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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


(Macdonald et al., 2003), at 82% in male patients and 96% in female
Disturbance in any of the phases of sexual behaviorinterest patients, whereas Montejo exhibited SD rate of 50% for male and 37%
(libido), arousal (erection, vaginal lubrication), ejaculation and or- for female. Comparatively, data in Asian countries is quite limited. Hui
gasmis considered sexual dysfunction (SD), which is common in revealed 13.4% of Chinese patients with rst episode of schizophrenia
patients with schizophrenia and may be related to the mental disorder in Hong Kong area had SD (Hui et al., 2013). And among Japanese
itself (e.g., negative symptoms, decreased initiative, and motivation), patients with schizophrenia and on antipsychotics, Fujii reported
psychosocial factors, general medical conditions or the use of psycho- 59.3% for male and 49.1% for female (Fujii et al., 2010). However,
tropic medications (de Boer et al., 2015). Although multiple factors SD rate in REAP study across Asia (record as presence or not) showed
interact, antipsychotics play an important part and can aect all phases as low as 3% (Xiang et al., 2011). One of the major factors contributing
of sexual behavior (La Torre et al., 2013). SD impacts not only to the variation of SD rates in dierent studies is whether the doctor
compliance with treatment but also the quality of life of patients asks the patient about SD directly. Studies that rely on the spontaneous
(Olfson et al., 2005; Rosenberg et al., 2003). reporting of side eects often reveal lower rates of SD, whereas studies
Studies have demonstrated a high and variable prevalence of SD using structured interviews or questionnaires obtain considerably
among patients taking antipsychotics due to dierent methodologies. higher rates (Serretti and Chiesa, 2011a, b). Meanwhile, choice of
In western countries, Baggaley found that SD occurred in 3080% of dierent instrument could also result in variety (Nebhinani et al.,
female patients and 4580% of male patients with schizophrenia 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. Psychiatry Research 246 (2016) 303307

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

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Y.-X. Wang et al. Psychiatry Research 246 (2016) 303307

SD rates between groups was conducted by a chi-square test, whereas alpha=0.902) was satisfactory, Item 36 were highly correlated to
the total scores of PRSexDQ, CGI-S and CGI-SF were compared by a the total. In contrast, item 7 was an exception and will be discussed
non-parametric Kruskal-Wallis test. further below. Moreover, the test-retest and inter-rater reliability were
both excellent.
3. Results The high correlation between the total scores of PRSexDQ and CGI-
SF revealed the validity of PRSexDQ in assessing SD severity. The PPV,
3.1. Demographic and clinical characteristics NPV, sensitivity and specicity all suggested its excellent performance
in diagnosis. For the individual items, items 36 covered four dimen-
In total, 179 patients were eligible during the assessment period, sions of sexual function and showed a perfect correlation with the
and 44 of them refused to participate. Cases unnished or with key corresponding items in UKU. Nevertheless, the correlation of item 7
information missing were deleted. A sample of 126 valid cases counted was inferior due to mismatching in content (UKU assesses the
in analysis. Among them, we assigned 80 patients to another interview disturbance of all side eects other than SD), although it was still
57 days after the initial assessment; 74 participants completed the re- acceptable (p < 0.01).
test. Additional ve cases were assessed by ve raters simultaneously. Item 7 involves the patient and his/her spouse's tolerance toward
The majority of the participants were males (68.3%), and the SD, which could be subjective. It had the lowest correlation with the
average age was 33.32 7.79 years old. Among all, 71.4% of the whole questionnaire and a higher Cronbach's alpha coecient would
patients were married and 29.4% smoked (all of them smoked less be obtained if deleted. Moreover, item 7 does not have weight in the SD
than 20 cigarettes per day). The demographic details are provided in assessment (if any item in items 36 obtains a score over 1, the patient
Table 1. All participants scored an average of 3.90 1.18 on CGI-S and has SD). However, item 7 still counts in the total score and is an
62.58 16.05 on PANSS. There were 94 patients (74.6%) taking indispensable part of the questionnaire because it measures the
antipsychotic monotherapy, among which olanzapine, risperidone disturbance that SD causes on relationship and whether the patient
and aripiprazole were the three most frequently used drugs. would discontinue medication due to SD. Comparing to the last
question of the analogous questionnaire ASEX (Are your orgasms
3.2. Reliability satisfying? ), item 7 focuses more on drug compliance, which is a key
problem in treatment (A. McGahuey, 2000). However, the results of
The results from the Cronbach's alpha analysis (alpha=0.902) item 7 showed that only 3% (1.6% out of 53.2%) of patients with SD
indicated that PRSexDQ-SALSEX demonstrated excellent internal symptoms thought SD was a crucial disturbance and considered
consistency in schizophrenia. Items were highly correlated with the discontinuing treatment, whereas 47.7 (25.4% out of 53.2%)of them
total (p < 0.001). The mean value and Cronbach's alpha coecient with considered SD to be bothersome but would not interfere with medica-
the item deleted are provided in Table 2. The questionnaire revealed tion. The percentage of poor tolerance was much lower than reported
strong test-retest reliability (ICC=0.907, 95% CI: 0.8720.936, p < by Montejo, using same questionnaire (Montejo et al., 2010). But
0.001). The correlation between the test and retest was also excellent ( similarly, a survey in India found that 91.7% of patients with schizo-
Table 3, p < 0.001 for all items). In addition, it proved excellent inter- phrenia reported good to fair tolerance to sexual side eects according
raters reliability by comparing between ve raters scores (ICC=0.924, to PRSexDQ, whereas 60% experienced SD and over one third
95% CI: 0.8770.957, p < 0.001). attributed SD to medications (Tharoor et al., 2015). This discrepancy
is an interesting phenomenon, still no solid evidence at present can
3.3. Validity explain the gap. Stigma of SD may be present, and thus, patients may
not report it when present. Furthermore, Asian people's conservative
The results showed that items 36 were highly correlated (p < attitude and fewer demands toward sex (Okazaki, 2002) may also be
0.001), whereas item 7 of the UKU Side Eects Rating Scale had a contributing factors, but further studies are necessary.
lower correlation coecient of 0.271 (p < 0.01) (Table 3). The total Moreover, question A (Item 1) screens whether the patient has
score of PRSexDQ had a perfect correlation with CGI-SF. In addition, noticed changes in sexual function since pharmacotherapy.
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. 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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Y.-X. Wang et al. Psychiatry Research 246 (2016) 303307

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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Y.-X. Wang et al. Psychiatry Research 246 (2016) 303307

translate and apply the questionnaire and provided powerful support cross-sectional study of side eects in neuroleptic-treated patients. Acta Psychiatr.
Scand. Suppl. 334, 1100.
during the procedure. Also we would like to thank all the participants Liu-Seifert, H., Kinon, B.J., Tennant, C.J., Sniadecki, J., Volavka, J., 2009. Sexual
and evaluators who took part in the study. dysfunction in patients with schizophrenia treated with conventional antipsychotics
or risperidone. Neuropsychiatr. Dis. Treat. 5, 4754.
Macdonald, S., Halliday, J., MacEWAN, T., Sharkey, V., Farrington, S., Wall, S.,
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