Psychiatry Research 210 (2013) 634640

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Psychiatry Research
journal homepage: www.elsevier.com/locate/psychres

Validation of Chinese version of the MacArthur Competence

Assessment Tool for Clinical Research (MacCAT-CR) in patients with
schizophrenia spectrum disorders
Tsuo-Hung Lan a,b, Bo-Jian Wu c,n, Hsing-Kang Chen c, Hsun-Yi Liao c, Shin-Min Lee c,d,
Hsiao-Ju Sun c
a
Department of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan
b
Department of Psychiatry, Taichung Veterans General Hospital, Taichung, Taiwan
c
Department of Psychiatry, Yuli Hospital, Department of Health, Hualien, Taiwan
d
Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan

art ic l e i nf o a b s t r a c t

Article history: There is a lack of validated instruments assessing the decision-making capacity to consent to clinical
Received 27 January 2013 research of patients with schizophrenia spectrum disorders who speak Chinese. This study aimed to
Received in revised form determine the validity and reliability of the Chinese version of MacArthur Competence Assessment Tool
3 June 2013
for Clinical Research (MacCAT-CR). The MacCAT-CR using a hypothetical study, the Positive and Negative
Accepted 4 July 2013
Syndrome Scale (PANSS), the Mini-Mental State Examination (MMSE) assessed 139 patients with
schizophrenia or schizoaffective disorder. The Cronbach's alpha coefcient was 0.74. The intra-class
Keywords: coefcients for understanding, appreciation, and reasoning scores ranged from 0.53 to 0.81. Regarding
MacArthur Competence Assessment Tool validity, the understanding, appreciation and reasoning scores were negatively correlated with the
for Clinical Research (MacCAT-CR)
PANSS (r ranged from
0.27 to
0.33), and the negative subscale score (r ranged from
0.31 to
0.37)
Schizophrenia
as well as positively correlated with the MMSE (r ranged from 0.26 to 0.43). All pvalues were less than
Validation
Taiwan 0.01. The factor analysis explained 57.6 % of the total variance; specically, Components 1 and
Chinese 2 contributed 44.5% and 13.1 % of the variance respectively. These ndings indicate that the Chinese
version of the MacCAT-CR is a reliable and valid instrument to assess the decision-making capacity to
consent to clinical research of patients with schizophrenia spectrum disorders.
& 2013 Elsevier Ireland Ltd. All rights reserved.

1. Introduction
Patients with mental disorders often present with impaired
capacity to consent to clinical research (Helmchen, 2010). Keeping
the ethical rules of clinical studies to shelter the rights of
participants and safeguard the trust of both the patients and
public should be taken into serious consideration (Helmchen,
2012).The MacArthur Competence Assessment Tool for Clinical
Research (MacCAT-CR) was developed to assess the decision-
making capacities to consent to clinical research (DMC)
(Appelbaum and Grisso, 2001), and this measure has been widely
used among people with schizophrenia (Carpenter et al., 2000;
Dunn et al., 2002; Moser et al., 2002; Stroup et al., 2005). Many
studies found that severity of symptoms and cognitive function are
associated with DMC to consent to research (Kovnick et al., 2003;
n
Correspondence to: Department of Health, Yuli Hospital, 448, Chung-Hua Road,
Yuli Township, Hualien 981, Taiwan. Tel.: +886 3 8886141; fax: +8863 8884707.
E-mail address: jamsab@mail2000.com.tw (B.-J. Wu).
Moser et al., 2002; Stroup et al., 2005), some of which found that
negative symptoms, rather than positive symptoms, have a sig-
nicant association with understanding scores of the MacCAT-CR
(Candilis et al., 2008; Moser et al., 2002; Stroup et al., 2005).
Although prior studies used the MacCAT-CR to explore patients'
DMC, an important issue that which parts of the MacCAT-CR are
commonly performed poorly in patients with schizophrenia spec-
trum disorders is rarely discussed. This issue is worth exploring for
researchers and clinicians to develop appropriate strategies to
enhance their DMC in these specic parts during the process of
participation in a clinical research.
Finally, it is important to develop and use empirically validated
MacCAT-CR for the evaluation of DMC of patients with schizo-
phrenia spectrum disorders across cultural and language groups
instead of a reliance on the English version alone. As we know,
Hebrew (Linder et al., 2012) and Dutch (Van Eyck et al., 2008)
versions of the MacCAT-CR have been validated. However, there is
a lack of translated and validated version of Chinese language
which about 1.3 billion people use. How to use the Chinese version
to investigate associated factors related to DMC among patients

