Abstract and Introduction
Despite guidelines for detection and treatment of Helicobacter pylori infection, recommendations to test patients before and after therapy are commonly not followed in the United States. At the Houston Consensus Conference, 11 experts on management of adult and pediatric patients with H pylori, from different geographic regions of the United States, met to discuss key factors in diagnosis of H pylori infection, including identification of appropriate patients for testing, effects of antibiotic susceptibility on testing and treatment, appropriate methods for confirmation of infection and eradication, and relevant health system considerations. The experts divided into groups that used a modified Delphi panel approach to assess appropriate patients for testing, testing for antibiotic susceptibility and treatment, and test methods and confirmation of eradication. The quality of evidence and strength of recommendations were evaluated using the GRADE system. The results of the individual workshops were presented for a final consensus vote by all panel members. After the Expert Consensus Development meeting, the conclusions were validated by a separate panel of gastroenterologists, who assessed their level of agreement with each of the 29 statements developed at the Expert Consensus Development. The final recommendations are provided, on the basis of the best available evidence, and provide consensus statements with supporting literature to implement testing for H pylori infection at health care systems across the United States.
Since 2015, 4 major Helicobacter pylori consensus documents have been published.[1–4] The stimulus for this consensus conference was that, despite previous guidelines, recommendations regarding appropriate testing before therapy were commonly not followed, and testing after therapy was also not recommended for practitioners in the United States. For example, a large 2007 retrospective study of US pharmacy claims involving 1.9 million health plan members showed serology to be the most common H pylori test used. A more recent study, performed between 2010 and 2013, analyzed first-time H pylori diagnostic tests among more than 100 million individuals and reported that serology was used in ~70% of 515,700 tests, of which 4.2% were positive. Serology was used in ~70%; 15,495 tests (4.2%) were positive. Despite the need to confirm the results of serologic tests in low prevalence populations, only a minority of patients with positive serology had confirmatory testing (ie, urea breath test [UBT] in ~16% and stool antigen immunoassay [HpSAg] testing in 11%) within the 14-day window allowed by the study. Although reimbursement potentially influences practice patterns, the Centers for Medicare and Medicaid Services reimburses all methods of H pylori testing and at that time reimbursed $19.80 for serology, $91.89 for UBT, and $19.62 HpSAg. Since that time, several commercial insurance companies have designated serology as not medically necessary and no longer reimburse for that test.
A 2017 study among practicing gastroenterologists reported gastric biopsy as the most common diagnostic method (59%) followed by HpSAg (20%); the predominance of biopsy likely reflected the fact that specialist practice often consists of referrals. The most common therapy prescribed was standard triple therapy, and among these 53% were for 14 days and 30% were for 7 or 10 days. This regimen has continued to be used despite data that the cure rates with standard triple therapy had fallen below 80% by 2000.[10–13] The issue of falling cure rates was not incorporated into the guidelines until 2012 and not explicitly until 2017. Moreover, despite declining eradication rates with standard triple therapy, gastrointestinal physicians report confirming H pylori eradication in only 58% of cases.
Clearly, a knowledge gap regarding best practices for H pylori diagnosis and therapy exists even among physicians most likely to be considered experts by their colleagues, and despite regularly updated guidelines, many gaps persist in practice. The guidelines developed by this consensus group focused on identifying the target populations for diagnosis and therapy with the aim of providing practical advice for US practitioners and recommendations for guidelines and to be adopted by US health care systems.
Clearly, performance gaps exists in the practice of H pylori diagnosis and therapy even among expert physicians, and despite regularly updated guidelines. We convened a consensus conference to develop a set of recommendations for appropriate diagnostic testing and treatment strategies focusing on eradication of active H pylori infections. These recommendations would provide practical advice for US practitioners, and also guidelines to be adopted by US health care systems.
Clin Gastroenterol Hepatol. 2018;16(7):992-1002. © 2018 AGA Institute