Curr Sex Health Rep DOI 10.1007/s11930-015-0052-z
MALE SEXUAL DYSFUNCTION AND DISORDERS (SE ALTHOF AND AW PASTUSZAK, SECTION EDITORS)
Review of Patient-Reported Outcome Measures for Sexual Dysfunction Leonard R. Derogatis 1
# Springer Science+Business Media, LLC 2015
Abstract Recently, the high prevalence of sexual dysfunctions in our society has become a topic of public awareness and has encouraged a substantial interest in the media and on the part of the pharmaceutical industry in the field of sexual functioning. This attention has resulted in an expansion in the development of measures of sexual function/dysfunction for use as outcome measures in clinical drug trials. The instruments tend to be brief self-report inventories, typically requiring no more than 20 min of respondent time for completion. All of these instruments must adhere to recently prescribed rigorous guidelines set forth by the FDA and be valid and reliable indicators of the sexual function constructs they purport to measure. The constructs that provide the framework of our diagnostic system for sexual dysfunctions are not amenable to direct physical measurement, so that they must be assessed via patient-reported outcome (PRO) measures. Although not as precise as physical measures, these psychological instruments do a capable job of quantifying and representing sexual functioning status in a concise and rigorous manner and have become indispensable tools in our clinical and research programs. Keywords Sexual function measurement . PRO’s . Sexual assessment . Sexual self-report . Self-report inventories
This article is part of the Topical Collection on Male Sexual Dysfunction and Disorders * Leonard R. Derogatis
[email protected] 1
Maryland Center for Sexual Health, Department of Psychiatry, Johns Hopkins University School of Medicine, 1300 York Rd. Suite 130, Bldg. A, Baltimore, MD, USA
Introduction The systematic assessment of human behaviors and capabilities via psychological measurement can be traced back surprisingly far, at least as far as the Chinese civil service over 1000 years BC. However, the beginning of modern psychological measurement is an innovation that first took shape at the turn of the 20th century [1]. During this extremely productive period, Galton developed the first psychological Bquestionnaire^ [2], Cattell coined the term Bmental test^ [3], Adolph Meyer developed the first psychiatric rating scale at Johns Hopkins [4], and Robert Woodworth constructed the first self-report symptom inventory at Columbia [5]. Any evidence of the psychological assessment of human sexual behavior is completely absent from this register of measurement innovations, in keeping with the social conventions of the time. A century later, circumstances have changed significantly. The awareness of a high prevalence of sexual disorders in the community [6], coupled with the contemporary expansion of research on pharmacologic treatments for sexual dysfunctions, has resulted in the development of a number of recent psychosexual measures. Much of this work has occurred during the past 15 years, paralleling the growth of research on pharmacologic treatments for sexual dysfunction and reflecting the emergence of Bpatient-reported outcomes^ (PRO’s) as standard outcome end points in trials regulated by the FDA. The term BPRO^ is an acronym proposed by the FDA to represent Bpatient-reported outcomes.^ PRO’s are intended to reflect any outcome based on self-report data provided by patients and used in the regulatory review process. These measures are used to help define or diagnose a condition and may also be used to demonstrate change from baseline to the end of a trial.
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For these reasons, it is important that clinicians as well as researchers in the field have accurate, up-to-date information concerning the outcome measures by which treatmentinduced changes are being recorded. The current review is designed to inform readers about the contemporary measurement options available for this purpose. In addition, it is important to understand the role that the FDA has had in establishing evaluative standards for these instruments. In December of 2009, the agency published a guidance titled BPatientReported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims^ [7]. The guidelines do not advance any new or innovative psychometric principles; however, they do outline in detail the expectations that the agency has regarding what they consider to be Bvalidated^ instruments. Obviously, a review on this topic could easily fill a book (see Davis, Yarber, Bauserman, Scheer and Davis, 1998 as an example) [8]. However, the PRO instruments reviewed here are limited to those that have an established, well-validated measurement profile, particularly in the field of clinical drug trials. The measures included are designed to not only assess sexual functionality, but also to address corollary questions concerning the detailed nature of dysfunctional states, such as distress or depression. It is virtually impossible to do such a review and not omit some deserving candidate(s). For any such oversights, I am truly sorry. However, I have tried my best to include those outcome measures that are currently principal to the field and stay within the page limit for the review.
