A template for informed consent forms in medical examination and treatment: an intervention study.
BACKGROUND
There are few studies to use a template to ensure that information provided to the patient in the process of informed consent is consistent. To examine the differences between informed consent forms based on a template and those not based on a template.


METHODS
An intervention study using a template for informed consent forms that could be modified according to test/treatment, specialty, setting and patient. Our sample included 22 departments at the University of Tokyo Hospital, a 1100-bed care referral center. Twelve items in each informed consent form were scored. Items included diagnosis and current condition, purpose of procedure, details and nature of procedure, effectiveness, patient specific information, changing one's mind, and the use of illustrations and figures. The 36 possible points for each form were summed for a total possible score of 108 points. Total scores and scores for each item were then compared between pre- and post-test forms.


RESULTS
Total number of points significantly increased from 70.9 to 96.9 between pre- and post intervention (p<0.001, paired t test). Internal medicine (pre: 68.6 to post: 101.9) showed a more significant increase in score than surgery (71.9 to 95.2) (ANOVA, pre-post: F(1,106)=324.8 p<0.001; interaction: F(1,106)=11.2, p<0.01). There was no difference in the rate of improvement between treatment and examination forms (ANOVA, pre-post: F(1, 106)=253.3, p<0.001; interaction: F(1,106)=2.8, p=0.1).


CONCLUSIONS
A template can increase the number of items described and the thoroughness in which they are described.
Center for Biomedical Ethics and Law, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.
Yoshiyuki
Y
Takimoto
Shoichi
S
Maeda
Brian Taylor
BT
Slingsby
Kenji
K
Harada
Takahide
T
Nagase
Hirokazu
H
Nagawa
Ryozo
R
Nagai
Ryozo
R
Naga
Akira
A
Akabayashi
D032882:Comprehension; D003219:Confidentiality; D032962:Consent Forms; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D007564:Japan; D010353:Patient Education as Topic; D010817:Physician-Patient Relations; D011996:Records; D035842:Research Subjects; D016896:Treatment Outcome