A booklet on participants' rights to improve consent for clinical research: a randomized trial.
A booklet on participants' rights to improve consent for clinical research: a randomized trial.
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DOI：
10.1371/journal.pone.0047023
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发表时间：
2012
期刊：
影响因子：
3.7
通讯作者：
Stewart RA
中科院分区：
文献类型：
--
作者：
Benatar JR;Mortimer J;Stretton M;Stewart RA
关于临床试验中受试者权利的信息变得越来越复杂和难以理解。这项研究评估了一本与所有研究相关的简单小册子是否提高了对受试者提供知情同意所需权利的理解。目前使用的21份国际临床试验的知情同意书(ICF)被分为与具体研究研究有关的信息和关于参与者权利的一般信息。编写了一本小册子，用简单的语言提供关于参与者权利的信息，以取代目前ICF对ICF每个组成部分的可读性，然后使用Flesch-Kincaid阅读易读性分数(FK)对该小册子进行评估。为了进一步评估小册子，282名住院患者被随机分为三种方式之一来展示研究信息：标准ICF、小册子与短ICF相结合、或小册子与简化ICF相结合。通过问卷调查评估研究方案和参与者权利相关信息的理解程度。在标准的ICF中，与参与者权利有关的信息平均占词汇的44%，而且比描述临床试验的信息更难阅读(分别为FK 25和(VS)41，p = 0.0003)。这本小册子减少了字数，并将FK从25个增加到42个。简化ICF的FK评分略高于标准ICF(50分对42分)。住院患者对手册和短小ICF62%(95%可信区间(CI)56至67)的正确或简化ICF62%(CI 58至68)的正确评估优于标准ICF的52%(CI 47至57)，p = 0.009。这是因为更好地理解了有关权利的问题(62%对49%，p = 0.0008)。对学习相关信息的理解，简化的ICF与标准的ICF相似(60%对，p = 为0.68)。小册子提供了一种简单、一致的方法来提供与所有研究相关的参与者权利信息，并提高了通常参与临床试验的患者的理解。
Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants’ rights. A booklet designed to provide information on participants’ rights which used simple language was developed to replace this information in current ICF’s Readability of each component of ICF’s and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant’s rights was assessed by questionnaire. Information related to participants’ rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.
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DOI：
10.1016/0197-2456(81)90019-2
发表时间：
1981-01-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
HOWARD, JM;DEMETS, D
通讯作者：
DEMETS, D
影响因子：
1.5
作者：
Marco, Catherine A.
通讯作者：
Marco, Catherine A.
影响因子：
168.9
作者：
Williams, BF;French, JK;White, HD
通讯作者：
White, HD
影响因子：
168.9
作者：
Joffe, S;Cook, EF;Weeks, JC
通讯作者：
Weeks, JC
DOI：
10.1016/s0197-2456(03)00003-5
发表时间：
2003-06-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Burman, W;Breese, P;Vernon, A
通讯作者：
Vernon, A