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TABLE OF CONTENTS


  1. Background
  2. Nominating Guideline Topics
  3. Mechanisms for Providing Guidance: Traditional Guidelines, Guideline Endorsements, Guideline Adaptations, and Provisional Clinical Opinions (PCOs)
  4. Inviting Panel Members
  5. Guideline Protocol Worksheet
  6. Systematic Literature Review
  7. Formulating Guideline Recommendations: Evidence-based and Consensus-based
  8. Appraising Study Quality and Summarizing the Strength of Evidence and Strength of Recommendations
  9. Additional Topics:Cost Considerations, Health Disparities, and Patient-Clinician Communication
  10. Review Process and Public Comment
  11. Dissemination and Implementation: Clinical Tools and Resources
  12. Development of Quality Measures
  13. Update Process
  14. Supplemental Information: Requests for Official Representatives and Options for Collaboration

BACKGROUND


The ASCO Guideline Procedures Manual is designed to assist ASCO expert guideline panels in the development of ASCO guidelines. Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.  The American Society of Clinical Oncology (ASCO) began its guidelines program in 1993 following an ASCO strategic planning initiative.  As part of this initiative, ASCO conducted a membership survey.  Guideline development was ranked second among the priority areas for ASCO by the membership.  In more recent membership surveys, ASCO guidelines have consistently ranked third behind the Annual Meeting and the Annual Meeting and the Journal of Clinical Oncology in terms of member value.  The impetus for guideline development is straightforward:  Guidelines are thought to improve cancer care by helping to bring practice in line with the state of the art in oncology as defined by empirical evidence. The guidelines program falls under the auspices of the ASCO Clinical Practice Guidelines Committee (CPGC).  The CPGC oversees development of guidelines and their panels. Guidelines address the use of generally established practices (use of adjuvant chemotherapy in colon cancer management). They are developed by Expert Panels that comprise individuals drawn largely from outside the CPGC membership. For additional information about the evolution of the ASCO guidelines program, see American Society of Clinical Oncology Clinical Practice Guidelines: Opportunities and Challenges.


NOMINATING GUIDELINE TOPICS


The Clinical Practice Guidelines Committee (CPGC) is charged with the responsibility of approving topics on behalf of the ASCO Board of Directors. Guideline Advisory Groups (AGs) make recommendations to the Clinical Practice Guidelines Committee (CPGC) on identifying and prioritizing topics for guideline development. This is with the goal of ASCO offering a more comprehensive portfolio of authoritative practice guidelines.  As delegated by the CPGC, Guideline AGs review the progress and direction of ASCO clinical practice guidelines relating to a particular disease site or cancer topic. Currently, AGs have been assembled for breast cancer, gastrointestinal cancer, genitourinary cancer, thoracic cancer, supportive care, survivorship, and resource stratification.  A Roles and Responsibilities document has been developed to assist with managing the functions of the AGs

Annually, ASCO will review guideline topic proposals from ASCO members. Each spring, a survey will be launched to provide members with an opportunity to submit topics for guideline development. The survey will ask questions such as, "Is there uncertainty or controversy about the relative effectiveness of available clinical strategies for the condition (s) for which guideline is proposed?" and "Is there perceived or documented variation in practice in the management of a given condition/ use of health care intervention?" The Topic Selection Algorithm may assist members in assessing the need for a guideline on a particular topic.  The nodes address the burden or importance of the condition or intervention, the degree of uncertainty or controversy about the relative effectiveness of existing clinical options, the perceived or documented variation in practice in the management of the condition or the use of the intervention, the availability of evidence to inform practice recommendations, and the existence of high-quality guidelines on the topic in question. In addition, It is critical that the CPGC be aware of existing guidelines on the same topic to avoid duplication of effort. Other groups’ guidelines, if judged to be methodologically sound by the CPGC's Methods Subcommittee, can be submitted for ASCO Endorsement consideration. After the survey closes, member-suggested topics will be provided to the appropriate Guideline Advisory Group (GAG) for review during their annual priority setting process. To submit a topic, please visit https://www.surveymonkey.com/s/ascoguidelinesurvey


MECHANISMS FOR PROVIDING GUIDANCE


While Clinical Practice Guidelines are the traditional way for ASCO to provide guidance, ASCO has several other mechanisms as well. The Provisional Clinical Opinion (PCO)

is intended to offer timely clinical direction to the ASCO membership following the publication or presentation of potentially practice-changing data from major studies. The PCO may serve in some cases as interim direction to the membership pending the development or updating of an ASCO clinical practice guideline.  Heretofore, there has not been a mechanism within ASCO for providing a rapid response to key data from clinical cancer research. The PCO offers such a mechanism.  