0165-1781/$ - see front matter & 2013 Elsevier Ireland Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.psychres.2013.07.002
 T.-H. Lan et al. / Psychiatry Research 210 (2013) 634640
with schizophrenia spectrum disorders is benecial to keep best
interests for a specic population that are highly vulnerable in the
process of clinical research.
The present study aimed to (1) translate and test the reliability
and validity of the Chinese version of the MacCAT-CR, and
(2) determine the subparts and items of the MacCAT-CR upon
which stable patients with schizophrenia spectrum disorders who
reside in a hospital-based therapeutic community perform poorly.
2. Methods
2.1. Participants
Participants were recruited from the patients of the therapeutic community at
Yuli Hospital, Department of Health, Taiwan. We recruited only stable patients
(1) who were educated at least for 3 years, and (2) whose scores of the Chinese
version (Guo et al., 1988) of the Mini-Mental State Examination (MMSE) (Folstein
et al., 1975) were greater than 20, and (3) who spoke Chinese and met the
diagnostic criteria for schizophrenia or schizoaffective disorder according to the
Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV). Partici-
pants were excluded from this study if they refused to be evaluated or had an acute
psychotic episode that required hospital transferal. The patient sample included 139
subjects, and the community comparison group included 30 controls without psychosis.
2.2. Measures
2.2.1. MacCAT-CR
Participants were audio recorded during their assessment using the Chinese
version of the MacCAT-CR (Appelbaum and Grisso, 2001). Each item of the MacCAT-
CR has a score that ranges from 02 with an objective scoring criteria. The MacCAT-
CR is structured according to the DMC four-abilities model (Appelbaum et al., 1999).
These abilities include an understanding of the nature of the research project and
its procedures (5 subparts, total 13 items, Range 026); an appreciation of the
effects of participation (3 subparts, Range 06); the ability to think rationally about
participation (4 subparts, Range 08); and the ability to choose (1 item, Range 02).
The original authors of MacCAT-CR (Appelbaum and Grisso, 2001) described a
hypothetical 6-week double-blind placebo-controlled randomized trial, which we
modied to an exploration of the effectiveness of a memory-enhancing drug for
cognitive decits (Appendix). The hypothetical study description included informa-
tion regarding randomized assignment, the ability to withdraw from the study,
drug administration, safety blood monitoring and repeated clinical interviews. As
our Appendix shows, the content of the MacCAT-CR can be classied by its sections
(e.g., understanding), subparts (e.g., U3: Effects on individualized care), and items
(e.g., U3A: placebo; U3B: randomization). However, for the sections of appreciation
and reasoning, there are no items but all subparts. In the section of understanding,
there are items in following subparts: U1(U1AD), U3(U3AC) and U4(U4AD). We
summed the scores and divided by the number of items to calculate the mean score
of each subpart, which ranged from 0 to 2. This procedure allowed us to examine a
given subject's DMC by assessing the average score for each subpart using the
original author's criteria. The score of 2 reects full comprehension, the score of
1 reects partial comprehension and 0 no comprehension. Following this concept,
for every participant, the mean scores of subpart U1, U3 and U4, and other scores of
subpart U2 and U5 were summed into a composite understanding score (maximum
composite score 10). Similarly, the scores of each subpart in other 2 sections were
summed into composite scores of appreciation and reasoning.
2.2.2. Other measures
Psychopathology was assessed using the Chinese version (Cheng et al., 1996) of
the Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987); clinical status
severity was evaluated with the Clinical Global Impression Scale (CGI)(Guy, 1976);
and cognitive function was assessed with the Chinese version of MMSE (Guo et al.,
1988). The total MMSE score is 33, which is 3 points greater than the original
version because the Chinese version added 3 questions to enhance the discriminant
validity in a population with relatively few years of education.
2.3. Procedure
The investigation was carried out in accordance with the latest version of the
Declaration of Helsinki, that the study design was reviewed by Institutional Review
Board of the Yuli Hospital and that informed consent of the participants was
obtained after the nature of the procedures had been fully explained. The study
began in Jan 2011 and was completed in June 2012. The MacCAT-CR scale was
translated into Chinese and back-translated into English. The back-translated
version was sent to the original author of the MacCAT-CR for revision. The revised
English version was translated back into Chinese for use in the current study. The
635
raters of PANSS, CGI and MMSE included a board-certied psychiatrist (BJW) and a
