[Evidence-based pharmacy - Assessement of quality and clinical relevance of study results]. / Qualitätsbewertung klinischer Studien. Ergebnisqualität: Wie man die Spreu vom Weizen trennt (Teil 2).

ABSTRACT

The critical appraisal of a study publication includes several steps: quality inspection of the study methodology, examination of the results, assessments of benefit and harm for the individual patient. If the first step of the "critical appraisal" determines, that different sources of bias were successfully eliminated or minimized in the study conduct, it is worthwhile to work through the article completely. In the second step, the size and confidence of the study results have to be examined in detail. Different outcome measures are used to describe the effect of an intervention in clinical trials. However, not all endpoints studied, or differences that are found between treatment groups, are important for the decision making of a patient. In the last step, the study results are interpreted for the individual patient in terms of the expected ben- efits and possible harms. While the control of methodical quality and the effect size of study outcomes may be based on formal criteria, professional value judgement is necessary for the transfer of study results to an individual patient, by which a recommendation can be made, adapted to the individual circumstances, needs and expectations of the patient.