Structural and organizational determinants of quality of care in patients with schizophrenia in Italy.

Several reports have described the poor quality of care delivered to psychotic patients. However, the context in which care was delivered, including the structure, organization, and performance of the health care system, as a possible determinant of quality of care has received less attention. In this study we explored the relationship between conformance with guidelines and structural and organizational characteristics in 2 departments of Mental Health in Italy. Dosing of antipsychotic drugs in the maintenance phase was investigated in 125 patients. Higher than recommended doses could be explained by the high patient caseload per psychiatrist, leading to insufficient contacts with patients and their families and to excessive reliance upon drug treatment. The analysis of structural and organizational determinants of care at the local level may help to explain insufficient quality and to plan suitable interventions.

Indicators of conformance with guidelines of schizophrenia treatment in mental health services.

OBJECTIVE: The aim of this study was to develop indicators of conformance in clinical practice with guidelines for care in schizophrenia. Recommended guidelines rarely apply to all patients and need to allow for social ability, family context, and phase of the disorder. These indicators were therefore devised for tailoring to patient characteristics and allowing for factors that may justify the lack of adherence to clinical guidelines. METHODS: A team of senior clinicians and methodologists reviewed three clinical guidelines (from the Schizophrenia Patient Outcomes Research Team, McEvoy and colleagues, and the National Institute for Health and Clinical Excellence) and defined criteria for their operationalization into clinical indicators. For each indicator, the team defined criteria for eligibility (requirements to be met to qualify for evaluation), conformance (criteria to be satisfied to comply with each recommendation), and moderators (factors that could justify the lack of application of a given recommendation). These indicators were tested with a random sample of 807 patients with schizophrenia or schizoaffective disorders in outpatient facilities, long-term residential facilities, and hospital units for acute care in the Piedmont region of Italy. RESULTS: A set of 15 indicators was derived, nine concerning pharmacological treatment and six for general care and psychosocial rehabilitation. Moderators such as patient or family refusal of antipsychotic treatment and the patient's level of disability helped to justify a considerable proportion of nonconformant care. CONCLUSIONS: The indicators developed are a simple and useful tool to monitor the conformance of care with recommended practices and to identify areas needing improvement.

Novel monoclonal antibody-based Helicobacter pylori stool antigen test.

BACKGROUND: A number of noninvasive tests have been developed to establish the presence of Helicobacter pylori infection. Although polyclonal antibody-based stool antigen testing has a good sensitivity and specificity, it is less accurate than urea breath testing. Recently, a monoclonal antibody-based stool antigen test demonstrated an excellent performance in diagnosing H. pylori infection in adults and in pediatric populations. AIM: To evaluate the diagnostic accuracy of a novel stool test based on monoclonal antibodies to detect H. pylori antigens in frozen human stool in the pretreatment setting. PATIENTS AND METHODS: Stool specimens were prospectively collected from 78 patients undergoing gastroscopy and stored at -20 degrees C until tested. Helicobacter pylori infection was evaluated by histology, rapid urease testing and urea breath tests ((13)C-UBT). Positivity of the three tests was considered the gold standard for H. pylori active infection. Patients with no positive test were considered negative. The gold standard was compare to the results of the monoclonal antibody stool antigen test. Frozen stool specimens were tested using a novel monoclonal-antibody-based enzyme immunoassay (HePy-Stool, Biolife-Italiana, Milan, Italy). RESULTS: The sensitivity and specificity of the monoclonal stool antigen test were 97%[95% confidence interval, (CI) 86-100] and 94% (95% CI: 81-99), respectively. Negative and positive predictive values were 97% (95% CI: 85-99), and 95% (95% CI: 83-99), respectively. The diagnostic accuracy was 96% (95% CI: 88-99). The likelihood ratio for a positive test was 17 and for a negative test was 0. CONCLUSIONS: Although the (13)C-UBT is the most accurate among the available noninvasive tests, our results show that an H. pylori stool test using monoclonal antibody might be an excellent alternative.

Salvage therapy after two or more prior Helicobacter pylori treatment failures: the super salvage regimen.

BACKGROUND: Although effective therapies are available for curing Helicobacter pylori infection, the problem persists about what to do for patients who fail two or more treatment courses despite a good compliance. AIM: To test a twice a day midday quadruple therapy as salvage therapy. METHODS: Dyspeptic H. pylori-infected patients who failed two or more courses of anti-H. pylori therapy received omeprazole 20 mg, tetracycline 500 mg, metronidazole 500 mg, and bismuth subcitrate caplets 240 mg twice a day (with the midday and evening meals) for 14 days. H. pylori status was evaluated by 13C-urea breath test and histology 4-6 weeks after therapy. Eradication was defined as no positive test. RESULTS: Seventy-one patients were enrolled and 68 completed the full 14 days of therapy (mean age 46 years; 28 men). Thirty-three patients had failed prior treatment twice, 19 had failed three times, and 16 had failed four or more times. The cure rates were: intention to treat=93% (66/71); (95% CI=84% to 98%), per protocol=97% (66/68); (95% CI=89%- 100%). Success was excellent irrespective of diagnosis, age, prior treatment protocols, or smoking status. Moderate side-effects were experienced by only two patients. CONCLUSION: Midday bismuth subcitrate based twice a day quadruple therapy was an excellent salvage therapy. BID midday quadruple regimen should be considered as the therapy of choice.