certied psychiatric nurse (HYY) who had reached a high standard of inter-rater
reliability (intra-class correlations ranged from 0.86 to 0.95) with the gold standard
raters from the Yuli Hospital research/training group.
Before the study began, we explained the content of this research to subjects
according to the informed consent, in which the concept of hypothetical study
about enhancing the memory was emphasized. For ensuring that all patients were
aware that the questions are related to a hypothetical study, we standardized our
instructive sentences as follows: We would like to ask your opinion about a
project which will be designed to improve people's memory. We just want to
realize what you think about this project. After the interview, we won't invite
anyone, of course, including you, to participate in any drug research like this
project. Please take it easy. During the process of interview, we repeatedly stressed
that this is just a survey about your opinion concerning this project; it is not a real
study. as necessary.
For the rating of the MacCAT-CR, 3 research assistants who had been trained to
conduct a semi-structured MacCAT-CR interview completed the interviews and
audio recordings for all patients and 30 controls. A certied psychiatrist (BJW) who
had been trained to score the MacCAT-CR completed these ratings after listening to
all the audio-recorded interview. For the validation of the MacCAT-CR, this study
adopted a method similar to a study that validated the MacCAT-CR using the
judgments of independent clinicians who specialized in DMC assessments (Kim
et al., 2007). Two certied psychiatrists (HGC and SYL) who were conducting and
designing research with the Good Clinical Practice (GCP) qualication, and who had
experience assessing DMC, served as expert judges. They assessed patients' DMC
based on the requirements of GCP in Taiwan. According to GCP, Department of
Health requires that investigators should inform subjects of content in the
informed consent as follows: the purpose of the research; how long and what
kind of treatment the subject will be expected to take part in the study; possible
risks/benets to the subject; participation is voluntary and that subjects can quit
the research at any time without penalty or loss of benets to which they are
otherwise entitled. These psychiatrists did not know how to score the MacCAT-CR.
They did not interview the subjects; rather, they were asked to listen to the audio-
recorded interview for 100 patients in the hypothetical study. They were told to
provide a categorical score using a semi-structured capacity assessment which we
dened as Brief Judgment Scale (BJS). The ratings were dened as follows: 3
represented a participant who was denitely capable of making a decision
regarding participation in clinical research; 2 represented a person who was
most likely capable; 1 denoted most likely not capable; and 0 signied
denitely not capable. Specically, if a patient received at least two 2s from
both judges, then the BJS declared them as capable of making a decision (BJS
coded as 1); otherwise, they were classied as not capable (BJS coded as 0).
2.4. Statistical analyses
2.4.1. Reliability
Internal consistency was evaluated using Cronbach's alpha coefcient. Thirty
patients were reassessed 2 weeks after the initial assessment to examine test/re-
test reliability using intra-class correlation coefcients.
2.4.2. Validity
Criterion validity was evaluated using the Pearson's correlations among the
MacCAT-CR scores and BJS scores. An exploratory factor analysis, which excluded
the subpart of expression of a choice, was conducted to test the construct validity
using a principal component analysis with varimax rotation. The KaiserMeyer
Olkin Measure and Bartlett's Test of Sphericity tested the sampling adequacy.
Factors with eigenvalues of at least 1 were retained for additional investigation. For
discriminant validity, we adopted the concept of a study that validated the MacCAT-
CR (Kim et al., 2007). Thirty controls without psychosis who were matched for
gender and age with 30 members of the patient group, were recruited from the
community. Comparisons of age, gender, and education level as well as the section
scores of the MacCAT-CR were made between the 30 controls and 30 patients.
If there was a signicant between-group difference with regard to education level,
then a general linear model was used to control this effect on the MacCAT-CR scores.
2.4.3. Correlation between MacCAT-CR and other covariates
Pearson's correlations were used for nding the relationship between scores of
MacCAT-CR and those of PANSS (positive, negative and general subscales), CGI and
MMSE. The signicance level was set at a value of 0.05 (two-tailed). SPSS version
11.5 (SPSS Inc., Chicago) was used for the statistical analyses. Pairwise deletion of
missing data was carried out in the analysis.
3. Results
3.1. Demographic data and other measured outcomes
Table 1 shows the demographic data and other measured
outcomes. The mean age was 50.2 years (S.D. 9.85). The mean
636 T.-H. Lan et al. / Psychiatry Research 210 (2013) 634640

