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J F Bergmann

Publications and source records attributed to J F Bergmann.

110 records · Page 7Linked to original sources

[Critical examination of scoring systems in therapeutic trials].

Scoring systems give a check-list and methodological informations which have to be found in controlled therapeutic trials reports and papers. These systems try to quantify each item to give a global score. The Chalmer's list is the most wellknown. It allows a balance in scoring taking in account the quality of the endpoints. Other lists are more simple. Many check-lists allow the scoring of the methodological design or the statistical analysis. In all systems the major methodological points are: the randomization, the description of the population, the double blind, the estimation of the sample size, the handling of withdrawal and drop out, the major endpoint, the patients follow-up, the statistical analysis and the data presentation. All these scoring systems have several limits: the quantitative evaluation of each item is subjective and the point scoring has never been validated, some scoring systems are old and don't integrate new methodological methods, the scores never included the clinical interest of the trial, some items are questionable, others are forgotten (intention to treat analysis, steering comity...). Scoring systems allow a control of the methodological quality of clinical trials but don't include the clinical or scientific interest of the study. These systems are a useful methodological tool for publication process in medical journals and for new drugs authorization. The evaluation by authors themselves of the quality of their papers using a standardized scoring system could clarify the reviewers decisions.

Clinical Trials as Topic↗

[Prognostic factors influencing healing of reflux esophagitis. A controlled trial of omeprazole versus ranitidine. Study group Omega].

Four hundred and thirty patients with grade 2 or 3 esophagitis were treated after 2/1 randomization for 8 weeks with omeprazole 20 mg (n = 294) or ranitidine 150 mg bid (n = 136). Apart from treatment, 8 epidemiological factors (gender, age, occupation, obesity, smoking, alcohol, NSAID, and coffee or tea consumption), 5 clinical factors (day/night pain distribution, burning score, severity of regurgitation and of dysphagia, number of painful episodes requiring prescription of an antisecretory agent during the previous year, and onset of symptoms before age 30) and 3 endoscopic factors (grade and upward extension of esophagitis, and existence of hiatal hernia > or = 5 cm) were analysed. The influence of these factors on healing at 8 weeks and on changes in symptoms was evaluated by multivariate analysis. 92.1% of patients enrolled were analyzed. In comparison with ranitidine, omeprazole increased the percentage of healed patients (93% v. 67.5%, p < 0.001) and the rapidity of disappearance of symptoms (5 days v. 7 days, p < 0.001). Independent good prognostic factors associated with healing rate were treatment with omeprazole (p < 0.001) and grade 2 esophagitis (p < 0.001) while those associated with the disappearance of symptoms were a low burning score (p = 0.001), advanced age (p = 0.004), treatment with omeprazole (p = 0.005), the absence of any occupation (p = 0.01) and male gender (p = 0.017). The results of this study show that, apart from treatment, endoscopic factors are predictive of the healing of reflux esophagitis treated by antisecretory agents while clinical factors are more important with regard to the disappearance of symptoms.

Alcohol Drinking↗