Symptomkontrolle und Lebensqualität als primärer Endpunkt klinischer Studien - ein "Systematic Review"
Symptom control and quality of life as primary outcome parameters in clinical studies - a systematic review
by Anna-Lena Haas
Date of Examination:2017-11-15
Date of issue:2017-11-09
Advisor:Prof. Dr. Bernd Alt-Epping
Referee:Prof. Dr. Bernd Alt-Epping
Referee:PD Dr. Julie Schanz
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Name:Dissertation, 01.11.2017, ediss. kein LL. optdocx.pdf
EnglishIntroduction: Even in incurable (“palliative”) stages of cancer, clinical studies focus on time dependent parameters, although both, the remaining length of life as well as the quality of life are found to be main objectives when undergoing anticancer therapy and in general. Methods: We therefore performed a systematic review analyzing randomized controlled or observational clinical studies that were designed and performed in order to investigate a possible benefit of systemic anticancer therapies on symptom burden and quality of life. Analyses of tolerability and toxicity data as well as clinical trials for symptom relieving substances that are not used for anticancer purposes were excluded. Results: The search string revealed 2229 abstracts that were categorized into five sub-categories, depending on study design and primary outcome parameters. 39 abstracts fulfilled the above named criteria and were included for detailed full text analysis. 13 of those studies named a patient oriented outcome parameter, such as quality of life or symptom burden, as the primary study endpoint. Conclusions: Our analysis reveals that, to date, secondary publications of QoL and toxicity data denote one of the major sources of information about the impact of anticancer therapies on QoL. Clinical studies investigating primarily the possible benefits of anticancer therapies on symptom burden and QoL are very rare. With respect to what we know about our patients´ wishes when entering incurable stages of their disease, symptom and QoL based outcome parameters should deserve much more explicit attention in clinical study design.
Keywords: quality of life; symptom control; systematic review; tumor therapy