Psychiatry Research 246 (2016) 303307

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

Chinese version of the Psychotropic-related Sexual Dysfunction

Questionnaire (PRSexDQ -SALSEX): Validity and reliability for
crossmark
schizophrenic patients taking antipsychotics

Yu-Xi Wanga, Ping Zhangb, Li-Min Xinc, Lin Chenc, Yan-Hong Liuc, Yun-Ai Sua, , Tian-Mei Sia,
a
National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital/ Institute of Mental Health), and the Key Laboratory of Mental
Health, Ministry of Health (Peking University), Beijing, China
b
Hebei Mental Health Center, Baoding, Hebei Province, China
c
Beijing Hui-Long-Guan Hospital,Peking University, Beijing, China

A R T I C L E I N F O A BS T RAC T

Keywords: This study was designed to examine the validity and reliability of the Chinese version of the Psychotropic-
Questionnaire Related Sexual Dysfunction Questionnaire (PRSexDQ-SALSEX) in patients with schizophrenia taking anti-
Reliability psychotics. It was conducted in a sample of 135 patients aged between 18 and 50 years old and diagnosed with
Validity schizophrenia. Demographic data and clinical features were assessed with PRSexDQ, the Positive and Negative
Sexual dysfunction
Syndrome Scale (PANSS), the Clinical Global Impression (CGI), and the Udvalg for Kliniske Undersgelser
Antipsychotics
(UKU) Side Eects Rating Scale. The internal consistency of the Chinese version of PRSexDQ using Cronbach's
was 0.902. The test-retest and inter rater reliability was both high with p < 0.001. PRSexDQ was correlated
with corresponding items in the UKU Side Eects Rating Scale (Items 4.124.16), and showed good sensitivity,
specicity, positive and negative predictive value. It could also clearly detect dierences in SD rates of three
monotherapy groups: patients treated with risperidone had the highest scores, followed by patients treated with
olanzapine, whereas patients treated with aripiprazole had the lowest scores. The Chinese version of PRSexDQ
is a reliable and valid instrument to assess patients with schizophrenia. Assessed by PRSexDQ, 53.2% of total
subjects in our study reported symptoms of SD.

1. Introduction (Baggaley, 2008). Rate of SD was obtained by Macdonald

Disturbance in any of the phases of sexual behaviorinterest
(libido), arousal (erection, vaginal lubrication), ejaculation and or-
gasmis considered sexual dysfunction (SD), which is common in
patients with schizophrenia and may be related to the mental disorder
itself (e.g., negative symptoms, decreased initiative, and motivation),
psychosocial factors, general medical conditions or the use of psycho-
tropic medications (de Boer et al., 2015). Although multiple factors
interact, antipsychotics play an important part and can aect all phases
of sexual behavior (La Torre et al., 2013). SD impacts not only
compliance with treatment but also the quality of life of patients
(Olfson et al., 2005; Rosenberg et al., 2003).
Studies have demonstrated a high and variable prevalence of SD
among patients taking antipsychotics due to dierent methodologies.
In western countries, Baggaley found that SD occurred in 3080% of
female patients and 4580% of male patients with schizophrenia
(Macdonald et al., 2003), at 82% in male patients and 96% in female
patients, whereas Montejo exhibited SD rate of 50% for male and 37%
for female. Comparatively, data in Asian countries is quite limited. Hui
revealed 13.4% of Chinese patients with rst episode of schizophrenia
in Hong Kong area had SD (Hui et al., 2013). And among Japanese
patients with schizophrenia and on antipsychotics, Fujii reported
59.3% for male and 49.1% for female (Fujii et al., 2010). However,
SD rate in REAP study across Asia (record as presence or not) showed
as low as 3% (Xiang et al., 2011). One of the major factors contributing
to the variation of SD rates in dierent studies is whether the doctor
asks the patient about SD directly. Studies that rely on the spontaneous
reporting of side eects often reveal lower rates of SD, whereas studies
using structured interviews or questionnaires obtain considerably
higher rates (Serretti and Chiesa, 2011a, b). Meanwhile, choice of
dierent instrument could also result in variety (Nebhinani et al.,
2012).

