UNDERSTANDING
2.11 STUDIES AIMED AT IMPROVING TRIAL PARTICIPANTS’
UNDERSTANDING
Various studies have been conducted globally aimed at improving trial participants’
understanding of research participation, including clinical trial procedures. Most of these studies have been conducted in developed countries. Simes et al. (1986) conducted one of the earliest interventions aimed at improving informed consent. In their study, 57 patients were randomised to an individual approach in which each doctor had discretion in determining the information that the individual wanted, or the uniform approach in which there was total disclosure of all relevant information. Comprehension was assessed qualitatively by asking questions which were aimed at establishing comprehension. Overall, patients’ understanding of both treatment and research aspects of the trial were significantly better in the total disclosure group than in the individual approach. A reassessment of comprehension four weeks after the initial assessment revealed no significant differences between the two arms. This suggests that the total disclosure approach was important only in improving short-term recall. It is possible that the two approaches were simply providing the same kind of information using two different approaches. This is evidence that the study was looking at simple recall. However, the findings from this study are difficult to interpret as the authors did not define the cut-off criteria for an acceptable recall score.
Fureman, Meyers, Mclelan, Metzger and Woody (1997) conducted a study aimed at evaluating a video tape specially produced to supplement written information about preventive HIV vaccine trials. The study involved 186 drug users randomly assigned to reviewing a pamphlet or watching a video prior to reviewing the same pamphlet. The video programme was modeled in the form of a talk show involving a panel of experts as well as some potential vaccine study participants, and was aimed at covering important information that trial participants were
supposed to be aware of concerning HIV vaccine trials. The effect of the two methods was assessed qualitatively by asking some questions aimed at eliciting recall of the information that had been provided. The findings suggested that the video/pamphlet combination was superior in improving retention of information one month later as compared to the pamphlet alone. The authors highlighted the challenge of communicating facts to a socially marginalized group and suggested that researchers should provide technical information in an understandable manner.
The participants in this study had been enroled in a longitudinal study for several years. It is possible that they may have received useful information informally about HIV vaccines. This information might have contributed to their high levels of knowledge about HIV vaccine trials.
A similar study conducted by Jimison, Sher, Appleyard and Le Vernois (1998) concluded that it was feasible to adapt a structured multimedia informed consent system to a specific trial and to incorporate techniques aimed at improving understandability of informed consent content.
In this study, the authors tested a prototype multimedia informed consent tool against a routine informed consent form. The prototype included information on clinical trials in general and information specific to the trial at hand. Prospective participants felt that the multimedia prototype gave them a greater sense of self control as they could proceed at their own pace.
They also liked the modular and hierarchic approach to presenting information and felt that this made the information more understandable. Institutional Review Board members, while finding the system valuable, expressed concerns about how to review the system for potential biases in presentation and also about legal issues relating to the replacement of the paper consent document.
Standard informed consent forms were tested against simplified forms in a study conducted by Davis, Holcombe, Berkel, Pramanik and Divers (1998). This study was based on the
realization that a high level of reading skill and comprehension are necessary to understand the
contents of the informed consent documents. In the study, 183 adults were randomised to read either the standard informed consent document which was written at sixth grade level, or a simplified form written at seventh (7th) grade level. Participants were then assessed to determine their comprehension levels and were then given the alternative form and asked which one they preferred and why. The majority of participants (62 percent) preferred the simplified form and 97 percent of the participants confirmed that the simplified form was simpler to read compared to the standard one. Surprisingly, the degree to which the two groups understood the contents of the two forms was the same. The average score for the simplified form was 58 percent while that for the standard form was 56 percent. The scores of the ten comprehension questions were reported, but there was no indication of what the response options were, thereby giving no information about the wrong answers that the respondents were selecting. The findings raise some serious questions regarding the adequacy of the design of informed consent forms for persons with low to marginal literacy skills. The study dealt with oncology patients and it is possible that they already knew about the oncology trial from their hospital visits or past experiences with trials. The findings suggest that that simplifying the informed consent materials is an important strategy in efforts aimed at improving participants’
comprehension. Researchers need to explore combinations of various methods to complement the simplified forms.
Dunn and Jeste (2001) reviewed various interventions aimed at improving trial participants’
understanding. They reviewed a total of 34 studies which included interventions aimed at improving understanding by participants. In 25 of the 34 studies reviewed, patients’
understanding showed improvement with a variety of interventions. Some of the successful interventions were based on the following characteristics: better organized processes, shorter and more readable informed consent documents, simplified and illustrated formats, and corrected feedback. Eleven studies compared simplified with standard (complex) forms.
Studies which involved the augmentation of the informed consent process with a video tape showed significant promise. In some of the studies reviewed, education and age were identified as predictors of understanding. The authors point out the challenge of distinguishing between understanding and recall in some of the studies and suggest the use of various interactive multimedia technologies in efforts aimed at improving understanding.
