Drop-out (clinical study)
As a drop-out or dropout (from English to drop out , “to fall out of something”, “not to participate in something”, German patient failure or short failure , or “study dropout ”) is usually the subject of a scientific examination in medical jargon - in particular a clinical study - which was originally recruited for this investigation, but which will drop out before the end of the actual study phase. The proportion of subjects / patients who dropped out of the total number of participants is called the failure rate and the proportion of subjects / patients who dropped out over time is called the drop-out rate .
As a rule, no distinction is made between the reasons why a subject left the study prematurely. For example, the study director can exclude him from a study because the inclusion criteria specified in the study plan are not (or are no longer) met (e.g. pregnancy , concealed previous illnesses), or he can participate in the study on his own initiative cancel ( side effects , afterthoughts, lack of time, etc.). Occasionally, however, a more precise classification is made, depending on whether the test subject actively dropped out of the study, was excluded from the study by the study director (investigator-caused discontinuation), and not the follow-up observation more was available (lost to follow-up ) or was excluded by the client (sponsor) (sponsor-initiated discontination). In individual cases, this must then be shown in the respective study report.
Strictly speaking, subjects designated as dropouts are to be distinguished from subjects designated as lost to follow-up . In research, the term lost to follow-up is generally used to describe the phenomenon that contact between the test person and the investigating scientist - especially in the follow-up phase of a study - has been broken off (e.g. because the test person has moved away unknown is). The test person may well have completed the actual study phase. However, since such a differentiation can be difficult in practice, all test persons who could not be taken into account in the data analysis are sometimes shown as lost to follow-up or as drop-outs. In individual cases, this must be defined in the respective final study report.
Web links
- Glossary of the German Cochrane Center (example of a broad definition) ( Memento from February 9, 2006 in the Internet Archive )
- Dropout, English-German glossary on the terminology of clinical studies by the American Translators Association (example of a narrow definition; PDF; 42 kB)
literature
- Angelika Caputo, Erika Graf: Planning a clinical study: How many patients are necessary? In: Martin Schumacher, Gabi Schulgen: Methodology of clinical studies. Methodological basics of planning, implementation and evaluation. Second, revised and expanded edition. Berlin u. a .: Springer-Verlag, 2007. ISBN 978-3-540-36989-9 .
Individual evidence
- ↑ Wolfgang Kiehl: Infection protection and infection epidemiology. Technical terms - definitions - interpretations. Ed .: Robert Koch Institute, Berlin 2015, ISBN 978-3-89606-258-1 , p. 18, keyword failure
- ↑ Wolfgang Kiehl: Infection protection and infection epidemiology. Technical terms - definitions - interpretations. Ed .: Robert Koch Institute, Berlin 2015, ISBN 978-3-89606-258-1 , p. 18, keyword failure