The cost-effectiveness of population Helicobacter pylori screening and treatment: a Markov model using economic data from a randomized controlled trial.

BACKGROUND: Economic models have suggested that population Helicobacter pylori screening and treatment may be a cost-effective method of reducing mortality from gastric cancer. These models are conservative as they do not consider that the programme may reduce health service peptic ulcer and other dyspepsia costs. We have evaluated the economic impact of population H. pylori screening and treatment over 2 years in a randomized controlled trial and have incorporated the results into an economic model exploring the impact of H. pylori eradication on peptic ulcer disease and gastric cancer. METHODS: Subjects between the ages of 40 and 49 years were randomly invited to attend their local primary care centre. H. pylori status was evaluated by (13)C-urea breath test and infected individuals were randomized to receive omeprazole, 20 mg b.d., clarithromycin, 250 mg b.d., and tinidazole, 500 mg b.d., for 7 days or identical placebos. Economic data on health service costs for dyspepsia were obtained from a primary care note review for the 2 years following randomization. These data were incorporated into a Markov model comparing population H. pylori screening and treatment with no intervention. RESULTS: A total of 2329 of 8407 subjects were H. pylori positive: 1161 were randomized to receive eradication therapy and 1163 to receive placebo. The cost difference favoured the intervention group 2 years after randomization, but this did not reach statistical significance (11.42 ponds sterling per subject cost saving; 95% confidence interval, 30.04 ponds sterling to -7.19 pounds sterling; P=0.23). Analysis by gender suggested a statistically significant dyspepsia cost saving in men (27.17 ponds sterling per subject; 95% confidence interval, 50.01 pounds sterling to 4.32 pounds sterling; P=0.02), with no benefit in women (-4.46 per subject; 95% confidence interval, -33.85 pounds sterling to 24.93 pounds sterling). Modelling of these data suggested that population H. pylori screening and treatment for 1,000,000 45-year-olds would save over 6,000,000 pounds sterling and 1300 years of life. The programme would cost 14, 200 pounds sterling per life year saved if the health service dyspepsia cost savings were the lower limit of the 95% confidence intervals and H. pylori eradication had only a 10% efficacy in reducing mortality from distal gastric cancer and peptic ulcer disease. CONCLUSIONS: Modelling suggests that population H. pylori screening and treatment are likely to be cost-effective and could be the first cost-neutral screening programme. This provides a further mandate for clinical trials to evaluate the efficacy of population H. pylori screening and treatment in preventing mortality from gastric cancer and peptic ulcer disease.

The Leeds Dyspepsia Questionnaire: a valid tool for measuring the presence and severity of dyspepsia.

BACKGROUND: There is currently no validated questionnaire that assesses both the presence and severity of dyspepsia. AIM: To develop the Leeds Dyspepsia Questionnaire (LDQ) as a measure of the presence and severity of dyspepsia, and to assess the validity, reliability and responsiveness of this instrument. METHODS: Unselected patients attending either a hospital dyspepsia clinic or a general practice surgery were interviewed by a trained gastroenterologist or a general practitioner on the presence and severity of dyspepsia. This opinion was compared with the results of the nurse-administered LDQ. Test-retest reliability was assessed by the same research nurse re-administering the LDQ 4-7 days after the initial visit in a subgroup of hospital patients. In a further subgroup of patients one researcher interviewed the patients and a second researcher re-administered the LDQ within 30 min to evaluate inter-rater reliability. The responsiveness of the LDQ was measured by repeating it in patients with endoscopically proven peptic ulcer or oesophagitis 1 month after receiving appropriate therapy. RESULTS: The LDQ was administered to 99 general practice and 215 hospital patients. In the GP population 41/98 (42%) had dyspepsia according to the GP and the LDQ had a sensitivity of 80% (95% CI: 65-91%) and a specificity of 79% (95% CI: 66-89%). The weighted kappa statistic for the agreement between the LDQ and the clinician for the severity of dyspepsia was 0.58 in the GP population and 0.49 in hospital patients. The kappa statistic for test-retest reliability was 0.83 in 107 patients. The LDQ had excellent inter-rater reliability with a kappa statistic of 0.90 in 42 patients. The median LDQ score fell from 22.5 (range 9-36) to 4.5 (range 0-27) in 12 patients 1 month after receiving appropriate therapy (Wilcoxon signed rank test, P < 0.0001). CONCLUSION: The LDQ is a valid, reliable and responsive instrument for measuring the presence and severity of dyspepsia.

