this is all about assessment procedures it can be used for projects...
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Questionnaires for Assessment of Female Sexual Dysfunction: A Review and Proposal for a Standardized Screener jsm_2395
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Annamaria Giraldi, MD, PhD,* Alessandra Rellini, PhD,† James G. Pfaus, PhD,‡ Johannes Bitzer, MD,§ Ellen Laan, PhD,¶ Emmanuele A. Jannini, MD,** and Axel R. Fugl-Meyer, MD, PhD†† *Department of Sexological Research, Psychiatric Center Copenhagen, University of Copenhagen, Copenhagen, Denmark; †Department of Psychology, University of Vermont, Burlington, Vermont, USA; ‡Center for Studies in Behavioral Neurobiology, Department of Psychology, Concordia University, Montréal, Canada; §Division of Family Planning, Sexology & Psychosomatic Obstetrics, University Hospital Basel, Switzerland; ¶Department of Sexology & Psychosomatic Obstetrics and Gynecology, University of Amsterdam, Amsterdam, Netherlands; **School of Sexology, Department of Experimental Medicine, University of L’Aquila, Italy; ††Department of Neuroscience, University of Uppsala, Sweden DOI: 10.1111/j.1743-6109.2011.02395.x
ABSTRACT
Introduction. There are many methods to evaluate female sexual function and dysfunction (FSD) in clinical and research settings, including questionnaires, structured interviews, and detailed case histories. Of these, questionnaires have become an easy first choice to screen individuals into different categories of FSD. Aim. The aim of this study was to review the strengths and weaknesses of different questionnaires currently available to assess different dimensions of women’s sexual function and dysfunction, and to suggest a simple screener for FSD. Methods. A literature search of relevant databases, books, and articles in journals was used to identify questionnaires that have been used in basic or epidemiological research, clinical trials, or in clinical settings. Main Outcome Measure. Measures were grouped in four levels based on their purposes and degree of development, and were reviewed for their psychometric properties and utility in clinical or research settings. A Sexual Complaints Screener for Women (SCS-W) was then proposed based on epidemiological methods. Results. Although many questionnaires are adequate for their own purposes, our review revealed a serious lack of standardized, internationally (culturally) acceptable questionnaires that are truly epidemiologically validated in general populations and that can be used to assess FSD in women with or without a partner and independent of the partner’s gender. The SCS-W is proposed as a 10-item screener to aid clinicians in making a preliminary assessment of FSD. Conclusions. The definition of FSD continues to change and basic screening tools are essential to help advance clinical diagnosis and treatment, or to slate patients adequately into the right diagnostic categories for basic and epidemiological research or clinical trials. Giraldi A, Rellini A, Pfaus JG, Bitzer J, Laan E, Jannini EA, and Fugl-Meyer AR. Questionnaires for assessment of female sexual dysfunction: A review and proposal for a standardized screener. J Sex Med **;**:**–**. Key Words. Female Sexual Dysfunction; Sexual Dysfunction; Psychiological; Questionnaire; Clinical Assessment; Diagnosis; Subjective Scales
Introduction
D
uring the past few decades, research in female sexual function and dysfunction (FSD) has attracted considerable interest. As a result, increased attention has been directed to the need for reliable test instruments that have been validated psychometrically to measure and diag-
© 2011 International Society for Sexual Medicine
nose sexual dysfunction in women, and to monitor treatment-induced changes in sexual function. The increased focus on developing these questionnaires has occurred within the context of a developing drug market interested in measures to assess the effectiveness of the drugs under study [1] and that comply with the strict requirements of the United States Food and Drug Administration J Sex Med **;**:**–**
2 (FDA; the FDA utilizes the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) definitions of FSD), but also in the context of an increased focus on women and sexual dysfunction as an area of intensified research and clinical interest [2]. Some have postulated that FSD is an invention that paves the road for the pharmaceutical industry to medicalize women’s sexuality and create an unnecessary need for pharmacotherapy [3]. Whereas this is not in keeping with epidemiological investigations, it can hardly be denied that many aggregating questionnaires targeting prevalence of FSD and its consequences are constructed in cooperation with pharmaceutical companies, occasionally appearing tailor-made to demonstrate beneficial effects of a certain drug treatment. However, despite current differences in definitions, categorizations, and classifications of severity, a growing body of epidemiological literature on women’s sexual function/dysfunction [4] has underscored the relevance that sexual function has for sexual and overall well-being, for both men and women. An overarching problem faced in the development of valid instruments for the assessment of FSD is the ongoing changes in how the different components of FSD are defined in diagnostic manuals such as the DSM-IV-Text Revision (TR) [5], the International Classification of Diseases (ICD-10) [6], the 2000 Consensus Report [7] and the reports from the Second and Third Consultations in Paris [4,8]. Traditionally, FSD is defined in the categories of hypoactive sexual desire disorder (HSDD), female sexual arousal disorder (FSAD), female orgasm disorder (FOD), and pain disorders, including dyspareunia and vaginismus [5,8,9]. Recently, a new entity, persistent genital arousal disorder (PGAD), has been introduced. This entity has though so far not been psychometrically evaluated in any questionnaires [8–10]. Additionally, there is evidence supporting the importance of including distress or bother as an added criterion for FSD [10–12] to differentiate individuals with a symptom from those with a dysfunction per se. Based on this, distress is included as a pivotal criterion for FSD in our report. Questionnaires play an important role in research and clinical practice both as diagnostic tools, measurement of treatment-induced changes, and as research tools when describing a study population and their sexual function. However, a correct use of questionnaires and a thorough J Sex Med **;**:**–**
Giraldi et al. understanding of what these questionnaires are designed to do (and not do), is necessary for an adequate interpretation of their scores. For example, a self-administered screener can be useful during assessment as indicator of whether the woman may have a dysfunction and in what domain the problem may lie. Within the clinical setting, responses to the screener should create an opportunity for the clinician to initiate or continue a dialog with the patient. An answer in a screener indicating likelihood for a sexual dysfunction should be followed with further diagnostic assessments employing more precise questionnaires to gather relevant information regarding specific areas of sexual function and to assess the severity of the condition. It is our strong belief that in women with sexual complaints, a reasonably meticulous case history is a sine qua non demand to obtaining relevant information early in the clinical setting. Thus, a screener or even a sophisticated questionnaire cannot substitute for a thorough case history. An individual case history must, as we see it, focus on the biological, psychological, and social context of the sexual problem. Questionnaires and standardized interviews can only partly be used to assess the potential role of social, relational, and psychological factors involved in the sexual problems of the individual. Further information may be required from medical tests to assess endocrine, vascular, urological, and psychiatric conditions that may underlie the sexual problem. A major challenge in the assessment of FSD is for the clinician or researcher to select the appropriate questionnaire among the large number of measures available and the numerous purposes of these measures. The need for psychometrically validated measures to diagnose and quantify a multifaceted entity such as FSD has led to the generation of many self-report questionnaires, some of which are general whereas others are more specific. The use of questionnaires may serve many purposes: as a general assessment and/or diagnostic tool for overall FSD or subdomains of FSD; assessment of aspects related to sexual function i.e., satisfaction, life, and partner aspects; assessment of FSD in selected groups of women; and measurement of treatment-induced changes. Clinical trials often generate and utilize their own questionnaires, each with a different focus and different set of questions. This makes the comparison of the results across trials complicated. Thus, the current clinical literature provides a number of measures to assess different dimensions of FSD for different purposes. A comprehensive review of the
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Questionnaires for Assessment of Female Sexual Dysfunction available measures and recommendations for clinicians therefore becomes particularly important [13], given that studies have shown that the reported occurrence of FSD varies substantially depending on which instrument is used [12]. Furthermore, in order to adequately employ measures within clinical and research practice, it is important to select questionnaires with appropriate psychometrics characteristics of reliability and validity. To address the need for a comprehensive critical review of instruments developed to assess sexual dysfunction, the Standard Committee of the International Society for Sexual Medicine (ISSM) dedicated its work to this subject. The present article presents the work done by members of the FSD subcommittee. The mandates of the FSD subcommittee in this regard were to: • Review questionnaires used in female sexual medicine and provide information on strengths and limitations of the selected instruments and their possible use, with focus on its usefulness in the everyday clinical setting. • Suggest a simple screening instrument for FSD for daily use in the clinical practice. It was not our intention to try to provide a comprehensive discussion of findings based on the reviewed measures, or to provide a validated measure to screen FSD, but rather to compile a comprehensive review of existing questionnaires and their psychometric characteristics with an aim to identify questions that could potentially be useful for clinicians who wish to screen for FSD in their practices. Here, we review the existing questionnaires to measure female sexual function and/or dysfunction, and then provide a description of methodology and questions for a new screener for FSD. Our endorsement of an instrument for clinical use reflects our evaluation of all the points later (Methods) and indicates that we came to the conclusion that, at the present time, the instrument offers the best option for clinicians who want to use the instrument to either screen or assess severity of sexual dysfunctions in a clinical setting, although we are addressing the instrument’s possible use in research or other settings when relevant. We endorsed scales for research purposes when enough information on validity (i.e., the ability of the instrument to measure the intended construct) and the reliability (i.e., the ability of the instrument to be accurate in its measure) of the scale were available even if not enough informa-
tion was available on the ability of the scale to discriminate between clinical and nonclinical levels of dysfunction.
Part 1: Review of Questionnaires
Methods Criteria for Inclusion Questionnaires were grouped into four levels based on their purposes and degree of development. Questionnaires in Levels I, II, and III have been validated, whereas questionnaires in Level IV are still under development. I. General assessment of FSD a. Global assessment of Female Sexual Function/Dysfunction b. Global assessment of sexual distress c. Assessment of satisfaction (including sexual partner-, life-, and treatment satisfaction) II. Assessment of specific functions/dysfunctions (e.g., desire, orgasm, etc.) III. Assessment of sexual function in selected groups or for groups with specific conditions (e.g., menopause, psychiatric problems) IV. Questionnaires under development In order to identify a reasonably complete list of questionnaires, we searched relevant databases for articles (Medline, PubMed, and PsychInfo), applied personal knowledge of FSD questionnaires, reviewed recent reports at relevant international meetings, and searched available handbooks pertinent to sexual function [14,15]. Instruments used in clinical trials not in the public domain were not included. We strived to include a wide array of questionnaires; not only those already well validated, but also ones that addressed one of the levels described above even if they were still under development or in the process of being validated at the time of this review. The authors of the instruments in progress were contacted with questions about the most recent developments for those scales. Thus, for a few questionnaires, preliminary data are discussed based on abstracts. These questionnaires were categorized as level IV.