Two additional processes for providing guidance to members include Guideline Endorsements and Adaptations. Other groups’ guidelines, if judged to be methodologically sound by the CPGC's Methods Subcommittee, can be submitted for ASCO endorsement or adaptation consideration. ASCO will consider other organizations guidelines for endorsement or adaptation in lieu of undertaking its own guideline on the same topics to avoid duplication of efforts. With an endorsement, the guideline panel agrees will all the recommendations as drafted by the organization, where as for adaptations, the guideline panel has either added qualifying statements or changed some recommendations. Both options enable ASCO to offer high-quality recommendations for practice. Additional information on endorsements, can be found in our process document.

ASCO considers endorsement of high quality guidelines from other organizations. If you have an Endorsement Request, please complete the ASCO Guideline Endorsement Request form


INVITING PANEL MEMBERS


Once a topic is approved by the CPGC, a guideline panel is assembled. The Guideline Panel Co-Chairs and ASCO staff should strive to assemble a panel no larger than 15 members. Each panel should have a representative from the Practice Guidelines Implementation Network (PGIN), and at least one patient representative. Prospective members are sent an invitation to join the panel, along with the Guideline Panel Roles and Responsibilities document. In addition, slide sets have been developed for the roles of Co-Chair, Member, PGIN Representative, and Patient Representative to further explain the responsibilities and processes.

Invitees who accept are required to complete a conflict of interest disclosure form. Members are provided a list of companies that could be affected, positively or negatively, by the outcome of the guideline. Although they are asked to disclose all their relationships, only those relationships with affected companies will be taken into consideration when trying to assemble a panel with an unconflicted majority, according to ASCO's Conflict of Interest Policy Implementation for Clinical Practice Guidelines.

Once the panel is assembled, the guideline preparation can begin.The work of a panel is confidential. The materials members receive, discussions, and the decisions made by the panels should not be shared with anyone outside the ASCO leadership and staff. Some of the materials may be highly sensitive, and there could be legal penalties for using or disclosing the information inappropriatelyNon-authors, including but not limited to third parties, with a direct or indirect financial interest, are not permitted prepublication access to ASCO-approved clinical practice guidelines, and related materials developed for ASCO publication and public dissemination.  An exception to this policy is individuals solicited by the corresponding author of the ASCO document, or staff acting in his or her behalf, for the purposes of invited and confidential peer review. (Approved by Board of Directors November 3, 2000). In certain cases, ASCO will share draft guideline documents with outside parties. In these select cases, the parties are required to sign a Non-Disclosure Agreement.


GUIDELINE PROTOCOL WORKSHEET


A key step in the conduct of ASCO guidelines is completion of the Clinical Practice Guideline Development Protocol Worksheet (the “Worksheet”).  The Worksheet specifies the purpose of the guideline, the target patient population and clinical outcomes of interest, key features of the systematic literature review, and a proposed timeline for guideline completion. ASCO staff, following an initial conference call with the Panel Co-Chairs and possibly others selected by the Co-Chairs (the Panel Steering Committee), will typically complete a first draft of as many sections as possible before sending it to the Co-Chairs for revision. For consistency a Worksheet template has been developed. The number of clinical questions addressed by the guideline should be limited to two or three.  Scope creep is endemic to guideline development and impedes the ability to create a focused work product in a timely fashion that is useful to clinicians.

Once the Co-Chairs have approved a first draft of the Worksheet, ASCO staff will submit the Worksheet on behalf of the Panel to the Clinical Practice Guidelines Committee’s Methodology Subcommittee for review and approval.  Usually, Subcommittee reviewers make suggestions for revision that are intended to clarify aspects of the plan for developing the guideline.  These suggestions are sent along to the Co-Chairs.  Work on the systematic literature review can proceed upon approval of the Worksheet by the Methodology Subcommittee.


SYSTEMATIC LITERATURE REVIEW


Upon approval of the Clinical Practice Guideline Development Protocol Worksheet, ASCO staff and the Expert Panel can begin work on the systematic review. “A systematic review is an integrative review of the literature on a specific clinical question or set of questions, characterized by explicit methods of data searching, selection, and review.  Inclusion and exclusion criteria for the review are stated up front and the goal is to reduce bias in identifying, selecting, and summarizing the evidence.” Systematic reviews are often contrasted with narrative reviews, which are selective and often biased summaries of research evidence.  The major difference between the systematic review and the narrative review relates to the transparency and formality of the processes used in each:  Systematic reviews are guided by explicit statements about literature search strategies and study selection criteria; narrative reviews are not guided by explicit methods or are much less so.

