The sex effects scale: pilot validation in a healthy population.

Abstract

Sexual dysfunction is frequently associated with depression and is often exacerbated by antidepressant treatment. The true prevalence of antidepressant minduced dysfunction during a major depressive episode is generally underreported, due to reliance on spontaneous self-report data and the reluctance of physicians to use standardized rating scales. The aim of this study is to validate the Sex Effects scale (SexFX) in a healthy population, addressing internal and inter-rater reliability, test-retest reliability, as well as convergent and divergent validity.
The SexFX is a 13-item scale that assesses severity of sexual dysfunction across the domains of desire, arousal, and orgasm based on the frequency of behaviour. Healthy participants (N = 53) had the SexFX and Changes in Sexual Functioning Questionnaire (CSFQ) administered at two timepoints, two weeks apart.
The Cronbach's a was 0.91 and 0.93 for the male and female scales, respectively, and inter-rater reliability was very high with ICCs of 0.99 for both the male and female scales. Concurrent validity with the CSFQ was adequate.
The SexFX demonstrated satisfactory psychometric properties, providing the results necessary to proceed with further validation trials.

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PS Y C H O P H A R M A C O L O G Y BU L L E T I N: Vol. 43 · No. 3 • 15
The Sex Effects Scale:Pilot
Validation in a Healthy Population
By Sidney H. Kennedy,Sakina J. Rizvi,
Kari Fulton,Janet Ellis,Lena C. Quilty,
Lakshmi Ravindran
Sidney Kennedy, MD, FRCPC, Department of Psychiatry, University Health Network and University
of Toronto, Toronto, Ontario, Canada. Sakina Rizvi, HBSc, Department of Psychiatry, University
Health Network and Departments of Pharmaceutical Sciences and Neuroscience, University of
Toronto, Toronto, Ontario, Canada. Kari Fulton, BScN, Department of Psychiatry, University Health
Network, Toronto, Ontario, Canada. Janet Ellis, MB, FRCPC, Department of Psychiatry, University
Health Network, Toronto, Ontario. Lakshmi Ravindran, MD, FRCPC, Centre for Addiction and
Mental Health, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
To whom correspondence should be addressed: Dr. Sidney H. Kennedy MD, FRCPC, Psychiatrist-
in-Chief, Department of Psychiatry, University Health Network, Room 222, Eaton North Wing 8th
F l o o r, 200 Elizabeth Street, Toronto, ON M5G 2C4. Phone: (416) 340-3888; Fax: (416) 340-419 8 ;
E -mail: sidney.kennedy@uhn.on.ca
ABSTRACT ~ Objective: Sexual dysfunction is frequently associated with depression and is
o f ten ex ac er ba ted by antidepressant tre a t m e n t .The true prevalence of a n t i d e p re s s a n t
induced dysfunction during a major depre s s ive episode is ge n erally underre p o rte d,due to
reliance on spontaneous sel f - re p o rt data and the rel u c tance of physicians to use sta n d a rd-
ized rating sca l e s .The aim of this study is to va l i d a te the Sex Effects scale (SexFX) in a
healthy population, ad d ressing internal and inter - ra ter rel i a b i l i ty, te s t - re test rel i a b i l i ty,
as well as conver gent and diver gent va l i d i ty. M a terials and Methods: The SexFX is a
1 3 - i tem scale that assesses severi ty of s exual dysfunction ac ross the domains of d e s i re,
a ro u s a l , and orgasm based on the fre q u e n cy of b e h av i o u r. Healthy participants (N 5 5 3 )
had the SexFX and Changes in Sexual Functioning Questionnaire (CSFQ) administered
at two timepoints, two weeks apart. Results: The Cronbach’s a was 0.91 and 0.93 for the
male and female sca l e s , re s p e c t ivel y, and inter - ra ter rel i a b i l i ty was very high with ICC s
of 0.99 for both the male and female scales.Concurrent validity with the CSFQ was ade-
quate. Conclusion:The SexFX demonstrated satisfactory psychometric properties, provid-
ing the results necessary to proceed with furt h er validation tri a l s . Ps ych o ph a rm a c o l o gy
Bulletin. 2010;43(3):15–25.
INTRODUCTION
Sexual dysfunction is estimated to occur in more than 50% of patients with
major depressive disorder (MDD).1–2Antidepressant treatment often com-
pounds this problem, causing treatment-emergent sexual side effects in male and
female patients receiving pharmacotherapy.3–5The extent to which an antide-
pressant medication induces dysfunction varies with dose and across drug classes.
Key Words: Major depressive disorder, sexual dysfunction, Sex Effects scale, reliability, validity
ORIGINAL RESEARCH