Review Criteria Each questionnaire was reviewed independently by at least two members of the FSD subcommittee. Their evaluation was based on six preestablished criteria: 1. Coherence between the constructs measured and the most current FSD definition. J Sex Med **;**:**–**
4 2. Evidence that the instrument can accurately measure the intended constructs. 3. Availability of norms based on sound epidemiological samples. 4. Adequacy of the instrument to be administered within a clinical practice. 5. Applicability of the instrument to women from different sexual orientations, relationship status, and ethnicities. 6. Availability of the instrument in multiple languages and cultures. The first preestablished criterion, consistency between the current FSD definition and the definition of constructs measured by the questionnaire, was considered a crucial characteristic, although very few questionnaires were adequate in this dimension because the FSD definition (and therefore diagnosis) has been in a constant state of flux as described earlier. The FSD diagnoses we agreed upon were the domains of HSDD (addressing both spontaneous and receptive desire), FSAD (with subtypes for subjective, genital, and combined arousal), FOD, and pain disorders (including sexual pain dyspareunia and vaginismus) [9]. PGAD was not included as it is still too new a domain and needs to find its place in the diagnostic system. The second criterion, evidence for sound psychometrics and validation, included a review of evidence that the questionnaires are reliable to use and valid for the measurement of the intended construct. Third, because clinicians would benefit the most from scales with cutoffs that discriminate between clinical and nonclinical levels of the symptoms, we reviewed the sensitivity and specificity of the scale to correctly and accurately identify people with the condition, and we stressed the importance of valid norms based on epidemiological studies using reasonably large populations, for instance following the principles of Prins et al. to assess the representativeness of the sample [16]. Fourth, characteristics of the questionnaires relevant to the everyday clinical settings were given priority. These included length of administration for the measure and ease of scoring as well as ease of use for the nonexpert. Fifth, to address the diversity of human sexuality, we reviewed the ability of the questionnaires to be applicable to a wide range of women of different sexual orientations, in different types of relationships (e.g., single, dating, in committed relationships), and from different ethnic groups. J Sex Med **;**:**–**
Giraldi et al. Sixth, given the international scope of the Committee’s goal, we also considered whether the instrument is available in different languages and whether these translations have been validated. We are not listing all languages, but provide information on whether the instruments have been translated and validated in two or more languages. Results
The search identified 27 instruments addressing different aspects of FSD. Of these, 13 were Level I, 7 were Level II, 5 were Level III, and 2 were Level IV. Given that none of the reviewed measures successfully met all six criteria, the Committee scored each questionnaire on each criterion so that the reader may be aware of the strength and limitation for each measure. This information is provided in Table 1. Below, we present a brief description of each questionnaire followed by a critical evaluation of strengths, limitations, and possible recommendations for use, with focus on daily use in a clinical practice. The presentations may vary in length and level of details based on the amount of information and how used the instrument is. We have not included all references for each instrument but have chosen pivotal references for each instrument.
Level IA: Comprehensive Function/Dysfunction Questionnaires Derogatis Sexual Function Inventory (DSFI) The DSFI [17,18] is one of the earliest developed self-report questionnaires. It consists of 245 items that comprise 10 subtests (see Table 1) and takes 45 minutes to complete. Scoring is a combination of yes/no, Likert scale, or true/false items. The validity of the DSFI was derived from a convenience sample of 213 young heterosexual women. No information is available on large population-based samples. The DSFI has shown adequate test–retest reliability after a 14-day interval (rs ⱖ 0.80) for constructs expected to remain stable across a 2-week span, and has also shown an adequate internal consistency (Cronbach’s alpha of 0.80 for six of the subtests). Convergent and discriminate validity of the DSFI has been adequately documented. The scale is available in several languages, but psychometrics qualities are available only for men, thus, at this point, these translations cannot be recommended to test female sexual function. Clinically, the total score for the DSFI has been shown to correctly identify 75% of women with
Sample (n)
?
399
259/582
1160
683
Level I DSFI [17,18]
DISF/DISF-SR [19]
FSFI [20–22]
SFQ [23–25]
SAQ-F [26]
Overall Information Experience Drive Attitudes Psych. Sympt. Affect Gender role Fantasy Body image Satisfaction Overall Sexual cognition & fantasies Arousal Sexual behavior and experience Drive Relation Overall Desire/Arousal Lubrication Orgasm Pain Satisfaction Overall Desire Arousal/lub. Arousal/sensation Orgasm Dyspareunia Enjoyment Partner Overall Pleasure Discomfort Habit
Domains
Review of level I, II, and III instruments
Questionnaire
Table 1
213 26 24 5 30 53 40 15 20 15 10 25 5 5 5 5 5 19 5 4–5 3 3 3 26 6 2 4 3 3 6 2 10 6 2 2
Items (N)
Yes
Yes
No
Yes
Yes
No
Yes
Yes
No
Cutoff
Yes
Partner required
Yes
4w/ < 20 m
No
Yes
4w/ < 20 m
4w/-
?
Yes
Scoring instruction
?/?
?/45 m
Time frames/time to administer
++
-
++
+
++
-
-
++
+
Validity
++
Reliability
No
Yes
Yes
?
No
Industry sponsored
Questionnaires for Assessment of Female Sexual Dysfunction 5
J Sex Med **;**:**–**
Continued
J Sex Med **;**:**–**
70 1335
883
195 (men & women)
Level II HSDD [40]
SADI [41]
507
SLQQ [36]
TSS [37,38,68] LiSat-9/-11 [39]
174/247 886
15 (30 couples)
GRISS [31,32]
FSDS/FSDS-R [33,34] SSS-W [35]
70 4500
269
Sample (n)
CSFQ [29] CSFQ-14 [30]
BIS-W [27]
Questionnaire
Table 1
Desire/Interest Distress Arousal/Desire Evaluation Physiology Motivation Negative/Aversion
Overall Interest/desire Activity Satisfaction Overall Desire Arousal Orgasm/completion Overall Sexual mal-adjustment Psychological mal-adjustment Female anhedonic Sexual experience Overall Overall Contentment Communication Compalibility Concern relationship Concern person Overall Sexual QoL Treatment satisfaction Different Modules Overall Closeness Health Spare time Provision Life as a whole
Domains
54
4
12/13 30 6 6 6 6 6 16 10 4 See text 8 (9)–11 3 3 2 2 1
22 5 9 6 (7) 14 5 3 6 28
Items (N)
No
No
Yes No
Yes
No No
No
No
Partner required
No
Yes
No Yes
No
Yes No
No
No
Cutoff
?/10 m
3 months / < 5 m
Current/? Current/5 m
Current/?
?/5–10 m Current/15 m
?/15 m
Yes
Yes Yes
Yes
Yes Yes
Yes
Yes
4w/ ⱕ 20 m
Current/20 m
Scoring instruction
Time frames/time to administer
+(+) -
+ ++
(+)
(+)
+
-
++ ++
(+)
+
+ ++
+
Validity
+
Reliability
No
Yes
Yes No
Yes
Yes No
?
No
No
Industry sponsored
6 Giraldi et al.
221/111
57
MSIQ [55]
ASEX [56]
Overall Desire Pleasure Responsiveness Arousal Orgasm Sexual self-image Sexual concerns Overall Desire Responsiveness Satisfaction (?) Overall
hQoL (in the aged) Psycho-somatic QoL Sex. activity Sex. function Partner’s view
Desire/interest Distress
Interest/Desire Love/emotional boundary Erotic/explicit Visual proximity Romantic implicit — Orgasm
32 13 7 8 4 7–19 37 9 7 7 3 4 4 3 10 4 4 2 5
39 28 adjectives 5
13 40
- = not tested; + = some measures; ++ = several measures. Time frame = time period the instruments measures. Samples = number of women included in validation and development of the instrument. M = minutes, w = weeks.
Different samples 829
359
Level III QSF [49]
MFSQ [50–52] PSFS [53,54]
263
20 actresses/629 1326
WISD/WISD-R [46,70] Orgasm rating scale [47]
DSDS [48]
448 & 90 1012
SIDI-F [42,43] CSDS [44,45]
?
No
? Yes
Yes
No (?)
No No
Yes (?) No
?
No
? No
Yes
Yes
No No
No No
?
?/Brief
? 4w/?
1 month/?
Not set/? 3 months/ 5–10 m None/5 m
4w/? Current/?
Yes
Yes
? Yes
Yes
Yes
Yes Yes
Yes ?
-
+ ++
++
++
+ ++
++
++
+
+
+
(+) -
+(+) ++
(+) +
+(+) +
No
Yes
? Yes
Yes
Yes
Yes No (?)
Yes No
Questionnaires for Assessment of Female Sexual Dysfunction 7
J Sex Med **;**:**–**
8 sexual dysfunction (diagnosed by an expert), which is low considering that chance alone accounts for 50% of correct identifications. The domains that showed to differentiate clinical from nonclinical samples were Affect, Body Image, and Satisfaction. Strengths and Limitations. The main virtue of this inventory is the pioneering groundwork it laid for the development of subsequent questionnaires. Furthermore, its development was not industry sponsored. A limitation of the DSFI is its length and formulation of items, which may be perceived as out of date by younger patients. An additional limitation is the lack of differentiation between types of sexual problems and the out-of-date definition of FSD that was used when the scale was built. For example, women with FSAD, HSDD, and FOD receive the same score in the DSFI. The inability of this questionnaire to distinguish between diagnoses is problematic for clinicians trying to identify specific types of FSD. Hence, these instruments cannot, without serious reservations, be recommended for standard clinical use with women.
