Validation of the Decreased Sexual Desire Screener (DSDS): A Brief Diagnostic Instrument for Generalized Acquired Female Hypoactive Sexual Desire Disorder (HSDD)

Authors


Anita H. Clayton, MD, University of Virginia, Department of Psychiatry & Neurobehavioral Sciences, 2955 Ivy Road, Northridge Suite 210, Charlottesville, VA 22903, USA. Tel: 434-243-4646; Fax: 434-243-4743; E-mail: ahc8v@virginia.edu

ABSTRACT

Introduction.  An accurate diagnosis of Hypoactive Sexual Desire Disorder (HSDD) currently relies on a time-consuming interview with an expert clinician. Limited access to such expertise means that many women with HSDD remain undiagnosed. The Decreased Sexual Desire Screener (DSDS) was developed to provide clinicians who are neither trained nor specialized in Female Sexual Dysfunction (FSD) with a brief diagnostic procedure for the diagnosis of generalized acquired HSDD in women.

Methods.  A prospective non-treatment multicenter study enrolled 263 women at 27 centers in North America in order to test the validity of the DSDS for diagnosing generalized acquired HSDD in women. Subjects completed the DSDS at the screening visit and their answers were reviewed with a clinician who was not an expert in FSD (“non-expert clinician”). Separately and while being unaware of the non-expert clinician's diagnosis, an expert clinician conducted a standard diagnostic interview.

Main Outcome Measures.  Diagnostic outcomes (generalized acquired HSDD or not) were compared. Primary endpoints included the sensitivity and specificity of the DSDS relative to the standard diagnostic interview. Subject and non-expert clinician debriefing were obtained via a written, structured interview. This ensured that a large sample could be tested under uniform conditions across multiple sites.

Results.  Diagnostic assessment by DSDS and standard diagnostic interview were in agreement in 85.2% (224/263) of cases, with the sensitivity and specificity of the DSDS 83.6% and 87.8%, respectively. Debriefing showed that the five DSDS questions were well understood by 85.4% (76/89) of subjects included in the debriefing exercise, while non-expert clinicians considered the DSDS questions adequate to diagnose HSDD in 92.9% (235/253) of cases.

Conclusions.  The DSDS is a sensitive and specific brief diagnostic instrument for generalized acquired HSDD in women that is quick and easy to use. Clayton AH, Goldfischer ER, Goldstein I, DeRogatis L, Lewis-D'Agostino DJ, and Pyke R. Validation of the Decreased Sexual Desire Screener (DSDS): A brief diagnostic instrument for generalized acquired female Hypoactive Sexual Desire Disorder (HSDD). J Sex Med 2009;6:730–738.

Introduction

Female Sexual Dysfunction (FSD) is a multifactorial condition that may involve biological, medical, and psychological factors. It is highly prevalent; an international consensus group of experts estimated that FSD affects more than 20% of women [1]. Although precise definitions of FSD continue to evolve, the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) recognizes four distinct disorders of sexual dysfunction in women [2]. They include Female Orgasmic Disorder (FOD), Female Sexual Arousal Disorder (FSAD), sexual pain disorders, and sexual desire disorders such as Hypoactive Sexual Desire Disorder (HSDD), in which deficient sexual desire causing personal distress is the defining characteristic. The DSM-IV-TR classifies FSD depending on whether the disorder is lifelong or acquired (developed after a period of normal functioning), situational or generalized (not limited to certain types of stimulation, situations, or partners), and because of psychological factors or combined psychological/medical factors.

Healthcare professionals are often reluctant to talk to their patients about sexual health, for several reasons including limited time, lack of training, embarrassment, and absence of effective treatment options [3]. An international survey of people aged 40 to 80 years found that only 8 to 10% of subjects had been asked about their sexual health during a routine visit to their doctor [4]. At present, an accurate diagnosis of HSDD requires a time-consuming and extensive diagnostic interview conducted by a clinician with specific training in female sexual disorders. Given the scarcity of clinical experts in FSD and the increased interest in the development of pharmacological treatments for HSDD, there will be a growing need for simple diagnostic instruments that can be used in everyday practice by clinicians who are not specialists or experts in FSD. As such, the U.S. Food and Drug Administration draft guidance on the development of treatments for FSD recommends that new diagnostic instruments should be developed and should be able to distinguish patients with FSD (or a specific component of FSD) from those without the disorder [5].

