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Standard Operating Procedure – Developing AUA White Papers

Standard Operating Procedures: Developing AUA White Papers [pdf]

6/13/2013

Introduction

The American Urological Association (AUA) is the premier professional association for the advancement of urologic patient care. Quality improvement and patient safety initiatives are important parts of the AUA’s mission to promote the highest standards of urological clinical care through education and research. To this end, the AUA develops a variety of publications for its members, such as clinical practice guidelines, best practice statements, policy statements and white papers coordinated by the Science and Quality Division. The Quality Department within the Science and Quality Division develops white papers on patient safety and other critical issues and also serves as a clearinghouse for white papers developed by other AUA departments. The management of clinical practice guidelines and technology assessments fall under the purview of the Guidelines Department. Each publication has been clearly defined by the AUA; for more information on standardized definitions, please see Standard Definitions for Clinical and Technology-Related Recommendations/Statements (2008) or a summary table in Appendix A. This overview of white papers is intended to describe the AUA’s process of developing white papers.

Definition

A white paper is a comprehensive qualitative assessment of a topic or topics that are approved by the AUA Board of Directors for development by a panel of experts that include urologists and may include other specialists. It states the AUA’s position or philosophy on a topic, often focusing on issues of patient safety or other issues of importance to urology. It can also be a brief explanation of an available technology in the field of urology. A white paper may present a policy statement on the topic. The process, use of evidence and expert opinion, and scope and length of a white paper are the focus of this document. For a list of stages in the process and approximate time required for each, see Appendix B.

Process

The AUA’s process of developing white papers begins with identification of the key issue(s) by the Quality Improvement and Patient Safety (QIPS) Committee or other sources, such as the AUA guidelines, the Agency for Healthcare Research and Quality, the Food and Drug Administration and the National Urology Research Agenda. When a topic is being considered, QIPS will also ascertain the opportunity for collaboration with other subspecialties. Recognizing the expertise of ancillary professionals as well as the collaborative nature of healthcare delivery, the AUA is committed to multi-disciplinary panels, if appropriate based on the topic, and partners with other subspecialties to populate the panel and develop the white paper. A memorandum of understanding between the two societies is drafted to ensure clear roles and responsibilities.

The QIPS Committee submits the topic to the Science and Data Advisory Group for approval and then on to the AUA Board of Directors for review and final approval.

To initiate the project, the panel chair is selected by the QIPS chair with input from other experts, as necessary. The panel chair and QIPS chair then select additional members of the panel with expertise in the topic area under consideration; in all, the panel should not exceed 10 members, which allows for adequate expertise and diversity of opinions without becoming cumbersome for scheduling and discussion purposes. All panel members are required to disclose any potential conflicts of interest (COI) through the AUA’s electronic submission process and sign non-disclosure agreements. These relationships are reviewed by staff to determine eligibility for panel inclusion.

The white paper panel accomplishes most of its work through conference calls and webinars, as needed. If necessary, an in-person meeting can be held if there are issues to be discussed. The panel works closely with the methodologist reviewing the literature. A medical librarian conducts literature searches to identify appropriate articles and saves the results in a format previously approved by AUA staff. The methodologist then reviews the abstracts to appraise the relevance and requests full-text articles of key studies. AUA staff assists in obtaining the full-text articles. A data extractor, under guidance from the methodologist, may extract the data from relevant articles. The methodologist qualitatively analyzes the available evidence and develops a findings report for panel review that summarizes the literature and provides data, as available. At this point, the panel chair drafts an abstract and outline to submit to the Journal of Urology for consideration. The Journal editors will determine if the white paper will be of interest to its readership and notify the panel chair of an invitation to submit a 4,000 word article to the Journal (see Appendix C for Journal of Urology submission steps).

After careful review of the evidence, the panel develops a summary of findings with conclusions and drafts the white paper with assistance from a medical writer. Through email and conference calls, the panel revises and finalizes its document. In addition, a summary manuscript is developed for submission to the Journal of Urology. For the purposes of fast tracking an online process in the Journal of Urology, the manuscript is submitted concurrent with final panel review. Additional revisions from the panel, QIPS, Science and Data Advisory Group, or the Board can be incorporated before final publication.

Once the panel has developed a draft of the white paper, it is reviewed by the QIPS Committee and Science and Data Advisory Group. The panel revises the document to incorporate feedback, as appropriate, and it is then sent to QIPS and the BOD for final approval.

Literature-Based Evidence

A white paper includes background information on the topic and discussion of the key findings in the literature. Under direction from the panel chair, a medical librarian conducts searches of online databases, such as PubMed and EMBASE, to identify relevant literature on the topic. To ensure no key articles are overlooked, the panel chair, along with the panel, provides guidance on relevant literature and the literature search timeframe that should be included in the white paper. A methodology consultant conducts a qualitative analysis of the available evidence, and the panel ultimately bases its white paper on this analysis. References are cited in the document, and evidence tables may be included as well.

Expert Opinion

The panel’s expert opinion is critical to a white paper. Often the scarcity of the literature does not allow for a more rigorous evidence-based document. Therefore, the panel must review the qualitative analysis and employ expert opinion to provide guidance on the selected topic. AUA panel members represent the leading experts in the field; therefore, their years of clinical and research experience are invaluable in assessing the literature and drawing conclusions that will be beneficial to the field of urology. In addition, the appropriate committees and councils review the white paper and provide valuable feedback; ultimately the AUA Board approves the final document.

