TY - JOUR
T1 - Understanding Verbosity
T2 - Funding Source and the Length of Consent Forms for Cancer Clinical Trials
AU - Duong, Quyen
AU - Mandrekar, Sumithra J.
AU - Winham, Stacey J.
AU - Cook, Kathryn
AU - Jatoi, Aminah
AU - Le-Rademacher, Jennifer G.
N1 - Funding Information:
This work was supported in part by K12CA090628 and by P30CA15083.
Publisher Copyright:
© 2020, American Association for Cancer Education.
PY - 2021/12
Y1 - 2021/12
N2 - Consent forms are an important educational tool that helps cancer patients decide on whether or not to enroll on a clinical trial, but wordiness potentially detracts from their educational value. This single-institution study examined word counts of consent forms for all phase I, II, and III solid tumor clinical trials between 2004 and 2010. Consent forms were categorized by trial funding source: (1) pharmaceutical company; (2) National Clinical Trials Network (NCTN); (3) R01- or other non-government grants; and (4) mixed (funding from multiple sources). Three hundred fifteen consent forms were studied; these included 106 (34%) pharmaceutical company; 145 (46%) NCTN; 44 (14%) R01 type; and 20 (6%) mixed. The overall median word count was 5129 words per consent form (interquartile range (IQR) range, 4226 to 6695). The median word counts per consent form (IQR) were 5648 (4814, 6803), 5243 (4139, 6932), 4365 (3806, 5124), and 4319 (3862, 5944), respectively, based on the above funding sources, showing that pharmaceutical company trial consent forms had the highest median word count. Of note, phase of trial was associated with consent form length (phase III were wordier), and consent forms manifested a consistent increase in wordiness over time. These observations underscore a timely need to find ways to limit the verbosity of consent forms, particularly in those from pharmaceutical company trials.
AB - Consent forms are an important educational tool that helps cancer patients decide on whether or not to enroll on a clinical trial, but wordiness potentially detracts from their educational value. This single-institution study examined word counts of consent forms for all phase I, II, and III solid tumor clinical trials between 2004 and 2010. Consent forms were categorized by trial funding source: (1) pharmaceutical company; (2) National Clinical Trials Network (NCTN); (3) R01- or other non-government grants; and (4) mixed (funding from multiple sources). Three hundred fifteen consent forms were studied; these included 106 (34%) pharmaceutical company; 145 (46%) NCTN; 44 (14%) R01 type; and 20 (6%) mixed. The overall median word count was 5129 words per consent form (interquartile range (IQR) range, 4226 to 6695). The median word counts per consent form (IQR) were 5648 (4814, 6803), 5243 (4139, 6932), 4365 (3806, 5124), and 4319 (3862, 5944), respectively, based on the above funding sources, showing that pharmaceutical company trial consent forms had the highest median word count. Of note, phase of trial was associated with consent form length (phase III were wordier), and consent forms manifested a consistent increase in wordiness over time. These observations underscore a timely need to find ways to limit the verbosity of consent forms, particularly in those from pharmaceutical company trials.
KW - Clinical trials
KW - Comprehension
KW - Consent forms
KW - Education
KW - Verbosity
KW - Wordiness
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U2 - 10.1007/s13187-020-01757-7
DO - 10.1007/s13187-020-01757-7
M3 - Article
C2 - 32385740
AN - SCOPUS:85084494553
SN - 0885-8195
VL - 36
SP - 1248
EP - 1252
JO - Journal of Cancer Education
JF - Journal of Cancer Education
IS - 6
ER -