Steve Biko Centre for Bioethics, University of the Witwatersrand, Johannesburg 2193, South Africa.
J Med Ethics. 2010 Apr;36(4):238-42. doi: 10.1136/jme.2009.033407.
This pilot study evaluated the speaking book 'What it means to be part of a clinical trial'. The book aims at empowering populations with information on their rights and responsibilities when enrolled in clinical research. Wide publication of the book-at significant cost-is anticipated. It is important that the book is evaluated within the communities for whom it is intended, and the necessary changes (if any) are made, before translation and large-scale publication takes place.
The objective of the study was to measure the efficacy and ease of use of the book.
Participants were recruited from a catering company. Participants were questioned on their knowledge of clinical trials and were then given the book. Instructions for use of the book were given to one group ('experimental' group). The other group ('control' group) was not given any instructions. A week later, the investigators returned, repeated the knowledge questions and asked 'ease of use' questions.
A two-way repeated measure of covariants showed a statistically significant positive increase in knowledge of clinical trials among the intervention group (p=0.02). Results for the control group displayed trends that were not statistically significant. Percentage analysis of 'ease of use' questions proved that the book is easy to use, although some changes would be beneficial.
This study revealed that the speaking book is easy to use. It significantly increased knowledge of clinical trials among the study sample if instructions on use of the book were provided.
本试点研究评估了有声读物《参与临床试验意味着什么》。该书旨在为参与临床研究的人群提供有关其权利和责任的信息。预计该书将以高昂的成本广泛出版。在进行翻译和大规模出版之前，重要的是要在该书的目标受众群体中对其进行评估，并在必要时进行修改。
本研究旨在衡量该书的功效和易用性。
参与者从一家餐饮公司招募。参与者被问及他们对临床试验的了解，然后向他们提供该书。对一组参与者（“实验组”）进行了使用该书的说明。另一组（“对照组”）未提供任何说明。一周后，调查人员返回，重复了知识问题，并询问了“易用性”问题。
双向重复测量协方差显示，干预组的临床试验知识呈统计学显著正向增加（p=0.02）。对照组的结果显示出没有统计学意义的趋势。“易用性”问题的百分比分析表明，尽管有些更改将是有益的，但该书易于使用。
本研究表明，有声读物易于使用。如果提供了使用该书的说明，它会显著提高研究样本对临床试验的了解。