Correspondence to: National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital/ Institute of Mental Health), and the Key Laboratory of Mental Health,
Ministry of Health (Peking University), Beijing 100191, China.
E-mail addresses: suyunai@163.com (Y.-A. Su), si.tian-mei@163.com (T.-M. Si).

http://dx.doi.org/10.1016/j.psychres.2016.05.063
Received 16 November 2015; Received in revised form 23 May 2016; Accepted 24 May 2016
Available online 30 September 2016
0165-1781/ 2016 Elsevier Ireland Ltd. All rights reserved.
Y.-X. Wang et al.
However, sexual disturbance is highly neglected and underrecog-
nized in clinical practice, particularly in Asian countries because Asian
people are more conservative in sex due to sociocultural factors
(Meston and Ahrold, 2010). Both doctors and patients are embarrassed
to talk about sexuality, so patients rarely report the sexual impairment
spontaneously and doctors do not asks questions about sexual side
eects regularly (de Boer et al., 2015). The large discrepancy in SD
rates between studies that rely on spontaneous report and those with
structured queries should not be ignored. Hence, a reliable, valid and
easy-to-use instrument for investigating SD rates in Chinese patients
with schizophrenia is urgently needed.
To date, the instruments that can evaluate psychotropic-induced SD
and available in Mandarin are the Arizona Sexual Experience Scale
(ASEX) and the Udvalg for Kliniske Undersgelser (UKU) Side Eects
Rating Scale. ASEX is a SD-specialized questionnaire comprised of ve
dimensions of sexual function on a scale ranging from hyperfunction
(1) to hypofunction (6). A subject would be regarded as SD if he or she
has a total ASEX score of 19, scores any one item with a score of 5,
or scores any three items with a score of 4 (A. McGahuey, 2000). This
scale showed adequate psychometric assessment properties in the US;
however, the Chinese version only went through preliminary reliability
and validity assessments in male patients with schizophrenia reported
in a conference abstract collection (Zhu et al., 2012), and no published
data could be found. The widely used clinical UKU Side Eects Rating
Scale also includes items concerning SD: ve for men and four for
women, scored from 0 (normal) to 3 (severe). Although it covers the
major dimensions of SD, it is not a specic questionnaire (Lingjaerde
et al., 1987).
PRSexDQ-SALSEX is a brief and clinician-administered question-
naire that includes seven questions in total. Questions A and B are
screening items to assess whether the patient had noticed changes in
sexual function since pharmacotherapy or during the last four weeks
and reported spontaneously. Items 3-7 are questions evaluating ve
dimensions of SD on a scale of 03: loss of libido, delayed orgasm or
ejaculation, lack of orgasm or ejaculation, erectile dysfunction in men/
vaginal lubrication dysfunction in women, and patient's tolerance of
SD. These items comprise the total score of PRSexDQ-SALSEX, which
ranges from 0 to 15. The original version of the questionnaire
demonstrated adequate psychometric properties in patients with
depression (Montejo et al., 2000). PRSexDQ also revealed feasibility,
good internal reliability, satisfactory validity and sensitivity to changes
in sexual function in patients with schizophrenia and other psychotic
disorders (Montejo and Rico-Villademoros, 2008). Compared to ASEX,
PRSexDQ covered all stages of sexual function and focused on changed
related to medication which made it more preferable (de Boer et al.,
2014).
The aim of this study was to test the validity and reliability of the
Chinese version of PRSexDQ-SALSEX in patients with schizophrenia
taking antipsychotics and to provide a reliable instrument for clinical
screening and assessment.
2. Methods
2.1. Subjects
This is a multicenter cross-sectional study conducted by 10
evaluators at three sites (Peking University Sixth Hospital, Beijing
Hui-Long-Guan Hospital and the Hebei mental health center). Half of
evaluators were in charge of the eligibility screening, recorded medica-
tion and clinical information, as well as CGI- I and PANSS. The other
ve evaluators mainly assessed sexual side eects- including CGI- SF,
UKU and PRSexDQ. All of the evaluators were trained psychiatrists