Hemodialysis intravascular hemolysis and kinked blood lines.

Between May 29 and September 13, 1991, 4 patients developed acute intravascular hemolysis during hemodialysis with Monitral-S delivery systems and Hospal BSM A77 blood lines. All had malaise, nausea and headache; 3 had severe abdominal pain and 2 became very ill. Plasma hemoglobins were 3-21 g/l and LDH 542-3,300 IU in the 4 patients. Hepatoglobin became unmeasurable in 3 and was 0.09 g/l in the 4th patient. Soon afterwards, we found the arterial blood line tightly kinked at the dialyzer inlet port in the 4th patient and released it; he developed abdominal pain, hemolysis was present. We then found these lines had an extra long pump segment, and the rest was short and fitted poorly. When put in the first tubing organizer, severe kinking could occur just after the pump segment, causing back pressure but no alarm. We produced early visible hemolysis in a 1-liter circulating closed loop blood system with the blood line kinked either at the dialyzer inlet or just below the first arterial line tubing organizer with 40 g/l free plasma hemoglobin by 30 min. We excluded reported causes of intravascular hemolysis during hemodialysis. No hemolysis occurred before or during the 9 months after we discarded BSM A77 lines. The evidence indicates that kinked blood lines caused the hemolysis.

i-STAT hand-held point-of-care analyzer for dialysis units.

The i-STAT hand-held analyzer assays ten tests including electrolytes, gases, urea, glucose, ionized calcium, and hematocrit. Eight different cartridges assay one to eight tests. We have previously confirmed or demonstrated that accuracy and precision for blood assays are comparable to accepted laboratory methods. We now report similar results for hemodialysis dialysate and peritoneal dialysis effluent. The i-STAT analyzer is simple to use, and dialysis nurses produced accurate results with 20 min training. The results are viewed digitally on the analyzer and automatically on a small attachable printer. i-STAT blood analysis is most valuable when results are desired immediately, anywhere, including before, during and after dialysis in hemodialysis units. Hemodialysate analysis using i-STAT can be most valuable for rapidly checking dialysis machine function such as dialysate mixing and conductivity and ramping results and dialysate concentrations prepared in the unit. Peritoneal effluent analysis is useful for rapid evaluation of membrane function.

Population-based and opportunistic screening and eradication of Helicobacter pylori. An analysis using trial baseline data. Leeds H. pylori Study Group.

OBJECTIVES: To examine whether screening and eradication of Helicobacter pylori by population-based invitation or opportunistic screening by general practitioners reduces costs to the National Health Service (NHS) of treating dyspepsia. METHODS: A limited dependent, variable, two-step regression analysis was used to explore the baseline annual health care costs of dyspepsia for men and women aged 40-49 enrolled in the Leeds H. pylori screening and eradication trial. RESULTS: Epidemiological and clinical questionnaires, general practitioner notes, and 13C urea breath test results were available for 4,754 individuals. After adjusting for covariates H. pylori was associated with a 6.7% increased probability of incurring gastrointestinal-related NHS costs (p < .0001) in the population aged 40-49. Additionally, H pylori increased average costs in those who seek medical care (p = .001). In consequence, H. pylori is associated with an average increased cost to the NHS of 0.30 Pound per year (95% CI: 0.17 Pound to 0.45 Pound) per adult aged 40-49. In those consulting for dyspepsia, the increased cost to the NHS was 1.04 Pounds per year (95% CI: 0.42 Pound to 1.75 Pounds) per patient. The cost of population screening and treatment would not be recovered in reduced dyspepsia costs in the lifetime of those screened. Assuming laboratory-based serology screening is used opportunistically in patients presenting with dyspepsia, it is estimated that costs would be recouped in 18 years. CONCLUSIONS: This observational data set suggests that the costs of screening and treatment in all individuals aged 40-49 or in those presenting in primary care with dyspeptic symptoms are unlikely to be attractive on the basis of cost savings alone.