Derogatis Interview for Sexual Function (DISF/DISF-SR) The DISF [19] is a 25-item semi-structure interview assessing five domains of sexual functioning: sexual cognition/fantasy, sexual arousal, sexual behavior/experience, orgasm, and sexual drive/ relationship. In addition to the interview, there is also a self-report scale (DISF-SR). Items are scores on a 4-point Likert scale and take 15–20 minutes to complete and are gendered keyed, meaning that it can be administered to either men or women. The scale can be interpreted at the level of the single items, the domains and/or the global summary score. Originally, the scale was normalized on a sample of 399 men and woman recruited from the community, age 19–64. The DISF showed a high interrater reliability of 0.91. Internal consistency for the five domains is adequate, from 0.74 for the Sexual drive/ Relationship, to 0.80 for the Orgasm domain. Test–retest reliabilities based on a 1-week interval fall in the acceptable range (0.80–0.90). The DISF and DISF-SR is available in eight European languages, but information on the validation of the translations and norms in the different countries is not available. The authors provide normative scores for men and women presented in standardized t format (i.e., mean = 50, standard deviation [SD] = 10). Although useful for a within person comparison J Sex Med **;**:**–**
Giraldi et al. with chart changes in one patient, these norms are not based on a true epidemiological population and therefore cannot be interpreted as the true norm. Strengths and Limitations. This interview addresses both male and female sexual functioning in a comparable way. Unfortunately, no information is available on the amount of training the interviewer needs to achieve reliability; thus, it is not possible, at this point, to comment on the feasible use of such interview in the general practitioner setting. In the hands of a moderately knowledgeable interviewer, this interview can provide a viable way to open up the provider–client’s communication on the topic and allows the interviewer to address all aspects of sexual function that are most salient to diagnose the main sexual dysfunctions. These factors and the lack of norms from epidemiologically sound samples and the lack of a comparison between women with and without sexual dysfunction prevent us, at this point to recommend this scale for daily clinical use.
Female Sexual Function Index (FSFI) The FSFI [20–22] is a 19-item questionnaire comprising six domains for the measurement of overall female sexual function. It takes approximately 15 minutes to complete and items are scored on either 0–5- or 1–5-point Likert scales, with zero scores indicating participants that need to be excluded from the analyses because of lack of sexual activities in the previous 4 weeks. The questionnaire was carefully developed for pharmacological clinical trials based on the DSM-IV-TR [5] diagnostic criteria for FSAD and the consensus report definitions [7]. The original development of the instrument was conducted on a relatively small sample of women with a male partner: 128 women diagnosed with FSAD and 131 controls (nonclinical) without a diagnosed sexual disorder (ages 21–70 years) [21]. In a later study, the FSFI was validated in a population of women with HSDD or FOD [22]. The FSFI has since been placed on a public domain: http://www.fsfi-questionnaire.com and has been completed by a large number of women with different clinical conditions [57–60]. Recently, the FSFI was used in one study of women with PGAD [61]. The FSFI has shown adequate test–retest reliability (r = 0.75–0.86) and an excellent internal consistency for both the total score and its subdomains (Cronbach’s a = 0.89–0.95). This scale also possesses adequate convergent/discriminant validity when tested against several instruments. The
Questionnaires for Assessment of Female Sexual Dysfunction items are developed for heterosexual women with a partner, but one study has used it in a homosexual population of 350 women in a modified version with a timeframe of 6 months [62]. This version of the FSFI showed good internal consistency (a = 0.84–0.96) although no information is available on the validity of the scale nor is empirical evidence provided on whether the time frame selected by the researchers was appropriate. Although several translations of the FSFI are available, not all have been adequately validated and there is a lack of information on the ability of those versions to reliably capture the intended constructs. As the FSFI has been used in multiple settings, it is impossible to include all data in this review. An analysis of sensitivity and specificity found that a score of 26.55 or lower is an indication that the woman may have a sexual dysfunction [22]. The instrument accurately distinguished between women with and without female sexual arousal dysfunction [22], and between women with and without female orgasmic dysfunction [20]. The desire domain was considered the least sensitive for the discrimination of individuals with and without HSDD, but recent analyses have shown that a score of 5 or less on the desire domain has adequate sensitivity (75.5%) and specificity (83.5%) for discriminating between women with and without HSDD [63]. Strengths and Limitations. This questionnaire has been utilized by clinicians and researchers in several clinical drug trials for the treatment of HSDD and FSAD as well in studies of clinical and nonclinical samples. Therefore the experience and pool of data using the instrument is large. The authors are constantly acquiring normative data on new samples. The scale is easy to administer and to score and has a cutoff score and thus an ideal measure in a clinical setting. Because it was developed for women with a male partner, a dysfunction bias can occur in women without partner or not sexually active [22]. The FSFI should not be considered a diagnostic tool and does not include specific questions on vaginismus. It is not a measure of sexual experience, knowledge, attitudes, or interpersonal functioning in women. In conclusion, the scale can be recommended for clinical practice as a measure of symptoms severity in heterosexual women who have been sexually active in the prior 4 weeks, but not as a diagnostic tool, and should be combined with a
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measurement of distress. Moreover, the present information on the instrument prevents us from recommending the scale to assess FSD in nonheterosexual women and in women without a partner.
Sexual Function Questionnaire (SFQ) The SFQ is a self-reported measure developed for pharmacological clinical trials [23,24]. The SFQ is mainly based on the DSM-IV-TR paradigm and the second Paris consensus meeting [5,8]. After pilot interviews with eight women, 34 items were generated through interviews (semi-structured) with 82 women. In the subsequent development phase, the questionnaire was reduced to 26 items subdivided into seven analytically supported domains. The SFQ is scored on a 5-graded Likert scale and takes about 10–20 minutes to complete. The SFQ was psychometrically tested in a clinical trial [24] of 781 heterosexual women who had displayed symptoms of different types of FSD, and 201 women without FSD. In a later study, 32, the number of subjects, was enlarged to 1,160, a sample size superior to those of most validation studies. Like the FSFI, it is designed for women with a partner, who have been sexually active within the last 4 weeks, but appears to be indifferent to women’s sexual orientation [23,24]. The test–retest reliability of the scale was poor to good (r = 0.21–0.71) when assessed with a 4-week interval in patients whose functional status remained stable. The scale showed fair or excellent internal consistency (Cronbach’s a = 0.70–0.91) for women with and without FSD, respectively. The worries about partner domain showed lower internal reliability (Cronbach’s a = 0.33–0.72) and thus scores on this factor need to be interpreted carefully. Also, convincing evidence has been accumulated on the ability of the instrument to measure factors relevant to sexuality and not completely overlapping with other factors such as anxiety and depression (r < 0.30). Concurrent and discriminant validity have also been demonstrated when compared with the DFSI, and the LiSat-8 checklist. The SFQ has been developed, validated, and used in multi-center European clinical trials, and has been translated into several languages. It was used in a recent Iranian study [25] of 547 women where a different factor structure was found: arousal–sensation, lubrication, and orgasm (9 items); desire and enjoyment (11 items); pain (3 items); and partner (2 items), indicating that the robustness of the SFQ domains construct may, be culturally dependent. There is a cut off J Sex Med **;**:**–**
10 score identifying women with the probability of FSD. Strengths and Limitations. The SFQ was carefully developed through the cooperation of a drug company and experts in sexual medicine. The scale has been validated in many languages and covers a wide sphere of female sexual function, although it does not include questions on vaginismus. Cutoffs for most of its domains makes the scale useful in a clinical setting. This is not a measure of sexual experience, knowledge, attitudes, or interpersonal functioning in women. In conclusion, the scale can be recommended for clinical practice as measure of symptoms severity in heterosexual women who have been sexually active in the preceding 4 weeks. It can, therefore, serve as a reasonable choice questionnaire for the initial diagnostics in women for assessment of FSD. However, the present information on the instrument prevents us from recommending the scale to assess FSD in women without a partner.
Sexual Activity Questionnaire (SAQ-F) The SAQ [26] is an abbreviated Norwegian modification of the sexual activity questionnaire developed by Thirlaway et al. to be used in a clinical trial for breast cancer [64]. The scale has been recently translated into English. This brief questionnaire comprises 10 items, all but one having a 4-graded categorical scale. The instrument is not based on any specific diagnostic paradigm and does not require respondents to be in a relationship, although, items appear to focus on heterosexual women. It takes 5–10 minutes to fill out. The instrument was developed epidemiologically based on a representative population of 20–69-year-old women (N = 1,165). However, the response rate to the mailed questionnaire was relatively low (42%). Among the 732 respondents who had a sexual relationship the preceding month, 93% completed the questionnaire. No information is available on the test–retest reliability for the scale. The internal consistencies of the comprehensive questionnaire (Cronbach’s a = 0.86) as well as of the Pleasure (Cronbach’s a = 0.89) and Discomfort (Cronbach’s a = 0.82) domains were excellent. No test of discriminant and convergent validity is available for the SAQ-F. No information is available on the ability of the scale to discriminate between women with and without sexual dysfunction. Also, no cutoffs are available nor is information available on the sensitivity and specificity of the scale. J Sex Med **;**:**–**
Giraldi et al. Strengths and Limitations. The strength of the SAQ-F is its brevity. The instrument development was not sponsored by industry and has a broad focus. Whereas this instrument in future research may prove psychometrically valid, the sphere of FSD addressed in this scale remains poorly defined and current psychometrics are insufficient. Although this is also simple to use and easy to administer, at the moment, this questionnaire cannot be recommended for clinical use.
Brief Index of Sexual Functioning for Women (BISF-W) The BISF-W [27] was meant to be comparable with the BSFQ for men, described by Reynolds et al. [28] on which it is partly based and developed for use in clinical trials. This is an 18-item questionnaire, not anchored in any specific paradigm, measuring three domains of sexual function and yielding a composite score using 5–7-grade categorical scale. The BISF-W can be administered to women with different sexual orientations and to women in no sexual relationships. The BISF-W takes 15–20 minutes to administer. In the original paper, the selected sample was 269 (nonclinical) women. Despite its intention to be useful with nonclinical as well as clinical populations, this scale has not been truly epidemiologically tested in a representative population sample. Test–retest reliability for the scale showed that, after 1 month, correlations ranged from r = 0.68– 0.78, indicating an adequate consistency in the measurement of sexual function. A factor analysis showed three subdomains including 15 items. However, several of these items were included in more than one factor and the explanation of total variance was rather low (51.2%). Hence, the construct validity may be criticized. Concurrent validity was assessed by comparison of factor scores with relevant aspects of the DSFI [18]. The results show a reasonable overlap between the DSFI factors and the BSFQ, confirming the labeling of factors. To our knowledge, no other domain validity studies have been performed. The interest/ desire domain has low internal consistency (Cronbach’s a = 0.39), perhaps explainable by its adaptation from the corresponding male scale. Consistencies are acceptable for the sexual activity (Cronbach’s a = 0.83) and satisfaction domains (Cronbach’s a = 0.74). Studies conducted with Polish, Italian, and French women utilized the BSFI but no information is available on the validity and reliability of the translated versions of the scale.