who worked in included sites and went through the consensus meeting
before recruitment. During a one-month period, all patients inter-
viewed by evaluators, diagnosed with schizophrenia and on antipsy-
chotics were screened consecutively for eligibility. The inclusion
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Psychiatry Research 246 (2016) 303307
criteria were as follows: a. age between 18 and 50 years old; b. married
or have regular sexual behaviors; c. diagnosed of schizophrenia
according to ICD-10 or DSM-IV; d. continuous antipsychotic medica-
tion over 4 weeks; and e. capacity to understand the aims of the study
and provide written informed consent. The exclusion criteria were as
follows: a. general medical conditions that may aect the sexual
function (i.e., cardiovascular diseases, endocrine disorders, hyperlipi-
daemia, urogenital diseases); b. drugs known for sexual eects, such as
antihypertensive, H2 receptor blocker; c. substance abuse, including
heavy smoking (over 20 cigarettes per day) and alcohol addiction; and
d. acute depressive state or taking antidepressants.
2.2. Assessment packet
Basic socio-demographic and clinical characteristics were collected
by a self-designed form, including age, gender, literacy, state of social
function, substance use and general medicine conditions. Information
on prescribed medication and doses for the past 4 weeks was recorded
as well.
PRSexDQ was the target questionnaire, and the UKU Side Eects
Rating Scale was used as a gold standard in the study. Among items of
UKU, item 4.12 diminished sexual desire, item 4.14 ejaculatory
dysfunction, 4.15 orgasmic dysfunction, 4.13 erectile dysfunction for
male (4.16 dry vagina for female), and overall disturbance caused by
side eects were applied and corresponded to PRSexDQ item 37. The
Positive and Negative Syndrome Scale (PANSS) was used to evaluate
the main type of symptoms and to rate the severity of schizophrenia
(Kay et al., 1987). In addition, the Clinical Global Impression-Severity
(CGI-S) and Clinical Global Impression-Sexual Function (CGI-SF) was
applied in the survey to evaluate the general state of the illness and
sexual function. Both have only one question and range in score from 1
(normal) to 7 (most severely ill).
2.3. Procedures
Authorized by the original authors, the questionnaire was trans-
lated from English into Chinese and back-translated to guarantee the
accuracy in language. The study was also approved by the independent
ethics committee or institutional review board of each study site.
All participants were assessed at their initial entry to assess internal
reliability. Then part of participants underwent a re-test by a dierent
rater 57 days later to analyze the test-retest reliability. In addition,
extra ve cases were assessed by ve raters simultaneously to test inter
rater reliability. Besides, to examine convergent validity, the items of
PRSexDQ were compared to equivalent questions in the UKU Side
Eects Rating Scale, and its total score was compared to CGI-SF. Using
the UKU scale as a reference, the sensitivity, specicity, positive and
negative predictive value (PPV and NPV) were measured to determine
the performance of PRSexDQ in diagnosing SD. Furthermore, as
preliminary application of the questionnaire, the SD rates were
calculated and compared within three groups of monotherapy anti-
psychotic (olanzapine, risperidone and aripiprazole) in order to test its
capacity to elicit dierences.
2.4. Statistical analysis
The data were statistically analyzed by the Statistical Package for
the Social Sciences (SPSS), version 20.0 (SPSS Inc., Chicago, IL, USA).
The demographic and clinical characteristics were presented descrip-
tively using the mean and standard deviation for continuous variables
and the frequency and percentage for categorical variables. The
internal reliability was assessed by Cronbach's alpha analysis. Test-
retest reliability and inter rater reliability were measured via the
intraclass correlation coecient (ICC). Bivariate correlation was used
to compare scores on single items between the test and retest, as well as
between PRSexDQ and the gold standard. In addition, a comparison of
Y.-X. Wang et al. Psychiatry Research 246 (2016) 303307

