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  • LIVER CIRRHOSIS  (1)
  • quality of life  (1)
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  • 1
    ISSN: 1569-8041
    Keywords: cross cultural comparison ; early breast cancer ; quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Aim: The aim of the study is to investigate quality of life (QoL) in the context of a multinational trial. The questions addressed are: is the Rotterdam Symptom Checklist (RSCL) 1) feasible and 2) reliable in cross cultural reearch, 3) is earlier validation confirmed in a multinational trial and 4) are there systematic differences in QoL accross cultures? Patients and methods: Patients with histologically confirmed stage II, node positive breast cancer, were randomised in a multinational trial (the ‘ZEBRA-study’) comparing standard chemotherapy (CMF) or temporary ovarian ablation by treatment with a LHRH analogue (Zoladex, Goserlin). Patients originating from 13 countries completed a QoL questionnaire at baseline and three months after the start of treatment. Results: 1) The questionnaire was completed by 689 patients at the first and 544 at the second measurement (response 78% and 68% respectively). The proportion of missing data was 〈2.5% for 87.8% and 92.7% of the items at the respective time points. 2) Reliabilities of the physical and psychological distress scale were ranging from 0.68 to 0.90 across cultures. Reliability of the activity scale ranged from 0.42 to 0.89. 3) The structure at baseline was in agreement with the two factor structure proposed earlier. 4) Cross-cultural comparison indicated a systematic difference in QoL across cultures (P = 0.0028–〈0.0001) as well as a difference in change across cul-tures. Conclusions: QoL assessment using the RSCL proved feasible in the context of multinational clinical trials. Psychometric qualities were satisfactory. Systematic differences in QoL were found between cultures. This finding implies that in multinational clinical trials, treatment comparisons with respect to QoL should carefully account for a differential impact of cultures on the results.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1573-2568
    Keywords: LIVER CIRRHOSIS ; TIPS ; INFECTION ; PREVENTION ; PORTASYSTEMIC SHUNT
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The aim of this study was to evaluate theefficacy of a single dose of a second-generationcephalosporine to prevent postinterventional infectionand to identify risk factors for postinterventionalinfection in patients receiving implantation or revisionof a transjugular intrahepatic portosystemic shunt(TIPS). Eighty-four patients (105 transjugularinterventions) were randomized receiving no antibiotictreatment (46 interventions) or 2 g cefotiam (56interventions) given at the beginning of the procedure.Patients with overt infection or those receivingantibiotic treatment in the preceding two weeks wereexcluded. Groups were comparable with respect tobiographic and medical data. Postinterventionalinfection was defined as an increase in WBC count(≥15,000/μl), fever (38.5°C), or a positiveblood culture. Infection occurred in 17% of the patients. Patients notreceiving cefotiam had a slightly higher incidence ofinfection (20%) than patients treated with cefotiam(14%, NS). Multivariate analysis demonstrated prognostic relevance for multiple stenting andperiprocedural use of a central venous line. Theclinical outcome of the patients was unaffected bycefotiam treatment. In conclusion, a single dose ofintrainterventional cefotiam does not prevent postinterventionalinfection. This may be due to the antimicrobial spectrumand short half-time of cefotiam. Strict adherence toaseptic conditions during intervention and early removal of central venous lines may reduce therate of post interventional infection considerably.Antibiotic prophylaxis with cefotiam does not seem to beuseful since it will not influence outcome andcosts.
    Type of Medium: Electronic Resource
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