UNDERSTANDING
2.6 ASSESSING PERSONS WITH LIMITED DECISION MAKING CAPACITIES
the individual and the community. Staff and the community monitor any issues arising in the study and work towards addressing them. During this post enrolment phase, the community advisory board (CAB) takes centre stage as the bridge between the community and the research team. During all three phases, researchers need to continuously provide information, assess understanding, and take positive steps to clarify any misunderstanding or misconception (Woodsong & Abdool Karim, 2005). This initiative by HPTN is very important as it is a clear acknowledgement that the area of informed consent needs concerted effort if informed consent is to be adequately informed.
The current section has highlighted some of the debates in the area of microbicide trials. The section has also highlighted some of the ways in which the microbicide trial community is responding to the ethical challenges. The next section is devoted to studies that have assessed trial participants with limited decision making abilities.
2.6 ASSESSING PERSONS WITH LIMITED DECISION MAKING
One of the studies focusing on patients with limited decision making capacities was conducted by Baskin, Morris, Ahronheim, Meier and Morrison (1998). The authors conducted a
quantitative study in the USA to identify barriers to informed consent for patients with
advanced dementia. They were interested in patients who were above 65 years. They recruited 165 patients and their surrogates. Three percent of the surrogates understood the purpose of the study but refused for the patients to enrol their wardees. About 19 percent of the surrogates were unable to understand the research protocol and therefore they could not give informed consent on behalf of the patients. No indication was given by the authors as to how they assessed the understanding of surrogates.
Pucci et al. (1999) report on a study which investigated the ability of middle-aged and elderly caregivers to understand and retain information about randomised controlled trials in patients with Alzheimer’s disease. They reported that 40 caregivers were given information in a semi- structured manner and were also provided with information sheets. Twenty-eight of the 40 caregivers could not explain why placebo, randomisation and double-blinding procedures were used in the trials. Eight of the forty only had a vague idea about experiment and possible use of a placebo but could not recall any other information. Twenty percent of the caregivers were not aware of the influence of chance in the process of assignment to treatment groups. The study identified a relationship between education level and understanding. Pucci et al. point to the complexity of methods for RCTs and the poor education of many potential participants as important factors in understanding the problem of low levels of understanding.
In a study to test a new tool to assess depressed patients capacities to consent, Appelbaum, Grisso, Frank, O’Donell and Kupfer (1999) recruited 26 women in USA diagnosed with depression and had joined a psychotherapy trial. Participants were recruited shortly after
joining the trial and having participated in the first session of the trial. They were given the MaCAT-CR, a semi-structured interview instrument which was designed to assess
understanding of disclosed information about the nature of the project and the study
procedures. The assessment tool was designed to assist in the assessment of competence to consent to treatment. It is administered in the form of a semi-structured interview format to assess and rate the abilities of potential research participants according to 4 components of decision making which are usually considered in clinical settings. The four abilities include understanding of disclosed information about research purposes and procedures, reasoning about participation, comparing alternatives in terms of their consequences, and appreciation of the effects of research participation.
The 26 women were administered the same MaCAT-CR tool about ten weeks later. The mean score of understanding was 23.33 out of a maximum of 26, with no volunteers scoring below 20. In this study, the authors unfortunately did not set the cut-off score judged as reflecting an adequate level of understanding. The MaCAT procedure also did not include patients’
understanding of why the trial was being conducted in that particular way. In this way, the procedure did not allow the patients to reason beyond recall of disclosed information (Appelbaum et al., 1999).
Kitamura and Kitamura (2000) reported on a quantitative study they conducted in Japan. The study was aimed at assessing clinicians’ judgement of psychiatric patients’ competence to give informed consent. A total of 176 members of the Japanese Society of Psychiatry and
Neurology gave clinical judgement in a questionnaire of competency. The study concluded that clinicians’ global judgement of patients’ competency was not reliable and recommended the use of structured interviews in improving the judgments. The findings from the study
clearly highlight the weaknesses in some studies that use self reports without conducting some tests employing valid measures.
Kovnick, Appelbaum, Hoge and Leadbetter (2003) reported on a study that was investigating competence to consent to research among long–stay patients with schizophrenia. In the study, the MacArthur Competence Assessment tool was administered to 27 patients and 24 members (normal controls) of the same age as the patients selected from the community. Significant differences were found between the patients and the control group that was made up of members from the general community. The differences related to the abilities of patients to understand disclosed information and use it to reason and appreciate the facts about the study.
Consequently, the degree of psychopathology and cognitive reasoning were found to be negatively correlated with understanding and appreciation of facts among the patients. The findings highlight the difficulties that patients encounter in providing consent to research and the need for using various techniques aimed at facilitating decision making in the face of decisional impairments.
Dunn and Jeste (2003) conducted a study aimed at establishing problem areas in the understanding of informed consent among middle aged and older patients with psychotic disorders. They examined a post-consent test of comprehension given to older patients with psychotic disorders in order to identify challenges in the understanding of informed consent for research. The study was comparing the effectiveness of a routine, paper-based disclosure of study information, with an enhanced computerized slide show incorporating more information.
