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.
A white paper is a comprehensive qualitative assessment of a topic or topics that are approved by the Science & Quality Council and the AUA Board of Directors for development by a panel of experts that include urologists and may include other subject matter experts. 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.
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 opportunities. 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 and specialties 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. Additional layers of review may be required to ensure that the leadership of both organizations approves the final document.
The QIPS Committee submits the topic to the Science and Quality Council 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 adhere to S&Q's guideline principles on conflicts of interest (COI) and disclose any potential COIs 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. During the white paper process, the panel will likely work with a medical librarian, methodologist, and medical writer. A medical librarian conducts literature searches to identify appropriate articles and saves the results in a format previously approved by AUA staff. If requested by the chair or panel members, 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. If requested, the methodologist qualitatively analyzes the available evidence and develops a findings report for panel review that summarizes the literature and provides data, as available.
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. Once the panel has developed a draft of the white paper, it is reviewed by the QIPS Committee and the Science & Quality Council, and peer reviewed by external reviewers, including UP editors. The panel revises the document to incorporate feedback, as appropriate, and it is then sent to QIPS and the BOD for final approval. In addition, a summary manuscript is developed by the chair and medical writer for submission to Urology Practice.
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 and, frequently, panel members conduct 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.
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 – 12-16 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 by the panel. The panel may also note the research issues to be addressed, index patient(s), literature search terms, and timeframe of publications to be included so that project consultants can begin their work.
The chair, with the assistance of the medical writer if needed, develops a summary version (a maximum of 4,000 words and 50 references) of the white paper for submission to Urology Practice (see Appendix C for Urology Practice submission steps).
The white paper is published on the AUA's website, and members are informed through various AUA publications, such as Urology Practice, Policy & Advocacy 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, Science & Quality Council and white paper panel members are encouraged to widely disseminate the document. If the white paper is developed through a partnership with another 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.
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. 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. If requested by the chair, 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, they will develop the new language for the white paper; additional assistance from the medical librarian and methodologist may be required. The panel may also decide against these options and determine that an update should be conducted again the following year. The AUA website will be updated to reflect that the white paper has been verified as accurate.
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.
Definition Summary for AUA Clinical and Technology Related Recommendations/Statements*
*Adapted from the AUA Definitions Document
|Guideline Related Products (Guidelines Dept.)||Other Departments|
|Policy Statement||Consensus Statement||White Paper|
based guidance with an explicit clinical scope and purpose
-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|
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 in 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||12-16 months|
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: Peer review by appropriate committees, councils, UP editors||1 month|
|Stage 9: Obrain AUA Board approval||1 month|
|Stage 10: Disseminate white paper||ongoing|
|Stage 11: Update Literature Review||every three years following publication|
White Paper Publication Track
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