The Decreased Sexual Desire Screener (DSDS) is a new brief diagnostic instrument that has been developed specifically to identify generalized acquired HSDD in pre-, peri-, and postmenopausal women. It was designed only to diagnose generalized acquired HSDD and not to diagnose or exclude other female sexual disorders, e.g., FSAD, FOD, and sexual pain, although these are often concurrent with HSDD.

The DSDS is intended for use by practicing clinicians with little or no experience in diagnosing HSDD. It builds on a diagnostic questionnaire that was used to support regulatory filings in the United States for a new treatment for HSDD in surgically postmenopausal women [6]. The questions in the DSDS are similar to those used in the earlier screening instrument, but to improve test specificity, a multi-point question was included to assist the clinician in identifying common rule-outs to the diagnosis of HSDD, as listed in the DSM-IV-TR [2] and clinical literature.

This article describes the results of a non-treatment validation study, in which the DSDS (Table 1) was compared with a standard diagnostic interview undertaken by an expert clinician. The goals of the study were to determine the validity of the DSDS to diagnose generalized acquired HSDD in women, and to determine whether the questions on the DSDS were clear to subjects and adequate for clinicians who are neither trained nor specialized in FSD (hereafter referred to as “non-expert clinicians”) to make the diagnosis.

Table 1.  The Decreased Sexual Desire Screener (DSDS) used in the non-treatment validation study
Dear Patient,
 Please answer each of the following questions:
1. In the past was your level of sexual desire or interest good and satisfying to you?Yes/No
2. Has there been a decrease in your level of sexual desire or interest?Yes/No
3. Are you bothered by your decreased level of sexual desire or interest?Yes/No
4. Would you like your level of sexual desire or interest to increase?Yes/No
5. Please check all the factors that you feel may be contributing to your current decrease in sexual desire or interest:
A: An operation, depression, injuries, or other medical condition
B: Medication, drugs or alcohol you are currently taking
C: Pregnancy, recent childbirth, menopausal symptoms
D: Other sexual issues you may be having (pain, decreased arousal or orgasm)
E: Your partner's sexual problems
F: Dissatisfaction with your relationship or partner
G: Stress or fatigue
Yes/No
When complete, please give this form back to your clinician
Clinician:
Verify with the patient each of the answers she has given.
The Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, characterizes Hypoactive Sexual Desire Disorder (HSDD) as a deficiency or absence of sexual fantasies and desire for sexual activity, which causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical, substance-related, psychiatric, or other sexual condition. HSDD can be either generalized (not limited to certain types of stimulation, situations, or partners) or situational, and can be either acquired (develops only after a period of normal functioning) or lifelong.
If the patient answers “NO” to any of the questions 1 through 4, then she does not qualify for the diagnosis of generalized acquired HSDD.
If the patient answers “YES” to all of the questions 1 through 4, and your review confirms “NO” answers to all of the factors in question 5, then she does qualify for the diagnosis of generalized acquired HSDD.
If the patient answers “YES” to all of the questions 1 through 4 and “YES” to any of the factors in question 5, then decide if the answers to question 5 indicate a primary diagnosis other than generalized acquired HSDD. Co-morbid conditions such as arousal or orgasmic disorder do not rule out a concurrent diagnosis of HSDD.
Based on the above, does the patient have generalized acquired Hypoactive Sexual Desire Disorder?
 ____YES ____NO

Methods

Subjects

Subjects were recruited from private practice, university clinics, investigative site databases that the sites maintain containing subjects indicating an interest in participating in clinical trials, and from advertisements placed in local media. Records were not kept of the number of women who were asked to participate but refused. Eligible subjects were women aged 18 to 50 years in a stable (at least 12 months' duration), monogamous, heterosexual relationship in which there was an absence of ongoing serious discord (in the opinion of the investigator, who interviewed the subject using specific questions about relationship discord). All subjects had to be newly recruited (i.e., not previously diagnosed with FSD by the investigator or site staff) and have a sexual partner who was physically available for at least 50% of the non-working week. The study population included subjects with HSDD, subjects with other types of FSD, and subjects with no FSD. The “no FSD” group included women responding to advertisements for volunteers with no sexual problems and women responding to advertisements for volunteers with complaints of sexual problems who were subsequently found not to have FSD according to DSM-IV-TR criteria. Every site was asked to recruit four subjects with HSDD, two with other FSD, and two with no FSD; a few were asked to increase their enrollment while maintaining this ratio of the three diagnostic groups.