Table 1 Table 2
Participant characteristics and demographic data. Factor analysis of patients with schizophrenia spectrum disorders.

Variables Max. Range Mean S.D. Component

scoren (N) (%)
1 2
Age (years) 26.774.5 50.18 9.85
Education (years) 316 10.39 2.97 A3 Possibility of withdrawal 0.824
Gender (male, N, %) 92 66.20 U5 Ability to withdraw 0.785
Expression of participation in study A2 Possibility of reduced benet 0.726
41 29.70 0.673
(N, %) U1 Nature of project
3.15 U3 Effects of individual care 0.664
Years of hospitalization 15.14 9.81 U4 Benets/risks/discomforts 0.653
39.70
PANSS 34116 63.03 14.96 U2 The primary purpose is research 0.636
PANSS-positive score 726 12.59 4.35 A1 No personal benet from study 0.578
PANSS-negative score 763 18.90 6.50 R2 Comparative reasoning 0.821
PANSS-general score 1752 31.55 7.59 R4 Logical consistency 0.768
MMSE score 2133 29.48 3.25 R1 Consequential reasoning 0.774
R3 Generating consequences 0.687
Understanding (sum of U1U5) 10 010 4.68 2.80
U1 Nature of project 2 02 1.06a 0.67 Note: Extraction method principal component analysis; rotation method varimax
U2 Primary purpose is for 2 02
0.82 0.80 with Kaiser normalization.
research
U3 Effects on individualized care 2 02 0.91b 0.75
U3A Placebo 2 02 1.10 0.99
U3B Randomization 2 02 0.99 1.00 of understanding, appreciation, and reasoning were 0.81 (95%
U3C Double-blind 2 02 0.65 0.93 CI 0.610.91, p 0.001), 0.73 (95% CI: 0.440.87, p 0.001), and
U4 Benets/risks/discomforts 2 02 0.93c 0.60 0.53 (95% CI: 0.020.78, p 0.001), respectively.
U4A Societal benet 2 02 0.55 0.67
2 02
With regard to the factor analysis, the KaiserMeyerOlkin
U4B Personal benet 0.52 0.78
U4C Muscle soreness 2 02 0.85 1.00 Measure was 0.88 and Bartlett's Test of Sphericity was 0.001, both
U4D Blood test 2 02 1.15 1.00 of which indicated that the sample size was sufcient for a factor
U5 Ability to withdraw 2 02 0.92 0.93 analysis. The factor analysis explained 56.5% of the total variance;
Appreciation (sum of A1A3) 6 06 1.98 2.0 specically, Components 1 and 2 contributed 42.8% and 13.6% of
A1 Object not personal benet 2 02 0.44 0.59 the variance respectively (Table 2). Regarding the sample of
A2 Possibility of reduced benet 2 02 0.76 0.90 subjects tested for discriminant validity, except for education level
A3 Withdrawal possible 2 02 0.76 0.91
(d.f.57, t 2.23, p 0.03), there were no signicant differences
Reasoning (sum of R1R4) 8 08 3.96 2.39 between controls and patients (Table 3). Thus, a general linear
R1 Consequential reasoning 2 02 0.99 0.66 model was used to control for the effect of education level on the
R2 Comparative reasoning 2 02 1.12 0.93
R3 Generating consequences 2 02 0.59 0.68
MacCAT-CR scores. Table 4 shows the mean between-group
R4 Logical consistency 2 02 1.25 0.74 differences adjusted by education level. Except for the section of
2 02
expression of a choice, there were signicant between-group
Expressing a choice 1.83 0.50
differences in 3 other section. The between-group difference effect
Note: S.D. standard deviation; PANSS Positive and Negative Syndromes Scales sizes for understanding, appreciation, reasoning ranged from
score; MMSE Mini-Mental Status Examination score 0.094 to 0.11, which according to Cohen (1988), are medium
n
The dened maximum scores in each section, subpart and item on the to large.
MacArthur Competence Assessment Tool for Clinical Research.
a
The mean of the sum of U1A, U1B,U1C and U1D.
b
The mean of the sum of U3A, U3B and U3C. 3.3. Correlation between the MacCAT-CR and other covariates
c
The mean of the sum of U4A, U4B, U4C and U4D.

