It is well recognised that there are significant deficiencies in the current process for obtaining informed consent for participation in clinical research.1-7 Various attempts have been made to enhance participant understanding, with limited success.1,8-12 Some strategies have resulted in improvements in information transmission to and retention by not only study participants but also patients in general.9,10,13-19 However, complex methods of information provision, such as multimedia methods, may cause confusion and thereby reduce understanding.20,21
Studies of the provision of information in clinical research have usually adopted the perspectives of researchers and regulatory bodies, rather than those of participants.22 There have been a few exceptions;23-26 for example, a comparison of an information statement developed by participants with an information statement developed by researchers showed that the former was associated with greater participant understanding.26 We therefore sought to assess the efficacy of a computer-based method of communicating information to prospective clinical trial participants, with the aim of improving participant understanding.
We used an open, randomised controlled study to compare two reading tasks — an interactive, user-friendly, computer-based presentation (the intervention) and a conventional paper-based statement (the control) — describing a mock study entitled Right Heart Catheterisation to Monitor Heart Attack Complications in Diabetic Patients.
Ethics approval was obtained from the Alfred Human Research Ethics Committee.
English-speaking, computer-literate patients with diabetes aged 18–70 years with self-defined English literacy and competency in computer use were eligible to participate. Participation was restricted to those who could travel to the hospital to take part in the study.
Participants were recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and the Baker IDI Heart and Diabetes Institute in Melbourne. The study was explained over the phone, and an information statement was mailed to all who were interested in participating. The mock nature of the study was explained over the phone, and also in person on the day of participation (before obtaining written consent and providing the reading task).
To allow for interim analysis, one of us (A S K) randomly assigned participants in blocks of 10 to the intervention and control arms of the study. Thus, of every 10 participants, five were assigned to the intervention group and five to the control group. An overview of the study protocol is shown in Box 1.
The paper-based statement was based on a typical information statement approved by the Alfred Human Research Ethics Committee. It was five pages (2044 words) in length, was attached to separate forms for consent and revocation of consent, and contained sections entitled: Introduction; Study sponsor; Purpose and background; Procedures; Possible benefits; Possible risks; Other treatments; Privacy, confidentiality and disclosure of information; New information arising during project; Results; Further information; Other issues or complaints; Participation is voluntary; Reimbursement for your costs; Ethical guidelines; Injury; Compensation; and Termination of the study. The reading level of the text was grade 10 — a reading age of 14–16 years.
The computer-based presentation was an interactive program that was displayed on a 17-inch computer monitor. Its structure and substantive content were identical to those of the paper-based statement. However, the computer-based presentation also included interactive, explanatory features; these included text boxes linked to keywords, to providing further explanation, hyperlinks to diagrammatic and pictorial presentations of procedures, and a video clip of a live right heart catheterisation procedure. The information was presented in concise sections, separated, at intervals, by a quiz (Box 2). Participants could move forward and backward through each page or skip to a specific page by clicking on a side panel. The text size was larger than in the paper-based statement, and the text was presented on a coloured background.
On the basis of an earlier study,8 the sample size was initially estimated as 100 for a power of 0.8, with an expected difference in means of 5% given a putative population standard deviation of 8.8. However, when variance was verified on the basis of the first 10 participants (SD, 7.6) the sample size was re-estimated as 60, to attain the same difference in means and power.
Participants’ levels of understanding were assessed using quantitative and qualitative measures. The key quantitative measure of understanding, and primary end point, was the percentage of correct answers to questions in a paper-based questionnaire (in multiple-choice, true/false and yes/no format) that was administered to both groups at completion of the reading task. This consisted of 43 questions: eight demographic questions (personal characteristics such as age and sex), 26 assessment questions, one question about hypothetical participation and eight distracter questions.
The time taken to complete each reading task was also measured. Unlike other studies that have compared a standard form to other procedures,12,27,28 time restrictions were not imposed. This was to respect different reading abilities.
Data were gathered from 60 participants (30 assigned to the computer-based task, and 30 assigned to the paper-based task), whose characteristics are summarised in Box 3. Most were male (42/60), most used computers on a daily basis (50/70), and 40% were working full-time (24/60). The mean age was 52.0 years (range, 27–70 years). In the group that completed the paper-based task, 21 of 30 had completed tertiary education, compared with 15 of 30 in the group that completed the computer-based task. All participants were fluent in spoken English, and all but one were fluent in written English.
The percentage of correct answers used to assess understanding was based on 23 of the 26 assessment questions (three assessment questions that were answered correctly by > 90% of participants were excluded from the analysis). The average percentage of correct answers for the group that completed the computer-based task was significantly higher than that of the group that completed the paper-based task (82% v 73%; P = 0.005 [two-tailed t test]).
