Implementation of the new American Cancer Society process for creating cancer screening guidelines
The American Cancer Society recently revised the methods it will use to develop cancer screening guidelines. This commentary provides a summary of those new methods, and commentary on the roles of laboratory-based specialists and cytologists in future screening guideline development.
Early in 2010 the American Cancer Society (ACS) Board of Directors appointed a workgroup to review the methods used by the ACS and other organizations to create cancer screening guidelines and to recommend any needed improvements. Throughout 2010 the workgroup developed draft recommendations, and after the release of an Institute of Medicine (IOM) report on this same topic in March, 2011,1 it completed its report. The ACS Board of Directors approved those recommendations in August 2011. ACS then published the details of its new process for creating cancer screening guidelines in a special communication in JAMA in December 2011.2 ACS staff and volunteer leadership are now engaged in the work of setting up the infrastructure to implement the new process for developing cancer screening guidelines. As the Chairman of the workgroup that developed the recommendations, I offer this commentary to summarize the process, specifically commenting on the potential implications for involvement by scientists and health care professionals who are expert in developing, evaluating, and using laboratory or cytology assays that have potential for early cancer detection.
ACS cancer screening guidelines have high credibility among the general population and health care providers, and they have been frequently used as the basis for legal mandates for health insurance companies.3-5 It is therefore very important that we ensure that the ACS cancer screening guidelines are credible and useful. Does that mean that the workgroup thought there were serious problems with past ACS guidelines? No; in fact, the workgroup thought that past ACS guidelines have been of high quality. The weaknesses we identified in the process of ACS guideline development were about consistency across the different guidelines, transparency of the process, objectivity relative to the evidence base, and communications.
In the past, ACS staff and volunteer leaders would appoint different cancer screening guideline groups for each new guideline. Those groups varied in size and composition, typically including mostly relevant specialists. For guidelines involving laboratory or cytological tests, experts in those areas were invited to be full participants in the guideline-writing groups. Each group then proceeded to use its own methods to review the evidence and write the guideline, and that guideline would then be published. Below I summarize the new ACS process for developing cancer screening guidelines according to the principles recommended by the IOM for trustworthy clinical guideline development1:
The process to be used by ACS for creating and communicating cancer screening guidelines in the future was publically declared in a JAMA special communication,2 and it will be detailed online as well in the future in a section of the ACS website to be dedicated to cancer screening guideline development. Transparency can also be achieved through open collaboration and communication. Although ACS will not produce cancer screening guidelines in partnership with other organizations, ACS will solicit input and comment from relevant experts and professional and interest groups on final drafts of guidelines before their publication.
Conflicts of Interest
The most difficult issue in cancer screening guideline development and the issue most heavily debated by the workgroup is the proper management of professional conflicts of interest. If the guideline appears to go beyond published evidence to promote greater use of procedures or tests provided by those who wrote the guideline, then the perception of conflict of interest can erode confidence in that guideline. Clearly, expertise of specialists is very much needed in guidelines, especially those that involve technical issues such as laboratory tests and cytology interpretations. However, the IOM concluded that because subspecialists may have economic conflict, they should not be directly involved in the final process of guideline writing, and the ACS workgroup agreed. ACS will therefore separate the process of receiving expert input from the process of writing guidelines. In the future, all ACS cancer screening guidelines will be written by a single team, the ACS Cancer Screening Guidelines Development Group. That group will also invite content-specific input from expert subspecialists for each particular guideline to help inform their process of interpretation of evidence, but those ad hoc advisors will not be directly involved in guideline writing. In this way, expert opinion can inform guidelines without the appearance of professional conflict of interest. The ACS Cancer Screening Guidelines Development Group will be composed of 12 members, including 1 patient advocate and 11 generalist health professionals with expertise in the interpretation of evidence.
Systematic Evidence Review
The process of conducting a systematic review has now been defined by the IOM as an essential component of a credible guideline development process.1, 6 The ACS Cancer Screening Guidelines Development Group will create contractual relationships with experienced systematic review authors, who will then be charged to objectively summarize the evidence. Those evidence summaries will then serve as the basis for the guidelines to be written by the group.
Grading the Strength of the Recommendations
The ACS Cancer Screening Guidelines Development Group will formally grade the strength of its recommendations to better support shared decision making by guideline users. The language to be used in grading to quantify the strength of recommendations will be specified as among the first priorities of the group.