Scope and Length

AUA white papers are limited to a narrow topic of immediate interest to AUA membership and should be focused on the needs of the audience. The development of a white paper is often initiated in an effort to be responsive to emerging issues of critical importance to the membership or to address issues of patient safety. For example, the AUA has developed the following:

While other more rigorous projects take a considerably longer period of time to develop (2+ years), white papers, which are approximately 10-20 pages in length and not intended to be comprehensive, can be completed within approximately 9 months, thus providing the membership with an assessment of the literature and AUA expertise on a particular topic in a quick timeframe. This is very important when an emerging issue needs to be quickly addressed.

The scope of the topic is defined in a topic refinement document, developed by the panel. This document clearly delineates the researches issues to be addressed, index patient(s), literature search terms, and timeframe of publications to be included. The methodology consultant develops the methodology protocol from the topic refinement document and includes the following:

Dissemination

The white paper is published on the AUA’s website, and members are informed through various AUA publications, such as the Journal of Urology, Health Policy Brief, AUA News, or other AUA publications. Additionally, a marketing plan to publicize and distribute the white paper is jointly developed by both the Marketing and Communications and Quality staff and may include plenary presentations or educational courses at the AUA Annual Meeting. QIPS, Health Policy Council and white paper panel members are encouraged to widely disseminate the document. If the white paper is developed through a partnership with another subspecialty organization, the subspecialty disseminates the white paper to its members. Also, the AUA provides the white paper to the American Board of Urology (ABU) to inform its standards of certification and ensure that its programs are based on the most current evidence-based information.

Updates

The AUA is committed to ensuring the accuracy and currency of its publications. Therefore, white papers are assessed by the Quality Department every three years to determine if relevant evidence has been published since the publication of the white paper that would require revisions to the panel’s findings. If a topic is of high priority, the AUA may decide to update it earlier than 3 years in order to ensure the incorporation of key articles. As the clearinghouse for all AUA white papers, Quality staff upload white papers to the Quality website. To assure currency, Quality staff will evaluate the publication date of a white paper and note when an update review is needed. They will then alert appropriate AUA staff that an assessment and potential revisions are due.

Similar to the AUA’s Update Literature Review process for its clinical practice guidelines, the update process for white papers entails a three-member panel comprised of the panel chair, another panel member and a new member not previously involved in the original panel but considered an expert in the subject.

The update is conducted in four stages:

To conduct the review, the medical librarian performs a search of literature published since the cutoff date in the existing white paper. The methodologist will conduct a qualitative analysis to provide the panel with information to make a decision about the accuracy of the white paper. The panel then determines whether a limited update is required or if a full revision of the white paper is warranted.

If the update panel decides that a revision or update is warranted, the QIPS chair is notified. If the decision is to revise the white paper, the QIPS chair and AUA staff determine a feasible timeline. If the panel recommends adding a limited update to the white paper, the medical librarian will conduct a literature search, the methodologist will conduct and report on a literature appraisal and the panel will develop the new language for the white paper. The panel may also decide against these options and determine that an update should be conducted again the following year. The quality manager modifies the AUA website to reflect that the white paper has been verified as accurate.

Conclusion

Since white papers offer the advantage of relatively quick turnaround, they can address important topics in a timely manner. However, the disadvantage is a less rigorous evidence review process often due to lack of available evidence or inadequate time to devote to a thorough systematic review and quantitative analysis. White papers provide the AUA with one more evidence-based resource to educate its members, research critical issues facing urologists and confront challenges facing the field of urology.


Appendix A

Definition Summary for AUA Clinical and Technology Related Recommendations/Statements*

*Adapted from the AUA Definitions Document

Guideline Related Products (Guidelines Dept.) Other Departments
Guidelines Best Practice
Statements (BPS)
Technology Assessment
(TA)
Policy Statement Consensus Statement White Paper
Definitions Evidence-
based guidance with an explicit clinical scope and purpose
Evidence
-based guidance that reflects the principles of the urology profession
Guideline process directed at an intervention A straight-forward declaration on a particular topic(s) The collective opinion of an expert panel A topic review focusing on issues of patient safety or other issues of importance to urology
Source of Evidence Randomized controlled trials (RCTs) utilized when available; non-RCT data are used if considered robust; strongest document Literature is reviewed; no data analysis performed Systematic review of the literature A cursory review of the literature Opinions Literature review
Expert Opinion Panel members review of literature and determine data to be extracted Panel members contribute knowledge and experience to conclusions Panel members review the literature and determine data to be extracted Developed by experts Opinion of an expert panel Opinion of an expert panel
Process Systematic/
scientific review, data extraction, meta-analysis
Extractions and meta-
analysis are not performed; Consensus is based on literature review
Appropriate qualitative and quantitative methods of synthesizing data from multiple studies are utilized Dictated by government agencies or endorsement of policies from other sources (e.g. AMA) Consensus, either formal or informal Review of the available literature by an expert panel
Length Approximately 50-100 pages Up to 50 pages Similar to guideline or BPS length 1-2 pages 5-10 pages 10-20 pages
Average Time 24-30 months N/A 24-30 months 1-3 months 6 months 9-12 months

Appendix B

Process of Developing an AUA White Paper

(Average Timeframe: 9-12 months)

Stage 1 Formulate topic 1 month
Stage 2 Identify panel members less than 1 month
Stage 3 Define scope of the topic 1 month
Stage 4 Review literature 1-2 months
Stage 5 Develop qualitative analysis 2 months
Stage 6 Review analysis and form conclusions 1 month
Stage 7 Draft white paper 2 months
Stage 8 Undergo review by appropriate committees and councils 1 month
Stage 9 Obtain AUA Board approval 1 month
Stage 10 Disseminate white paper ongoing
Stage 11 Update literature review every three years following publication

Appendix C

White Paper Publication Track

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