SD rates between groups was conducted by a chi-square test, whereas
the total scores of PRSexDQ, CGI-S and CGI-SF were compared by a
non-parametric Kruskal-Wallis test.
3. Results
3.1. Demographic and clinical characteristics
In total, 179 patients were eligible during the assessment period,
and 44 of them refused to participate. Cases unnished or with key
information missing were deleted. A sample of 126 valid cases counted
in analysis. Among them, we assigned 80 patients to another interview
57 days after the initial assessment; 74 participants completed the re-
test. Additional ve cases were assessed by ve raters simultaneously.
The majority of the participants were males (68.3%), and the
average age was 33.32 7.79 years old. Among all, 71.4% of the
patients were married and 29.4% smoked (all of them smoked less
than 20 cigarettes per day). The demographic details are provided in
Table 1. All participants scored an average of 3.90 1.18 on CGI-S and
62.58 16.05 on PANSS. There were 94 patients (74.6%) taking
antipsychotic monotherapy, among which olanzapine, risperidone
and aripiprazole were the three most frequently used drugs.
3.2. Reliability
The results from the Cronbach's alpha analysis (alpha=0.902)
indicated that PRSexDQ-SALSEX demonstrated excellent internal
consistency in schizophrenia. Items were highly correlated with the
total (p < 0.001). The mean value and Cronbach's alpha coecient with
the item deleted are provided in Table 2. The questionnaire revealed
strong test-retest reliability (ICC=0.907, 95% CI: 0.8720.936, p <
0.001). The correlation between the test and retest was also excellent (
Table 3, p < 0.001 for all items). In addition, it proved excellent inter-
raters reliability by comparing between ve raters scores (ICC=0.924,
95% CI: 0.8770.957, p < 0.001).
3.3. Validity
The results showed that items 36 were highly correlated (p <
0.001), whereas item 7 of the UKU Side Eects Rating Scale had a
lower correlation coecient of 0.271 (p < 0.01) (Table 3). The total
score of PRSexDQ had a perfect correlation with CGI-SF. In addition,
the sensitivity and specicity of PRSexDQ in identifying SD were 0.94
and 0.93, respectively, whereas the PPV and PNV were 0.87 and 0.93,
respectively.
alpha=0.902) was satisfactory, Item 36 were highly correlated to
the total. In contrast, item 7 was an exception and will be discussed
further below. Moreover, the test-retest and inter-rater reliability were
both excellent.
The high correlation between the total scores of PRSexDQ and CGI-
SF revealed the validity of PRSexDQ in assessing SD severity. The PPV,
NPV, sensitivity and specicity all suggested its excellent performance
in diagnosis. For the individual items, items 36 covered four dimen-
sions of sexual function and showed a perfect correlation with the
corresponding items in UKU. Nevertheless, the correlation of item 7
was inferior due to mismatching in content (UKU assesses the
disturbance of all side eects other than SD), although it was still
acceptable (p < 0.01).
Item 7 involves the patient and his/her spouse's tolerance toward
SD, which could be subjective. It had the lowest correlation with the
whole questionnaire and a higher Cronbach's alpha coecient would
be obtained if deleted. Moreover, item 7 does not have weight in the SD
assessment (if any item in items 36 obtains a score over 1, the patient
has SD). However, item 7 still counts in the total score and is an
indispensable part of the questionnaire because it measures the
disturbance that SD causes on relationship and whether the patient
would discontinue medication due to SD. Comparing to the last
question of the analogous questionnaire ASEX (Are your orgasms
satisfying? ), item 7 focuses more on drug compliance, which is a key
problem in treatment (A. McGahuey, 2000). However, the results of
item 7 showed that only 3% (1.6% out of 53.2%) of patients with SD
symptoms thought SD was a crucial disturbance and considered
discontinuing treatment, whereas 47.7 (25.4% out of 53.2%)of them
considered SD to be bothersome but would not interfere with medica-
tion. The percentage of poor tolerance was much lower than reported
by Montejo, using same questionnaire (Montejo et al., 2010). But
similarly, a survey in India found that 91.7% of patients with schizo-
phrenia reported good to fair tolerance to sexual side eects according
to PRSexDQ, whereas 60% experienced SD and over one third
attributed SD to medications (Tharoor et al., 2015). This discrepancy
is an interesting phenomenon, still no solid evidence at present can
explain the gap. Stigma of SD may be present, and thus, patients may
not report it when present. Furthermore, Asian people's conservative
attitude and fewer demands toward sex (Okazaki, 2002) may also be
contributing factors, but further studies are necessary.
Moreover, question A (Item 1) screens whether the patient has
noticed changes in sexual function since pharmacotherapy.
Table 1
Demographic and clinical data.