Table 4 shows that the BJS scores were positively correlated

duration of hospitalization were 15.1 years (S.D. 9.81). The
majority of subjects were male patients (66.2%). A total of 111
subjects (79.9%) were diagnosed with schizophrenia, remaining
ones were diagnosed with schizoaffective disorder. Nearly two-
thirds of patients did not choose to participate in the hypothetical
clinical study (n 98, 70.3%). The reasons for refusing to partici-
pate were as follows: (1) 18 (18.3%) for I am ne. There is no need
to take part in a study like this. (2) 17 (17.3%) for I worry about
possible side-effects.(3) 17 (17.3%) for I don't want to have my
blood drawn (4) 9 (9.2%) for I don't want to take more
medicine.(5) 9 (9.2%) for I don't want to be used as a guinea
pig.(6) 6 (6.1%) for I have no time.(7) 22 (22.4%) for No
specifying any reason. Missing data were reported as follows:
2 for U4 (Benets/risks/discomforts), 1 for A1 (No personal benet
from study), 1 for positive scores and 8 for educational years.
3.2. Reliability and validity
Cronbach's alpha coefcient of the MacCAT-CR was 0.74. After
deleting the item expression of a choice, Cronbach's alpha
coefcient was 0.79. The intra-class coefcients for the sections
with scores of understanding (r 0.58, p 0.001), appreciation
(r 0.67, p 0.001) and reasoning (r 0.28, p 0.004). The scores
of understanding and appreciation were negatively correlated
with all PANSS subscales scores. However, reasoning scores were
negatively correlated with negative and general scores but not
positive scores. The MMSE scores were all positively correlated
with scores of understanding, appreciation and reasoning.
3.4. Subparts of the MacCAT-CR upon which patients performed
poorly
The subparts with the MacCAT-CR mean scores less than
1 dened as between no comprehension and partial comprehen-
sion in DMC are listed below in ascending order. A1: Object not
personal benet (mean score 0.44, S.D. 0.59); R3: Generating
consequences (mean score 0.59, S.D. 0.68); A3: Withdrawal
possible (mean score 0.72, S.D. 0.90); A2: Possibility of reduced
benet (mean score0.76, S.D. 0.91); U2: Primary purpose is
research (mean score0.82, S.D. 0.80); U3: Effects on individua-
lized care (mean score 0.91, S.D. 0.75); U5: Ability to withdraw
(mean score0.92, S.D. 0.93); U4: Benets and risks/discomforts
 T.-H. Lan et al. / Psychiatry Research 210 (2013) 634640 637

Table 3
Comparisons between patients and controls regarding MacCAT-CR scores.

a b c
Variables Control Patient Mean difference before P value before Mean difference after P value effect size after
group group adjustment adjustment adjustment adjustment

Age (years) 42.5 42.6
0.17 0.94

Gender: male 30, 50% 30, 50%
1.0
(n, %)
Education 12.5 10.5
(years) 2.02 0.03
Understanding 7.8 5.4 2.40 0.001 1.46 0.001 (0.115)
Appreciation 4.1 2.4 1.60 0.001 1.09 0.019 (0.094)
Reasoning 5.8 4.0 1.73 0.001 1.32 0.012 (0.108)
Expression of 2.0 1.9
0.03 0.313 0.04 0.27 (0.022)
a choice

Note: MacCAT-CR MacArthur Competence Assessment Tool for Clinical Research global score.
a
An independent t-test was applied for continuous variables, whereas a chi-square test was applied for categorical variables.
b
General linear regression models in which the dependent variables were the scores of understanding, reasoning, appreciation, expression of a choice, and the MacCAT-
CR global score, and the independent variables were group (i.e., controls vs. patients) and years of education.
c
Partial eta squared.