Questionnaires for Assessment of Female Sexual Dysfunction Scoring instructions are given, but no cutoffs for categorizing level of function/dysfunction are provided. Although to the best of our knowledge no studies have reported the sensitivity and specificity of this scale, clinical trials utilizing this scale have been able to show treatment-related improvements in the BISF-W domains [65]. Strengths and Limitations. The most notable strength of this scale is its neutrality with regards to women with different sexual preferences and partner status. Limitations of the scale include a weak internal consistency and reliability of the sexual interest/desire domain, and the lack of published data on discriminant validity, and specificity. For these reasons, the BISF-W, one of the earliest questionnaires on FSD, cannot at present be recommended for clinical use.
Changes in Sexual Functioning Questionnaire (CSFQ) The CSFQ [29,30] was developed in cooperation with a pharmacological industry. The original CSFQ comprised more than 30 items for women and was later modified to a 14-item version and split up into a female (CSFQ-14-F) and a male version. These items are not anchored in any specific diagnostic system. A factor analysis performed for the aggregated sample of women and men (N = 6,268) identified three domains, one including 13 of the items. Operationally, items were assigned to different domains, conforming to four of the five original CSFQ–scales: sexual desire/frequency, sexual desire/interest, arousal/ excitement, and orgasm/completion. Three sexual response cycle-scales included desire, arousal, and orgasm/completion. Differently from what the name suggests, the CSFQ does not explicitly measure change, although repeated measurements using the scale may show if change occurs. The scale takes 20 minutes to complete. The CSFQ was originally developed on a small sample of 70 female medical students and psychiatric residents. In these samples, internal consistency and both 1-week and 1-month test-retest reliability were good. Later it was validated on a larger sample (CSFQ-14-F) encompassing 4,500 women. In spite of the large number of women included in the development, this instrument has not been truly epidemiologically validated (i.e., this sample is not representative for the overall population). The CSFQ-14-F is a relative newcomer and information on reliability is not currently available. The internal consistency of the CSFQ-14-F, both concerning the aggregation of items (Cron-
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bach’s a = 0.90) and the two different sets of domains is acceptable to excellent (Cronbach’s a = 0.68–0.86). Concurrent validity was established between SFQ and DISF-SR. No cutoffs are currently available. Strengths and Limitations. The CSFQ-14-F may, in time, be a valuable measure to assess overall sexual function/dysfunction in women, especially because this scale is not biased toward any particular sexual orientation or a woman’s current involvement in a relationship. Its brevity is particularly appealing but could also run the risk of being criticized for being too simplistic to capture the nuances of different sexual dysfunctions. One of the drawbacks is the lack of items addressing some important aspects of FSD such as dyspareunia. At the moment, further research is needed concerning the reliability and validity of the scale and thus it cannot be currently recommended for routine clinical practice.
Golombok–Rust Inventory of Sexual Satisfaction (GRISS) The initial version of the GRISS [31,32] included 96 items on sexual function (not sexual satisfaction) developed by sex therapists. The sexual dysfunction measured by this scale does not correspond to the standardized definitions adopted by this committee. Through the elimination of items with extreme scores, the scale was reduced to 56 items for men and women: 28 were included in the female scale and 28 in the male scale. The scale was first divided into seven subscales comprising four items each. It is possible to compute a total score. The factors infrequency, noncommunication can be directly compared between men and women because gender-specific weights based on the normal population allow for comparison based on the norms for men and women. It does not need to be administered to both partners of the dyads but can independently be used to assess women. However, it requires for women to be in a relationship. It takes approximately 15 minutes to complete. Initially, the scale was administered to 44 couples. Later, the validation of the scale included scores from 30 couples receiving sex therapy. The GRISS has been widely used and data exist on large samples recruited from both the clinical and the nonclinical population, but none of the samples can be considered an unbiased sample of the population. A Dutch version exists but no information is available on the validity and reliability of the translation [66]. J Sex Med **;**:**–**
12 A high correlation was found between the clinician report of severity of dysfunction (0 = no problem to 3 = severe problem) and the overall score (r = 0.56, P < 0.001). A later study [66] of internal consistency of the questionnaire found that a fourfactor construction was more stable. Discriminant validity was tested by comparing the diagnoses reported by the clinicians with the scores obtained in the single scales. The scale showed to be sensitive to treatmentinduced changes in sexual function as tested in 30 couples who received five psychotherapy sessions. The overall score was able to discriminate between clinical and control groups. The distinction between clinical and nonclinical patients was made by an interview conducted by experienced sex therapists. Strengths and Limitations. One strength of the GRISS is the availability of a comparable scale for men. Unfortunately, the concepts tested by the items are associated with somewhat outdated views of female sexuality. Some of the areas of sexual function, such as vaginismus, occupy a prominent part of the scale, while other aspects more prevalent among women, such as hypoactive sexual desire, are part of a general scale that measures overall “sexual maladjustment.” Currently, this scale cannot be recommended for routine clinical use.
Level IB: Distress/Personal Problems Female Sexual Distress Scale (FSDS-R) The FSDS [33] was initially developed to assess a unidimensional concept of personal distress associated with sexual problems. The original scale included 20 items later reduced to 12. More recently, a 13th item has been introduced to the scale (FSDS-R) [34]. Items address both intensity and frequency of distress and are scaled on a 5-point Likert scale. The items are phrased so that they can be completed independently of sexual orientation and relationship status. It takes about 5–10 minutes to fill out. The initial pool of items was generated by a committee of experts and was then piloted on 78 women. Subsequent studies were conducted on samples recruited for treatment outcome studies and from the community with samples as large as 174. Test–retest reliability at 1- and 4-week intervals was adequate, and the internal consistency for individuals with (Cronbach’s a = 0.88) or without (Cronbach’s a = 0.86) FSD was excellent. The J Sex Med **;**:**–**
Giraldi et al. addition of the 13th item did not appear to modify the psychometrics qualities [34]. An analysis of the sensitivity of all cutoff scores revealed that ⱕ15 is the most sensitive and specific cutoff score to distinguish women without and with sexual distress among women. In addition, the FSDS was shown to be sensitive to treatmentinduced changes in a sample of 160 women with FSAD [33]. This questionnaire has been utilized by clinicians and researchers in several clinical drug trials for the treatment of HSDD and FSAD as well in studies of clinical and nonclinical samples. Therefore, the experience and pool of data using the instrument is large. The authors are constantly acquiring normative data on new populations. The scale has been validated in several languages. Strengths and Limitations. The industrysponsored, well-validated FSDS focuses on personal distress and thus allows clinicians to address an aspect of FSD that is often missed in reports on FSD. This instrument can be recommended for clinical use.
Level IC: Satisfaction Sexual Satisfaction Scale for Women (SSS-W) The SSS-W [35] was developed based on prior studies of sexual satisfaction. The authors suggest that women’s sexual satisfaction has two components, Personal and Relational, and items were developed to represent these components. The factor structure of the questionnaire supported five domains. Each domain includes six items. A total score can be calculated for overall sexual satisfaction. Response options are along a 5-point scale ranging from strongly agree to strongly disagree The scale takes approximately 15 minutes to complete. After an initial item-development phase, the instrument was validated on 119 female college students and subsequently tested on 181 women aged 18–70 years recruited from the community. The scale has not, to our knowledge, been used on a population-representative sample. The internal consistency for the SSS-W and for its domains is good to excellent (a = 0.72–0.94), while test–retest reliability is slightly lower (Pearson’s r = 0.72–0.87), though fully acceptable, with some exception for the communication domain (r = 0.60). Thus, the scale can be considered reliable. The convergent validity of all domains with the FSFI is at the level of P < 0.001. The validity determined against the Lock Wallace Marital
Questionnaires for Assessment of Female Sexual Dysfunction Adjustment Test (LW-MAT) is also generally acceptable. Multiple regressions indicated that the domain scores explain about 40% of the FSFI (satisfaction domain) and the LW-MAT. Data on discriminant validity, sensitivity, and specificity has not so far been published. Currently, the scale is available exclusively in English and no validity information is available for individuals from different ethnic backgrounds or women in same sex relationships. Although the items are appropriate for women from different sexual orientations, no information is available on the validity of this scale in non-heterosexual women. There is no cutoff score. The scale could distinguish between women with and without sexual problems in a sample recruited from the community (44% of the sample had no sexual problems) and assessed from a trained interviewer [35]. Strengths and Limitations. The SSS-W appears to be a well-designed, comprehensive instrument with adequate preliminary psychometric properties. Its development was not sponsored by industry and its uniform scaling may compensate for its relative lengthiness. The only evident shortcomings of the instrument are a lack of prospective validation studies, a somewhat weak background of its domain structure, and the lack of cutoffs. In the future, the SSS-W may be recommendable for routine clinical use, but further validation is needed.