3.4. Sexual function Mean SD

The assessment of sexual function using CGI-SF and PRSexDQ- Age (y) 33.32 7.79
SALSEX pointed a mean score of 2.14 1.40 and 3.05 3.89, respec- CGI-S 3.90 1.18
PANSS 62.58 16.05
tively. The total average score of UKU was 6.90 5.32. The SD rate CGI-SF 2.14 1.40
among all participants was 53.2% (67/126) assessed by PRSexDQ (any PRSexDQ SELSEX 3.05 3.89
item in items 37 scored over 1 point) and 49.2% (62/126) by UKU. In UKU 6.90 5.32
contrast to the high positive rate, patients who reported spontaneously N=126 %
Male 86 68.3
only accounted for 8.7% of the entire sample. The detailed PRSexDQ
Smoking( < 20/d) 37 29.4
scores of each item are shown in Table 4. Marital State Unmarried 29 23.0
For patients with monopharmacy therapy, the three most fre- Married 90 71.4
quently used drugs among valid cases were compared: the olanzapine, Divorced 7 5.6
risperidone, and aripiprazole groups had SD rates of 50%, 84.2%, and Education background (missing Primary school or below 31 24.6
data in 4 cases) Middle school 60 47.6
12.5%, respectively (p < 0.001). Their total scores in PRSexDQ and College or above 31 24.6
CGI-SF also revealed signicant dierences, whereas illness severity Social State (missing data in 3 Out of work/school 48 38.1
showed no dierences (Table 5). cases) Partly working/studying 38 30.2
Full-time working/ 37 29.4
studying
4. Discussion
Antipsychotic Medication Monopharmacy 94 74.6
Polypharmacy 32 25.4
According to the results, the internal reliability (Cronbach's

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Table 2
Internal consistency of PRSexDQ.

Mean Value with item deleted Item-total correlation Cronbach's alpha with item deleted

Item 3: Loss of libido 2.29 0.816** 0.867

Item 4 Delayed ejaculation/orgasm 2.56 0.803** 0.870
Item 5 Lack of ejaculation/orgasm 2.51 0.824** 0.865
Item 6 Erectile/vaginal lubrication dysfunction 2.53 0.745** 0.884
Item 7 Patients tolerance of SD 2.30 0.603** 0.912