The Nature of Psychological Measurement In contrast to physical measurement (like weight or distance), the principal function of psychological measurement is to provide valid, reliable operational definitions for hypothetical constructs, i.e.,entities that lack tangible material features. Sexual functioning, sexual desire disorder, and sexual satisfaction are all hypothetical constructs and must be operationally defined before they can be quantified and subjected to scientific manipulation. The methods and techniques of psychometrics provide the mechanism whereby these constructs become defined, quantified, and transformed into scientific variables capable of evaluation via scientific data analysis. However, because measurement is focused on constructs rather than tangibles, underlying measurement scales are not as sophisticated or powerful as those utilized in the physical sciences. This fact has sometimes been misconstrued to suggest that psychological measures are Bsoft^ or Bless scientific^ than measures of physical variables. This is not the case, but what is true about psychological as opposed to physical measurement is that because accompanying measurement scales are not as advanced, resulting errors of measurement are larger.
This characteristic does not result in psychological measurement being less scientific, it simply means that it is less precise.
Nosology of Sexual Dysfunctions A central issue in the measurement of sexual functioning resides in the diagnostic system (nosology) we currently use to define sexual dysfunctions. This is so because most of our measures of sexual functioning are designed around diagnostic models. There are two predominant nosologic systems currently in place for the diagnosis of sexual disorders: the World Health Organization’s International Classification of Diseases-10 [9] and the Diagnostic and Statistical Manual of Mental Disorders-5 of the American Psychiatric Association [10]. Current systems are very much a product of Masters and Johnson’s [11, 12], and later Kaplan’s [13], research and thinking concerning the sexual response cycle, which strongly emphasized sequenced and coordinated phases of desire, arousal, orgasm, and resolution. In this model, derangement or dysfunction can occur in any or multiple phases of the cycle, and the diagnosis is usually made independent of an etiological statement. The condition, so determined, is then assigned a label consistent with the dysfunctional phase (e.g., hypoactive sexual desire disorder, female arousal disorder, female orgasmic disorder). Consistent with this system, contemporary measuring instruments are designed to generate scores on Bdomains^ comparable to the major phases of the sexual response cycle. This mapping of outcome measurement domains directly to diagnostic construct categories has been recently identified as a potential multiplier of measurement error in situations where the diagnostic system is imprecise [14]. However, for the time being, this approach remains standard methodology. In addition to domain scores, many instruments also generate an aggregate Btotal score,^ which is designed to reflect the respondent’s status on a higher-order construct such as overall quality of sexual functioning.
Primary Applications for Measures of Sexual Function Basically, there are two primary areas of application for psychological instruments in the assessment of sexual function: screening and outcome measurement. In the screening application, a brief test or inventory may be used as a selection device for presumptive evidence of sexual dysfunction and/or its level of severity. Such assessments can be employed in primary care practices to identify patients with less obvious sexual dysfunction [15]. These
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screens also employed in many clinical trials as part of formal inclusion/exclusion criteria (e.g., the patient will be excluded if she does not score ≥15 on the female sexual distress scale (FSDS)). The screening functions of these instruments are many and varied and may arise in both clinical and research applications. For an in-depth review of screening with psychological measures, see Derogatis and Culpepper [16]. In the case of clinical research, more often than not, PRO instruments measuring sexual function are used as outcome measures. In this role, they are utilized to evaluate, in double blind, placebo-controlled designs, the efficacy of one or another form of treatment intervention, often a therapeutic drug. Since research with investigational drugs done in support of a New Drug Application (NDA) is closely regulated by the FDA, the standards put forward in the agency’s recent guidance [7] strongly influence PRO design. In order to support a labeling claim tied to an effectiveness endpoint, the designated instrument must be demonstrated to be an instrument that has been Bvalidated^ to establish such a benefit in the specific population under study.
