Lung cancer patients' perceptions of informed consent documents.
OBJECTIVE
To compare patients' perceptions and preferences of two different versions of informed consent documents.


METHODS
Patients eligible for a trial of palliative chemotherapy for lung cancer (N = 22) were randomly assigned to receive either an original consent document or a shortened version written for the present study. Semi-structured interviews were conducted after the patients had read the consent documents. The interviews were transcribed verbatim and analysed using qualitative content analysis.


RESULTS
Few differences between the two groups were found with respect to patients' assessment of the amount of content and the most important information in the documents. Information about disease and treatment seemed to be of most interest for the patients, while information about research aspects of the study such as financing, confidentiality and publishing (formalities) was judged to be of lesser relevance. Two patients who read the original document indicated that they treated the formalities as secondary.


CONCLUSIONS
Patients seemed to pay little attention to the research aspects, and thus risked to misunderstand the main point of the consent document.


CONCLUSIONS
The structure of consent documents should clarify for the readers that they are asked to take part in research, and that participation is voluntary.
Sand
Kari
K
Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, St. Olavs Hospital, NO-7006 Trondheim, Norway. kari.sand@ntnu.no
Loge
Jon Håvard
JH
Berger
Ola
O
Grønberg
Bjørn Henning
BH
Kaasa
Stein
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007258:Informed Consent; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009664:Norway; D010166:Palliative Care; D017060:Patient Satisfaction; D018579:Patient Selection