decline, patient values and preferences likely would play an increasingly greater role in determining the best treatments or interventions for each patient.

3.3 The Final Conference

As the evidence reviews were completed and the tables and profiles prepared, the manuscripts and recommendations were drafted. Members of the article committees convened by phone or e-mail to discuss the evidence and work on drafting and grading the recommendations. These discussions generally resulted in agreement on both the quality of the evidence and strength of the recommendations. The manuscripts and supporting tables were then reviewed by members of the Executive Committee and, after several iterations, the revised versions were shared among all panelists and the representatives of invited organizations in advance of the conference. The other panelists and representatives were asked not only to provide feedback but also to review the recommendations to identify any controversies. A recommendation was deemed to be controversial if at least one person disagreed with the wording or the grading, if there was controversy in practice, if there were wide variations in practice, or if at least one person asked that it be discussed among the broader panel and association representatives. These identified controversies composed the main agenda for the conference.

Fiscal constraints did not permit all panelists to attend the conference in person, so a virtual meeting was provided in which panelists could see and hear the presentations, participate in the discussions via a monitored chatroom, and vote on the recommendations. Voting on the recommendations was synchronized such that the in-person attendees and the virtually participating attendees were able to vote as a group simultaneously and anonymously. Final vote tallies are available upon request, but it is not possible to associate individual votes with individual panelists. Association representatives were not permitted to vote unless they were approved panelists, since they did not pass through the COI review process. Panelists who were approved with management were not permitted to vote on any recommendations for which they had relevant conflicts. To keep track of conflicts relative to the recommendations, a COI grid (Fig 1) was prepared by the topic editors for each article committee. These grids were shared with all members of the panel and the association representatives during the conference so that managed conflicts would be transparent. Because these conflicts were relevant at the time of the conference voting, these are the grids published as online supplements to the various articles. The conflicts disclosed at the time of the submission for publication are the narrative summaries.

Figure Jump LinkFigure 1. This conflict of interest (COI) grid was used to document existing COIs of panelists who were approved with management and supervise their voting privileges on a recommendation-by-recommendation basis. Some topic editors used color-coding to facilitate instantaneous monitoring.Grahic Jump Location

In advance of the conference, the controversial recommendations were identified, as described previously. During the conference, panelists representing both sides of any controversies were provided with time to make their case but encouraged to base it on the results of the evidence review. After the formal presentations, each controversy was opened for discussion by all in-person and virtual attendees. All attendees were permitted to participate in the discussions, but only approved panelists who did not have relevant conflicts were permitted to vote. The voting procedure used the GRADE grid20 for achieving consensus on the recommendations and their grades. Based on the a priori determination of the Executive Committee and standard ACCP policies, at least 80% of those voting were required to vote in favor of a recommendation for it to be approved as achieving consensus. If there were recommendations for which 80% consensus could not be achieved, the ACCP policy was followed allowing for a recommendation with 67% to 79% agreement to be published and an “additional consideration” section drafted by those panelists voting in the minority against recommendation. Any drafted recommendations that did not achieve a 67% consensus were not included in the publication. The only exceptions to this development and approval process are the recommendations regarding lung cancer screening using low-dose CT (LDCT) scanning. The ACCP had partnered with other organizations and conducted a multisociety collaborative for the evidence review and development of a guideline for LDCT screening.21 All recommendations were approved through all societies in this collaborative. This initiative coincided with the development of LC III; therefore, it was decided that the multisociety process for the evidence review, guideline development, and approval would also represent the process for LC III for LDCT screening. The multisociety paper and recommendations, which were published shortly before the LC III panel conference, were nevertheless reviewed and discussed at the conference.

At the end of the conference, there were still a number of recommendations that were not ready for panel discussion and voting, some of which were sent back to the article committees for significant revisions. These were brought to the full panel on a post-conference webinar 1 month after the in-person conference. All recommendations were discussed and voted upon using the same process as at the conference, except that polling was used for the webinar. Nonetheless, the voting was still anonymous. At the end of the meeting, there was one recommendation that was voted upon, but it was generally agreed that because of attrition and a technology malfunction, the recommendation should be revoted upon using an online survey. This and three other recommendations that had not been available in revised form were voted on and approved through a SurveyMonkey poll that was sent to the entire panel (but not to the association representatives this time, as the discussion had already taken place and the representatives did not have voting privileges). All final tallies are available upon request.