Essential Characteristics of Validated Measures of Sexual Function As is true of scientific measurement in general, the two most fundamental characteristics of good psychological measurement are reliability and validity. The former refers to the consistency or replicability of measurement; it represents the ratio of true variation in the measurement to variation due to error. In contrast, validity addresses the essence of what is being measured; it reflects the degree to which an instrument measures what it purports to measure. Unlike reliability, which is established through a specifically prescribed series of studies, the validation of a measuring instrument is programmatic in nature. Validation is a continuing process which accumulates evidence from numerous exercises, studies, and trials; it is enduring, at least theoretically, and validation operations serve to continually test and extend the generalizability of an instrument’s validation envelope. Nunnally [17] has likened the validation process to B…an expanding network of circumstantial evidence^ supporting the validity of the test instrument. Table 1 lists the principal psychometric characteristics that are fundamental to validated PRO outcome measures. Of these, discriminative validity is a very powerful form of validation, and two essential indicators of discriminative validity are sensitivity to functional versus dysfunctional status and sensitivity to therapeutically induced change. Both of these validity criteria are examples of Bcriterion-oriented validation,^ where test performance is validated against a logical external criterion (e.g., presence of the condition or response to treatment). The former references an instrument’s capacity to discriminate
Table 1 Principal features of validated instruments (PRO’s) to measure sexual functioning Reliability Reliability Validity Validity Validity Content validation Brevity
(Internal consistency) (Test-retest) (Sensitivity to functional vs dysfunctional status) (Sensitivity to therapeutically induced change) (Convergent with other validated instrument(s)) (Readability, understanding, relevance)
sexually dysfunctional individuals from persons free of any sexual disorders (its sensitivity and specificity in epidemiological terms), whereas the latter refers to an instrument’s sensitivity to treatment-induced change. It is worth noting that a demonstration of one form of validity does not necessarily guarantee the other, since these capacities are not always present together. Table 1 lists a series of additional features of validated instruments that measure sexual function. An additional feature that has been strongly emphasized in FDA guidance has to do with content validation. This validation requisite arises from the agency’s strong belief that clinical trial outcome measurement must have patient input to be truly valid and that item content must be clearly understood by patients to achieve this goal. This means that item content should be developed with patient participation in the process, i.e., through focus groups, cognitive debriefing, and be evaluated by patients in terms of clarity, comprehension, and relevance to their condition.
Specific Measures of Sexual Function The discussion that follows, in combination with the detailed information contained in Table 2, characterizes 7 contemporary instruments designed to measure quality of sexual function, including the female sexual distress scale (FSDS/ FSDSR). The latter is included because it has become something of a standard in assessing sexually related personal distress among women, a sufficient level of which must be demonstrated before a DSM-5 diagnosis of sexual dysfunction can be assigned. All of these instruments have been developed recently, with the majority having been validated during the past decade. These instruments vary primarily in terms of their levels of comprehensiveness; however, all have performed well against established psychometric criteria and have sound empirical evidence of reliability and validity. The Arizona Sexual Experience Scale (ASEX) is a 5-item self-report inventory using a 6-point Likert scale method. It was designed by McGahuey and his colleagues [18] to provide a pertinent, expedient, and minimally intrusive method to evaluate sexual dysfunction and changes in sexual function in
YES Cut—off Score(s) .93/.96 YES .87-.93 .93
–
YES
YES .85/.78 YES .42-.78 .79-.91
−
YES
NO .86/.93 YES .62-.84 .87-.96
−
YES
YES .97/.88 YES .73-.95
.64-.84
−
YES
YES .92/.89 YES .82
.79-.86
−
YES
YES .89/.75 YES YES .84-.92 .80-.90 .74-.80
.82/.90
<20 min.
<15 min.
37
26
<5 min.
<15 min. 15
12/13
15 min. 19
SR Female only
<15 min. 25
Female Sexual Distress Scale (FSDS/FSDS-R)
<10 min.
SR Male and Female CI and SR Male and female SR Female only SR Male only SR Female only SR Female only Arizona Sexual Experience Scale (ASEX) Derogatis Interview for Sexual Functioning (DISF-SR) Female Sexual Function Index (FSFI) International Index of Erectile Function (IIEF) Profile of Female Sexual Function (PFSF) Sexual Function Questionnaire (SFQ)
5
Drive, arousal, penile erection/vaginal lubrication, orgasm, satisfaction Cognition, arousal, behavior, orgasm, drive/relationship, total score Desire, arousal, lubrication, orgasm, satisfaction, pain Erectile function, orgasm, desire, intercourse satisfaction, overall Desire, arousal, orgasm, pleasure, concerns, responsiveness, self-image Desire, arousal-sensation, arousal-lubrication, enjoyment, orgasm, dyspareunia, partner, total Unidimensional scale measuring sexually related personal distress. BR^ version has an additional desire item
.91
.80
YES YES −
Ther. Chhg. Funct/Dys IRR IC (α)
TRT
Discriminant validity Reliability Domains Admin. time No. of items Modality**/Gender Inventory name
Table 2
Descriptive and psychometric properties of 7 contemporary measures of sexual function
Sens./Spec.