ASCO Staff uses the information entered into the Worksheet, including the clinical questions, inclusion/exclusion criteria for qualified studies, search terms/phrases, and range of study dates, to perform the review. The initial steps of defining the clinical questions, specifying inclusion and exclusion criteria for studies that will qualify, and suggesting relevant literature search terms or phrases, and the range of study dates are completed in the course of filling in the Worksheet. Literature searches are of selected databases, including The Cochrane Library, Medline (via PubMed), and EMBASE, are preformed.  Initial searches are done to identify systematic reviews, meta-analyses, and practice guidelines on the topic in question. More targeted searches on the condition or intervention are done in collaboration with the panel co-chairs using the search terms and inclusion and exclusion criteria specified in the Worksheet.  The literature search should include search terms to address health disparities as relevant to the clinical questions considered by the particular guideline. ASCO staff complete a first-level screening of the abstracts from these searches to eliminate obvious “false positives.” Although not utilized often at ASCO, meta-analyses may also be employed to aid in guideline development.


FORMULATING GUIDELINE RECOMMENDATIONS


The aim of this section is to help panel members move from the empirical evidence, as summarized in the systematic review of the literature (with or without meta-analysis), to the actual guideline recommendations for clinical practice, or adoption of a new technology..  The section summarizes some key features of the evidence-based consensus approach used by ASCO in developing recommendations; discusses the role of expert opinion in this process; summarizes the why and how of the narrative approach to characterizing the status of the evidence and to crafting recommendations, with concrete examples drawn from existing guidelines; and concludes with a discussion of the utility of evidence classification schemes for informing discussions about recommendations.

The Evidence-Based Consensus Approach to Guideline Development

ASCO uses an evidence-based consensus approach to developing guideline recommendations.  This approach requires explicitness (i.e., clarity of presentation) in describing the methods used for making practice recommendations.  The entire process of developing guidelines should be transparent to the guideline user.  Transparency is intended to achieve clarity about how various underlying factors were considered by the expert panel in informing clinical recommendations. 

  • At the core of the evidence-based consensus approach is the systematic review.  The systematic review is conducted as specified by the guideline development protocol that you completed in your role as panel co-chairs.  The eventual guideline recommendations are informed by the results of the systematic review, blended with expert interpretation of evidence, and considered together with a range of other factors. 

  •  The opinions of clinical or disease experts, those of clinical researchers, and those of methodological experts are combined in interpreting available evidence on the guideline questions.  As noted in the American College of Cardiology/American Hospital Association guideline development manual, expert interpretation will always be necessary, and serves “as a funnel through which evidence on multiple questions is combined, condensed, and formulated into recommendations.”

Consensus-Based Approach to Guideline Development

ASCO clinical practice guidelines are based on systematic reviews of the literature, the gold standard in clinical practice guideline development. Systematic reviews serve as the evidentiary basis for drafting principles of clinical care. However, few guideline questions can be directly or completely answered only considering the evidence. Interpretation and extrapolation of evidence are often necessary. As such, many guideline recommendations entail some degree of consensus among guideline panel members.

For some clinical questions, limited evidence or high-quality evidence is not available to inform recommendations. In the past, ASCO either avoided the topic, provided guidance based on weak or insufficient evidence, or published a review of the evidence rather than a guideline. In 2010, the ASCO Board of Directors approved the development of guideline recommendations using a formal consensus methodology. The methodology proposed for adoption is based on the modified Delphi technique utilized by Cancer Care Ontario for use in guideline development. (Falkson 2008; Falkson 2009; Cancer Guidelines Resources Center)

 A systematic review is the first step in this process, as with any ASCO guideline. A protocol with clearly defined clinical questions, comparisons of interest, and search parameters guides the systematic literature review. The protocol also includes prospective identification of study design type(s) that will be considered, e.g., randomized, controlled trials (RCTs) and specific selection criteria to include or exclude studies. The guideline panel should prospectively define the steps to be taken is insufficient evidence is identified that meet study selection criteria. If the formal consensus methodology is considered, this methodology to develop consensus recommendations can be applied to an entire guideline or just those clinical questions for which sufficient evidence is lacking. Table 1 is an abbreviated depiction of the process. For further information, please see "American Society of Clinical Oncology Clinical Practice Guidelines: Formal Systematic Review–Based Consensus Methodology" by Loblaw, et al.

DECISION POINTS

The decision to incorporate the formal consensus process generally occurs following completion of the literature search for the systematic review, after the evidence has been identified and preliminarily assessed. If evidence identified is not considered appropriate, limited, inconsistent, indirect, or of poor quality, then the formal consensus-based methodology may be considered. While the decision to move incorporate consensus recommendation(s) may vary, the common thread is lack of sufficient evidence. Table 1 provides an abbreviated depiction of the modified Delphi consensus process.