Final article revisions were made within the subsequent 2 weeks in preparation for the ACCP review process. The Executive Committee did conduct a final review during this time to ensure consistency, completeness, and thoroughness of the manuscripts before approving each article for ACCP review.

3.4 Internal and External Peer Review

Once Executive Committee approval was received, the articles were submitted to ACCP staff for several layers of review. All reviewers were required to undergo a full COI appraisal before being approved. In the first round of reviews, the Thoracic Oncology NetWork reviewed the content of the manuscripts and the members of the GOC assessed the manuscripts for adherence to the methodology and conformance with the evidence. The ACCP President also appointed members of the Board of Regents to evaluate the guidelines in depth. All comments were collated into spreadsheets to ensure that they were appropriately answered. GOC and board reviewers discussed each comment and determined which should be mandatory for the authors to amend and which were provided as suggestions for improvement. All reviews and comments were anonymous, and authors were required to respond to all mandatory issues either by revising the manuscripts or providing written justification explaining why they did not agree with the reviewers’ comments.

The revised manuscripts were submitted for round II review, simultaneously with the Journal peer review. Once the GOC and board reviewers approved the manuscripts, the ACCP President, President Elect, President Elect Designee, and Immediate Past President reviewed the guidelines. Approval was granted pending confirmation from the Board of Regents, before submission to the journal for final review by the Journal Editor.

In addition to this extensive review process, which included nearly 30 individual reviewers from the ACCP leadership, external organizations were provided with opportunities to provide feedback before, during, and just after the conference. This final version was submitted for consideration for endorsement to all of the invited organizations, whether or not they sent representatives to the conference. However, once the guidelines were approved by the ACCP Board of Regents, no further changes were accepted. Organizations that provided endorsements are listed in each article.

3.5 Patient Values and Preferences

Clinical practice guidelines are meant to inform the physician-patient decision-making process with the best available assessment of the evidence. However, for any individual patient, values and preferences become relevant, and not all patients will choose the recommended courses of treatment or diagnostic strategies in the guidelines. Values and preferences are more likely to be variable when there are weak recommendations. By definition, recommendations are most likely strong when most patients under most circumstances would make the same choices. When values and preferences were strong factors, authors noted this in the Remarks section below the recommendation.

3.6 Resource Considerations

ACCP guidelines include consideration of resources in recommendations under selected circumstances.22 If it is likely that resource considerations would impact the direction or strength of a recommendation, a search for cost-effectiveness studies may have been conducted. Most recommendations in these guidelines do not include a full assessment of resource considerations. However, they can be adapted to middle- and low-income countries using the ADAPTE strategies.23

3.7 Limitations

Although the ACCP is moving toward the production of evidence profiles for all guideline recommendations, there were many recommendations for which profiles were not developed, mostly because of resource constraints. When possible, methodologists created evidence profiles, and all panelists were educated on how to read and interpret them. The PICO-based systematic literature review process was followed for most recommendations, but there were some that could have benefited from meta-analyses.

One limitation of all guidelines today is that they are not able to adequately address complex patients with multiple morbidities. This is largely because these patients are generally excluded from clinical trials and are often not included in observational studies. Since guidelines are reliant on evidence published in the peer-reviewed literature, the scientific foundation impedes the process of providing good guidance for these patients and is a limitation in these guidelines. Therefore, the ACCP encourages funding agencies to ensure that topics with limited evidence are addressed in future research.

These guidelines are widely disseminated through the CHEST journal publication, National Guidelines Clearinghouse, and Guidelines International Network library. Additional clinical resources will soon be available to users of CHEST Evidence, an upcoming tool for searching the content of ACCP guidelines. Patient education guides will be posted on The CHEST Foundation’s OneBreath.org website.