NO
Published norms
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patients taking psychotropic drugs. The ASEX represents sexual function in males and females, regardless of sexual orientation or relationship with a partner. It measures quality of functioning in terms of 5 questions, each representing one domain or construct: drive, arousal, penile erection/vaginal lubrication, ability to reach orgasm, and satisfaction from orgasm. These were selected because they have a history of representing the components of sexual function most commonly impaired by psychotropic drugs and are consistent with domains of sexual function described in the DSM-IV, DSM-5, and ICD-10. The ASEX is interpreted based upon a total score and/or assessment of scores on individual items. It takes less than 15 min to administer and score. Reliability coefficients for internal consistency and test/retest forms are excellent, and favorable test results of concurrent, convergent, and discriminative validity have been reported. No norms have been published to date. The ASEX currently demonstrates numerous desirable characteristics of psychological outcome measures, particularly brevity. However, because each of the 5 primary domains are defined by only a single item, problems with content validity may arise when attempting to use it in FDAregulated trials. The Derogatis Interview for Sexual Functioning (DISFSR) is a coordinated set of brief gender-matched inventories designed to provide an estimate of the quality of an individual’s current sexual functioning [19]. A comparable pair of semistructured interviews, the DISF is also available. There are gender-specific male and female versions of both the DISF-SR and the DISF. All instruments in the DISF-SR series are designed to be interpreted at three distinct levels: discrete items, functional domains, and aggregate summary (total) score. DISF items are arranged into five primary domains of sexual functioning: sexual cognition/fantasy, sexual arousal, sexual behavior/experience, orgasm, and sexual drive/relationship. In addition, a DISF total score summarizes quality of sexual functioning across the five primary DISF-SR domains. The DISF-SR takes approximately 10 to15 min to administer. Internal consistency reliabilities for measures of the DISF-SR are well within acceptable ranges (e.g., >.85), as are test-retest coefficients (>.80). The DISF/DISF-SR has demonstrated good discriminative validity and sensitivity to treatment-induced changes in both male and female versions, and gender-keyed norms (in terms of area T-scores) are available for all versions of the test. The instrument continues to be utilized as an outcome measure in a diverse range of applications, from studies on sexual functioning in women with 46 XX ovarian insufficiency [20], to evaluations of the impact of hematopoietic cell transplantation on sexual functioning [21]. The Female Sexual Functioning Index (FSFI [22] is a brief, (19-item) self-report inventory designed to measure the quality of female sexual functioning. The FSFI represents sexual functioning on six primary dimensions of sexuality plus an
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aggregate total score. The FSFI was initially validated on a clinically diagnosed sample of women with female sexual arousal disorder. Subsequently, the validation statement was extended to include women with a primary clinical diagnosis of inhibited female orgasm disorder or hypoactive sexual desire disorder [23]. Internal consistency reliability coefficients were reported to be all in the .90’s in the former study and in the acceptable range in the latter. The discriminant validity (i.e., patients versus controls) of the FSFI was clearly demonstrated in both studies, as was confirmation of divergent validity. Recent work with the instrument has demonstrated respectable content validity for the scale [24] and established clinical cutoff scores for some of the domains with HSDD patients [25]. The FSFI has been translated into several dozen languages, and validation studies continue with the FSFI in numerous countries around the world. The Index of Premature Ejaculation (IPE) is a recently developed self-report inventory that focuses on the subjective aspects of the premature ejaculation experience, serving as a compliment to the time measures based on intravaginal ejaculatory latency time (IELT). The IPE was developed in a number of major stages involving developing the item pool for the prototype, content analysis through patient interviews, and sequential quantitative psychometric analyses. The process resulted in reducing the 17-item prototype to a final 10item version [26]. As part of the psychometric analysis, the IPE was subjected to factor analysis based upon a relatively small sample of 85 men. Initially, four factors, accounting for approximately 59 % of the variance, were observed; however, after subsequent evaluation, only three were retained: sexual satisfaction, control, and distress. A slightly modified principal component analysis was done on the 10-item version, and a three factor solution was observed. The IPE has demonstrated very good discriminant validity (known groups) and good convergent validity, correlating well with IELT. The IPE also showed high reliabilities, with internal consistency (coefficients alpha) ranging from .87 to .96 for the three domain scores and test-retest reliabilities varying