- Describe your topic.
- In community patients, can general screening of anti-nuclear antibodies (as opposed to targeted screening according to certain clinical criteria) lead to early detection of systemic autoimmune rheumatic diseases?
- Describe why this topic is important.
- Detection of anti-nuclear antibodies (ANAs) is the hallmark of systemic autoimmune rheumatic diseases (SARDs) such as systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, myositis, and mixed connective tissue disease. Past studies have indicated that ANAs demonstrate a hierarchy of specificity whereby certain autoantibodies exhibit a temporal relationship to actual diagnosis of SARDs (1-5). Traditionally, the ANA test has been mostly ordered by rheumatologists. However, several factors have contributed increased demand for ANA testing from non-rheumatology providers, including: 1) increased prevalence of SARDs; 2) demonstrated overlap of ANA test utility in disease states involving other organ systems (eg, autoimmune hepatic diseases); 3) greater prominence of primary care physicians as case-finders in a changing healthcare environment; and 4) automated and high-throughput testing approaches that can more easily meet demand. With increasing laboratory workload for ANAs and their potential predictive role, particularly ordered by primary care physicians on community patients, it is unclear whether it is useful to use this test as a screen for SARDs. Indeed, increasing pressures on referrals from the community are leading to longer wait times to see specialists such as rheumatology. Potential drivers of these increased referrals may be due to false positive ANA results and that greater than 20% of the normal healthy population may have positive ANA (6-8). Consequently, the Choosing Wisely campaigns from the United States and Canada have led to recommendations to reduce ANA subserology testing, repeat ANA testing, and ANA screening test in patients without specific signs or symptoms of SARDs (9-11). 1. Swaak and Sweenk, Annals of the Rheumatic Diseases, 1985, 44, 245-251 2. Weiner et al, Arthritis Rheum 1991;34:68–77 3. Waltuck and Buyon Ann Intern Med. 1994;120:544-551 4. Simon et al., Lupus 2004;13:177–81 5. Arbuckle et al., N Engl J Med 2003;349:1526-33 6. Kavanaugh A, et al. Arch Pathol Lab Med. 2000 Jan;124(1):71-81 7. Solomon DH, et al. Arthritis Rheum. 2002 Aug;47(4):434-44 8. Tozzoli R, et al. Am J Clin Pathol. 2002 Feb;117(2):316-24 9. Yazdany et al., Arthritis Care & Research Vol. 65, No. 3, March 2013, pp 329 –339 10. Rouster-Stevens et al., Arthritis Care & Research Vol. 66, No. 5, May 2014, pp 649 – 657 11. Chow et al., The Journal of Rheumatology April 2015, 42 (4) 682-689
- Tell us why you are suggesting this topic.
- Recommendations for the appropriate clinical use of ANA will improve patient care through accurate diagnosis of a SARD and/or prediction of eventual occurrence of a SARD.
- Target Date.
- Describe what you are doing currently and what you are hoping will change because of a new evidence report.
- ANA screening in community patients is ordered by primary care physicians. In addition, ANA screening may be partly driven by rheumatologists at respective medical centers, whereby an ANA may be required for a referral. More clarity regarding the use of ANA screening will help direct appropriate use of healthcare funds and whether this will improve diagnosis and management of patients with SARDs and other conditions that appear to show linkages to ANA test positivity.
- How will you or your group use the information from a new evidence report?
- We will collaborate with rheumatologists and other specialists who use ANA testing with regard to the clinical utility of ANA results, and develop a joint clinical and laboratory medicine practice guideline and/or policy. Findings from this guideline will help to engage stakeholders from a variety of other clinical societies such as clinical immunology, nephrology, gastroenterology, neurology, dermatology, internal medicine, and family medicine.
- How would you or your group plan to disseminate information from the report? Who would you plan to disseminate it to?
- The American Association for Clinical Chemistry collaborates with a number of clinical societies with regard to professional practice and educational activities. We will disseminate information through position statements and/or white papers, and to relevant clinical societies (rheumatology, clinical immunology, nephrology, gastroenterology, neurology, dermatology, internal medicine, and family medicine).
- Do you know of organizations that could use an evidence report to change clinical practice? Are you a part of, or have you been in contact with, any organizations that might implement the research findings of an evidence report?
- As mentioned above, the American Association for Clinical Chemistry collaborates with a number of clinical societies (rheumatology, clinical immunology, nephrology, gastroenterology, neurology, dermatology, internal medicine, and family medicine).
- Information About You: (optional)
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- Provide a description of your role or perspective.
- Professional society: Co-chair of the Evidence-Based Laboratory Medicine Committee, American Association for Clinical Chemistry
- If you are you making a suggestion on behalf of an organization, please state the name of the organization.
- American Association for Clinical Chemistry (AACC)
- Please tell us how you heard about the Effective Health Care Program.
- Ongoing collaboration between the AHRQ and AACC.
