Patient understanding of research: developing and testing of a new questionnaire.

Abstract:

:Lack of understanding or knowledge of research among patients participating in randomized clinical trials (RCTs) is common. However, there is a lack of validated measures to assess the extent of the problem. The aim of this study was to develop and pilot a questionnaire to assess knowledge and understanding of RCTs in the cancer setting. A 13-item four-part questionnaire was developed and piloted with three groups: patients with cancer who had no experience of clinical trials (n=26); patients with cancer who had previously participated in an RCT (n=26) and research nurses (n=26). The groups were compared using non-parametric anova techniques which showed a highly statistically significant difference between the nurses and both patient groups (P<0.001). The difference between the patient groups was not significant (P=0.231). Cronbach's alpha was computed at 0.77. After studying correlation of individual questions and verbatim comments from respondents, one question was removed from the questionnaire, but this did not have a major effect on the properties of the tool. Minor changes were made to six other questions and the revised tool will now be used and further tested in a large randomized controlled trial to improve informed consent in trial participation.

authors

Hutchison C,Cowan C,Paul J

doi

10.1111/j.1365-2354.2006.00732.x

subject

Has Abstract

pub_date

2007-03-01 00:00:00

pages

187-95; quiz 195-6

issue

2

eissn

0961-5423

issn

1365-2354

pii

ECC732

journal_volume

16

pub_type

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