Sexual Life Quality Questionnaire (SLQQ) The SLQQ was developed by Woodward et al. [36] in cooperation with an industrial partner. It intends to be a uniform instrument that can be used for evaluation of sexual Quality of Life (QoL) and satisfaction in men with erectile dysfunction (ED) and their partners. Among the 16 items, 10 address a domain termed QoL and 6 address treatment satisfaction. The QoL section does not explicitly ask about quality of sexual life, but addresses ease of penetration and orgasm. The treatment satisfaction section measures ease and efficacy of treatment. All 10 items are reported on a scale ranging from worse (0) than before the ED developed. The scale can be used only with heterosexual women involved in a relationship. The questionnaire was developed using two samples of urology patients and their partners. During a careful two-step development, a total of 180 men and 127 women completed the QoL part. In the subsequent prospective step, approximately 100 patients (mean age 57 ⫾ 10 years) and 100 partners completed the
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questionnaire before and after treatment for ED. A 60% retention rate for female partners was reported, indicating an adequately representative sample. No population-representative sample was utilized to test the scale. In very stringent analyses, Cronbach’s a was generally excellent (a > 90) both for the QoL and treatment satisfaction. No results for test–retest analysis are available. According to the authors, a factor analysis did indeed suggest that QoL and treatment satisfaction are conceptually distinct structures, but it is impossible to evaluate the accuracy of this information as no statistics were provided to support the statement. The two-factor structure accounts for 72% of the variance in the scale, indicating the items provide an appropriate explanation of the underlying construct. The sensitivity and specificity of the scale was assessed in another study on sexual satisfaction after treatment for ED [67] and the sensitivity of the SLQQQoL in female partners of men with ED appeared excellent. No information is available on the scale translated in different languages or administered to women from different ethnicities. No cutoffs are available for the scale. Strengths and Limitations. This instrument is interesting and may, in time, show adequate psychometric qualities. A major limitation of the scale, besides its restricted use for ED patients and their partners, is the absence of a definition of QoL and the relatively questionable face validity of the items (only two of the items explicitly include the term “satisfaction”). More information on the ability of this instrument to discriminate between women with and without sexual dysfunction is required before it can be recommended as a standardized instrument for routine clinical practice.
Treatment Satisfaction Scale (TSS) The TSS [68] is an industry-supported sexual life quality questionnaire that intends to measure patient and partner satisfaction during treatment of male sexual dysfunction. The female part of the original TSS focuses mainly on satisfaction with the male partner’s erectile and ejaculatory functioning, and also on her desire, orgasm, and sexual pleasure. This female part of the original questionnaire contains 12 pretreatment and 19 active treatment items After deliberations, the number of questions were reduced thereafter focusing exclusively on satisfaction with male partner’s erectile ability This final version contains six subdomains with one to three items each, plus five items in the J Sex Med **;**:**–**
14 medical module [37]. The items are answerable on 5-point Likert scales and mostly address satisfaction. A factor analysis was computed on the original questionnaires completed by 317 men with ED and 70 female partners. Unfortunately, no adequate epidemiological study has been conducted to test the validity of the scale. The internal consistencies of all four pre- and posttreatment modules is excellent (a = 0.88– 0.92). No test–retest has so far been attempted. Unfortunately, necessary details of the factor analysis conducted by the authors are not available. Concurrent validity as measured for all modules against the International Index of Erectile Function and the SLQQ domains is at least at the P < 0.05 level [38]. The scale takes a few minutes to complete and the items and instructions are clear. However, it was developed for heterosexual couples. The scale was initially carefully conceptually and linguistically developed in several languages but information on the validity and reliability for each language is not available. No information is available on whether the scale can discriminate between women with and without a sexual dysfunction. No cutoffs are reported and no information on specificity and sensitivity is available. Strengths and Limitations. The basic strengths of the TSS are its wide scope and inclusion of a variety of aspects of satisfaction in women in relationships with men with ED and its availability in multiple languages. Further validation studies are said to be ongoing. Although the TSS has been used in recent clinical trials, further explorations of its psychometrics are necessary. Because of the limited information available, this instrument cannot be recommended for routine clinical practice at the moment.
Life Satisfaction Checklist (LiSat-9/-11) LiSat [39] is one of few epidemiologically validated instruments. The underlying paradigm of the instrument is that satisfaction with life as a whole, and with 10 different life domains, mirrors a subject’s level of coping. It originally comprised eight to nine items, of which one addressed satisfaction with sexual life. Items are identical for women and men. A subsequent analysis added two items on satisfaction with somatic and psychological health to create the LiSat-11. Each item utilizes a 6-point graded scale. This version was used in an epidemiological investigation in Sweden of 1,335 women and 1,475 men aged J Sex Med **;**:**–**
Giraldi et al. 18–74 years whose partners were not studied [39]. The checklist can be completed in approximately 5 minutes. Test–retest reliability assessed with a 4-week interval is fair to good (rs = 0.60–0.81). No further analyses of reliability have been performed. The checklist has a robust factor structure for the four domains on satisfaction with: Closeness, Health, Spare Time, and Provision. These factors explained 70% of the variance, indicating that the items adequately captured the underlying construct of global QoL, with the factor Closeness and family life (40% of variance). The internal consistency for all the items was low to adequate, ranging from a = 0.57 to 0.79. The validity and reliability of the scale is available in numerous languages. Convergent validity is evidenced by the moderate correlation between distress about the sexual dysfunction and overall sexual satisfaction, satisfaction with partner relationship and spare time, and low correlation with somatic and psychological health. Strengths and Limitations. The strength of this instrument is that it strictly adheres to the term satisfaction, it has been epidemiologically developed, and it can be used with couples. However, only one item is utilized to assess sexual satisfaction, and the current absence of important psychometric analyses makes it dubiously recommendable as a routine clinical instrument.
Level II: Specific Dysfunctions HSDD Screener The HSDD screener [40] was developed with support from an industrial partner. The motivation for the development of this screener was to standardize the screening of HSDD in primary clinical settings. The items were carefully designed by involving focus groups with women from a representative range of ages, and from different countries in the European and North American continents. The screener contains four questions (three on desire/interest and one on distress) each scored on a 5-graded Likert scale. The development of this scale is based on convenience samples of 676 postmenopausal women, average age 54.5 years with clinically or web-based self-reported HSDD, and 283 women with no self-reported FSD. The original development showed excellent results of its validity and its internal consistency was also adequate (Cronbach’s a = 0.79). The results from the HSDD screener
Questionnaires for Assessment of Female Sexual Dysfunction were compared with a clinical assessment conducted by trained interviewers using a structured diagnostic method, a standardized interview with adequate reliability and validity. The results showed an 83% agreement between clinical diagnosis and screener, corresponding to kappa statistics = 0.67, indicating substantial agreement between the two methods. The screener can be used on women not in a relationship and is applicable to non-heterosexual women. Item instructions are clear and cutoffs are identified for each item. The instrument takes less than 5 minutes to administer and does not require training, In fact, physicians administering the screener were able to correctly score the scale in 97.9% of the cases. Strengths and Limitations. The HSDD screener is easy to use, valid, and clinically useful to identify postmenopausal women who are likely to be experiencing HSDD. Despite the shortness of the screener, questions about distress are included making this screener particularly useful from a clinical point of view. It can be used in women with and without a partner. In addition, it may be particularly useful to utilize this measure to provide an initial screener for participants’ recruitment in treatment outcome studies. It can be recommended for daily clinical use, but it has to be recognized that it does not assess other types of sexual dysfunction than HSDD.
Sexual Arousal and Desire Inventory (SADI) The SADI is a 54-item scale developed without industry support [41]. The SADI uses adjective descriptors to assess sexual arousal and desire in both women and men. The descriptors are rated along a 6-point Likert scale. A four-factor model was found for both women and men, but accounting for only 42% of the total variance, thus indicating that the items only partially assessed the underlying construct. The SADI can be used to assess both “state” and “trait” sexual arousal and desire, with the instructions altered at the beginning to have subjects reflect upon either induced sexual arousal in the laboratory or clinic (e.g., following the presentation of an erotic film), or on their normative sexual interactions (which can be specific to sexual intercourse or masturbation, or open-ended to include all sexual activity). It takes about 10 minutes to fill out. The original scale was developed in English and was tested on over 300 men and women (ages 19–45 years), with the majority being young, Canadian, heterosexual undergraduate students.
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Cronbach’s a coefficients demonstrated excellent reliability of the SADI subscales (a > 0.92). Evidence of convergent validity between the SADI subscales and other scales, e.g., Multiple Indicators of Subjective Sexual Arousal, the Sexual Desire Inventory, and the Attitudes Toward Erotica Questionnaire, that measured the same constructs was strong. Discriminant validity was also confirmed between the SADI subscales and the other scales that did not measure levels of sexual arousal, desire, or affect, such as the Beck Depression Inventory-II (BDI-II). The scale is currently being evaluated in terms of its ability to discriminate between individuals with different sexual dysfunctions. The SADI has been translated into several main languages. These translations showed similar factor structures and item loadings. The instrument can be used with all women independently or their sexual orientation of relationship status. Strengths and Limitations. The SADI is a valid and reliable research and clinical tool to evaluate both state and trait aspects of subjective sexual arousal and desire in women (and men). One advantage of the scale is its flexibility: it can be tailored to assess overall (trait) sexual arousal and desire in a normative period preceding an interview (e.g., 4 weeks), or to assess those variables following a particular treatment or experimental manipulation (state). However, the combined variance explanation by the four domains is rather low. Additional data on the epidemiological validity of the scale would provide valuable normative information. The SADI may become useful both for initial screening and outcome following treatment interventions. At the present time, the questionnaire cannot be recommended for routine clinical use.
Sexual Interest and Desire Inventory—Female (SIDI-F) The SIDI-F [42,43] is a clinician-administered tool specific to problems in sexual desire among premenopausal women. The most recent version of this instrument comprises 13 items targeting aspects of sexual desire along with other nondesire compartments. Items are scored on 4-, 5-, or 6-point Likert scales. Initially, 17 items were tested on 448 premenopausal women aged 18–45 years in stable heterosexual relationships. After reevaluation, 13 items remained; five of these showed a clear relationship with levels of HSDD severity. The 13-item SIDI-F was psychometrically tested on 130 women with primary HSDD and J Sex Med **;**:**–**
16 124 women with no FSD recruited from different European countries and from North America. The scale has excellent internal consistency (Cronbach’s a = 0.90). Five items, Receptivity, Initiation, Desire-Frequency, Desire-Satisfaction, and Thoughts-Positive, had the highest Cronbach’s a (= 0.79), confirming that the core construct measured by the SIDI-F is better captured by those items. Items with rather unsatisfying inter-item reliability were Affection, Erotica, ArousalFrequency, Arousal-Ease, Arousal-Continuation, and Orgasm (Cronbach’s a ⱕ 0.59). The SIDI-F had acceptable test–retest reliability after a 28-day lag time (r = 0.72) [42]. The internal consistency was lower in women from the European Union (Cronbach’s a = 0.79) than that of women from the United States (a = 0.90). The SIDI-F was able to discriminate between women with and without HSDD, and showed adequate discriminant validity with the Marital Adjustment Scale. The scale had high convergent validity with the FSFI Total Score and the CSFQ Total Score (a ⱖ 0.75). The scale has been validated in multiple languages. It requires an interviewer, but is easy and fast to administer. Strengths and Limitations. The careful analyses used for item selection is certainly a strength of this scale. The scale includes distress as an important part of FSD. Future studies are needed for validation of the SIDI-F including specificity and sensitivity in other populations than premenopausal women, in women not in relationship and in non-heterosexual women. It will likely be recommendable for routine clinical use after further psychometric assessment.