Table 4 should ask participant about the reasons why they decide to
Correlation coefcients among the MacCAT-CR score and other outcomes. participate or don't do in the study, and explore the conse-
quences related to their decisions. Further exploration revealed
BJSa P N G PANSS CGI MMSE
BJS scores were signicantly correlated with scores of R1
Understanding 0.55nn
0.19n
0.27nn
0.36nn
0.32nn
0.12 0.43nn (r 0.36, p 0.001), R2 (r 0.20, p 0.038), but not signicantly
Appreciation 0.67nn
0.17n
0.35nn
0.30nn
0.33nn
0.20n 0.33nn correlated with R3 (r 0.15, p 0.12). It indicates that researchers
Reasoning 0.28nn
0.08
0.37nn
0.18n
0.27nn
0.24nn 0.26nn
seemed to have difculties in grasping the meaning of generat-
Choice 0.12
0.10
0.20n
0.11
0.16
0.02 0.16
ing consequence, and hardly incorporate this concept into the
Note: p values were calculated using Pearson's correlation analysis. assessment of DMC.
BJS Brief Judgment Score; a analyzed by data set of 100 subjects; MacCAT- With regard to construct validity, the exploratory factor analysis
CR MacArthur Competence Assessment Tool for Clinical Research global score; conrmed the presence of 2 components. Component 1 included all
PANSS Positive and Negative Syndromes Scale score; P PANSS positive score;
subparts of understanding and appreciation, Component 2 included
N PANSS negative score; G PANSS general score; MMSE Mini-Mental Status
Examination score; CGI Clinical Global Impression score. all subparts of reasoning. The fact that the content of some subparts
n
po 0.05. of appreciation corresponds with some of understanding might
nn
p o0.01. partially explain this bi-component model. Specically, U3: Effects
on individualized care corresponds with A2: Possibility of reduced
benet; U2: Primary purpose is research corresponds with A1:
(mean score 0.93, S.D. 0.60); and R1: Consequential reasoning Object not personal benet; and U5: Ability to withdraw
(mean score 0.99, S.D. 0.66). corresponds with A3: Withdrawal possible.