PARTICIPANTS

Steering Committee

A Steering Committee, including the Panel Co-chairs and one or two additional panel members, is formed for any guideline that will include formal consensus. For guideline topics relevant to multiple specialty areas, the Steering Committee should include representatives from other specialties if possible.

Consensus Group

The consensus group includes all Panel members who are not members of the Steering Committee, as well as other subject-matter experts and community-based practitioners. Sources for potential members include experts who could not participate in the guideline panel, members of ASCO’s Practice Guideline Implementation Network (PGIN), and members of other ASCO Committees, particularly the Clinical Practice Committee. The suggested target number of participants in the Consensus Group is between 30 and 40. Participation of non-physicians will be considered on a case-by-case basis.

Conflict of Interest Policy

Consensus Group invitees will be asked to complete the same disclosure form that prospective members of a guideline panel complete. The requirement for an unconflicted majority, noted in ASCO's Conflict of Interest Policy Implementation for Clinical Practice Guidelines, also applies to the Consensus group.


RECOMMENDATION DEVELOPMENT

Drafting Consensus Recommendations and Clinical Considerations

The Steering Committee is responsible for developing preliminary consensus recommendations, generally accomplished through multiple teleconferences. The Steering Committee will also prepare clinical considerations for each of the consensus recommendations. The clinical considerations document describes the underlying logic or justification for a given recommendation. This background information is shared with the Consensus Group at the same time that they are provided with the ratings form for Round One. Recording teleconference(s) where the Steering Committee discusses the background and considerations for each consensus recommendation can facilitate development of the clinical considerations.

The clinical considerations, prepared by the Steering Committee, replaces the literature discussion in the guideline manuscript. This material may be updated during the Panel Meeting but the final form, as shared with Consensus Group members, is the iteration to be used in the manuscript. Minimal modifications are expected while drafting the manuscript, and should not include significant changes to the content included.

The Steering Committee may choose to re-write or append the clinical considerations for any consensus recommendation that is substantively changed following a Consensus Round (due to lack of agreement and/or feedback from the Consensus Group). If that a recommendation was revised extensively, the clinical considerations should be modified before the Consensus Group begins for another round of ratings. 

Guideline Panel Meeting

Draft consensus recommendations and clinical considerations are presented at the panel meeting. Discussion of supporting evidence (e.g., epidemiologic data, clinical experience, trial data of study designs excluded from the systematic review) among Panel members may require modification of either the draft consensus recommendations and/or the clinical considerations. Both are updated, as necessary, before sending materials to the Consensus Group for the first Consensus Round.

Rating of Recommendations

Members of the Consensus Group are asked to rate their agreement with each consensus recommendation on a five- or seven-point Likert scale ranging from strongly agree to strongly disagree, as depicted in Table 2 (lower score corresponds with a higher agreement). The rating form includes additional space for raters to provide free-text comments. Each round of ratings is referred to as a Consensus Round.

Table 2. Round One Rating Form Example

 

Strongly Agree

Agree

Neither Agree nor Disagree

Disagree

Strongly Disagree

Clinical Question






Consensus Recommendation Text

For subsequent rounds, Consensus Group members are provided with the previous iteration of the recommendation and the ratings distribution, along with the revised recommendation, as depicted in Table 3. Modifications to text style (bold, italics) may be made to highlight changes in the recommendation language. Consensus Group members are again asked to rate their level of agreement with the recommendation text on a five-point Likert scale.

Table 3. Subsequent Rounds Rating Form Example

Clinical Question

Rating Frequency

Percent Agree

Median

Agree à Disagree

1

2

3

4

5

Previous iteration

10

10

5

5

0

66%

2

Updated recommendation text









ASSESSMENT OF RATINGS

Collection of Ratings Data

Ratings will be collected from Consensus Group members either by sending individual emails to each member of the group or an online survey tool (Zoomerang).

Review of Ratings

The percent agreement and median score for each question is calculated, as is the overall response rate. The percent agreement refers to the number of raters who indicated either “agree” or “strongly agree” divided by the total number of raters for the round. Non-responders are not included in the denominator. A frequency table depicting the collective ratings is then prepared for review by the Steering Committee, as in Table 4. Free-text comments from the Consensus Group members are also compiled into a single document, organized by question. The Steering Committee then meets to discuss results from the Consensus Group ratings and make revisions accordingly.