between .62 to .84. Most recently, the IPE was reviewed in a comprehensive assessment of contemporary diagnosis, assessment, and treatment of premature ejaculation [27]. The International Index of Erectile Function (IIEF) is a 15item self-report inventory developed by Rosen and his colleagues [28] to provide a brief measure of erectile function and capacity. It has been frequently recommended as a primary endpoint in clinical trials of erectile dysfunction (ED) and has become a standard in that regard. The IIEF was developed in conjunction with the clinical trial program for sildenafil (Viagra) and has since served as a major endpoint in over 50 clinical trials [29]. It has now been linguistically validated in over 32 languages. The IIEF represents quality of male sexual function in terms of 5 domain scores: erectile function, orgasmic function, sexual desire, sexual satisfaction, and overall
satisfaction. The IIEF does not possess a total score. Both internal consistency and test-retest reliabilities are superior for the scale, and there is factor analytic confirmation of the principal domains. Sensitivity and specificity are also very good, and concurrent validation against other comparable measures has been shown. Discriminative validity has been well established in comparisons of functional versus dysfunctional samples, and sensitivity to therapeutic change has been robustly demonstrated within the context of clinical trials of sildenafil and other treatments for ED. A 5-item brief form of the IIEF termed the sexual health inventory for men (SHIM) has been developed and validated, along with an ED severity scale [29]. Most recently, research has established a minimally clinically important difference (MCID) for the erectile function subscale [30] and determined that the size of the MCID varies with baseline severity scores. Rosen and his colleagues have also derived an IIEF-based definition of Bresponder^ which effectively serves as a responder definition for PDE-5 inhibitor treatment [31]. The Profile of Female Sexual Functioning (PFSF) [32, 33] was designed by Proctor & Gamble Pharmaceuticals Inc. to serve as a major outcome measure in their trials of Intrinsa, a transdermal testosterone treatment system for women suffering from low sexual desire. Qualitative linguistic validation was conducted in women with HSDD and non-HSDD women in eight countries to ensure that items would have the same meaning across languages. The resulting instrument was evaluated in 332 oophorectomized women with HSDD and 258 age-matched nonoophorectomized controls. Item analyses resulted in 37 items organized into seven domains (sexual desire, arousal, orgasm, sexual pleasure, sexual concerns, sexual responsiveness, and sexual self-image). Excellent reliability and validity of the 7 domains were observed in all geographies tested. Statistically significant differences between women with low libido and control women were found for all domains and all geographies, providing strong evidence of discriminative validity for the PFSF. In addition, measures of test-retest and internal consistency reliability were well within recommended limits. The PFSF is an instrument specifically designed to measure sexual desire in women with low libido. Excellent psychometric properties have been established across a number of geographies and languages, making it useful for assessing therapeutic change in multinational clinical trials. A brief form of the PFSF has also recently been developed [34]. The Sexual Function Questionnaire (SFQ) [35] is a selfreport questionnaire designed as an outcome measure for female sexual function. It is composed of 26 items reflecting major aspects of the sexual response cycle—desire, arousal, and orgasm—as well as dyspareunia. The item content was generated from the aggregated responses of 82 women to a semistructured interview. Factor analysis yielded seven
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domains of female sexual function: desire, physical arousalsensation, physical arousal-lubrication, enjoyment, orgasm, dyspareunia, and partner relationship. The item content of the SFQ was reviewed by an external panel of clinicians with expertise in psychology, physiology, gynecology, physical medicine, and the treatment of FSD. Internal consistency reliability of the domains ranged from 0.79 to 0.91 for all domains except partner relationship, which was .65, and testretest reliability is in the acceptable range. Validation studies included two 12-week randomized, controlled clinical trials evaluating sildenafil citrate against placebo in premenopausal and postmenopausal women with a diagnosis of FSD that included FSAD (n=781) and two normative 4-week trials in age-matched premenopausal and postmenopausal women without symptoms of FSD (n=201). Women in these studies were aged 18–69 years. Discriminant validity was demonstrated with a significant difference between baseline mean SFQ domain scores of women with FSD compared to women without FSD (p<.0001). Sensitivity to therapeutically induced change over time was established using a global efficacy question in both clinical studies. Significant differences were evident between positive and negative responders to this question. More recently, Symonds and her colleagues have developed a revised version of the SFQ termed the SFQ-28, culling out weaker items and replacing them with stronger candidates [36]. Factor analysis