Subjects receiving any medical or psychotherapeutic treatment for sexual dysfunction, or medication likely to contribute to sexual dysfunction or affect the central nervous system (in the opinion of the investigator who interviewed the subject) were excluded. Pregnant or lactating subjects were not eligible to participate, nor were subjects with pregnancy-related sexual dysfunction. Other exclusion criteria included a history of Major Depressive Disorder within the previous 12 months, another Axis I or II disorder, a history of dementia or other neurodegenerative diseases, organic brain disease, stroke, transient ischemic attacks, epilepsy, significant brain trauma, or brain surgery.

Study Design and Outcome Measures

The study was conducted at 20 centers in the United States and seven sites in Canada. No treatment (i.e., no drug, sex therapy, or specific psychotherapy for FSD) was promised or given. Institutional Review Boards approved the study protocol at every participating center, and all subjects gave written informed consent. Informed consent was obtained after a member of the study staff described the study details to the subject, answered any questions that the subject had, and the subject indicated a willingness to participate in the study.

To avoid subject bias, the DSDS assessment was carried out as a one-way crossover in which subjects entering the study were asked first to complete the DSDS (Table 1) at the screening visit. A “non-expert clinician” (i.e., a clinician who was neither trained nor specialized in FSD, and had not been trained in the use of the standard diagnostic interview or the DSDS) then reviewed the DSDS with the subject to clarify the answers given and determine whether the subject met the DSM-IV-TR diagnosis of generalized acquired HSDD. If a woman answered “no” to any of the questions 1 through 4, then she would not qualify for a diagnosis of HSDD, whereas an answer of “yes” to questions 1 through 4 and of “no” to all parts of question 5 on clinician review would yield a diagnosis of generalized acquired HSDD. If a “yes” answer was given to questions 1 through 4 and to any part of question 5, then the clinician would discuss the answer given to question 5 with the patient and decide if a primary diagnosis other than generalized acquired HSDD was appropriate. Essentially, a “yes” to any part of question 5 would alert the clinician to the need to discuss this issue with the patient to determine whether this factor was a cause of her deficient desire. Comorbid conditions such as FSAD or FOD would not rule out a concurrent diagnosis of HSDD.

Non-expert clinicians included physicians, physician's assistants, clinical psychologists, and nurse practitioners in the United States and Canada, as well as study coordinators in Canada. Subsequently, an expert clinician who had been trained and tested on accurate diagnosis of FSD (i.e., after training, the clinician watched a video of a patient and made a diagnosis, and it was then checked that their diagnosis agreed with that of an established FSD expert) at the same investigational site conducted the standard diagnostic interview with each subject and recorded the FSD diagnosis based on the results of this interview and their clinical judgment. The diagnostic interview used as the standard in this set of studies included the Clinical Interview for FSD, Sexual Symptoms Checklist, and Contributing Factors Checklist (tools developed for this set of studies), plus any other aspects of the subject's history that the expert clinician considered relevant. The Clinical Interview for FSD was based on an integrated transcript of the questions asked in several diagnostic interviews by an expert diagnostician (AHC); a panel of FSD experts reviewed the transcripts and agreed that the composite interview was thorough and sufficient for the purpose. The Sexual Symptoms Checklist asked about the presence of, and distress or interpersonal difficulties associated with, each of the 17 (female) sexual symptoms recognized by DSM-IV-TR and/or the recent interdisciplinary consensus panel's definitions of FSD. The Contributing Factors Checklist asked about the occurrence, currency, and contribution to FSD of each of the 14 “contextual descriptors” recognized by the consensus panel [7]. The non-expert and expert clinicians were not permitted to discuss their DSM-IV-TR diagnoses with each other until these had been formally documented.