Table 4. Results- Round One

Clinical Questions

Score Frequency (all N=31)

% Agree

Median

1

2

3

4

5

(1)   Question

15

13

1

1

1

90.3

2

(2)   Question

11

16

2

2

0

87.1

2


DEFINING CONSENSUS

Threshold for Adoption of a Consensus Recommendation

Compiled ratings from a Consensus Round must meet a minimum threshold in order for a recommendation to be adopted, listed below. The Guideline Panel should prospectively determine if the consensus threshold for a given recommendation or set of recommendations is to be higher than the minimum listed below.

  • Strong Consensus: If >90% of the respondents from the Consensus Group rate a recommendation as either “strongly agree” or “agree” and the median score is 1, the recommendation is adopted.
    • This assumes that “strong agreement” on the Likert scale is scored as a one.
    • Only “strongly agree” and “agree” are included in the percent agreement calculation
    • If a 7-point Likert scale is utilized, “minimally agree” is not considered in the percent agreement, only “strongly agree” or
  • Consensus: If > 75% and <90% of the respondents from the Consensus Group rate a recommendation as either “strongly agree” or “agree” and the median is either 2 or 1, the recommendation is adopted.
  • No Consensus: If consensus is not achieved following two rounds of ratings, then the Steering Committee may opt to leave a clinical question unanswered and state, “Consensus could not be achieved.”


REVISING RECOMMENDATIONS

Content Modifications

Following the first round of ratings, the Steering Committee must revise consensus recommendations that do not meet the pre-defined threshold criteria. Free-text comments from the Consensus Group carefully considered when making revisions. The Steering Committee chooses whether to solicit input from the Guideline Panel when re-drafting consensus recommendation. The Panel must be consulted if the Steering Committee chooses to revise the recommendation following two unsuccessful consensus rounds. The alternative is to leave the clinical question unanswered

Style Modifications

The Steering Committee may modify either the style or language of the recommendation, without changing the content of the recommendation. The Steering Group can, but is not required, query the Consensus Group to determine which option is preferred. Raters are simply asked which iteration they prefer and a simple majority determines which recommendation text is included in the guideline.

References

Falkson CB, Bezjak A, Darling G, et al. The management thymoma: a systematic . J Thorac Oncol 2009;4:911-9.

Cancer Guidelines Resource Centre. http://www.cancerview.ca/idc/groups/public/documents/webcontent/cep_mod_delphi_consns.pdf 2010.

Falkson C, Bezjak A, Darling G, al. e. The Management of Thymoma: Evidentiary Base and Consensus Process. A Quality Initiative of the Program in Evidence-Based Care (PEBC). Cancer Care Ontario (CCO). https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=34332. 2008.

APPRAISING STUDY QUALITY AND SUMMARIZING THE STRENGTH OF EVIDENCE AND STRENGTH OF RECOMMENDATIONS


In 2010, ASCO’s Clinical Practice Guideline Committee (CPGC) agreed that increasing the transparency of the quality and strength of evidence that informs guideline recommendations would enhance ASCO’s guidelines. The use of summary ratings was also seen as an effective strategy to enhance readability that could also increase the uptake of ASCO guidelines. Importantly, appraising and synthesizing the body of evidence, as well as rating the strength of guideline recommendations, further increase ASCO’s concordance with the 2011 Institute of Medicine’s (IOM) standards for developing trustworthy clinical practice guidelines and systematic reviews. To inform the best method of addressing quality issues, an environmental scan was conducted to review the approaches and tools various organizations use to assess the quality of studies, strength of evidence, and strength of recommendations. There have been many quality and rating systems developed or used by a variety of organizations (e.g., Grading of Recommendations Assessment, Development and Evaluation [GRADE], United States Preventive Services Task Force [USPSTF], Agency for Healthcare Research and Quality [AHRQ], Cochrane Collaboration, and the Scottish Intercollegiate Guidelines Network [SIGN]). Based on a review of the quality assessment approaches identified, a five-step approach to carry out quality appraisal, strength of evidence ratings and strength of recommendations ratings for use in ASCO guidelines was developed.

Five steps are used to appraise the three core domains of 1) quality appraisal, 2) rating the strength of the evidence, and 3) rating the strength of recommendations. Figure 1 provides an overview of the specific steps and ratings. Appendix 1 outlines the specific quality appraisal and rating steps in greater detail, and Appendix 2 presents a sample table of recommendations. The proposed approach was primarily adapted from those developed by the AHRQ, USPSTF, and GRADE and is summarized below:

