Eileen Condon October 28, 2011 SEARCH Program Abstract Background Helicobacter Pylori: Treatment Rates and Strategies for Improvement in a Community Health Center Population Gastric cancer is a major global health problem, with approximately one million new cases diagnosed every year (Selgrad, Bornschein, Rokkas & Malfertheiner, 2010). The clinical manifestations of gastric cancer do not typically become evident until an advanced stage, resulting in the second highest mortality rate among all cancers, and approximately 700,000 deaths each year (Malfertheiner, Bornschein & Selgrad, 2010). In patients with advanced disease, the 5 year survival rate is only 10-15% (Selgrad et al., 2010), as available treatments at this late stage are limited (Malfertheiner et al., 2010). Therefore, the high incidence, mortality rate and limited treatment options of gastric cancer make early screening and intervention essential in at-risk patients. The most important risk factor for the development of gastric cancer is an infection with Helicobacter pylori (Selgrad et al., 2010). Eradication of H. pylori with triple or quadruple therapy has been proven to greatly reduce the risk of gastric cancer (Fuccio, Zagari, Minardi, & Bazzoli, 2007), and the earlier the bacteria is eradicated, the more significant the decrease in risk (Selgrad et al., 2010). However, a point of no return has also been identified, and once pre-neoplastic changes, including gastric atrophy and intestinal metaplasia, have occurred, H. pylori eradication is much less likely to prevent the progression to invasive cancer (Malfertheiner et al., 2010). This not only demonstrates the need for early screening of high risk individuals, but the necessity of early intervention and H. pylori treatment in the prevention of gastric cancer. H. pylori is also associated with other gastrointestinal disorders. Approximately 85% of patients with gastric ulcer disease and 95% of patients with duodenal ulcer disease tested positive for H. pylori in initial clinical studies (Goldman & Ausiello, 2008). H. pylori infection has also been associated with
extragastric disorders, including idiopathic thrombocytic purpura and iron deficiency anemia (Malfertheiner & Selgrad, 2010). The American College of Gastroenterology has outlined a number of guidelines for the diagnosis and management of H. pylori infection (Chey & Wong, 2007). However, failure rates of H. pylori eradication are increasing, and second and third line therapies are often required for adequate treatment. A number of factors may contribute to this, with the most important being increasing antibiotic resistance and poor patient compliance (McLoughlin, Racz, Buckley, O Connor & O Morain, 2004). Thus, even in patients with resolved symptoms, confirmation of H. pylori eradication is recommended in order to assess the treatment s effectiveness (Crowe, Feldman & Travis, 2011). Although H. pylori infection is more common in developing countries, its prevalence in the United States varies widely by geographic area, age, race, ethnicity and socioeconomic status (Brown, 2000). In developing countries, most individuals become colonized with H. pylori during childhood. This results in a very high incidence of H. pylori among immigrants from developing countries (Goldman & Ausiello, 2008), and puts the community health center population at high risk for infection. Furthermore, lack of insurance, poor medication compliance or lack of follow up may make identification, treatment and eradication confirmation of H. pylori difficult to obtain. Objectives The purpose of this study was to 1) determine the treatment rates of H. pylori positive patients at the Bridgeport Community Health Center (BCHC) in 2010; 2) to identify a list of patients who had not received adequate treatment, or who had not received post treatment testing to confirm H. pylori eradication; 3) to determine barriers to effective treatment and follow up testing in this population; and 4) to develop a more efficient system for identifying patients in need of screening, treatment or retesting. Methods Current screening, diagnosis and management guidelines for H. pylori infection were reviewed. A review of current literature on the relationship between H. pylori infection and gastric cancer was
performed. Literature on the incidence and impact of H. pylori infection on the community health center population was reviewed, although very little informative data was obtained. A review of current literature on barriers to H. pylori treatment in high risk populations was also performed, yielding similarly limited results. A list of H. pylori positive patients from 2010 was obtained from one provider at the Bridgeport Community Health Center. Paper charts were reviewed for a sample of 25 patients, and electronic medical records were crossed referenced for accuracy of data. Treatment rates, medication compliance and lab results were recorded, as well as any notes on side effects or barriers to treatment. This data was used to provide a list of patients who were untreated, as well as those who had received treatment, but