Search PubMed⌕ Search

Biomedical subjects

W Zielinski

Publications and source records attributed to W Zielinski.

7 recordsLinked to original sources
PubMed2006

Evaluation of drug toxicity in clinical trials.

An increasing number of drugs removed from the market because of unacceptable toxicity raises concerns regarding pre-approval testing of drug safety. In the present paper it is postulated that the non-inferiority type of trial should be abandoned in favor of the superiority trial with active controls and less stringent (p<0.1, both for efficacy and toxicity) statistics. This approach will increase sensitivity of detection of drug-induced adverse effects at the expense of increasing false positive results regarding the difference in efficacy between the tested and reference drug. Such a move will increase the protection of future patients. In addition, the proposed design is far more acceptable from the clinical (e.g. no need to specify the statistically expected "unimportant" number of deaths) and ethical points of view, as well as being favored by the strong incentive of involved parties. In the second part of this paper arguments are presented in favor of the hypothesis that placebo (still used in some superiority trials) does not induce adverse effects. The assertion that placebo may induce adverse effects is probably biased by the nature of the clinical experiment. Such a conclusion is supported by studies indicating that placebo-induced adverse effects are disease -- and treatment -- specific. The modification of clinical trials according to the proposed changes may increase the trials' sensitivity at detecting adverse effects of drugs.

Clinical Trials as Topic↗
PubMed2001

[Evidence-based medicine in internal guideline development in a general hospital--the Park-Clinic EbM-Project].

Evidence-based medicine (EbM) is despite its historical roots still a young concept that is quite relevant in everyday work, but yet little used. The first hospital specific approach to implement EbM into the health care system and daily clinical practice in Germany is recorded in the project of the Park-Klinik Weissensee (Berlin). Implementation and execution of EbM into daily routine should be reached through five steps which should result in better quality of treatment of the patients: 1. EbM-Training for hospital staff; 2. EbM-Search (= access to electronic databases and EbM-information); 3. Guideline-Committee (= hospital committee for the development of clinical practice guidelines); 4. EbM-Recommendation (= use of EbM-information in discharge letters) and, finally 5. EbM-Events (= vocational trainings for hospital physicians and general practitioners). Although project duration is yet quiet short, first results allow to look into the future with confidence. At the same time it can be recognized how long and difficult the way for all participants will be to reach evidence-based information and communication. The "Park-Klinik EbM-Project" can make an important contribution to health care services research in Germany.

Education, Continuing↗
PubMed1997

[The significance of appendectomy for appendicitis on subsequent fertility].

A study was undertaken to determine fertility in a group of females who as children had been operated on for appendicitis. The 134 women operated on for appendicitis were reviewed. Their ages ranged from 2-18 years at the time of appendectomy. Our data show that perforated appendicitis before puberty has little if any role in the etiology of tubal infertility.

Adolescent↗
PubMed1989

[Comparison of Cabot/Nesbit orchidopexy with Petrivalsky/Schoemaker orchidopexy].

Two groups of each 50 children with maldescensus testis treated by two different techniques of orchiopexy are compared together. Two to five years after operation the localization and size of the testes are recorded. In the group of children with orchiopexy according to Cabot/Nesbit the failure rate was 12%, in contrast to only 6% failures and larger testes in the Petrivalsky/Shoemaker group. Therefore, the technique of Petrivalsky/Shoemaker is recommended, especially in small children.

Child↗
PubMed1987

[Do arteriopathies in patients in their 50s present special characteristics?].

The 50s represent a hinge age-period during which atherosclerosis is more frequent but arterial disease does not appear to present features differing from those observed in neighbouring age groups. There is of course a higher frequency of atherosclerotic lesions of other arterial territories and a fairly high incidence of diabetes. With respect to the latter disease, apart from the typical association arteritis-diabetes, some cases are simply of atherosclerosis developing at the same time as the diabetes. Arteritis of lower limbs can present as two principal types in patient in their 50s: elective aorto-iliac arterial disease similar to early onset atherosclerosis in younger patients and more diffuse forms more typical of arterial disease in the elderly.

Arteriosclerosis↗