  • Quality appraisal. It is proposed that evidence informing guideline recommendations be formally appraised to evaluate the reliability and validity of the evidence. These assessments of quality will be made for individual sources of evidence (i.e., individual trials, systematic reviews, etc.) using pre-specified criteria, which are based primarily on elements of quality related to study design, methodology, and risk of bias. A sample of the study quality appraisal checklist developed/adapted for randomized controlled trials is provided in Appendix 3.
  • Strength of evidence. The quality of the total body of evidence used to inform a given recommendation will be assessed to evaluate its validity, reliability, and consistency. This assessment will consider the individual study quality ratings, the overall risk of bias, and the overall validity and reliability of the total body of evidence. The summary rating will be an indication of the Panel’s confidence in the available evidence.
  • Strength of recommendations. The Panel provides a rating of the strength of each recommendation. This assessment is primarily based on the strength of the available evidence for each recommendation and it is an indication of the Panel’s confidence in its guidance or recommendation. However, where evidence is lacking, it also affords panels the opportunity to comment on the strength of their conviction and uniformity of their agreement that the recommendation represents the best possible current guidance.

Increasing transparency and explicitness in guideline development meets ASCO’s commitment to continuous quality improvement, increases guideline usability, and conforms to the IOM standards on the development of clinical practice guidelines. 


ADDITIONAL TOPICS

Cost Considerations

The inclusion of a section in the guideline where costs and/or commentary about published cost-effectiveness analyses relative to the clinical question should be considered optional. When guidelines address a narrow clinical question, for instance, one where one or a few drugs are the focus (e.g anti-emetics), then it is highly encouraged that a table be prepared listing drug costs of the available therapies at the time a draft is finalized.

Guidelines should include a table similar to the example below.

Anti-emetic

Manufacturer

Usual dose, delivery and Schedule

“Cost”, Internet Data Source

Zofran

Glaxo Smith Kline

24 mg, p.o. 1 hour before chemotherapy

4 mg (10 each), $223, drugstore.com

Zofran

Same

8 mg, p.o. 3X per day on day of radiation therapy

8 mg (10 each), $365, drugstore.com

Other examples of where a cost table should be considered are for comparisons of alternative diagnostic procedures where there are commonly available billing codes used for reimbursement.For complex multi-faceted procedures (i.e., sentinel lymph node biopsy, laparoscopic colectomy) there are many dimensions that must be evaluated and a cost section should be considered carefully before inclusion in a guideline.

Cost-effectiveness Analysis

The broad subject area of what represents ‘value’ among new cancer interventions reflects an individual or group making an implicit cost-effectiveness judgment or analysis.While cost-effectiveness issues are a major cancer policy question, the methodology-working group recognizes that this issue can distract from the prior focus of the guideline process, which is the scientific evidence. However, economic analyses (cost-effectiveness, cost-utility, cost-benefit) are important elements of technology assessments. If there are published cost-effectiveness analyses addressing the subject, then a review with or without a commentary on the strength of the analyses should be included as a distinct commentary section of the guideline.   No endorsement or rejection of the relative value of this work should be made. Expanding the role of cost-effectiveness analysis in the guideline process will require a clear mandate from the ASCO Board.


Health Disparities

Disparities are addressed in the systematic review and specific studies should be referenced in the guidelines. Efforts are underway to expand this section of the guideline.


Patient-Clinician Communication

ASCO has incorporated a patient communication section into each guideline.  This section presents possible options on how oncologists can communicate with their patients. In many cases, the patient representative assists in drafting this section.representative assists in drafting this section.

REVIEW PROCESS AND PUBLIC COMMENT


ASCO has a rigorous review process for guidelines. After the draft has been approved by the Guideline Panel, it is distributed for external review by experts on the guideline topic and submitted for peer review at the Journal of Clinical Oncology (JCO). ASCO Guidelines are reviewed and approved by the Clinical Practice Guidelines Committee (CPGC) before final submission to JCO.

Because ASCO Guidelines are submitted to the JCO, they are subject to an embargo policy and can not be posted publicly prior to publication. After publication, guidelines are posted on the ASCO Guidelines Wiki for comment. The site provides oncologists, practitioners and patients with an opportunity to provide feedback or submit evidence on individual published guidelines. All information is open for viewing. However, to comment or submit new evidence, an ASCO Guidelines Wiki user account is needed. To receive your user account, please contact guidelines@asco.org. Comments are reviewed by staff and the Guideline Panel Co-Chairs, and a response is posted after approval by these groups. 