Cues for Sexual Desire Scale (CSDS) The CSDS [44] was originally created to explore low sexual desire in women with HSDD. Based on the sexual desire model provided by Levine [69], the authors collected empirical evidence for the cues that activate sexual interest in women. The CSDS asks women to indicate their interest in sexual activities after exposure to sexual cues that normally increase desire in women. Participants rate on a 5-point Likert scale from “not at all likely” to “extremely likely.” The original 120 items were generated by 50 women (18–67 years old) in response to the prompt: “What makes you desire sexual activities?” Based on data from 874 women, the items were then reduced to 40 items subdivided into four analytically supported factors. The inter-item reliability was high while no information is available on test–retest reliability. The J Sex Med **;**:**–**
Giraldi et al. scale was able to discriminate between women with and without HSDD among premenopausal and menopausal women [44,45], but no information has been given on its responsitivity (ability of the CSDS to detect treatment-induced changes). Strengths and Limitations. A clear strength of this non-industry–sponsored questionnaire is the focus on clinically meaningful aspects of sexual desire. Unfortunately, very little information is available on psychometrics necessary for the clinical validation of the scale. Additionally, norms are needed for different groups of women based on characteristics such as sexual orientation, ethnic background, relationship status, hormonal and developmental differences. Because of these limitations, this questionnaire is at the moment not recommendable for routine clinical use.
Women’s Sexual Interest Diagnostic Interview (WSID) and the WSID-Short Form (WSID-SF) The WSID [46] is an industry-sponsored instrument consisting of a structured interview primarily to assess HSDD in clinical patients, but also to address other types of FSD. This interview is based on the DSM-IV [5] and the consensus report [7]. It addresses distress, objective and subjective arousal, and partner relationship. Two versions have been developed: a structured clinicianadministered interview and a self-report version using an interactive voice response system. The interview consists of 39 items that use a yes/no dichotomy or 5-graded Likert scales. Interestingly, the interrater reliability was assessed and found adequate using trained actresses in video-taped situations. Based on the preliminary investigations, the short from was developed (WSID-SF) in a study on 629 postmenopausal women aged 39–66 years evaluated for HSDD [70]. The WSID-SF is a nine-item questionnaire and includes questions about distress. Items were answered using a touch-tone telephone. The women were all in a stable relationship, but no information on the partner’s gender was provided. The questionnaire exists only in an English version. There is no information on the time it takes to answer the questionnaire. A subgroup of 175 subjects were also interviewed by an experienced clinician. The current study demonstrated good diagnostic sensitivity (70%) and specificity (89%) with a kappa coefficient of 0.46 reflecting agreement on the diagnosis of HSDD between the clinician and the WSID-SF [70].
Questionnaires for Assessment of Female Sexual Dysfunction Strengths and Limitations. This structured questionnaire is in its very early phase of development, but the results are promising. This instrument is easy and quick to administer and can be used by nontrained clinicians to screen for HSDD. It includes distress as an important part of HSDD. A limitation is that it only covers HSDD and no other female sexual dysfunction. There is no information on whether it can be used in homosexual women and women without a partner. It is easy to answer and may be used in the future for screening of women for HSDD. It can be recommended for daily clinical use for screening for HSDD in postmenopausal women. It has to be recognized that it does not assess other types of sexual dysfunction than HSDD.
Decreased Sexual Desire Scale (DSDS) The DSDS [48] is a 5-item instrument, developed with industry support. This scale is intended as a screener for the use of nonspecialists to identify generalized, acquired HSDD in pre-, peri-, and postmenopausal women. It is based on the DSM-IV definitions [5] and focus primarily on HSDD. The DSDS has four items addressing desire and distress. If the woman answers no to any item, she does not qualify as having HSDD. The fifth item consists of seven questions pertaining to surgery, medical conditions and depression, reproductive, partner’s sexual problems, relationship, stress, and nonsexual symptoms typical of the menopausal transition. The DSDS was developed on 141 women with HSDD, 47 with other FSDs and 75 women without FSD. The validity of the instrument was tested by comparing the scoring of the DSDS computed by nonexpert clinicians with the clinical diagnosis of an expert. A yes to any of the seven questions needs to be explored by the clinician. The instrument has high sensitivity (0.84) and specificity (0.88). This measure takes 5–10 minutes to administer and has been translated into several languages. Although participants’ sexual orientation was not specified and the validation was not provided for non-heterosexual women, the wording of the screener could be used for women in same sex relationships. Strengths and Limitations. This instrument is easy and quick to administer and can be used by nontrained clinician to screen for HSDD. At the same time, the simplicity of the scale could omit important aspects of HSDD necessary to make a diagnosis. In summary, the instrument can be
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recommended for routine clinical use in women solely as a screener for acquired HSDD.
Orgasm Rating Scale (ORS) The development of the ORS was partly sponsored by the industry [47]. The ORS consists of a list of adjectives scored on a 5-point Likert scale ranging from “does not describe orgasm at all” to “describe it perfectly.” The scale is solidly based on the authors’ model that orgasm, in men and women, is best described by Sensory and Affective dimensions. Based on prior evidence that men and women describe orgasms using similar words, the 28 adjectives used in the scale are used for both men and women. The scale, however, distinguished responses regarding orgasm reached during solitary masturbation and orgasm reached during sex with a partner. The scale is quite lengthy to complete but provides a comprehensive description of people’s experiences of orgasm. The ORS was originally developed using a sample of 888 (523 women) students. In a subsequent analyses independent cross-validation was performed on 798 (503 women) students on an average of 23 years old (SD = 7.3). Factor analysis yielded different factor patterns for women and men, but unfortunately, coefficients of fit indices were below the standard cutoff indicating that the data did not adequately fit with the model, other than for women who described orgasm during masturbation (no partner involved). For the women, 11 factors were identified (50 items). The final 28 adjective list has excellent internal consistency, whether addressing the orgasm experience at solitary masturbation (women Cronbach’s a = 0.89) or at sex with partner (women Cronbach’s a = 0.88). The items can be applied to individuals independently from their sexual preference or relationship status. Instructions are clear and the items are easy to understand. So far, no norms or cutoffs have been published to clarify what scores to expect for women (or men) with orgasm dysfunction. Strengths and Limitations. The ORS presents a conceptual step forward to our measure of orgasm. Admittedly, it appears time consuming and the lack of model fit is a major drawback; however, in contrast to all other questionnaires reviewed in this report, it gives a detailed picture of the orgasm experience, thus bridging some of the simplification perils of questionnaires vs. a proper individual case history. Further psychometric investigations of reliability and validity are needed, as are test– retest reliability, norms, and cutoff scores for J Sex Med **;**:**–**
18 function and dysfunction. The instrument cannot, at the time, be recommended for daily clinical use.
Level III: Specific Conditions Aging: Scale for Quality of Sexual Function (QSF) The QSF [49] has been developed with industry support to capture health-related QoL (hQoL) with special focus on sexual functioning in aging women and men. The scale was not based on any particular diagnostic paradigm of sexual functioning, but rather focused on the definition of QoL. The instructions are clear. The scale, however, takes time to complete. The initial developmental phase consisted of 48 items mailed to a reasonably epidemiologically well-defined sample of 1,200 Germans (response rate 68%). Among respondents, 359 were women (and 379 men). Each item included in the most current version of the QSF is assessed along 5-graded categorical scales whose anchors vary based on the item. The factor analyses for this scale was computed on data derived from both genders and identified four domains (Table 1). Unfortunately, the four factors explained only 49% of the variance and some of the items showed quite low loadings within the factor where they were assigned. Cutoffs were provided for all four factors and for overall scores in terms of No, Little, Mild, Moderate, or Severe complaints/problems. The internal consistency for each factor was adequate to excellent for the comprehensive scale (Cronbach’s a > 0.80) and for three of the domains (Cronbach’s a = 0.90–0.75). The domain inquiring about the partner’s view had a markedly lower internal consistency (Cronbach’s a = 0.57). No further reliability data have been reported. Also, no validity assessments are reported in the original article. The items are indifferent to sexual preference and an ongoing partner relationship is not required. The final questionnaire (32 items) has been validated in English. It has no cutoff score distinguishing between dysfunction and nondysfunction. Strengths and Limitations. A strength of this questionnaire is its partial initial epidemiological development. Another strength is the versatility of the items that can be administered to both men and women. A limitation is a pronounced lack of explicit items that address orgasm or pain during sexual activities. Unfortunately, there is, at present, a serious lack of measures of reliability and validity. When more information on the psyJ Sex Med **;**:**–**
Giraldi et al. chometrics of this scale is available, the QSF could be considered valuable for comparison of aspects of middle-aged and elderly couples’ sexual experiences. Because of the limitations, the QSF currently cannot be recommended for routine clinical use.