In a study aimed at evaluating the impact of an educational booklet on women’s knowledge of and willingness to participate in a randomised clinical trial of a breast cancer treatment, Ellis, Butow and Tattersall (2002) randomised 83 women to either receive standard information or standard information plus booklet. The booklet contained information on the need for clinical trials and the manner in which randomised controlled trials (RCTs) are conducted. The researchers concluded that educating women using an educational booklet was not effective in improving recruitment of women to the RCT. It is important to note that the study was aimed at assessing the impact of the educational booklet on recruitment and not specifically on their understanding of clinical trial procedures, so its relevance to this study is limited.
In a study aimed at improving the understanding of informed consent among middle aged and elderly patients with psychotic disorders, Dunn et al. (2002) randomised 80 patients and 19 normal comparison participants to receive a routine consent or enhanced consent. The enhanced consent consisted of a computerised slide show incorporating more structure and review of important information. A comprehension test was administered after the consent procedure. The normal comparison participants scored better than the patients overall. The patients who received the enhanced consent scored better than those who got the routine consent. Patients on the enhanced consent did not differ from the normal comparison
participants who received routine consent. Comprehension was reported only in terms of how many achieved 100 percent. The questionnaire was not included in the report and so it was
difficult to understand the areas of comprehension that were tested or answered wrongly. The study established, that among patients, comprehension test scores correlated with levels of education and cognitive performance. The findings suggest that structured presentation of information may help patients with cognitive impairments to understand information concerning research and research related procedures.
In a study aimed at comparing the usefulness of various sources of information, Agre and Rapkin (2003) compared the effectiveness of information provided through videotape, computer and booklet against the standard written consent form. All three methods had been demonstrated to be effective in separate studies and yet no study had been conducted
comparing the three methods. The study involved patients, family members and surrogates who were waiting for patients. The study observed that there was no evidence of significant differences in patient knowledge related to any of the alternative consent tools. It was observed, however, that computer and video formats produced slight improvements in
understanding over booklet and standard formats. Interestingly, the study found that no one in any group or age group answered more than two thirds of the knowledge questions correctly.
The authors therefore concluded that there was a need for more research on this issue. Such research could focus on the types of questions that were asked and even the contents of the various interventions used in the study. The authors have also suggested that instead of having detailed and longer informed consent documents, it might be better to have a form covering key facts accompanied by appropriate resources that provide more details. They concluded that media consent tools should not be considered a panacea for improving informed consent and that these tools cannot simply be a conversion of standard consent information to another format.
The reading level of documents is important in the informed consent process as it contributes in a significant way towards understanding of the information presented in the documents. Coyne et al. (2003) conducted a randomised controlled study that assessed the effectiveness of an easy-to-read consent statement when compared with a standard consent statement. The authors hypothesised that the easy-to-read statement would result in higher levels of comprehension, lower patient anxiety, higher levels of patient satisfaction, and higher patient accrual. Patients in the easy-to-read arm demonstrated lower levels of anxiety and higher satisfaction compared with patients who received the standard package. Patient comprehension and accrual were not affected by the intervention. This study confirmed that trial information can be simplified without omitting useful information. The authors caution, however, that the generalisability of the findings from this study may be limited by characteristics of the patient sample.
Agre et al. (2003) reported on eight studies that involved interventions aimed primarily at impacting on decision making, knowledge and therapeutic misconception. The interventions used included video and computer based programmes aimed at providing information, modified consent forms for low literacy populations, role plays, and decision aids. Six of the studies were randomised controlled trials (RCTs). To their surprise, most of the interventions did not significantly improve knowledge of consent information. The majority of participants in one of the studies incorrectly described therapeutic aims as a purpose of the trial, even after viewing the intervention video. It is not clear what type of information was provided through the various interventions. The interventions could simply have been attempts to package the same information from consent documents into different formats. For all eight studies, there was no gold standard for maximizing understanding. The authors pose various questions including: what should be the gold standard for maximizing understanding? What should we expect people to know? Do scores on knowledge quizzes actually reflect an understanding of the information? Are all the elements of equal importance?
In a study to evaluate a prototype informed consent process, Colletti et al. (2003) concluded that participation in the prototype informed consent process was associated with substantial and sustained improvements in knowledge. Baseline data on knowledge levels was obtained before the implementation of the prototype. Participants from the intervention group were given a booklet that described a hypothetical HIV vaccine trial. The low literacy participants were offered an audiotape recording of the informed consent form. Immediately after reading or listening to the tape, participants were allowed to discuss any questions with trained study staff and they were encouraged to take the booklet or tape home to read and to discuss with others.
Participants were invited to come back to the clinic after one or two weeks to discuss with a trained staff member. After discussions, the trained member would then ask questions aimed at assessing the trial participants’ understanding of key concepts. Participants were then requested to complete a self-administered questionnaire to assess their understanding of the hypothetical situation, as well as their willingness to join the hypothetical study. Significant improvements in understanding were observed among the low literacy participants. The findings from this study demonstrate the importance of giving potential participants time to read and discuss information provided in a simple way.