DISSEMINATION AND IMPLEMENTATION: CLINICAL TOOLS AND RESOURCES


In 2005, ASCO instituted a program for developing guideline derivative products, Clinical Tools and Resources (CT&Rs), to to more widely disseminate, in a practical and user-friendly form, the recommendations contained in the guidelines. These CT&Rs include:

  1. Patient Material:  Each guideline is accompanied by a short summary containing information like: key messages, questions to ask your doctor, and what this means for patients. The patient guides are developed by ASCO's Communication Department and are available on cancer.net.
  2. Power Point Slide Set: Slides containing sections like Clinical Questions, Background, Methodology, Evidence, Recommendations, and Implications. These slides are designed to be used during Tumor Boards, Grand Rounds, and similar lectures. A slide set is developed for every guideline. A recent example is the Fertility Preservation Slide Set.
  3. Flow Sheet or Algorithm: These tools could be used by clinical practices in their daily activities and included in patients’ records.  The intent is to create a practical product that will facilitate guideline adherence in day-to-day situations for the practicing clinician.  An example is ASCO's HER-2 Testing Algorithm.
  4. Tables: If applicable, ASCO will develop tables with the recommendations and other information like dosing, for example. ASCO's VTE Recommendations and Dosing Table is an example.
  5. Decision Aid/Discussion Guide- These expert-produced tools facilitate shared decision-making by enabling clinicians to display graphical, text, and spoken presentations of data from ASCO Guidelines to patients and caregivers. The Decision Aids discuss benefits and risks of interventions from the Guidelines and include opportunities for patients to weigh their options. ASCO's PSA Testing Decision Aid Tool and Non-Small Cell Lung Cancer Decision Aid Tools are examples.

ASCO's Implementation Strategy also involves working with the Practice Guidelines Implementation Network (PGIN).


DEVELOPMENT OF QUALITY MEASURES


The CPGC and Guideline Expert Panels work in partnership with the Quality of Care Committee (QCC) to develop quality measures from ASCO Guideline recommendation. The measures can be incorporated into the Quality Oncology Practice Initiative (QOPI). Guideline recommendations are presented to the QOPI Steering Group to identify those appropriate for translation into quality performance measures to be implemented into QOPI. Recommendations are also evaluated by the Measures Subcommittee to determine if quality measures, appropriate for development and use aside from QOPI are required. Those recommendations selected for measure development are prioritized by the Leadership of the QCC to determine the timeline for development and implementation, considering existing measure development projects and available resources. The list of measures and additional information on the methodology can be found at qopi.asco.org.


UPDATE PROCESS


Mechanisms for Updating Guidelines 

  1. Panel steering committee receives letter annually from ASCO staff inquiring about the need for update that year
  2. Every two or three years panels must do formal updated literature searches
  3. Ad hoc update needed if key evidence is published (Signals Approach)

Review and approval options

  • Scenario 1:  No new evidence.  Publish an “e-update” with notice in JCO and JOP.  Insert box at top of guideline that summarizes literature search including dates and number of abstracts reviewed, and indicates no new evidence identified and thus no changes to recommendations.  Approval by co-chairs and Clinical Practice Guidelines Committee (CPGC) leadership.  To Executive Committee of ASCO Board of Directors for final approval. 
  • Scenario 2:  New evidence/no change to recommendations.  Same “e-update” approach with summary of search and review, plus include a list of relevant references identified.  Approval by co-chairs and panel and CPGC leadership.  To Executive Committee of ASCO Board of Directors for final approval. 
  • Scenario 3:  New evidence/recommendations change.  Current review and approval process for substantive updates and publication in print and online versions of JCO with summaries and derivative products in the JOP.
  • Scenario 4:  Ad hoc, rapid update.  New evidence/change to recommendations.  Publish an “e-update” with notice in JCO and JOP with summary of key new evidence.  Would allow for more rapid change to a guideline without a formal, comprehensive literature search and review.  Change would be made to selected recommendations based on relevant published high-impact evidence or regulatory decisions.  Example:  ASCO’s 2003 NSCLC guideline update includes a recommendation for gefitinib.  FDA label change in June 2005 limits gefitinib indication.  Guideline has not been updated to reflect this. 

Guide to “Signals” Updating of Clinical Practice Guidelines for Panel Co-Chairs (Adapted from Shojania et al, Ann Intern Med 2007;147:224-233)

To ensure that ASCO guidelines remain as current as possible, ASCO requires an annual assessment of the literature for each of the ASCO guidelines to determine the need for an update of each guideline.  The purpose of the annual assessment is to identify new, practice-changing data that might warrant an update of the guideline.  This document outlines formal criteria for identifying these new, practice-changing data. 

To begin this process, ASCO staff will provide panel co-chairs with an updated literature search on the guideline questions.  ASCO staff will complete an initial screening of the search yield in accordance with the inclusion and exclusion criteria of the systematic review conducted for the original version of the guideline, or for the latest substantive update thereof.  Based on this screen, ASCO staff will provide co-chairs with a set of the relevant abstracts or, if available, the full text articles for review.  The co-chair review is guided by a short  questionnaire that reflects the criteria, or “signals,” for identifying new and potentially practice-changing evidence. 