As the expanding research into diagnostic techniques and treatment options continues to evolve, the guidelines must be updated and kept current. This edition of the ACCP Lung Cancer Guidelines will be the last to be published as a complete collection, as the ACCP is now embarking on a new living guidelines model (LGM) for revising existing recommendations and developing new recommendations as the literature evolves. This will include a continual assessment of the currency of these recommendations relevant to new research studies as they are published. The review cycle for the ACCP Lung Cancer Guidelines will begin 1 year after publication unless the content experts who monitor the literature bring a recommendation or set of related recommendations to the attention of the GOC, suggesting that those recommendations are in need of updating sooner. The new LGM will permit a more nimble approach to guideline development but also requires a point-of-care accessible vehicle, CHEST Evidence, for the users to readily search for the most current version. These features will be described in greater detail in upcoming publications. As a step in this direction, these guidelines will be published primarily online with a printed version of the Executive Summary, containing all of the recommendations, the introduction, and this article on methodology. All narratives for each article with their supporting tables, figures, and algorithms will be available online at journal.publications.chestnet.org.

The third edition of the ACCP Lung Cancer Guidelines has been developed using a more explicit and transparent approach to a PICO-based evidence review, assessment of study quality, and evolution of evidence-based recommendations. Adherence to stricter standards for COI guided the composition of a panel at lower risk of introducing any biases into the process. The rigorous reviews ensured balanced and evidence-based results.

This is the last of the comprehensive ACCP Lung Cancer Guidelines that will appear as a complete set. Going forward, PICO questions will be evaluated individually or in small, related groups to identify where new studies have been published that could impact either the direction or strength of the recommendations. Subsequent PICO questions will be developed into new or revised recommendations using the ACCP LGM, which will allow for quicker and more nimble updates of the guidelines. These more current recommendations will be published but will also be readily accessible through a rapid search of CHEST Evidence. Associated clinical resources will also be accessible in CHEST Evidence.

Author contributions: Dr Lewis served as guarantor. The authors on this article all served as members of the LC III Executive Committee.

Dr Lewis: contributed to producing the first draft and was responsible for the final article.

Dr Addrizzo-Harris: contributed as the liaison to the Guidelines Oversight Committee and reviewed and approved the final article.

Ms Diekemper: contributed to sections related to her role as guideline methodologist and reviewed and approved the final article.

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts: Dr Lewis makes public statements and give presentations about the ACCP Guideline Methodology at conferences and other meetings on this topic. Her expenses are sometimes reimbursed. She received one small honorarium ($150) from the Institute of Medicine in 2011. Dr Addrizzo-Harris and Ms Diekemper have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Role of Sponsors: The American College of Chest Physicians was solely responsible for the development of these guidelines. The remaining supporters played no role in the development process. External supporting organizations cannot recommend panelists or topics, nor are they allowed prepublication access to the manuscripts and recommendations. Further details on the Conflict of Interest Policy are available online at http://chestnet.org.

Other contributions: We thank W. Michael Alberts, MD, MBA, FCCP, Chair, and Frank C. Detterbeck, MD, FCCP, Vice Chair, who provided excellent leadership and guidance throughout. We also thank these physician methodologists who were especially helpful in conducting systematic reviews and focusing the emphasis on the evidence: Belinda Ireland, MD; Joseph Ornelas, PhD(c); Gaetane C. Michaud, MD, FCCP; and Alex A. Balekian, MD, MSHS.

Endorsements: This guideline is endorsed by the European Society of Thoracic Surgeons, Oncology Nursing Society, American Association for Bronchology and Interventional Pulmonology, and the Society of Thoracic Surgeons.

ACCP

American College of Chest Physicians

COI

conflict of interest

GOC

Guidelines Oversight Committee

GRADE

Grades of Recommendation, Assessment, Development, and Evaluation

LC III

3rd edition of the American College of Chest Physicians Lung Cancer Guidelines

LDCT

low-dose CT

LGM

living guidelines model

PICO

population, intervention, comparator, and outcome

RCT

randomized controlled trial

Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical Practice Guidelines We Can Trust. Washington DC: Institute of Medicine; 2011.
 