Sastry et al. (2004) report on a study they conducted in India, aimed at optimizing informed consent among low literacy populations. They assessed pregnant women’s understanding of group education and counselling about HIV/AIDS provided at an antenatal clinic. They then enhanced the group education and counselling process with the use of culturally appropriate visual aids, and assessed the subsequent changes. They found that the use of visual aids improved women’s understanding from 38 percent to 72 percent. They also found that when the same visual aids were reinforced during individual counselling, women’s overall
comprehension rose to 96 percent. This study confirmed that complex information can be
clearly conveyed and understood even in populations of low literacy and even within busy and limited-resource government hospital settings. The study also confirmed that the standard model of conveying information may not be sufficient to ensure understanding of participants.
This approach has been used successfully in developing countries in the areas of public health, nutrition, sanitation, health and family planning (Howze, 2009; Olatoye, 2005). The important issue to note is that such visual aids should be developed with the specific population in mind in order to ensure their positive impact. The study has successfully demonstrated that, with some effort, it is possible to improve understanding about research and research procedures.
Flory and Emanuel (2004) reviewed research on interventions aimed at improving research participants’ understanding of information disclosed during informed consent. They did a Medline search covering studies conducted between 1966 to March 2004 and they identified 42 studies that met their inclusion criteria. They found that out of 12 trials that used multimedia interventions, three showed significant effectiveness, and of 15 trials that used some enhanced informed consent documents, six showed significant improvements in understanding. Five of the 6 studies were unfortunately of limited quality, thereby limiting their conclusiveness.
Lower education was associated with limited levels of understanding in the majority of trials.
This review concluded that efforts to improve understanding through the use of multimedia and enhanced informed consent forms have had only limited success. Flory and Emanuel (2004) further concluded that having a team member or a neutral educator who spends more contact time with participants appeared to be the most effective way of improving research
participants’ understanding, but that this needed further research.
A study was conducted to assess the usefulness of a 20-minute video which was developed for use in recruitment for a microbicide study (Friedland et al., 2004). The video was developed as an intervention aimed at improving comprehension in the microbicide trial. The team also
developed a booklet that was used as a supplement for the video. The primary purpose of the video was to introduce the trial and to explain the concepts of microbicide, randomisation and blinding. The video also addressed other issues such as HIV testing and voluntary
participation. The video, which was filmed in three South African languages, was pilot-tested through focus group discussions and local community advisory groups. The video was revised and finalized based on the feedback from the focus group discussions. The authors found that the combination of presenter, interviews and animation which was used in the video held viewers’ attention. Furthermore, the video encouraged people to discuss issues openly and to ask questions. Unfortunately, the team did not formally test the effectiveness of the video and the booklet as their main aim was simply to assist in the microbicide study recruitment efforts.
Wray, Stryker, Winer, Demetri and Emmons (2005) conducted a pilot study aimed at assessing the effectiveness of trial-specific tailored materials in improving understanding of research.
They recruited 118 candidates from oncology trials and randomly assigned them to tailor-made materials or to a generic booklet about clinical trials. Participants rated tailor-made materials as a useful reference, but there were no major differences between the two groups in terms of understanding. This finding could have been influenced by factors such as length, complexity and readability of the tailor-made materials. The investigators did not control for participants duration of trial experience.
In order to promote understanding of HIV preventive microbicide trials, a team developed a booklet which explained the basic elements of informed consent with simple language and illustrations (Woodsong, 2005). Based on review of literature and her own studies, Woodsong suggested that investigators conducting HIV prevention research in developing countries need to use creative approaches in improving comprehension. The author confirmed that concepts associated with research such as randomisation, placebo and double-blinding are difficult
concepts to convey to illiterate persons. However, the effectiveness of this booklet has not been assessed in a systematic way.
In an effort to improve understanding of microbicide trials by potential participants, Woodsong and Abdool Karim (2005) proposed a conceptual framework for an enhanced informed consent process. The framework consists of three stages, namely pre-enrolment, enrolment and post- enrolment stages. The pre-enrolment phase includes a community engagement process, during which researchers work with community representatives and community advisory boards in developing a message that is culturally appropriate. In the enrolment phase, the researchers deal directly with the potential participants in conveying information in a way that is meaningful and acceptable to the individual. In the post-enrolment phase, the researcher continually checks on the willingness of the individual to continue in the study and also conveys any new information they would have found out about the study or the product being tested. This conceptual framework is based on the authors’ field experience and appears useful, but was not tested to confirm its effectiveness.
More and more, children are taking part in research which is frequently aimed at addressing problems specific to them. There is therefore the need to conduct research which looks at ways of obtaining informed consent from children. Barnett, Harrison, Newman Bentley and
Cummins (2005) conducted a study which looked at the impact of different styles of informed consent documents for children. The authors concluded that a story format was clearly superior in maximizing children’s understanding. However, it should be noted that this study has been criticised for failing to provide information on what types of questions were included in the assessment questionnaire and how the validity of the assessment questionnaire was assured (Cracowski & Paris, 2005). The study has also been questioned on the use of a prompting questionnaire, as well as for the effect of the environment in which the intervention