not post-treatment testing to confirm eradication. A plan for contacting these patients, as well as the development of a reminder system within the EMR, was discussed with the BCHC staff and providers. Results Of the 25 patient sample, 17 patients had been prescribed a triple therapy treatment regimen during a follow up visit. However, of these 17 patients, only 4 had documentation in the chart confirming that therapy had been completed. Furthermore, only one patient had received follow up testing to determine H. pylori eradication. Of the 7 untreated patients, 3 were seen in the clinic for appointments following the positive result, but H. pylori was not discussed and treatment was not initiated. Other barriers to treatment identified included lack of prescription coverage by insurance, charts and lab results unavailable during walk-in visits, discontinuation of treatment due to side effects, and lack of patient follow up despite multiple contact attempts. Conclusions Effective eradication of H. pylori is essential for the prevention of gastric cancer, and the treatment of gastrointestinal disorders like peptic ulcer disease. Although it is frequently screened for in the BCHC population, follow up for the H. pylori positive patients remains inefficient. Encouragingly, the
results of this study revealed that the majority of H. pylori positive patients were prescribed an appropriate treatment regimen at BCHC. However, patient compliance with medication therapy remains unknown, and post treatment testing was not done routinely. In order to truly confirm the eradication of H. pylori infection, providers should address medication compliance in follow up visits, and record whether therapy was completed in the medical record. Furthermore, given increasing rates of antibiotic resistance, patients should be retested to determine the need for a second line treatment regimen. Although the incidence of H. pylori infection in the community health center population is likely high, and its impacts can be very detrimental if untreated, there is surprisingly limited data on the barriers to treatment in at-risk populations. Some barriers to treatment may be very difficult to overcome, such as lack of patient follow up, or inability to afford medications. However, provider and environmental related barriers can be addressed. At BCHC, a review of the current guidelines from the American College of Gastroenterology was provided to enhance understanding and compliance by providers. The recent implementation of electronic medical records is another important change that will be used to improve compliance. The EMR makes lab results easier to obtain, and past notes easier to review, enhancing the provider s ability to determine whether treatment was initiated or completed. In order to take advantage of this system, providers were encouraged to develop a personal reminder system within the EMR, such as a brief note or chart update, so that a timely and effective approach to therapy can be implemented for future patients. A list of past untreated patients was also provided, so that follow up can be pursued and proper treatment can be initiated.
References Brown, L. (2000). Helicobacter pylori: epidemiology and routes of transmission. Epidemiology Review. 22(2); 283-97. Chey, W. & Wong, B. (2007) American College of Gastroenterology Guideline on the Management of Helicobacter pylori Infection. American Journal of Gastroenterology, 102(8):1808-25 Crowe, S., Feldman, M. & Travis, A. (2011). Indications and diagnostic tests for Helicobacter pylori infection. Up To Date. Retrieved from http://www.uptodate.com/contents/indications-anddiagnostic-tests-for-helicobacter-pyloriinfection?source=search_result&search=helicobacter+ pylori&selectedtitle=2%7e150#h27. Fuccio, L., Zagari, R., Minardi, M & Bazzoli, F. (2007). Systematic review: Helicobacter pylori eradication for the prevention of gastric cancer. Aliment Pharmacology Therapy, 25, 133-41. Goldman, L & Ausiello, D. eds. (2008). Cecil Textbook of Medicine. 23 nd edition. Philadelphia: Saunders. Luther, J., Higgins, P. D., Schoenfeld, P. S., Moayyedi, P., Vakil, N., & Chey, W. D. (2010). Empiric quadruple vs. triple therapy for primary treatment of helicobacter pylori infection: Systematic review and meta-analysis of efficacy and tolerability. American Journal of Gastroenterology, 105(1), 65-73. Malfertheiner, P., Bornschein, J., & Selgrad, M. (2010). Role of helicobacter pylori infection in gastric cancer pathogenesis: A chance for prevention. Journal of Digestive Diseases, 11(1), 2-11. Malfertheiner, P., & Selgrad, M. (2010). Helicobacter pylori infection and current clinical areas of contention. Current Opinion in Gastroenterology, 26(6), 618-623. McLoughlin, R. M., O'Morain, C. A., & O'Connor, H. J. (2005). Eradication of helicobacter pylori: Recent advances in treatment. Fundamental & Clinical Pharmacology, 19(4), 421-427.
Selgrad, M., Bornschein, J., Rokkas, T., & Malfertheiner, P. (2010). Clinical aspects of gastric cancer and helicobacter pylori--screening, prevention, and treatment. Helicobacter, 15(Suppl 1), 40-45.