Clinical trial: knowledge of negative Helicobacter pylori status reduces subsequent dyspepsia-related resource use.

BACKGROUND: Screening for Helicobacter pylori reduces dyspepsia and dyspepsia-related costs in positive individuals. AIMS: To assess effect of knowledge of H. pylori status on healthcare-seeking in negative individuals. METHODS: H. pylori-negative subjects in a community screening programme were randomized to placebo triple therapy or informed of their negative H. pylori status. Dyspepsia-related resource data were extracted from primary care records at 2 years, and National Health Service reference costs were applied to calculate the total cost per subject. Proportions of individuals incurring any cost were compared using a relative risk (RR) and 95% confidence interval (CI). Differences in costs were compared using an independent sample t-test. RESULTS: A total of 1353 H. pylori-negative individuals were randomized to placebo whilst 1355 were informed of their infection status. In the placebo arm, 212 (16%) subsequently incurred any dyspepsia-related cost compared to 172 (13%) informed of their infection status (RR of incurring cost = 0.81; 95% CI: 0.67-0.97). Those informed of their infection status incurred lower costs (mean saving per individual = pound 11.02; 95% CI: - pound 3.52 to 25.56). CONCLUSIONS: H. pylori-negative individuals informed of infection status sought health care for dyspepsia less often than those who were unaware. Population screening may reduce dyspepsia-related costs in uninfected, as well as infected individuals.

Sexual activity questionnaires in clinical trials: acceptability to patients with gynaecological disorders.

OBJECTIVE: To assess the feasibility and acceptability of including sexual activity questionnaires in gynaecological clinical trials. DESIGN: A longitudinal quality of life study during the Maintenance Interferon Trial and the EVALUATE Hysterectomy Trial. SETTING: Gynaecology clinics and women's homes. SAMPLE: Ninety-six women with advanced ovarian cancer participating in the Maintenance Interferon Trial and 542 women undergoing a hysterectomy in the EVALUATE Hysterectomy Trial. METHODS: Quality of life questionnaires, including the sexual activity questionnaire, were completed by women prior to randomisation and periodically after randomisation. MAIN OUTCOME MEASURES: Compliance rates of the sexual activity questionnaire, both overall and with respect to the level of sexual functioning and age of the women. Attitudes of the women towards completing the questionnaire, and suitability of using the sexual activity questionnaire in clinical trials. RESULTS: Compliance rates of over 80% were achieved in both trials, both overall and for each questionnaire completed. The age of the woman did not appear to influence the completion of the questionnaire, nor did her level of sexual functioning. Women were supportive of the research and did not find the questionnaire intrusive. CONCLUSIONS: It is feasible to include sexual activity questionnaires in gynaecological clinical trials requiring repeated assessment of quality of life over a long period of time. The sexual activity questionnaire is an appropriate tool to carry out investigations of sexual functioning and is worth considering for use in future clinical trials.