USPSTF: Insufficient Evidence for Celiac Disease Screening

Diana Phillips

March 28, 2017

The practice of screening asymptomatic individuals for celiac disease is not supported by the available evidence, but neither is it refuted, according to a panel of experts.

"[T]he current evidence is insufficient to assess the balance of benefits and harms of screening for celiac disease in asymptomatic persons," the US Preventive Services Task Force (USPSTF) writes in its recommendation statement. The statement, published today in JAMA, is the first statement the group has issued on celiac disease screening.

The recommendations are based on a comprehensive review of available evidence regarding the accuracy of screening in asymptomatic populations, the potential risks and benefits of screening vs not screening, and the risks and benefits of treating screen-detected celiac disease.

On the basis of that review, which is also published in JAMA, the Task Force also determined that inadequate evidence exists to assess the effectiveness of treatment of screen-detected, asymptomatic celiac disease compared with no treatment or treatment that is started after a clinical diagnosis.

Acknowledging that clinical decisions are based on multiple considerations and not on evidence alone, the statement authors stress that "[c]linicians should understand the evidence but individualize decision making to the specific patient or situation." Similarly, "policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms," they write.

Importantly, the recommendation does not apply to patients with symptoms of celiac disease, such as diarrhea, abdominal pain, and unexplained weight loss.

In the evidence review, Task Force member Roger Chou, MD, from the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, Portland, and colleagues report that they found no studies comparing screening vs no screening; targeted vs universal screening; or the potential harms of screening in asymptomatic adults, adolescents, or children. And while the available evidence supports the accuracy of serologic tests, "almost all studies on diagnostic accuracy evaluated populations with symptoms of celiac disease or in whom symptom status was not reported," they write.

Limited data were also available for the assessment of the benefits of screen-detected treatment vs no treatment (one trial), the benefits of screen-detected treatment vs treatment imitated after clinical diagnosis (no studies), and the potential harms of treatment (one trial).

"The major limitation of this review is the lack of evidence to address the [key questions]," the authors write. "In addition, although numerous studies evaluated the diagnostic accuracy of tests for celiac disease in patients who were not asymptomatic, the applicability of findings to screening settings is uncertain."

A draft version of this recommendation statement was released in March 2016 and posted for public comment on the USPSTF website from May 3 to May 30, 2016.

In response to patient comments about their own delayed diagnoses because of atypical or nonspecific symptoms, the Task Force expanded the Suggestions for Practice section of the guideline, calling attention to the prevalence of atypical symptoms and delayed diagnoses. Specifically, celiac disease "may also manifest as nonspecific, nongastrointestinal symptoms, including anemia, osteoporosis, chronic fatigue, peripheral neuropathy or ataxia, and short stature," according to the statement. Further, evidence suggests "that some patients may have symptoms for years before being diagnosed."

The Task Force also addressed commenters' concerns about individuals at increased risk for the disease, including family members of patients with celiac and those with other autoimmune conditions. "The USPSTF revised the 'Research Needs and Gaps' section to emphasize the importance of developing evidence to guide clinical practice for this population," the authors write.

In an accompanying editorial, Rok Seon Choung, MD, and Joseph A. Murray, MD, both from the Division of Gastroenterology and Hepatology, Mayo Clinic in Rochester, Minnesota, acknowledge that the Task Force conclusion and recommendation "will undoubtedly be disappointing for many clinicians as well as some patients." But, they note, the review "has appropriately identified the need for data to provide direction in this fundamental area." In particular, the review "highlights the lack of the data on natural history of silent or subclinical celiac disease and whether these patients progress to symptomatic celiac disease, develop consequent complications, or have spontaneous regression of this condition."

Having a low threshold for testing for celiac disease is reasonable, the editorialists write, "especially in high-risk populations such as those with an affected family member or type 1 diabetes mellitus."

Given the increasing availability of less invasive diagnostic testing and easier access to a gluten-free diet — both of which reduce the diagnostic and treatment burden associated with celiac disease — "it behooves the medical research community to provide the data to determine who should be screened and treated for celiac disease, and when and how," according to the editorial authors. "This will require carefully crafted and ambitious studies to address this question in high-risk groups as well as in the general population, which includes most persons with undetected celiac disease," they write. "The increasing adoption of a gluten-free diet by a significant portion of the population may be filling the vacuum left by the uncertainty of current screening and diagnostic approaches."

The guideline authors have disclosed no relevant financial relationships. Editorial writer Dr Murray reported receiving grants from Alvine Pharmaceuticals, Alba Therapeutics, the National Institutes of Health, the Obercotter Foundation, and Broad Medical Research Foundation/CCFA; serving on the advisory board of Celimmune; and serving as a consultant for BioLineRx, GlaxoSmithKline, Genentech, Glenmark Pharmacueticals, Boehringer Ingelheim, ImmunsanT, Institute for Protein Design (PvP Biologics), Takeda, Innovate Biopharma, and Intrexon. Dr Choung has disclosed no relevant financial relationships.

JAMA. 2017;317:1252-1257, 1258-1268, 1221-1223.  Recommendation statement, Evidence review, Editorial

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