Universität zu Köln

Gaertner, Jan ORCID: 0000-0002-8824-7117, Weingaertner, Vera, Lange, Stefan, Hausner, Elke, Gerhardus, Ansgar ORCID: 0000-0003-3637-7419, Simon, Steffen T., Voltz, Raymond, Becker, Gerhild ORCID: 0000-0001-9060-0285 and Schmacke, Norbert (2015). The Role of End-of-Life Issues in the Design and Reporting of Cancer Clinical Trials: A Structured Literature Review. PLoS One, 10 (9). SAN FRANCISCO: PUBLIC LIBRARY SCIENCE. ISSN 1932-6203

Full text not available from this repository.

Abstract

Background Randomized controlled trials (RCTs) are important sources of information on the benefits and harms patients may expect from treatment options. The aim of this structured literature review by the German Institute for Quality and Efficiency in Health Care was to explore whether and how the end-of-life (EoL) situation of patients with advanced cancer is considered in RCTs investigating anti-cancer treatments. Methods Our journal pool comprised 19 medical journals, namely five preselected key general medical journals as well as 14 specialist journals (mainly cancer) identified via a scoping search. We systematically searched these journals in MEDLINE to identify RCTs investigating anticancer treatments for the following four cancer types: glioblastoma, lung cancer (stage IIIb-IV), malignant melanoma (stage IV), and pancreatic cancer (search via OVID; November 2012). We selected a representative sample of 100 publications, that is, the 25 most recent publications for each cancer type. EoL was defined as a life expectancy of <= two years. We assessed the information provided on (1) the descriptions of the terminal stage of the disease, (2) the therapeutic goal (i.e. the intended therapeutic benefit of the intervention studied), (3) the study endpoints assessed, (4) the authors' concluding appraisal of the intervention's effects, and (5) the terminology referring to the patients' EoL situation. Results Median survival was <= one year for each of the four cancer types. Descriptions of the terminal stage of the disease were ambiguous or lacking in 29/100 publications. One or more therapeutic goals were mentioned in 51/100 publications; these goals were patient-relevant in 38 publications (survival alone: 30/38; health-related quality of life (HRQoL) or HRQoL and survival: 6/38; symptom control or symptom control and survival: 2/38). Primary end-points included survival (50%), surrogates (44%), and safety (3%). Patient-reported outcomes (PROs) were assessed in 36/100 RCTs. The implications of treatment-related harms for the patients were discussed in 22/100 appraisals. Terminology referring to the patients' EoL situation (e.g. terminal) was scarce, whereas terms suggesting control of the disease (e.g. cancer control) were common. Conclusions The EoL situation of patients with advanced cancer should be more carefully considered in clinical trials. Although the investigation and robust reporting of PROs is a prerequisite for informed decision-making in healthcare, they are rarely defined as endpoints and HRQoL is rarely mentioned as a therapeutic goal. Suggestions for improving standards for study design and reporting are presented.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Gaertner, Jan UNSPECIFIED orcid.org/0000-0002-8824-7117 UNSPECIFIED Weingaertner, Vera UNSPECIFIED UNSPECIFIED UNSPECIFIED Lange, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Hausner, Elke UNSPECIFIED UNSPECIFIED UNSPECIFIED Gerhardus, Ansgar UNSPECIFIED orcid.org/0000-0003-3637-7419 UNSPECIFIED Simon, Steffen T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Voltz, Raymond UNSPECIFIED UNSPECIFIED UNSPECIFIED Becker, Gerhild UNSPECIFIED orcid.org/0000-0001-9060-0285 UNSPECIFIED Schmacke, Norbert UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-394574
DOI:	10.1371/journal.pone.0136640
Journal or Publication Title:	PLoS One
Volume:	10
Number:	9
Date:	2015
Publisher:	PUBLIC LIBRARY SCIENCE
Place of Publication:	SAN FRANCISCO
ISSN:	1932-6203
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language RANDOMIZED PHASE-II; CELL LUNG-CANCER; ADVANCED PANCREATIC-CANCER; RECURRENT GLIOBLASTOMA; SYMPTOM BURDEN; OUTCOME MEASURES; CHEMOTHERAPY; MULTICENTER; GEMCITABINE; COMBINATION Multiple languages Multidisciplinary Sciences Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/39457