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Both selective serotonin reuptake inhibitors (SSRIs) and serotonin nor-
epinephrine reuptake inhibitors (SNRIs) can cause significant impair-
ment in libido, arousal or orgasm.6Antidepressants that act on other
receptors including dopamine (bupropion) and melatonin (agomela-
tine) are less likely to be associated with sexual dysfunction.7–10
The management of sexual dys f u n c t i on is a neglected aspect of ph a r-
m a c o t h e rapy despite being rated as ‘e x t re m e ly import a n t’ , ‘ve ry impor-
t a n t’ or ‘i m p o rt a n t’ by 85% of MDD patients receiving an
a n t i d e p re s s a n t .1 1C on s e q u e n t ly ,since sexual dys f u n c t i on in depre s s i on is
a leading cause of treatment discon t i n u a t i on or non - a d h e rence duri n g
s h o rt and lon g - t e rm treatment with an antidepre s s a n t ,1 2 – 1 5it should be
s ys t e m a t i ca lly evaluated during the appro p riate phase of antidepre s s a n t
t re a t m e n t .
One large review of antidepressant trials, demonstrated only 8% of
trials used a specific instrument to assess sexual adverse events,16and in
a separate study patients were twice as likely to report sexual side effects
upon direct questioning compared to reliance on spontaneous self-
report (69% vs.35%).17This supports the use of validated scales that are
brief and easy to administer during drug development as well as in clin-
ical practice in order to more effectively identify and manage sexual side
effects.
Many sexual function scales exist that qualitatively address subjective
aspects of sexual dysfunction.Although the gold standard sexual function
scales such as the Derogatis Sexual Function Inventory18and Female
Sexual Function Index19have been used extensively in clinical research,
the use of scales specifically designed for depressed populations is prefer-
able in MDD samples. Several scales have been created and validated for
MDD: the Arizona Sexual Experience scale (ASEX),20the Psychotropic
Related Sexual Dysfunction Questionnaire (PRSexDQ or SalSex),21–22
and the most-frequently used measure in depression research, the
Changes in Sexual Functioning Questionnaire (CSFQ).23–24The Sex
Effects Scale (SexFX) was developed as a brief 13-item gender-specific,
clinician-administered instrument to assess treatment-emergent sexual
dysfunction in depression.Where other scales primarily measure the sub-
jective quality of sexual experience, the SexFX primarily measures the
frequency of sexual experiences in the domains of desire, arousal and
orgasm, yet also includes a subjective evaluation of the intensity of sexual
satisfaction in a global satisfaction domain. This makes the scale partic-
ularly useful in evaluating the side effects of pharmacotherapy, by pro-
viding a quantitative behavioural index of sexual dysfunction.
The clinical validity of the SexFX has been previously established in
depressed populations comparing sexual side effects associated with dif-
ferent antidepressants.10,25The purpose of this study is to assess the
PS Y C H O P H A R M A C O L O G Y BU L L E T I N: Vol. 43 · No. 3
SEX EFFECTS SCALE VALIDATION
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Fulton,et al.

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psychometric properties of the SexFX in a healthy population. The
parameters that will be assessed include internal consistency reliability,
test-retest and inter-rater reliability, as well as concurrent and divergent
validity.
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PS Y C H O P H A R M A C O L O G Y BU L L E T I N: Vol. 43 · No. 3
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