Request for Letters of Interest from Potential Guideline Development Partners

ACR GUIDELINES FOR THE TREATMENT OF RHEUMATOID ARTHRITIS

Release Date: March 20, 2013

Deadline for Letters of Interest (receipt deadline): July 15, 2013

The ACR requests letters of interest from teams or individuals who wish to partner with the ACR in developing evidence-based clinical practice guidelines for the treatment of rheumatoid arthritis.  The guidelines will cover use of corticosteroids, DMARDs, and biologics, including newer oral agents; the final scope and clinical questions to be addressed in the guideline will be finalized after the guideline development team has been confirmed. The guidelines will be developed primarily for specialists who care for RA patients, but may also be used by primary care providers and others who care for these patients. The guidelines will be developed in accordance with the ACR’s standardized approach, which includes use of the GRADE methodology. Overall, the guidelines will conform to AGREE II criteria.[1]  Details of the ACR’s guideline development methodology, processes and related timelines are available in the ACR Guideline Manual, which is posted on the ACR web site.

The ACR intends to partner with a team of individuals to develop these new RA guidelines. Letters of interest will be accepted from teams as well as from individuals who are not proposed part of a team. Well-formed teams will be given preference over individuals, but the ACR may decide to invite an interested and qualified individual to become part of the ACR project team, even if they are not part of a proposed team.

The main focus of the letter of interest should be on the people who are proposed to partner with the ACR on this project, their qualifications for this work, and the particular roles for which they would be best suited. The successful letter of interest will:

  1. Propose a well-qualified, balanced guideline development group to assemble and review the evidence and determine the appropriate recommendations. The membership of the guideline development group will be broadly based, including rheumatologists, other physicians, specialists and health professionals who care for patients with rheumatoid arthritis. It will include private practitioners as well as academicians and at least one knowledgeable consumer and one patient advocacy group representative. Rheumatology private practitioners and academicians must be included.
  1. Divide the proposed guideline development group into the following sub-groups:
  • A Core Leadership Team of no more than 4-5 people, led by a principal investigator who will be accountable with ACR staff and committee volunteers for completion of the project according to a project plan and timeline that are finalized after the guideline development team is confirmed. Other members of the Core Leadership Team must include the literature review leader and the guideline panel leader, if the PI is not serving in this role (see below).
  • A Literature Review Team of approximately 10-12 people, led by a designated literature review leader who is part of the Core Leadership Team. The Literature Review Team will conduct the review of available evidence that will serve as the basis of the recommendations made in the guideline. NOTE: Because of the PI’s prominent role in development of the final guidelines and the need for some separation between the literature review and the recommendation development processes, the project PI may not also lead the literature review.
  • A Voting Panel of approximately 10-12 people led by either the PI or another designated guideline panel leader, who is part of the Core Leadership Team. The Voting Panel will lead the decision process regarding the recommendations.
  1. Include a complete disclosure of relationships for each person in the proposed guideline development group (see Application Procedures below), a commitment to follow the ACR disclosure and COI policies, and a summary of how the following ACR COI requirements are met in the proposed guideline development group composition:
  • At least 51% of the overall guideline development group (i.e., anyone who is intellectually involved in the project) must have no conflicts of interest related to the subject of the guideline. Similarly, at least 51% of the Literature Review Team and 51% of the Voting Panel must have no conflicts of interest related to the subject of the guideline. NOTE: The 51% unconflicted threshold is a minimum; the ACR’s goal will be to have significantly more than 51% unconflicted participants overall and on each smaller subgroup to allow for unanticipated mid-project personnel shifts (e.g., a participant drops out due to illness or schedule changes).
  • The project PI must not have conflicts of interest related to the subject matter of the guideline.
  • The literature review and voting panel leaders should also be unconflicted with regard to the subject matter of the guideline.

Through these and other COI requirements that are outlined in the ACR Guideline Manual, the ACR’s intent is not to exclude investigators with potential conflicts from participating in this project, but rather, to manage such conflicts in a prospective, structured and reasonable manner to minimize the likelihood of inappropriate influence of such conflicts on guideline development. Specifically, the ACR’s disclosure and COI policies and procedures are meant to deal with individuals' conflicts that may potentially bias how evidence is chosen, assembled, assessed and synthesized, or bias the recommendations based on such evidence.  The description of strategies for managing conflicts of interest related to the specific agents and approaches used to treat RA will be explicitly laid out in the final guideline manuscript.

  1. Affirm a commitment to actively work with the ACR to complete the guideline within a 12-18 monthtime frame, as specified in the project timeline that will be developed by the ACR once the guideline development team has been confirmed.
  1. Affirm a commitment to keep all guideline deliberations and materials confidential until publication. This includes a commitment to NOT participate in other, non-ACR guideline development efforts with similar topics until after publication of the ACR guideline.
  1. Agree to work with the ACR annually after guideline publication to review updated literature searches, if requested by ACR, with a goal of evaluating the need for guideline revisions or complete updates. NOTE: This is not a requirement for an annual literature review update, but rather, a scan of the updated literature search conducted by the ACR’s librarian, to help the ACR determine if a guideline update is warranted. See pages 22-24 of the ACR Guideline Manual for more details about this annual ACR evaluation.
  1. Agree to work with the ACR to complete (an) interim update(s) as warranted by new developments in the field, if requested and funded by the ACR.