Articulation of the Recommendations
ACS guidelines will clearly describe both the benefits and the harm of screening. This is difficult, both because clear evidence of the magnitude of benefits and harm may not be available, and because benefits and harm are usually qualitatively different types of outcomes. Any conclusion about the net balance of benefits and harm will therefore always be in part a values-based judgment. A clear explanation of the values that have affected recommendations will help ACS to assist both providers and the general public to make their own decisions about cancer screening.
Before the process of peer review for publication, each ACS cancer screening guideline will undergo a formal review process that includes opportunities for experts, professional organizations, and advocacy groups to provide review and comment. The published guidelines will then also summarize any differing opinions, and provide a discussion of reasons for any differences to assist readers with their personal, practice, and policy decisions.
There will be a formal review and rewriting of every ACS cancer screening guideline at least every 5 years. The ACS will also perform an informal yearly update of the scientific evidence, and more frequently as needed, depending on the emergence of important new clinical evidence or new technologies.
The challenge of professional conflicts of interest was identified as a major issue by the IOM, and was also a major point of discussion by the ACS workgroup. Our main challenge was to identify a proper role for clinical subspecialists in creating guidelines, such as those who would be most knowledgeable about laboratory and cytology assays that might be useful for cancer screening. Clearly, the analyses of particular screening decisions should be informed by the best clinical judgment, but specialty expertise and freedom from conflict of interest can be in conflict when specialists write the guidelines themselves. ACS needed to develop a process that would use the valuable clinical expertise of specialists but that would at the same time avoid real or perceived conflicts of interest. The decision to allow for the input of specialists for guidelines for particular cancer sites or particular types of assays while also keeping them sufficiently separated from the guideline writing was the solution that will now be enacted. ACS staff and senior volunteer leaders are now engaged in the process of inviting members for the ACS Cancer Screening Guidelines Development Group. For each specific guideline, the group will then identify ad hoc specialists to provide needed technical input into the guideline development process.
The creation of an independent process for systematic review will also be a new procedure for the ACS. The ACS Cancer Screening Guidelines Development Group will provide specifications for reviewing contractors to define the evidence questions that should be summarized, then will use that evidence as the basis for its guidelines. ACS staff are now assessing the potential contractors for these evidence reviews, and among the first tasks of the ACS Cancer Screening Guidelines Development Group will be to enact those collaborative and contractual relationships.
Another important new feature of the ACS process is the phase of prepublication peer review, which will offer an opportunity for other experts and other groups to comment and then to highlight any important differences. Although the ACS may develop guidelines that differ from those of other organizations, soliciting input before final publication will increase the likelihood of achieving broader national consensus. This type of open communication will be increasingly important to the US public as we proceed with health care reform, and as cancer screening choices involve increasingly complex factors, including emerging laboratory assays that could be useful for identifying early cancer. As both imaging techniques and biomarker assays become both more expensive and also more sensitive for tiny cancers, the ACS Cancer Screening Guidelines Development Group will face substantial new challenges in judging the benefits versus the harm tied to financial costs, false-positive tests, and overdiagnosis.
Although specialists in laboratory-based cancer detection tests and clinical cytology will likely not be full members of the ACS Cancer Screening Guidelines Development Group, their input into ACS cancer screening guidelines will be more important than ever with emerging new biotechnologies. Under this new process, laboratory and cytology experts will have ample opportunity to provide their professional input into cancer screening guideline development in 3 areas. First, via the ACS website and other channels, they can suggest the needs and opportunities for consideration of new screening guidelines based on new and emerging technologies. Second, they can provide input into specific guidelines as they are under development by joining the specialists providing ad hoc input to the ACS Cancer Screening Guidelines Development Group. Third, they can provide reviews and comments on draft guidelines before their publication during the prepublication peer review phase of guideline development.
In summary, the main features of the new ACS process are a consistent approach to guideline development, a single generalist expert group to write all guidelines, the use of systematic reviews of the evidence as the basis for each guideline, increased attention to explicit comparisons of benefits and harm, review and comment by independent experts before publication, and increased attention to communication. This new process should provide ample opportunities for laboratory specialists and cytologists to have meaningful input into future ACS cancer screening guidelines, and should ensure that ACS cancer screening guidelines will continue to be a trustworthy source of information to guide clinical practice, personal choices, and public policy about cancer screening.
No specific funding was disclosed.
CONFLICT OF INTEREST DISCLOSURES
The author made no disclosures.