The signals for a substantive guideline represent two major categories of changes in the available evidence:  (a) a potentially invalidating change in evidence, and (b) a major change in evidence.  “Evidence” and “findings” as used here refers to the following:

  1. At least one new high-quality RCT with a population at least twice/three times the size of the largest RCT currently cited in the recommendation
  2. At least one new meta-analysis with one new trial not considered in the existing recommendations

[Note.  The above section may need to be adjusted depending on the original evidence considered for the guideline.  For example, some guidelines (RFA, Fertility) were based on cohort studies, case-control studies, etc., as no RCTs were available at the time of the original systematic review.  So, evidence that fits parameters for signals for those guidelines might include:  the first RCT; a cohort study double the largest in the existing guideline; a large new series from a group cited in the existing guideline, etc.]

Response to Requests for Revising Guidelines or Adding New Material

Any individual or organization may submit comments or new suitable evidence to the ASCO Clinical Practice Guidelines Committee (CPGC) at any time regarding existing guidelines. These data will be considered in the standard guideline review process at the time of the next scheduled update, as per CPGC policy. If these data include new randomized clinical trial (RCT) data published in peer-review literature, these data will be reviewed by co-chairs or steering group of the applicable ASCO panel or the CPGC to determine if the data meet the established criteria for an ad hoc update. Any conflicts of interest of individuals soliciting the CPGC, should be disclosed, as per ASCO policy.

Guideline Status

ASCO guidelines are reviewed for their currency and validity on a regular basis. We note the current guideline status on each page as Current, Affirmed, Review in Progress, or Archived. Please find a brief description of these terms below:

  • Current: The guideline was published within the last 2 years. The recommendations are current, accurate and valid
  • Affirmed: The guideline was published more than 2 years ago and was last reviewed by the Expert Panel on (add date). The recommendations are current, accurate and valid

  • Review in Progress: The guideline is being assessed for currency or an update is in progress. The status of the guideline and recommended care options may change as a result
  • Archived: The guideline recommended care options are no longer current or valid. This guideline should be used for historical purposes only 

SUPPLEMENTAL INFORMATION


Official Representative Requests

Occasionally, ASCO receives requests from other organizations to appoint Official ASCO Representatives to participate in guideline development panels. Organizations should strive to follow standards for guideline development that have been established by the Counsel of Medical Specialty Societies (CMSS) and the Institute of Medicine (IOM). While serving on these panels, the representatives can inform ASCO staff and the CPGC Leadership if it's an endorsement opportunity. In this situation, ASCO would request an advance copy of the guideline manuscript so a panel can be assembled and a manuscript drafted for submission to JCO in a timely manner. ASCO uses the AGREE II Tool for assessing the quality of guidelines.

To request Official ASCO Representatives, please complete the  ASCO Representative Form and submit it to guidelines@asco.org. The ASCO Leadership will approve and appoint the member.


Options for Collaboration

ASCO welcomes the opportunity to work with other organizations to develop high quality guidelines and reduce duplication of effort. ASCO has a variety of opportunities for collaborative efforts in guideline development. Requests can be sent to guidelines@asco.org.

ASCO often nominates representatives to serve on guideline expert panels from other guideline development organizations. To request Official ASCO Representation, please complete the request form (insert link to form). Conversely, organizations may also be asked to nominate representatives to serve on an ASCO guideline expert panel on behalf of their organization.

Upon or nearing completion of a guideline, participating organizations may request an advance copy to consider for endorsement.  Anyone reviewing ASCO guideline manuscripts are asked to sign a Non-Disclosure Agreement (NDA). A list of guidelines in development can be found on the Guidelines Wiki Homepage.

ASCO and other organizations may also opt to jointly develop a guideline. Please see information on ASCO's processes for jointly develop a guideline. Please see information on ASCO's processes for Joint Guideline Development. The expert panel membership may be split in a variety of iterations between ASCO representatives and representatives from the partnering organization.  Depending on the type of joint initiative, the costs of development are shared according by the respective organizations. For joint guidelines, participating organizations sign a Memorandum of Understanding (MOU) to finalize the details.  The organizations also have to agree on a conflict of interest policy to follow. Typically, the most stringent policy is followed. ASCO’s policy can be found at: http://www.asco.org/sites/www.asco.org/files/conflict_of_interest_policy_implementation_for_clinical_practice_guidelines_8.8.2013_0.pdf.

ASCO considers endorsement of high quality guidelines from other organizations. If you have an Endorsement Request, please complete the ASCO Guideline Endorsement Request form


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