ELIGIBILITY REQUIREMENTS

Letters of interest may be submitted by teams or individuals from domestic for-profit and nonprofit organizations, public or private, including but not limited to universities, colleges, hospitals, laboratories, and private practices. Collaborations that include individuals from multiple types of institutions/organizations are particularly encouraged. The ACR requires that private practitioners as well as academicians must be included in guideline development groups, to better reflect the intended audience for the final guideline. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators and members of guideline development groups.

Individuals whose primary employment is with the pharmaceutical, biotechnology or insurance industries are not eligible to apply and should not be included in proposed guideline project development groups; “primary employment” is defined as 50 percent or more of an individual’s working time.

FUNDS AVAILABLE

The ACR budget for this project is $100,000. The ACR will cover all project expenses directly. The project budget may include some salary support or honoraria for either the project PI or the literature review leader; this support and the entire project budget will be discussed with the PI and literature review leaders, at the time they are being confirmed. The project budget may also include honoraria for members of the literature review team and the voting panel to acknowledge their efforts and time spent on this activity, and possibly other consultants deemed necessary for the successful completion of the project. No indirect costs or overhead are provided to individuals’ organizations.  Additional funding will be separately provided for any future guideline updates.

ACR Approval process / OWNERSHIP and Publication of Guidelines

  • Following project completion, ACR staff and the project PI will submit the final report in the form of a manuscript to the ACR and its journals. The paper will be peer reviewed by expert reviewers and will be subjected to a formal ACR review process. The principal investigator will be responsible for any revisions required by the ACR or the reviewing journal.
  • The final ACR Board-approved manuscript will be copyedited and published jointly in Arthritis Care and Research and Arthritis and Rheumatism. Authorship will be individual, but the guidelines will be copyrighted by the ACR.
  • Upon final approval by the ACR, the recommendations will be known as the 2014 ACR Guidelines for the Treatment of Rheumatoid Arthritis.

The guidelines, including any future updates, will also be posted on the ACR website. The review process for any update(s) will be similar to that of the original guideline, unless changes are minor. The update(s) may also be published in AC&R and A&R according to the same process described above, which is described in more detail in the ACR Guideline Manual. Further details on the ACR policies and procedures re: practice guidelines can also be found in the manual.

APPLICATION PROCEDURES / Guidance about Disclosures

Standardized forms for the submission of letters of interest to the ACR are not provided. Letters over 10 pages will not be considered for evaluation. This page count should include but may not be limited to a complete list of investigators and personnel who are proposed to work on the project, a specification of the capacity in which each person would work (e.g., lit review team, voting panel), and a description of their relevant expertise and experience.

Two appendices are required outside of the 10 page limitation: 1) a curriculum vitae (CV) or NIH biosketch for each of the listed participants; and 2) a completed ACR disclosure form for each project development group member (i.e., anyone intellectually involved in the entire guideline development process). This is an essential part of the application; applications that do not include a CV/biosketch and a completed disclosure form for all intellectually involved persons will not be considered.

Disclosures should include relationships with commercial entities and insurance companies, as well as additional categories requested on the ACR disclosure form (e.g., primary employment, sources of personal income, intellectual property, research grants/contracts that directly support the person disclosing, medical and non-medical industry investments, organizational benefit, activities with other organizations, including any current or anticipated similar guideline efforts, and relevant disclosure of first degree family members). Applicant disclosure information is shared with reviewers as the final project participants are being selected.

Although full disclosure of relationships is required, investigators should pay particular attention to relationships with the companies listed on the affected companies list for this project.

The ACR defines “affected companies” as those that are reasonably likely to be positively or negatively affected by care delivered in accordance with the guideline. The above list is not meant to be all-inclusive, but rather, to provide guidance for individual disclosure; applicants who have relationships with other affected companies, as defined above, must disclose that information on their disclosure forms.

PIs of ACR guideline development projects must be free of conflicts of interest relevant to the subject matter of the project for at least one year prior to the proposal deadline, through the project until publication, and they are expected to remain free of such conflict of interest for at least one year after publication.

The majority (51 percent) of the guideline project development group must be free of conflicts of interest relevant to the subject matter of the project for at least one year prior to the proposal deadline and throughout the project until publication. This percentage must be maintained throughout the guideline development timeframe, until publication. This percentage is also applied separately to the Literature Review Team and the Voting Panel.

The conflict of interest thresholds will be based on an evaluation of relationships, primarily with affected companies. If a person has any relationship with an affected company, that person is counted as conflicted (toward the allowed threshold) regardless of the type or subject of the relationship.

An electronic copy of the final letter of interest should be e-mailed by July 15, 2013 to:
Practice Guidelines Subcommittee
c/o Regina Parker
American College of Rheumatology
2200 Lake Boulevard NE
Atlanta, GA 30319
rparker@rheumatology.org

Letters of interest not provided in electronic format will not be reviewed. Questions about the application process can be directed to Amy S. Miller (amiller@rheumatology.org) or Regina Parker (rparker@rheumatology.org).

1. The AGREE Next Steps Consortium. Appraisal of gudelines for research and evaluation II:   AGREE II instrument. The AGREE Research Trust; 2009. Available:
www.agreetrust.org/new-agree-ii-training-tools/ (accessed 2011 Jun 28)