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Introduction: A system for monitoring the use of aphaeresis in the treatment of ulcerative colitis (UC), named system for monitoring aphaeresis in ulcerative colitis (SiMAC), was designed in 2006 in the Basque Country. In the present study, the opinion of the clinicians who participated in SiMAC was evaluated, in order to identify the barriers and gather suggestions that could improve implementation of this kind of system. Methods: A mixed questionnaire was designed, in order to gather clinicians' assessments of the SiMAC monitoring system. Results: The response rate was 73.9% (17/23). The data from 40.96% (159/388) of patients with UC treated with aphaeresis was recorded. The main reasons for not including the data from all treated patients were a lack of required data or not meeting the study inclusion criteria. Positive aspects of the SiMAC were identified, as the simplicity of data collection and its systematic, multi-center approach. The negative aspects mentioned were the use of a local computer application and the lack of time for health professionals to enter data. Discussion: The use of monitoring systems helps to formalize the introduction of technologies of little-known effectiveness; involve clinicians and medical societies in coming to agreement and obtaining information about the safety, effectiveness or efficiency of new technologies; and provide relevant information to health-care administrations for making decisions about the introduction of new technologies into healthcare practice. In order for a monitoring system to work, the process must be straightforward. A minimum set of key variables that are easy to collect must be selected, and an effort made to involve a range of stakeholders, especially institutions and scientific societies, to support the work group.

Background In the last few years, a new non-pharmacological treatment, termed apheresis, has been developed to lessen the burden of ulcerative colitis (UC). Several methods can be used to establish treatment recommendations, but over the last decade an informal collaboration group of guideline developers, methodologists, and clinicians has developed a more sensible and transparent approach known as the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). GRADE has mainly been used in clinical practice guidelines and systematic reviews. The aim of the present study is to describe the use of this approach in the development of recommendations for a new health technology, and to analyse the strengths, weaknesses, opportunities, and threats found when doing so. Methods A systematic review of the use of apheresis for UC treatment was performed in June 2004 and updated in May 2008. Two related clinical questions were selected, the outcomes of interest defined, and the quality of the evidence assessed. Finally, the overall quality of each question was taken into account to formulate recommendations following the GRADE approach. To evaluate this experience, a SWOT (strengths, weaknesses, opportunities and threats) analysis was performed to enable a comparison with our previous experience with the SIGN (Scottish Intercollegiate Guidelines Network) method. Results Application of the GRADE approach allowed recommendations to be formulated and the method to be clarified and made more explicit and transparent. Two weak recommendations were proposed to answer to the formulated questions. Some challenges, such as the limited number of studies found for the new technology and the difficulties encountered when searching for the results for the selected outcomes, none of which are specific to GRADE, were identified. GRADE was considered to be a more time-consuming method, although it has the advantage of taking into account patient values when defining and grading the relevant outcomes, thereby avoiding any influence from literature precedents, which could be considered to be a strength of this method. Conclusions The GRADE approach could be appropriate for making the recommendation development process for Health Technology Assessment (HTA) reports more explicit, especially with regard to new technologies.

BODY: BACKGROUND: In some cases, Helicobater pylori infection persists even after 3 eradication treatments. AIM: To evaluate the efficacy of an empirical forth-line rescue regimen with rifabutin in patients with 3 eradication failures, extending the experience of an ongoing multicenter study. METHODS: Design: Multicenter, prospective study. Patients: Patients in whom the following 3 eradication treatments had consecutively failed: 1st treatment: PPI + clarithromycin + amoxicillin; 2nd treatment: quadruple therapy (PPI + bismuth + tetracycline + metronidazole); 3rd treatment: PPI + amoxicillin + levofloxacin. Intervention: In patients failing these 3 regimens, a 4th regimen with rifabutin (150 mg b.i.d.), amoxicillin (1 g b.i.d.) and a PPI (standard dose b.i.d.) was prescribed for 10 days. Outcome: Eradication was confirmed using the 13C-urea breath test 4-8 weeks after therapy. Compliance and tolerance: Compliance was determined through questioning and recovery of emptymedication envelopes. Incidence of adverse effects was evaluated by means of a questionnaire. RESULTS: One-hundred and twenty-one patients (mean age 50 years, 41% males, 27% peptic ulcer/ 73% functional dyspepsia) were included. Compliance: 8 patients did not take correctly the medication (in 6 cases due to adverse effects). Per-protocol and intention-to-treat eradication rates were 54% (95%CI=44-64%) and 52% (43-61%). Adverse effects were reported in 40 S-334 AGA Abstracts (33%) patients, the most frequent being: nausea/vomiting (severe in 2 patients), asthenia/ anorexia, abdominal pain, diarrhea, fever, metallic taste, myalgia, hypertransaminasemia, leucopoenia (,1,500 neutrophils), thrombopoenia (,150,000 platelets), headache, and aphthous stomatitis. Myelotoxicity resolved spontaneously in all cases. CONCLUSION: Even after 3 previous H. pylori eradication failures, an empirical fourth-line rescue treatment with rifabutin may be effective in approximately 50% of the cases. Therefore, rifabutinbased rescue therapy constitutes a valid strategy after multiple previous eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole, tetracycline, and levofloxacin.