Hormonal: McCoy Female Questionnaire (MFSQ) The MFSQ [50–52] is a self-reported questionnaire that measures sexual function related to changes in sex hormones such as those secondary to oral contraception and to the menopausal transition. The original version of the MFSQ used 17 questions answered on 7-point Likert scales. A later revision of the questionnaire added two more questions on attraction. The original 19 items were divided into five domains supported by factor analysis. The evidence for the validity of the original MFSQ is derived from studies comparing women taking oral contraception with women not taking contraception, and comparing menopausal women on hormone replacement therapy (HRT) and those not taking hormones. From the data available, it is not possible to derive a clear picture of the discriminant validity of this instrument, mostly because different studies utilized different combinations of the original 19 items. The Australian version of the MSFQ (the SPEQ) was shown to have adequate sensitivity and specificity for the discrimination between women with and without sexual dysfunction. The questionnaire is specific for heterosexual women and, although the authors first developed the instrument to be administered to women involved and not involved in relationships, there is no information, or norms, on how the scale should be scored for single women. The scale has been translated in several languages and a shorter English version has been validated on a sample of Australian women [50]. The SPEQ has shown fair to excellent test–retest reliability during a 1 week lag (r = 0.71–0.95). The Italian version of the MFSQ (the MFSQ-I) was able to distinguish between women with and without an FSD diagnosis determined by an interview administered by a clinical expert [52]. Unfortunately, given that different items were included in different modifications of the scale, it is not possible to evaluate the psychometrics of the MFSQ. Strengths and Limitations. The MFSQ has been translated into a number of languages. Also, this measure has shown sensitivity in assessing changes
Questionnaires for Assessment of Female Sexual Dysfunction in sexuality associated with hormonal status. Unfortunately, the numerous versions make the information on reliability and validity problematic. Moreover, some of the items are neither clearly defined nor in line with current definitions of sexual arousal and orgasmic response. Instruction scores are unclear: The original version of the MFSQ includes an item on frequency of sexual activities that is not clearly integrated in the total score. Based on these limitations, the MSFQ cannot be recommended for daily clinical use.
Menopausal: Profile of Female Sexual Function (PFSF) The PFSF [53,54] is a multidimensional questionnaire that was developed in several languages with support from the pharmaceutical industry. This scale is mainly based on the paradigm of the DSMIV-TR and recommendations of the Second Consultation on Sexual Medicine in 2004 [5,8]. The PFSF focuses on sexual function/dysfunction in surgically and naturally menopausal women. This instrument encompasses 37 items using 6-graded categorical scales. It was developed using 427 surgically or naturally menopausal women with HSDD and 359 naturally menopausal, nonHSDD women. Factor analysis based on the original 325 participants yielded factors factors. Explanations of variance are not reported by the authors. All domains have good to excellent internal consistency (Cronbach’s a = 0.74–0.96), while interval for test–retest reliability (interval not specified by the authors) is partly less impressive though generally acceptable (r = 0.57–0.91). Concurrent validity of the PSFS vs. the DISF-SR is good for relevant comparisons. The scale has excellent discriminant validity for surgically- and naturallymenopausal women with HSDD vs. controls. The PFSF can be completed by women with different sexual orientations and independently from commitment in a relationship. Neither cutoffs nor time consumption for completing this rather lengthy questionnaire are provided by the authors. The scoring instructions are clear. The norms are not based on an epidemiologically representative sample. Strengths and Limitations. The PSFS was carefully developed; it has generally adequate psychometric properties and is recommendable for clinical use with menopausal women. However, the lack of cutoffs is a clear limitation that needs to be considered if the instrument is to be used in clinical practice.
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Menopausal Sexual Interest Questionnaire (MSIQ) The MSIQ [55] is a unidimensional 10-item questionnaire for the assessment of sexual interest in postmenopausal women developed with pharmaceutical industry support. A pilot study of 224 postmenopausal women was performed to identify items. A study on postmenopausal women with (N = 221) and without (N = 111) HSDD tested the reliability and validity of this instrument. A principal components analysis explaining 75% of the variance identified three domains: Desire, Responsiveness, and Satisfaction. The scale showed excellent inter-item reliability (Cronbach’s a ⱖ 0.87) and acceptable test–retest reliability (r = 0.57–0.76). The discriminant validity of all three domains as well as sensitivity and specificity appear adequate. The questions do not require an ongoing partner relationship and are independent of sexual preference. No cutoffs are available. The time for administration appears very brief. Strengths and Limitations. Although some basic information on reliability and validity has been provided, this questionnaire was developed on small samples of women. A somewhat odd satisfaction label adds to our suggestion that although potentially promising, that pending further psychometric analyses the MSIQ cannot yet be recommended for routine clinical use.
Psychiatric: The Arizona Sexual Experiences Scale (ASEX) The ASEX [56] is a very brief, non-industry– sponsored five-item scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and orgasm satisfaction separately for men and women. The scale is not paradigmatically anchored in any particular theoretical or clinical system. Questions are rated along a 6 point Likert scale, thus composite scores range from 5 to 30. The ASEX was validated in a very small sample of women and men above the age of 17 years. Among this sample, 22 women were controls and 35 were psychiatric patients undergoing drug therapies for anxiety, panic, or depression (age range 28 to 62 years). The instrument is quick to administer and easy to score. The items are clear. The scale has been validated in a Turkish version [71]. Internal consistency was excellent (Cronbach’s a = 0.91). Test–retest reliability (1–2-week intervals) for the pooled female/male patients and controls was excellent (r = 0.80 and 0.89). Good J Sex Med **;**:**–**
20 discriminative validity between total scores for female patients and controls (P < 0.01) was demonstrated. Strong convergent and discriminant validity was assessed using correlations with the Brief Index of Sexual Functioning, BDI, and Hamilton Depression Rating Scale. ReceiverOperator Characteristic analyses indicated that a score over 19 is the most sensitive and specific to identify women and men with sexual dysfunctions. Strengths and Limitations. Despite the comprehensive psychometric testing and the brevity of the instrument, the very small sample used for the development of this questionnaire is problematic. Within certain areas of psychiatry, this instrument could be used to monitor sexual problems when they are not the primary focus of the clinical investigation. The ASEX cannot at the moment be recommended for routine clinical use. Data from an epidemiologically sensitive sample may improve the applicability of this instrument as a simple screener in the clinical setting.
Level IV: Instruments Currently Under Construction The Female Sexual Encounter Profile [72] is a 6-item diary used to assess sexual function that has been used to assess levels of sexual functioning in the areas of female sexual arousal. The scale was originally developed by a pharmaceutical company. Unfortunately, little information is available on the psychometrics of this instrument. The Detailed Inventory of Sexual Health Experience Survey (DISHES) [73] aims to provide a measure of sexual function, satisfaction or distress, the relationship between sexual function and intimate relationships, women’s health status, and hormonal status. Only preliminary results are available on a sample of 100 women, but currently, data from 1,000 women (personal communication) is under analysis. Discriminant validity was assessed by comparing the scores between women at “high” and “low” risk for sexual dysfunction determined through a review of medical records. The definition of “high” and “low” risk was not explained in the published abstract. Convergent validity was computed by comparing the ability of DISHES to the ability of the FSFI for predicting people in the “high” and “low” risk categories among postmenopausal women. Part 2: Development of the Sexual Complaints Screener for Women (SCS-W)
Through our review of available questionnaires it emerged that the field of sexual medicine has yet to J Sex Med **;**:**–**
Giraldi et al. develop a comprehensive self-report screener for sexual dysfunction that can be easily and quickly administered by nonspecialized clinicians and that addresses all domains of FSD, including distress. As described in the introduction, one aim of the Standards Committee was to develop a suggestion for such a screener.
Method Creating a state-of-the-art screener requires multiple steps: A) The identification of targeted areas that need to be included in the screener. B) The involvement of focus groups to provide qualitative data on the most appropriate wording of each item. Ideally, these groups would be conducted in different cultures and different languages so that different items would be culturally sensitive rather than having to rely on translations. C) Items derived from focus groups would then be administered to a large group of women with and without HSDD, FSAD, FOD, and sexual pain disorder. Experienced interviewers familiar with FSD should be involved in this phase of development to differentiate women with and without FSD. This phase of screener development would help identify the most useful items to retain for the screener and would provide information on reliability (i.e., test–retest analyses) and validity of the screener, in addition to information on cutoffs and sensitivity/specificity qualities of the screener. D) Finally, the screener should be administered to a large sample representative of the population to provide essential epidemiological data on norms. We provide here the product of the earliest development phase: the experts’ identification of the key areas to be addressed in the screener and their opinion on the way items could be formulated, with the understanding that these items may not reflect the best way to present these questions to the clients/participants. The first draft of the screener was developed by members of the FSD subcommittee and then presented to the full ISSM Standards Committee. Each item was discussed and revised until consensus was obtained about its content and clarity. The revised screener was thereafter sent to all members of the ISSM Standards Committee for approval. In a simultaneous process, a screener for male sexual dysfunction was
Questionnaires for Assessment of Female Sexual Dysfunction also developed. Our collective aim was that the length and structure of the male and female screeners would be similar. When developing the screener, the FSD subcommittee identified relevant domains based on current definitions of FSD [4] and attempted to provide an instrument that could be administered quickly. The structured questionnaire encompasses 10 items; each of the sexual function/ dysfunction items, constructed so that an a-series taps the degree to which the woman perceives dysfunction per se and a parallel b-series that addresses the intensity of personal problems (distress) caused by a dysfunction (Appendix 1). The screener intends to cover sexual desire/interest, objective and subjective arousal, orgasm, pain, vaginismus, PGAD, and satisfaction with one’s sex life. PGAD was included although it is not found yet in any official diagnostic guidelines, but as it is a condition where more and more data are being collected, we found it most correct to include it. In the validation process, it will show whether it is relevant in a screener like the one proposed here. A 5-point Likert scale was agreed upon except in the case of one question on self-reported overall sexual satisfaction (taken from the LiSat 8–11 checklist) where a 6-point scale is used [38]. The basis for the development of this (and the corresponding male) screener is the large-scale epidemiological investigation performed in Sweden in the late 1990s where both functions/dysfunctions per se, and concomitant personal problems, were measured in relative frequencies [74,75]. This brief, self-administered screener is neither sufficiently detailed for obtaining an adequate diagnosis, nor is it constructed to provide end points for specific clinical trials. It is not constructed to be used as an aggregated scale, and it should be noted that the screener suggested in this article that it is not yet psychometrically tested for its construct, reliability, or validity. Therefore, the committee is unable to comment on the feasibility of the proposed items to be accurate, sensitive, or specific for the identification of patients who could be suffering of sexual dysfunction. In its future work, the Committee plans to explore the construct, reliability, and validity of the screener in a set of multi-site trials. Conclusions
Numerous theoretical and clinical models have been proposed to describe and explain female sexual function and various dysfunctions [5,7–9].