confirmed the basic dimensional structure of the SFQ-28, and internal consistency reliability ranged from .70 to .93. Test-retest reliabilities varied from .77 to .93, and known groups and convergent validation were established. As it is defined now, the SFQ-28 appears to represent a more sensitive version of a well-validated previous instrument. The Sexual Interest and Desire Inventory (SIDI) is a brief, clinician-administered instrument focused on measuring severity and change in response to treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The SIDI was developed in part through item response theory (IRT) which is a contemporary model for the design of psychological instruments. After an initial prototype of 17 items [37], the SIDI was subsequently pared down to a 13-item scale [38]. Studies have shown the SIDI to have high internal consistency reliability (coefficient alpha=.90) and have demonstrated discriminant validity (known groups) relative to cases versus noncases of HSDD. Further, it has shown good convergent validity with domains from the FSFI in the same study sample. The SIDI has a somewhat unique measurement format in that items address both intensity and frequency of sexual events; this distinctive format can provide unique information but requires an interviewer familiar with the scale format. The female sexual distress scale (FSDS) [39] was developed to quantify and measure the construct of sexually related personal distress. The presence of manifest or measurable
distress has been a required criterion for a diagnosis of FSD in the DSM-IV, DSM-5, and ICD-10 systems; however, no operational mechanism for measuring distress had ever previously been provided. Initial studies of the FSDS showed it to have high reliabilities, with internal consistency coefficients ranging from .93 to .97 and test-retest coefficients at .83 to .92 in a series of studies including 500 women [39]. More recently, the scale was revised, with a single item focused on distress from low desire added. The revision has been termed the FSDS-R. Initial internal consistency reliability was .86, with test-retest coefficients being approximately.74. Discriminant validation based on known groups (FSD cases versus noncases) was very high, with sensitivity=.93 and specificity=.96 [40]. In addition, formal content validation of the FSDS-R resulted in excellent qualitative results [40, 41]. The FSDS-R is a very brief (approximately 5 min), psychometrically sound PRO instrument that is very easy to use. It has shown excellent ability to discriminate between FSD patients and nonpatients, as well as having shown sensitivity to therapeutically induced change. It has been used in HSDD patients, women suffering from FSAD, and women with orgasmic disorders, and has shown sensitivity to the effects of a number of different pharmacologic agents.
Conclusion In this review, I have tried to provide a selective overview of the PRO instruments currently available to measure the status of an individual’s sexual functioning. These instruments are, for the most part, well-established measures that focus on basic dysfunctions in sexual desire, sexual arousal, orgasm, and distress. These measures are not designed to address more unique and complex sexual anomalies such as gender dysphoria, sexual addiction/compulsivity, or paraphilias. As mentioned previously, much of the momentum for the growth of measurement in this field has come directly from a significant increase in the development and use of these instruments in clinical drug trials. While the pharmaceutical industry has substantial resources that can be brought to bear in facilitating and accelerating the development of PRO’s, it is also worth mentioning that industry focus tends to be almost exclusively on the development and approval of drug products, which may color the nature of the PRO development and its potential for generalized usage in nonpharmaceutical settings. Most of the PRO instruments reviewed here are designed for only one gender, while other measures feature both male and female versions. Most of the instruments used in sexual medicine have been designed as self-report inventories; however, several scales have also been developed as brief interviews. The content of the latter tends to be quite similar to
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their self-report counterparts; however, the clinical interview format introduces professional clinical judgment and greater flexibility into the evaluation process. In the context of clinical trials, these instruments provide an important quantitative adjunct to the basic Bevent diaries^ that have historically been utilized as primary endpoints in treatment trials in this area. Because the diaries represent a less sophisticated measurement form (i.e., Bcounting^ or Benumeration^), they are generally not as sensitive to treatment effects unless the effect size under study is quite large. Psychometrically derived instruments provide a more flexible and sophisticated evaluative mechanism to assess outcome efficacy, and do so in a relatively efficient, and sensitive manner [42]. Compliance with Ethics Guidelines
Conflict of Interest interest.
Leonard R. Derogatis declares no conflict of
Human and Animal Rights and Informed Consent This article does not contain any studies with human or animal subjects performed by the author.
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