Patient representatives' views on patient information in clinical cancer trials
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Patient representatives' views on patient information in clinical cancer trials. / Dellson, Pia; Nilbert, Mef; Carlsson, Christina.
In: BMC Health Services Research, Vol. 16, 36, 2016, p. 1-5.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Patient representatives' views on patient information in clinical cancer trials
AU - Dellson, Pia
AU - Nilbert, Mef
AU - Carlsson, Christina
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
KW - Journal Article
KW - Research Support, Non-U.S. Gov't
U2 - 10.1186/s12913-016-1272-2
DO - 10.1186/s12913-016-1272-2
M3 - Journal article
C2 - 26831330
VL - 16
SP - 1
EP - 5
JO - BMC Health Services Research
JF - BMC Health Services Research
SN - 1472-6963
M1 - 36
ER -
ID: 164817607