4.2. Correlation between DMC and other covariates

4. Discussion
4.1. Validity and reliability
Our study, which recruited these patients from a hospital-
based therapeutic community, revealed adequate inter-rater and
testretest reliabilities. In addition, the Chinese version, which
discriminates the MacCAT-CR section scores of patients from
controls, indicated a fair discriminant validity. This nding
matches those of previous studies (Jeste et al., 2006).
Regarding expert judgment, the moderate correlation between
the MacCAT-CR section scores and the DMC level via the BJS
revealed a robust criterion validity. The value of correlation
coefcient between BJS and understanding/appreciation were
higher than 0.5; however, the value between BJS and reasoning
was only 0.28. It might reect the fact that clinical investigators
view the concept of understanding and appreciation in the
MacCAT-CR as much more compatible with their experience of
assessing DMC than that of reasoning. This nding is well-
matched with the GCP guideline in Taiwan which asks clinical
researchers to inform the participants of nature of project, effect
on individualized cares, benets/risks and ability to withdraw. The
above disclosure is highly associated with the concept of under-
standing and appreciation but not with that of reasoning in the
MacCAT-CR. Moreover, GCP dose not require that researchers
The scores of understanding, appreciation and reasoning had
negative correlations with the PANSS negative subscales. Speci-
cally, the level of negative symptoms in patients with schizophre-
nia or schizoaffective disorder was associated with patient DMC
regarding consent. The general subscale score was also negatively
correlated with scores of appreciation and understanding. This
nding is compatible with those of previous studies (Moser et al.,
2002; Stroup et al., 2005). However, these studies did not nd a
signicant correlation between DMC level and positive symptoms
of schizophrenia; therefore, negative symptoms had a greater
affect on DMC than positive symptoms. In contrast, our study
showed that positive subscale scores were negatively correlated
with levels of understanding and appreciation, and this nding is
consistent with a study that found the psychoticism scores of the
Brief Psychotic Rating Scales were also negatively correlated with
scores of understanding and appreciation (Kovnick et al., 2003).
Our inpatients might have been similar to the participants in the
aforementioned study (Kovnick et al., 2003); nonetheless, both
inpatients and outpatients comprised the participant groups of
other studies (Moser et al., 2002; Stroup et al., 2005). Additionally,
we found DMC was negatively correlated with general subscale
scores. The score of one item of the general subscale, G12: Lack of
Judgment and Insight, was signicantly negatively correlated
with scores of understanding (r
0.29, p 0.001), appreciation
638 T.-H. Lan et al. / Psychiatry Research 210 (2013) 634640
(r
0.23, p 0.006) and reasoning (r
0.19, p 0.026). This
nding suggests an association between the competence of
consent to research and insight of the mental illness, which is
compatible with studies that found schizophrenic patients with
poorer insight of mental illness, have more impaired competence
of consent to treatment (Capdevielle et al., 2009; Ruissen et al.,
2012). Nonetheless, our nding is different from a study which
revealed no signicant correlation between MacCAT-CR scores and
insight (Palmer and Jeste, 2006). Possible explanations for the
discrepancies between this study and ours, respectively, could be
the source of patients (mostly outpatients vs. all inpatients),
severity of psychopathology (mean PANSS scores: 58 vs. 63), and
rating instrument of insight (Birchwood Insight Scale Total vs.
PANSS-G12).
Our study found a positive correlation between the MMSE and
MacCAT-CR scores, which matches the ndings of prior studies
that found cognitive function is associated with DMC (Dunn et al.,
2007; Stroup et al., 2005). Our nding is compatible with a study
showed that cognitive function is the primary predictor of DMC
with regard to consent to clinical research (Palmer and Jeste,
2006). These ndings indicate that cognitive decits has a negative
impact on the decisional capacity of patients with schizophrenia
spectrum disorders concerning their participation in clinical trials
or cooperating with as it relates to their rights, interests, risks and
benets. It is important to clarify here is, we do not mean that the
MacCAT-CR should not be used in special groups of patients with
impaired cognition. On the contrary, the MacCAT-CR, which is a
useful scale especially to differentiate between who are compe-
tent to consent to research and those who are not, is sensitive to
detect the poor performance of DMC in patients with impaired
cognition. For those who have cognitive decits with poor DMC
identied by the MacCAT-CR, re-explanations and interactive
consent process are extremely necessary to enhance patients'
understanding and may reduce many misunderstandings (Palmer
and Jeste, 2006).
On the other hand, the concept of competence does not seem
applicable to all illnesses in the same way. In fact, some studies
criticized the MacCAT-CR for overstressing the importance of
cognitive function as the major determinant of DMC and over-
looking other factors, such as affective components (Berghmans
and Widdershoven, 2003), emotions (Charland, 1998) and
healthcare-related values (Karel et al., 2010), which possibly play
a more signicant role than cognitive function in DMC among
patients with non-psychotic disorders, such as anorexia nervosa
(Tan et al., 2006) or dementia (Karel et al., 2010). Some researchers
argued that there might be more dimensions of DMC than the
4 sections dened in the MacCAT-CR (Tan et al., 2006; Tan et al.,
2003). A better exploration of the concept of DMC in patients with
a variety of psychiatric diagnoses is needed in future research.
4.3. Subparts and items of the MacCAT-CR upon which patients
perform poorly
We found participants did not sufciently understand the
following core concepts: (1) A1: Object not personal benet;
(2) A2: Possibility of reduced benet (3) U5 and A3: Participants
have the right to refuse to participate or withdraw from the
research. Interestingly, among these subparts, the lowest mean
score was the A1: Object not personal benet. When we asked
Do you believed that you have been asked to be in this study
primarily for your personal benet? Is it the most important
purpose for asking you to participate in this research?, only 5%
of patients (7/139) answered correctly. This result was compatible
with those of other items: U4B: Personal benet (mean
score0.52, S.D. 0.78) and U4A: Societal benet (mean
score0.55, S.D. 0.67). Many patients believed that their doctors
would surely give the new effective medicine to benet them.
These ndings are consistent with the result of a study focusing on
exploring the therapeutic misconception in 87 schizophrenic
patents invited to participate in a hypothetical clinical research
