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Patient representatives' views on patient information in clinical cancer trials

Dellson, Pia LU ; Nilbert, Mef LU and Carlsson, Christina LU (2016) In BMC Health Services Research 16(1).
Abstract
Background: Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Methods: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative... (More)
Background: Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Methods: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Results: Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. Conclusions: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Clinical trial, Patient information, Cancer, Patient preferences, Layout, Focus group interview
in
BMC Health Services Research
volume
16
issue
1
publisher
BioMed Central
external identifiers
  • wos:000369182000001
  • scopus:84958123189
  • pmid:26831330
ISSN
1472-6963
DOI
10.1186/s12913-016-1272-2
language
English
LU publication?
yes
id
8889d004-b032-4ed4-ac77-e31ed099fd6b (old id 8728597)
date added to LUP
2016-03-01 07:15:00
date last changed
2017-01-01 06:00:32
@article{8889d004-b032-4ed4-ac77-e31ed099fd6b,
  abstract     = {Background: Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Methods: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Results: Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. Conclusions: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.},
  articleno    = {36},
  author       = {Dellson, Pia and Nilbert, Mef and Carlsson, Christina},
  issn         = {1472-6963},
  keyword      = {Clinical trial,Patient information,Cancer,Patient preferences,Layout,Focus group interview},
  language     = {eng},
  number       = {1},
  publisher    = {BioMed Central},
  series       = {BMC Health Services Research},
  title        = {Patient representatives' views on patient information in clinical cancer trials},
  url          = {http://dx.doi.org/10.1186/s12913-016-1272-2},
  volume       = {16},
  year         = {2016},
}