Patient representatives' views on patient information in clinical cancer trials
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/8728597
- author
- Dellson, Pia LU ; Nilbert, Mef LU and Carlsson, Christina LU
- organization
- publishing date
- 2016
- 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
- article number
- 36
- publisher
- BioMed Central (BMC)
- external identifiers
-
- wos:000369182000001
- scopus:84958123189
- pmid:26831330
- 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
- 2016-04-01 14:01:13
- date last changed
- 2022-04-06 08:23:42
@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.}},
author = {{Dellson, Pia and Nilbert, Mef and Carlsson, Christina}},
issn = {{1472-6963}},
keywords = {{Clinical trial; Patient information; Cancer; Patient preferences; Layout; Focus group interview}},
language = {{eng}},
number = {{1}},
publisher = {{BioMed Central (BMC)}},
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}},
doi = {{10.1186/s12913-016-1272-2}},
volume = {{16}},
year = {{2016}},
}