Frequencies of percentages of correct answers for both groups are shown in Box 4. These scores were clearly different in the two groups — scores of participants who completed the computer-based task were skewed towards the higher percentages, and scores of participants who completed the paper-based task were lower and more spread out. The group that completed the computer-based task had a highest individual score of 96% (two participants with 22 correct answers) and a lowest of 65% (two participants with 15 correct answers), compared with 91% (5 participants with 21 correct answers) and 17% (one participant with four correct answers), respectively, in the group that completed the paper-based task. The participant who was not fluent in written English achieved the highest assessment score in the group that completed the paper-based task. Multivariate analysis showed no correlation between percentages of correct answers and age or sex.
Significantly more participants in the group that completed the computer-based task expressed interest in taking part in the mock study, if it were real (23 v 17 participants; P = 0.01).
The interviews undertaken after participants completed the reading tasks were 3–18 minutes in duration. A selection of representative quotes from the interviews is presented in Box 5. The computer-based task received positive feedback, especially about its presentation and special features. Participants stated that these characteristics made them feel better informed and better able to make a decision about being involved in the study. Participants in the group that completed the paper-based task stated that they found the information difficult to understand, and made negative comments about the length and presentation of the document. After verbally explaining to participants the nature of the other form of information delivery tested in this study, more participants from both groups stated that they believed they would find a computer-based presentation easier to understand (21 in the computer-based task group, 18 in the paper-based task group).
This study has shown that a computer-based approach to communicating information about clinical research to prospective trial participants can improve the consent process, compared with a conventional approach using a paper-based statement. Four key findings related to this improvement.
First, we found a major difference between the groups in the understanding of the more complex details of the study. Other studies examining the efficacy of multimedia consent processes in enhancing understanding of clinical trials have shown limited success.29-31
Second, participants who completed the computer-based task felt more comfortable in making a decision about being involved in the study. Building trust between researchers and participants is a cornerstone of any study, and feeling informed about a study may help improve these relationships and allay participant anxiety about taking part in a study.23 The quizzes within the computer-based task allowed participants to self-assess their understanding and affirm, for themselves, their eligibility to participate in it. This could not only save researchers valuable time in explaining study procedures11 but also facilitate an appropriate emphasis on issues of special concern to individual participants23 without rushing the consent process. This feature may benefit mass screening programs where large numbers of individuals can self-assess their understanding and also self-select themselves as potential participants, in addition to being contacted by researchers to take part in a study.
Third, the overall lower assessment scores in the group that completed the paper-based task raise concerns about participants’ levels of understanding when this conventional system is used. Further, the wide range of these scores in this group suggests variability in understanding among participants enrolling in research studies with paper-based information statements.9 Participants in the group that completed the computer-based task received and understood uniform and complete information presented in an attractive manner. This is likely to be of significant advantage in multicentre trials, where a computer-based approach could be employed to uniformly and reliably communicate with participants at many locations.
Fourth, participants in the group that completed the computer-based task were more likely to indicate a willingness to participate in the mock study (if it were real). This could indicate a benefit in recruiting (and perhaps even retaining) study participants.8
Our study had some limitations. It was restricted to English-speaking, computer-literate patients with diabetes. Although the computer-based method was successful in our study, further research is necessary to assess its efficacy in other settings and participant groups. Also, we measured participants’ levels of understanding immediately after they completed the reading tasks; this may have demonstrated improvement in information recall rather than understanding,9 but it is more likely that both are improved. In addition, further research is needed to assess whether the findings apply equally to men and women.
1 Protocol used to compare a computer-based presentation with a paper-based statement of information relating to a mock study
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4 Assessment scores of participants*
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* Assessment scores represent percentages of correct answers to 23 assessment questions. |
5 Quotes from participants regarding the methods of information presentation
General comments about the computer-based presentation
“I don’t think you could get it any easier ...”
Positive aspects of the computer-based presentation
Shortcomings of the paper-based statement
Presentation could be improved
“There is some scope of it missing, in terms of presentation.”
Received 28 April 2009, accepted 19 October 2009
Abstract
Objective: To assess the efficacy, with respect to participant understanding of information, of a computer-based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials.
Design, setting and participants: An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27–70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne.
Intervention: Participants were asked to read information about a mock study via a computer-based presentation (n = 30) or a conventional paper-based information statement (n = 30). The computer-based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages.
Main outcome measures: Understanding of information as assessed by quantitative and qualitative means.
Results: Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer-based task than the group that completed the paper-based task (82% v 73%; P = 0.005). More participants in the group that completed the computer-based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer-based presentation to the paper-based statement (21 in the computer-based task group, 18 in the paper-based task group).
Conclusions: A computer-based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.