Qaseem A, Forland F, Macbeth F, Ollenschläger G, Phillips S, van der Wees P Board of Trustees of the Guidelines International Network. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. 2012;156(7):525-531. [CrossRef] [PubMed]
 
American College of Chest Physicians. Diagnosis and management of lung cancer. ACCP evidence-based guidelines. Chest. 2003;123(suppl 1):1S-328S. [CrossRef]
 
American College of Chest Physicians. Diagnosis and management of lung cancer. ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007;132(suppl 3):1S-422S. [CrossRef] [PubMed]
 
Alberts WM. Introduction to the third edition: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):38S-40S. [CrossRef] [PubMed]
 
Leone FT, Evers-Casey S, Toll BA, Vachani A. Treatment of tobacco use in lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e61S-e77S. [CrossRef] [PubMed]
 
Silvestri GA, Gonzalez AV, Jantz MA, et al. Methods for staging non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e211S-e250S. [CrossRef] [PubMed]
 
Ramnath N, Dilling TJ, Harris LJ. Treatment of stage III non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e314S-e340S. [CrossRef] [PubMed]
 
Detterbeck FC, Postmus PE, Tanoue LT. The stage classification of lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e191S-e210S. [CrossRef] [PubMed]
 
Wisnivesky JP, Yung RC-W, Mathur PN, Zulueta JJ. Diagnosis and treatment of bronchial intraepithelial neoplasia and early lung cancer of the central airways: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest..2013; 143(5)(suppl):e263S-e277S. [PubMed]
 
Howington JA, Blum MG, Chang AC, Balekian AA, Murthy SC. Treatment of stage I and II non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e278S-e313S. [CrossRef] [PubMed]
 
Shrier I, Boivin JF, Platt RW, et al. The interpretation of systematic reviews with meta-analyses: an objective or subjective process? BMC Med Inform Decis Mak. 2008;:8:19
 
Guyatt G, Akl EA, Hirsh J, et al. The vexing problem of guidelines and conflict of interest: a potential solution. Ann Intern Med. 2010;152(11):738-741. [CrossRef] [PubMed]
 
American College of Chest Physicians. Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines.Chest. 2012;141(2)(suppl):e1S-e801S.
 
Oxman AD, Guyatt GH. Validation of an index of the quality of review articles. J Clin Epidemiol. 1991;44(11):1271-1278. [CrossRef] [PubMed]
 
Shea BJ, Grimshaw JM, Wells GA, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol. 2007;:7:-10.
 
Whiting P, Rutjes A, Westwood M, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011;155(8):529-536. [CrossRef] [PubMed]
 
Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force. Chest. 2006;129(1):174-181. [CrossRef] [PubMed]
 
Guyatt GH, Cook DJ, Jaeschke R. Pauker SG, Schünemann HJ. Grades of recommendation for antithrombotic agents: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008;133(suppl 6):123S-131S.
 
Jaeschke R, Guyatt GH, Dellinger P, et al GRADE Working Group. Use of GRADE grid to reach decisions on clinical practice guidelines when consensus is elusive. BMJ. 2008;337:a744. [CrossRef] [PubMed]
 
Bach PB, Mirkin JN, Oliver TK, et al. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012;307:2418-2429. [CrossRef] [PubMed]
 
Guyatt G, Baumann MH, Pauker S, et al. Addressing resource allocation issues in recommendations from clinical guideline panels: suggestions from an American College of Chest Physicians task force. Chest. 2006;129(1):182-187. [CrossRef] [PubMed]
 
The ADAPTE Collaboration. The ADAPTE Process: Resource Toolkit for Guideline Adaptation. version 2.0.http://www.g-i-n.net. 2009. Accessed September 12, 2012.
 