(Dunn et al., 2006). In that study, researchers used Therapeutic
Misconception Scale to ask every subject 6 questions about their
understanding of clinical research. The question with the lowest
percentage of being answered correctly (51.7%) was that In this
study, I will certainly get a medication that is designed to improve
my condition (False). All these ndings indicate a very great
percentage of schizophrenic patients present with therapeutic
misconception about obtaining personal benets in a clinical
study, which is worthy to be fully made clear in the process of
informed consent. Additionally, items of understanding that
scored less than 1 point were worth noting: U3C: Double blind
(mean score0.65, S.D. 0.93) and U3B: Randomized assignment
(mean score 0.99, S.D. 1.0). With regard to double-blind design,
numerous participants thought that their doctors were aware of
the nature of the medication and confused routine treatments
with clinical trials. For randomization, many believed they would
receive novel medication. Finally, 2 subparts of reasoning were
with mean scores less than 1: R1: Consequential reasoning and R3:
Generating consequences. Most of those who chose to deny
participating in this research were unable to provide a conse-
quence that might affect their daily lives with regard to the
benets and risks/discomforts of participation in clinical research.
The misconception of getting personal benet from the clinical
study, which is evidenced by lower scores of specic items or
subparts (e.g., top 3 of the lowest mean scores in our study: A1:
Object not personal benet, U4A: Societal benet and U4B:
Personal benet), were particularly worth noting for researchers
to make more detailed explanation while recruiting patients to
participate in clinical studies. It is important to clarify these core
concepts via repeated explanation, specic tools, e.g., a computer-
ized slideshow (Dunn et al., 2002) or a multimedia consent
procedure augmented with video presentation (Jeste et al., 2009).
4.4. Cultural difference and decisional making
Cultural values serves as an important factor in making medical
decision across ethnicities and races (Kagawa-Singer et al., 1997;
Tam Ashing et al., 2003). There are important cultural differences
between countries in East Asia including China and the western
societies, such as USA where the MacCAT-CR was developed and
tested. The fact that there is a lack of clinical studies using
translated version of MacCAT-CR in countries in East Asia till
now might partly reect cultural differences on the view of
competence assessment in psychiatric patients. For instance,
Chinese particularly are considered to have stronger familial
connections than westerners, and families may play a key role in
making medical decisions in Chinese society (Kim et al., 1999).
Chinese also view collectivism more important than individualism
for subjective well-being (Cheung and Leung, 2007), which may
have an impact on DMC. Moreover, the stigma of psychiatric
disorders, which has an association with patients' cognitive insight
of their illness, varies across cultures (Grifths et al., 2006; Ng,
1997; Turvey et al., 2012). As we mentioned before, in our studies,
there was an association between the insight of mental illness and
DMC. Thus, all these cultural factors might have an effect on the
assessment of DMC among Chinese patients with schizophrenia
spectrum disorders. However, based on the available data, a clear
understanding of the cultural difference involved in the effects on
DMC is still lacking. Future studies are needed to explore this issue
in more detail.
 T.-H. Lan et al. / Psychiatry Research 210 (2013) 634640
4.5. Strength and limitation
The strength of this study is that it the rst one which
validated the Chinese version of MacCAT-CR. As we know, it is
also the rst exploratory factor analysis of the MacCAT-CR. In
addition, we conducted a survey which enrolled a large sample
size of long-term hospitalized patients to determine which parts
of DMC were poorly performed. Finally, using the BJS to obtain
DMC levels for each participant might adjust the outcome
inconsistencies between the experts and offer relatively credible
data for validation. There are some limitations of this study. First,
all of the patients were from one medical center, and all the
ndings may be generalized only to similar populations (e.g.,
stable institutionalized patients with schizophrenia spectrum
disorders who are predominantly males). Second, in our study,
the value of correlation coefcient between psychopathology and
MacCAT-CR sections were all below 0.5, which indicates a mild to
moderate correlation between these 2 factors. This result might
be due to that our subjects were all stable patients whose
psychotic symptoms were less severe than those who were in
acute relapse. In other words, compared with patients in our
study, those who are with acute psychosis, correlations between
symptoms and DMC are possibly stronger. For patients with an
acute psychotic episode who are eligible for studies regarding
acute treatment of their symptoms, the association between
psychopathology and DMC still needs to be explored and
validated in further research. At last, as many studies have done,
we used a hypothetical study (Jeste et al., 2009; Kovnick et al.,
2003); however, this procedure differs from previous studies in
which most participants were included in an actual clinical trial
(Kim et al., 2007; Stroup et al., 2005). Patients who participate in
an actual, ongoing study might pay much more attention to the
disclosure of content and provide more accurate information
than they did in our hypothetical study.
In summary, these ndings suggest that the Chinese version
of the MacCAT-CR is a reliable and valid instrument to assess
DMC of stable patients with schizophrenia spectrum disorders
regarding participation in clinical research. Some specic parts
of the MacCAT-CR are more difcult for patients with impaired
DMC to comprehend (e.g., benets to the population and
individual, double-blind design, randomization). Using this vali-
dated Chinese version of the MacCAT-CR, we hope clinicians and
investigators can single out and monitor individuals at high risk
of poor DMC, e.g., patients with impaired cognitive function,
prominent psychotic symptoms or poor insight. Consequently,
we can develop proper strategies to guard best interests for
the patients with schizophrenia spectrum disorders in the near
future.
Appendix. Content of the hypothetical study and MacCAT-CR
Understanding
U1 Nature of project
U2 Primary purpose is for research
U3 Effects on individualized care
(a) Placebo
(b) Randomization
(c) Double blind
U4 Benets/Risks/discomforts
(a) Societal benet
(b) Personal benet
(c) Muscle soreness
(d) Blood checking
639
U5 Ability to withdraw
Appreciation
A1 Object not personal benet
A2 Possibility of reduced benet
A3 Withdrawal possible
Reasoning
R1 Consequential reasoning
R2 Comparative reasoning
R3 Generating consequences
R4 Logical consistency
Expressing a choice
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