(Taken from application) The goal of the proposed research is to lay the groundwork for a multi-center, randomized double-blind, placebo-controlled trial to evaluate the cost-effectiveness of alternative management strategies for patients with dyspepsia seen in primary practice settings in Houston. Dyspepsia, which is defined here as epigastric or upper abdominal pain of one or more weeks' duration, is extremely common and accounts for substantial health care expenditures. In addition, lack of consensus exists concerning its optimal management because there is insufficient scientific basis to guide clinical decision making. This lack of consensus is heightened in light of new evidence indicating a major role for Helicobacter pylori (Hp) in the pathogenesis of peptic ulcer disease, coupled with serologic Hp tests for use in primary practice settings and effective therapies for eradicating infection. In the multi-center trial, the hypothesis to be examined is that a strategy that incorporates testing for and treatment of Hp infection (Hp-based Strategy) is more cost-effective than a strategy based on empiric antisecretory therapy (Empiric Strategy). Patients will be recruited at 4 centers (VA; County; 2 Private Practices), randomized to the treatment strategies, and followed over 1 year. The primary outcome will be relief of dyspepsia pain, as to the treatment strategies, and followed over 1 year. The primary outcome will be relief of dyspepsia pain, as denoted by dyspepsia-specific scales. Secondary outcomes include endoscopic findings and ulcer complications. Previously, a pilot study conducted at 2 centers (VA; Private Practice-1) demonstrated the feasibility of patient recruitment and that the scales fulfilled requirements regarding ease of burden, comprehensibility and sensitivity to detect dyspepsia pain.
The Specific Aims of the proposed research, which builds upon the pilot study, are: 1) to evaluate the responsiveness of the dyspepsia-specific scales to change in patients' outcomes (dyspepsia pain) over time; 2) to demonstrate patient recruitment at the 2 remaining centers (County; Private Practice-2); and 3) to demonstrate retention of patients in the study. The design of the proposed research consists of two parts. The first part is a randomized, double-blind trial comparing a 6-week course of antisecretory therapy versus placebo in patients with dyspepsia recruited at 2 centers (VA; County) and followed over 1 yr. The second part is a survey to be conducted at Private Practice-2, in which patients with dyspepsia will complete the scales.
| Rabeneck, Linda; Wristers, Kimberly; Souchek, Julianne et al. (2003) Impact of upper endoscopy on satisfaction in patients with previously uninvestigated dyspepsia. Gastrointest Endosc 57:295-9 |
| Rabeneck, Linda; Souchek, Julianne; Wristers, Kimberly et al. (2002) A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia. Am J Gastroenterol 97:3045-51 |
| Rabeneck, Linda; Wristers, Kimberly; Campbell, Catherine et al. (2002) Sociodemographics, general health, and psychologic health in uninvestigated dyspepsia: a comparison of public and private patients. J Clin Gastroenterol 34:516-22 |
| Rabeneck, L; Cook, K F; Wristers, K et al. (2001) SODA (severity of dyspepsia assessment): a new effective outcome measure for dyspepsia-related health. J Clin Epidemiol 54:755-65 |