The authors recruited 102 middle-aged and older patients with schizophrenia (and other related psychotic disorders) and 20 normal comparison participants and randomised them to the two information disclosure methods. After the information disclosure, the researchers administered a 20-item questionnaire aimed at assessing comprehension of information disclosed during the
informed consent process. They established that patients had more difficulty than normal comparison individuals regarding open-ended questions and study procedures. Among patients, the enhanced procedure was associated with better performance on questions concerning risks. They concluded that study procedures, study risks and study benefits constituted problem areas in informed consent and that these needed to be focused on if attempts to improve informed consent were to be successful (Dunn & Jeste, 2003).
In a study conducted to examine issues surrounding the obtaining of informed consent from older and frail patients, Barron, Duffey, Byrd, Campbell and Ferrucci (2004) noted that the challenges involved in obtaining informed consent from older patients include physical frailty, reduced autonomy, and impaired-decision making due to dementia, delirium or other mental illnesses that affect older persons. The authors noted that it became difficult to evaluate decision-making capacities in old-aged participants as, in some cases, the decision-making capacity may be partly impaired. The authors also singled out studies that look at end of life issues in old age. Such studies typically involve frail older participants and take place in institutions where the older patients may have neither rights nor privacy. The authors recommended that research involving older patients should use simple language in informed consent documents.
Palmer et al. (2005) conducted a study aimed at assessing the capacity to consent to research among older persons with schizophrenia, Alzheimer’s disease or diabetes mellitus. The main aim of their study was to compare the decisional capacities of the three patient groups and to examine the effectiveness of a brief set of screening questions in detecting impaired
understanding. The researchers used a 3-item decisional questionnaire and the MacArthur competence assessment tool for clinical research. They reported that patients with diabetes mellitus performed best on the capacity instruments while patients with Alzheimer’s disease
had the worst performance and patients with schizophrenia were in the middle. The level of cognitive functioning as measured by the Mini Mental State Examination (MMSE) was
generally the best predictor of decisional capacity. The three-item questionnaire that they were testing was found to be sensitive to impaired understanding as measured by the MacArthur Tool.
In another study aimed at assessment of therapeutic misconception in older schizophrenic patients, Dunn, Palmer, Keehan, Jeste and Appelbaum (2006) found that patients with less education or worse cognitive functioning had higher levels of therapeutic misconception.
Degree of therapeutic misconception was inversely related to understanding. The authors examined the frequency of therapeutic misconception with a true/false scale among 87 middle aged and older patients with schizophrenia. They assessed the therapeutic misconception levels based on what the patients thought about a hypothetical double blind, placebo controlled trial.
The patients were informed that they were going to be invited to join the hypothetical trial.
Therapeutic misconception was assessed using six true/false questions; each question had a possible score of zero (0) for the correct answer and one (1) for the wrong answer. Those participants with a higher total score (closer to 6) had higher levels of therapeutic
misconception. Overall, 69 percent of the participants were classified as having some level of therapeutic misconception. The majority of participants were aware that the researcher would be blind to medication assignment. The strongest correlates of therapeutic misconception were found to be lower education, severity of cognitive deficits, and worse decisional capacity.
In a study aimed at improving informed consent among patients with psychiatric conditions, Wirshing, Wirshing, Marder, Liberman and Mintz (1998) designed and evaluated a rigorous informed consent procedure for patients with schizophrenia. In their study, informed consent documents were read and explained to patients and then a questionnaire was administered to
assess their levels of comprehension. Protocol procedures were repeated until patients answered 100 percent of the questions correctly. Patients were asked the same questions 7 days later to ascertain what they could recall. Patients’ median score on the first test was 80 percent. 53 percent of patients required a second trial to obtain 100 percent correct, while 37 percent required 3 or more trials. Generally, scores improved from day 1 to day 7. On the seventh day, 96 percent of patients felt adequately informed. The study demonstrated that with some effort on the part of informers, persons with decisional incapacity are able to understand and retain some critical informed consent information. The authors did not report how they tested for reliability and validity. The questionnaire used in the study included various aspects of trial information but the authors did not report the analysis of the individual responses. It is therefore not clear which aspects were better understood. Overall, the questionnaire appears to test knowledge recall and ability to learn correct answers rather than measuring understanding.
In order to investigate the perceptions of participants in depression prevention trials, Busby- Grant, Mackinnon, Christensen and Walker (2009) examined participants’ motivations for joining the research and their views on randomisation. The researchers also wanted to find out if the participants understood their right to withdraw from the research at anytime. They recruited 900 adults out of a total of 105,000 that they had initially targeted, who had reported elevated depression symptoms in both urban and rural areas of Australia. Participants were required to rate their agreement or disagreement with statements in the questionnaire. The respondents expressed a variety of reasons for joining depression prevention trials including altruism. The participants were not concerned about randomisation. Over half (56 percent) of the 900 respondents did not state preference for any particular treatment arm. The findings suggest that participants indicating elevated symptoms of depression are more likely to view depression prevention trials in a positive way. This finding perhaps points to an expectation of some personal benefit in the form of prevented illness.
The current section by focusing on persons with limited decision making capacity, has highlighted challenges that researchers may face in conducting research with persons with limited decision making abilities (including both patients and surrogates). The next section focuses on participants from oncology trials.