**
p < 0.001

Table 3 to Question A reported the changes even they had already observed the
Test-retest reliability and convergent validity: bivariate correlation of items. abnormality. The low spontaneous report rate again demonstrates the
importance of having a reliable assessing instrument and of assessing
Test-retest Test-Retest Convergent Item-Gold
Reliability Correlation Validity Standard
the sexual function regularly to detect potential disturbances.
Correlation Previous evidence has proven the signicant dierences on sexual
impairment between aripiprazole, olanzapine and risperidone. The
Item 3 0.753** Item 3 - UKU 4.12 0.851** majority of opinion is that risperidone is most likely to cause
Item 4 0.625** Item 4 - UKU 4.14 0.440**
Item 5 0.892** Item 5 - UKU 4.15 0.439**
hyperprolactinemia and has the highest rate of SD side eect (60
Item 6 0.731** Item 6 - UKU 4.13 0.637**(Male) 70%) among atypical antipsychotics (Dossenbach et al., 2004; Liu-
(Male) Seifert et al., 2009). Specically, risperidone cast more severe impacts
- UKU 0.903**(Female) on sexual function than olanzapine (Knegtering et al., 2006). In
4.16(Female)
contrast, aripiprazole, belonging to the relatively low SD rate group
Item 7 0.819** Item 7 - UKU 0.271*
overall disturbance (Serretti and Chiesa, 2011a), was proved to lower the elevated prolactin
Total 0.825** Total - CGI-SF 0.907** level caused by other APs in many studies (Byerly et al., 2009; Chen
et al., 2015). The scale here clearly distinguished the three drugs
**
p < 0.001 eects on sexual function, which indicated its further capability to
*
p < 0.01
detect dierences between diverse populations.
There are limitations to this study. It was a cross-sectional, open-
Table 4
label study and had no control group data among public population.
Results of sexual function assessed by PRSexDQ.
Although raters underwent standard training, bias still exists inevitably
Yes % due to the open label design as well as subjective impression during
rating process. And for assessment of inter rater reliability, result will
Item1: Awareness of 43 34.1%
be more convincing if a larger sample involved. Also we did not include
changes
Item2: Report 11 8.7%
assessment of the baseline when patients were not taking antipsycho-
spontaneously tics. Furthermore, we did not perform a follow-up evaluation to
0 % 1 % 2 % 3 % demonstrate the sensitivity of changes. Another caveat is the unba-
Item 3: Loss of libido 67 53.2% 37 29.4% 8 6.3% 14 11.1% lanced gender ratio: male participants were twice as prevalent in the
Item 4 Delayed 92 73.0% 16 12.7% 8 6.3% 10 7.9%
sample compared to female participants. This unbalanced ratio was
ejaculation/orgasm
Item 5 Lack of 87 69.0% 21 16.7% 7 5.6% 11 8.7% because some females were reluctant to talk about sexuality due to
ejaculation/orgasm embarrassment (Brotto et al., 2005). In contrast, male patients were
Item 6 Erectile/vaginal 82 65.1% 29 23.0% 9 7.1% 6 4.8% more willing to talk about sexuality. Sociocultural factors in China may
lubrication also be involved. Furthermore, to a certain extent, sexuality is still a
dysfunction
Item 7 Patients 68 54.0% 24 19.0% 32 25.4% 2 1.6%
forbidden topic in public discussion, particularly for women.
tolerance of the
sexual dysfunction 5. Conclusions

The Chinese version of PRSexDQ-SALSEX is a brief and semi-

Table 5
Comparison between olanzapine, risperidone, aripiprazole. structured instrument with good psychometric properties in patients
with schizophrenia. It focuses on psychotropic-induced SD, and the
Olanzapine Risperidone Aripiprazole Statistic assessment process is rapid because it only includes 7 items.

N=32 N=19 N=16 p

Conict of interest
SD Rate 16 50.0% 16 84.2% 2 12.5% < 0.001
Mean SD Mean SD Mean SD
None.
PRSexDQ 2.63 3.42 5.32 4.38 0.50 1.55 < 0.001
CGI-SF 1.91 1.06 2.89 1.45 1.25 0.68 < 0.001
CGI-S 3.94 1.27 4.11 1.15 4.06 1.44 0.897 Role of funding source

This study was supported by National Key Technologies R & D

Approximately 34.1% of patients answered yes to this question, which
Program of China (No. 2015BAI13B01).
is considerably lower than the SD rate assessed by PRSexDQ. This
discrepancy could be explained by the fact that some participants had
sexual impairment before taking medicine or a portion of the patients Acknowledgements
paid little attention to sexual changes. In addition, the results of
question B indicated that less than a quarter of those who answered Yes We would like to thank Prof. Angel L. Montejo and his team, the
original authors of the PRSexDQ-SALSEX who authorized us to

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translate and apply the questionnaire and provided powerful support
during the procedure. Also we would like to thank all the participants
and evaluators who took part in the study.
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