Reinert, Christiane and Kremmler, Lukas and Burock, Susen and Bogdahn, Ulrich and Wick, Wolfgang and Gleiter, Christoph H. and Koller, Michael and Hau, Peter (2014) Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials. EUROPEAN JOURNAL OF CANCER, 50 (1). pp. 150-158. ISSN 0959-8049, 1879-0852
Full text not available from this repository. (Request a copy)Abstract
Introduction: In randomised controlled trials (RCTs), patient informed consent documents are an essential cornerstone of the study flow. However, these documents are often oversized in format and content. Clinical experience suggests that study information sheets are often not used as an aid to decision-making due to their complexity. Material and methods: We analysed nine patient informed consent documents from clinical neuro-oncological phase III-studies running at a German Brain Tumour Centre with the objective to investigate the quality of these documents. Text length, formal layout, readability, application of ethical and legal requirements, scientific evidence and social aspects were used as rating categories. Results were assessed quantitatively by two independents investigators and were depicted using net diagrams. Results: All patient informed consent documents were of insufficient quality in all categories except that ethical and legal requirements were fulfilled. Notably, graduate levels were required to read and understand five of nine consent documents. Discussion: Quality deficits were consistent between the individual study information texts. Irrespective of formal aspects, a document that is intended to inform and motivate patients to participate in a study needs to be well-structured and understandable. We therefore strongly mandate to re-design patient informed consent documents in a patient-friendly way. Specifically, standardised components with a scientific foundation should be provided that could be retrieved at various times, adapted to the mode of treatment and the patient's knowledge, and could weigh information dependent of the stage of treatment decision. (C) 2013 Elsevier Ltd. All rights reserved.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CROSS-SECTIONAL SURVEY; INFORMED-CONSENT; CLINICAL-TRIALS; COGNITIVE DEFICITS; CANCER-PATIENTS; BRAIN-TUMORS; FORMS; PARTICIPATION; READABILITY; GLIOMA; Patient information; Informed consent; Clinical trial; Neuro-oncology; Qualitative analysis; Ethics |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 29 Nov 2019 13:48 |
| Last Modified: | 29 Nov 2019 13:48 |
| URI: | https://pred.uni-regensburg.de/id/eprint/11091 |
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