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This poses a challenge for the assessment of sexual problems for both specialist and nonspecialist alike, and for the preparation of clinical trials and measurement of clinically relevant endpoints. The availability of adequately validated and easy to use questionnaires could provide a valuable support for nonspecialists interested in assessing sexual problems in their patients. Based on this aim, the present analysis first reviewed published questionnaires that measure different aspects of women’s sexual function. Our second aim was to suggest an easyto-use screener for FSD, primarily as an aid for the clinician not specifically trained to diagnose FSD. In the review of existing questionnaires, 27 were identified that have been developed with different purposes over the past two decades, as the definitions of FSD have developed and changed. In this context, we must point out that no questionnaire covers all domains of women’s sexual function/ dysfunction as currently defined. Very few of the questionnaires reviewed have been thoroughly validated epidemiologically in reasonably large, randomized, representative samples. On the other hand, several instruments have been analytically and epidemiologically described. Several of the questionnaires are useful for screening specific sexual problems, whereas others provide a measure for the severity of specific symptoms or diagnoses. Some questionnaires are also validated for measuring treatment-induced changes in sexual behavior or function. However, the ongoing shift in definitions of different components or types of FSD makes it difficult, if not impossible, to compare the virtues and shortcomings of different questionnaires. This review reveals a serious lack of standardized, internationally (culturally) acceptable questionnaires that are truly epidemiologically validated in general populations and that can be used in women with or without a partner and independent of the partner’s gender. Such instruments should preferably be “neutral” in those regards, and should ideally not be tailor-made for specific industrial purposes. However, we hope that this overview provides the reader adequate information on which FSD-related questionnaires can be used at the present time for clinical or research purposes, and what their major strengths and limitations are. Following the instructions of our Committee Chair, we have endeavored to suggest areas to be included in a brief FSD-screening tool. The construction of the screener is, to a certain extent, based on methods used in previous epidemiological research [76]. The present preliminary suggesJ Sex Med **;**:**–**
22 tions for a brief FSD-screening tool aimed to address all domains of sexual dysfunction without limiting the questions to women in a heterosexual relationship. Moreover, we aimed at developing a quick screener that includes sexual dysfunctions per se and personal problems/distress, focused on the current situation (last 6 months), and addressed sexual satisfaction. The screener is primarily meant to initiate and facilitate communication about sexual issues between the nonspecialist in sexual medicine and the patient as a support for clinicians who may be less familiar with sexual medicine who may not routinely discuss sexual issues with their patients. Furthermore, it is aimed at helping the clinician identify when further need for assessment may be indicated. This is intended to lead to differential diagnostics and perhaps a choice of treatment that will maximally benefit the patient. Additionally, it may serve to break cultural or individual resistance related to disclosing sexual problems to a clinician. A self-administered screener can be useful in the initial process as indicator of whether the woman has or is at risk of having a dysfunction and in what domain the problem may lie. Answers to the b-series questions that indicate dysfunctional distress (personal problems) should create an opportunity for the clinician to initiate or continue a dialog with the patient. Since the Standards Committee developed the screener, Kriston et al. have published their data on a one-question screener for routine use to open the discussion about sexuality and indicating whether the woman has FSD or not [77]. They reported, based on data on 6,194 women, that one dichotomous question for overall satisfaction with sexual life had an acceptable sensitivity (76.4%) and specificity (76.5%) while a more extensive five-question version had higher sensitivity (83.1%) and specificity (81.2%) in identifying women with FSD. This could proceed to further diagnostic assessment during which more precise questionnaires may provide relevant information for the clinician to identify areas of sexual function that need further exploration, and that would finally be explored with a relevant case history. Thus, a screener or even a sophisticated questionnaire cannot substitute for a thorough case history. Acknowledgments
The authors want to express their thanks to the International Society for Sexual Medicine for establishing J Sex Med **;**:**–**
Giraldi et al. the Standards Committee, which we have been a part of. Thanks to the rest of the members for feedbacks and fruitful discussions. A special thanks to our Chair, Professor Dr. Hartmut Porst, for his tremendous work and dedication to the Standards Committee, creating some of the best and most inspiring meetings we have ever attended. Corresponding Author: Annamaria Giraldi, MD, PhD, Department of Sexological Research, Rigshospitalet 7411, Blegdamsvej 9, Copenhagen, 2100, Denmark. Tel: (45) 35 45 76 79; Fax: +4535457684; Email:
[email protected] Conflict of Interest: Annamaria Giraldi: Advisory board: Boehringer Ingelheim, Bayer Schering, Grant recipient: Boehringer Ingelheim, speaker: Beohringer Ingelheim, Eli Lilly. Alessandra Rellini: None. James G. Pfaus: Advisory board: Boehringer Ingelheim, Takeda/ Lundbeck, Eli Lilly. Contract grants: Boehringer Ingelheim, Takeda/Lundbeck, Eli Lily. Speaker: Boehringer Ingelheim. Research grants: Canadian Institutes of Health Research, Fonds de la recherche en santé du Québec, Natural Sciences and Engineering Research Council of Canada. Johannes Bitzer: Advisory boards of Bayer Health Care, MSD, Lilly, Pfizer, Boehringer, Procter and Gamble and has received honoraria for lectures and educational material by Bayer Health Care, MSD, Lilly, Pfizer, Boehringer, Procter and Gamble, Solvays Pharma. Ellen Laan: Trimel Biopharma. Emmanuele A. Jannini: None. Axel R. Fugl-Meyer: None.
Statement of Authorship
Category 1 (a) Conception and Design Annamaria Giraldi; Alessandra Rellini; Axel R. Fugl-Meyer; James G. Pfaus; Johannes Bitzer; Ellen Laan; Emmanuele A. Jannini (b) Acquisition of Data Annamaria Giraldi; Axel R. Fugl-Meyer; Alessandra Rellini; James G. Pfaus; Johannes Bitzer; Ellen Laan; Emmanuele A. Jannini (c) Analysis and Interpretation of Data Annamaria Giraldi; Axel R. Fugl-Meyer; Alessandra Rellini; Johannes Bitzer; Ellen Laan; Emmanuele A. Jannini
Category 2 (a) Drafting the Article Annamaria Giraldi; Axel R. Fugl-Meyer; Alessandra Rellini; James G. Pfaus; Johannes Bitzer; Ellen Laan; Emmanuele A. Jannini (b) Revising It for Intellectual Content Annamaria Giraldi; Axel R. Fugl-Meyer; Alessandra Rellini; James G. Pfaus
Questionnaires for Assessment of Female Sexual Dysfunction
Category 3 (a) Final Approval of the Completed Article Annamaria Giraldi; Alessandra Rellini; Axel R. Fugl-Meyer
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Appendix 1 Sexual Complaints Screener for Women (SCS-W) This screener is a series of questions concerning your sexual experiences during the last 6 months. Each question can be answered by circling the condition that best characterizes your personal experience. Sexual activity includes any activity aimed at experiencing sexual satisfaction and enjoyment. The term sexual activity does not necessarily include sexual intercourse (vaginal or anal penetration).
1a) Some women experience lack of or low sexual interest/desire in sex. Has this happened to you during the last 6 months? 0. Never/almost never 1. Rarely 2. Sometimes 3. Often 4. Almost all the time/Always
1b) Has this been a personal problem for you? 0. Not at all a problem 1. A very small problem 2. Some problem 3. A considerable problem 4. A very great problem
2a) Some women do not experience physical sexual excitement (e.g., genital swelling, vaginal wetness, tingling sensation) during sexual stimulation and/or sexual activity. Has this happened to you during the last 6 months? O No sexual activity 0. Never/almost never 1. Rarely 2. Sometimes 3. Often 4. Almost all the time/Always
2b) Has this been a personal problem for you? 0. Not at all a problem 1. A very small problem 2. Some problem 3. A considerable problem 4. A very great problem
3a) Some women do not feel sexually turned on or do not have pleasurable sexual feelings when engaging in sexual activity. Has this happened to you during the last 6 months? O No sexual activity 0. Never/almost never 1. Rarely 2. Sometimes 3. Often 4. Almost all the time/Always
3b) Has this been a personal problem for you? 0. Not at all a problem 1. A very small problem 2. Some problem 3. A considerable problem 4. A very great problem
4a) Some women experience difficulties reaching orgasm during sexual activities despite feeling sexually excited. Has this happened to you during the last 6 months? O No sexual activity 0. Never/almost never 1. Rarely 2. Sometimes 3. Often 4. Almost all the time/Always
4b) Has this been a personal problem for you? 0. Not at all a problem 1. A very small problem 2. Some problem 3. A considerable problem 4. A very great problem
5a) Some women experience genital pain during or shortly after sexual activity. Has this happened to you during the last 6 months? O No sexual activity 0. Never/almost never 1. Rarely 2. Sometimes 3. Often 4. Almost all the time/Always
5b) Has this been a personal problem for you? 0. Not at all a problem 1. A very small problem 2. Some problem 3. A considerable problem 4. A very great problem
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Appendix Continued 6a) Some women experience difficulties allowing vaginal penetration despite their wish to do so. Has this happened to you during the last 6 months? O No sexual activity 0. Never/almost never 1. Rarely 2. Sometimes 3. Often 4. Almost all the time/Always
6b) Has this been a personal problem for you? 0. Not at all a problem 1. A very small problem 2. Some problem 3. A considerable problem 4. A very great problem
7a) Some women experience persistent and unwanted genital arousal (tingling, throbbing, pulsating) in the absence of any sexual interest. Has this happened to you during the last 6 months? 0. Never/almost never 1. Rarely 2. Sometimes 3. Often 4. Almost all the time/Always
7b) Has this been a personal problem for you? 0. Not at all a problem 1. A very small problem 2. Some problem 3. A considerable problem 4. A very great problem
8a) During the last 6 months, my sexual life has been: 0. Very unsatisfying 1. Unsatisfying 2. Rather unsatisfying 3. Rather satisfying 4. Satisfying 5. Very satisfying 10) Is there anything else you would like to tell us with respect to your sexual life? For those who have not been sexually active during the last 6 months please explain why you have been sexually inactive. 11) Would you want your physician (counselor) to further explore sexual difficulties and/or problems with you?
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0. No 1. Not now 2. Yes