Figures

Figure Jump LinkFigure 1. This conflict of interest (COI) grid was used to document existing COIs of panelists who were approved with management and supervise their voting privileges on a recommendation-by-recommendation basis. Some topic editors used color-coding to facilitate instantaneous monitoring.Grahic Jump Location

Tables

Table Graphic Jump Location
Table 1 —Strength of the Recommendations Grading System

References

Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical Practice Guidelines We Can Trust. Washington DC: Institute of Medicine; 2011.
 
Qaseem A, Forland F, Macbeth F, Ollenschläger G, Phillips S, van der Wees P Board of Trustees of the Guidelines International Network. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. 2012;156(7):525-531. [CrossRef] [PubMed]
 
American College of Chest Physicians. Diagnosis and management of lung cancer. ACCP evidence-based guidelines. Chest. 2003;123(suppl 1):1S-328S. [CrossRef]
 
American College of Chest Physicians. Diagnosis and management of lung cancer. ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007;132(suppl 3):1S-422S. [CrossRef] [PubMed]
 
Alberts WM. Introduction to the third edition: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):38S-40S. [CrossRef] [PubMed]
 
Leone FT, Evers-Casey S, Toll BA, Vachani A. Treatment of tobacco use in lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e61S-e77S. [CrossRef] [PubMed]
 
Silvestri GA, Gonzalez AV, Jantz MA, et al. Methods for staging non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e211S-e250S. [CrossRef] [PubMed]
 
Ramnath N, Dilling TJ, Harris LJ. Treatment of stage III non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e314S-e340S. [CrossRef] [PubMed]
 
Detterbeck FC, Postmus PE, Tanoue LT. The stage classification of lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e191S-e210S. [CrossRef] [PubMed]
 
Wisnivesky JP, Yung RC-W, Mathur PN, Zulueta JJ. Diagnosis and treatment of bronchial intraepithelial neoplasia and early lung cancer of the central airways: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest..2013; 143(5)(suppl):e263S-e277S. [PubMed]
 
Howington JA, Blum MG, Chang AC, Balekian AA, Murthy SC. Treatment of stage I and II non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl):e278S-e313S. [CrossRef] [PubMed]
 
Shrier I, Boivin JF, Platt RW, et al. The interpretation of systematic reviews with meta-analyses: an objective or subjective process? BMC Med Inform Decis Mak. 2008;:8:19
 
Guyatt G, Akl EA, Hirsh J, et al. The vexing problem of guidelines and conflict of interest: a potential solution. Ann Intern Med. 2010;152(11):738-741. [CrossRef] [PubMed]
 
American College of Chest Physicians. Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines.Chest. 2012;141(2)(suppl):e1S-e801S.
 
Oxman AD, Guyatt GH. Validation of an index of the quality of review articles. J Clin Epidemiol. 1991;44(11):1271-1278. [CrossRef] [PubMed]
 
Shea BJ, Grimshaw JM, Wells GA, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol. 2007;:7:-10.
 
Whiting P, Rutjes A, Westwood M, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011;155(8):529-536. [CrossRef] [PubMed]
 
Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force. Chest. 2006;129(1):174-181. [CrossRef] [PubMed]
 
Guyatt GH, Cook DJ, Jaeschke R. Pauker SG, Schünemann HJ. Grades of recommendation for antithrombotic agents: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008;133(suppl 6):123S-131S.
 
Jaeschke R, Guyatt GH, Dellinger P, et al GRADE Working Group. Use of GRADE grid to reach decisions on clinical practice guidelines when consensus is elusive. BMJ. 2008;337:a744. [CrossRef] [PubMed]
 
Bach PB, Mirkin JN, Oliver TK, et al. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012;307:2418-2429. [CrossRef] [PubMed]
 
Guyatt G, Baumann MH, Pauker S, et al. Addressing resource allocation issues in recommendations from clinical guideline panels: suggestions from an American College of Chest Physicians task force. Chest. 2006;129(1):182-187. [CrossRef] [PubMed]
 
The ADAPTE Collaboration. The ADAPTE Process: Resource Toolkit for Guideline Adaptation. version 2.0.http://www.g-i-n.net. 2009. Accessed September 12, 2012.
 
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