The diagnoses (i.e., that the subject has generalized acquired HSDD or that the subject does not have generalized acquired HSDD) made by the non-expert clinician using the DSDS and the expert clinician using the standard diagnostic interview were compared. Primary endpoints included the sensitivity and specificity of the DSDS relative to the standard diagnostic interview, together with subject and non-expert clinician debriefing. The debriefing process involved completion of a written, structured interview so that a large set of subjects and non-expert clinicians could be tested under uniform conditions across multiple sites and the data could be analyzed statistically. The goals were to assess subject understandability of the DSDS items and adequacy of the items to non-expert clinicians for the purposes of diagnosis, and to decide whether any modifications to the DSDS would be required. No attempt was made to obtain a full cognitive debriefing in the typical sense, i.e., to test the relevance, clarity, and comprehensiveness of the instrument from the subject's perspective. Understandability was considered sufficient as the endpoint for subjects' debriefings as subjects could not be expected to know what was relevant and comprehensive for diagnosing HSDD. Likewise, adequacy was sufficient as the endpoint for clinical debriefings as it subsumes understandability, relevance, and comprehensiveness as well as determines the overall utility of the instrument. Debriefing of subjects was conducted immediately after they completed the DSDS and debriefing of non-expert clinicians was conducted via retrospective probing every time they used the DSDS.

Sample Size Estimation and Statistical Analyses

Estimations of DSDS sensitivity and specificity were used to determine sample size. Based on an expected sensitivity of 88%, it was calculated that a sample size of 100 would give a 95% confidence interval of 79.6% to 93.4%. It was thought that approximately 200 subjects would need to be screened by non-expert clinicians before 100 subjects with HSDD were diagnosed. Thus, the validation study required at least 100 subjects with HSDD to estimate DSDS sensitivity and approximately 100 subjects with some symptoms of FSD but without HSDD to estimate DSDS specificity. A sample of 30 HSDD subjects was estimated as adequate for debriefing purposes, with a further 10 non-FSD subjects to ensure that responses at both ends of the spectrum of sexual functionality were properly evaluated. A sample of 25 to 30 non-expert clinicians was determined to be sufficient for clinician debriefing.

Point estimates and 95% confidence intervals were calculated for the sensitivity and specificity of the DSDS using the expert clinician's diagnosis as the standard for comparison. Debriefing interviews were summarized by descriptive statistics.

Results

Subjects

A total of 296 women were screened, of whom 263 subjects met eligibility criteria and participated in both diagnostic procedures. This population consisted of 141 subjects with a primary diagnosis of HSDD by standard diagnostic interview, 47 with a primary diagnosis of other FSD (not HSDD), and 75 with no FSD (Table 2). Since the DSDS was not designed to distinguish between primary and secondary HSDD, all subjects with HSDD (either primary or secondary), as determined by the standard diagnostic interview, were considered to have HSDD. As Table 2 shows, demographic characteristics of the three diagnostic groups were broadly similar, with a majority of subjects Caucasian, married, and premenopausal.

Table 2.  Demographic characteristics of subjects diagnosed by the standard diagnostic interview (N = 263)
 HSDDOther FSDNo FSD
  1. Data are N (%), unless otherwise stated.

  2. HSDD = Hypoactive Sexual Desire Disorder; No FSD = no Female Sexual Dysfunction; Other FSD = Female Sexual Arousal Disorder and/or Female Orgasmic Disorder.

  3. Menopausal status was determined by STRAW criteria [8].

No. of subjects1414775
Mean age ± SD years38.4 ± 8.832.3 ± 8.934.7 ± 9.4
Race   
 White111 (78.7)33 (70.2)59 (78.7)
 Black21 (14.9)10 (21.3)10 (13.3)
 White Hispanic8 (5.7)4 (8.5)5 (6.7)
 Black Hispanic1 (0.7)0 (0)1 (1.3)
 Asian0 (0)0 (0)0 (0)
Menopausal status   
 Premenopausal98 (69.5)40 (85.1)64 (85.3)
 Perimenopausal25 (17.7)4 (8.5)6 (8.0)
 Postmenopausal18 (12.8)3 (6.4)5 (6.7)
Marital status   
 Married95 (67.4)28 (59.6)42 (56.0)
 Living together27 (19.1)7 (14.9)18 (24.0)
 Dating19 (13.5)12 (25.5)15 (20.0)

In total, 89 subjects at 11 investigative sites underwent debriefing (51 with HSDD, 14 with other FSD, 24 with no FSD); this subset of women was broadly representative of the entire sample (Table 3). Non-expert clinicians completed debriefing forms after 253 of the 263 DSDS-based interviews.

Table 3.  Demographic characteristics of the subset of subjects who underwent debriefing (N = 89)
 HSDDOther FSDNo FSD
  1. Data are N (%), unless otherwise stated.

  2. HSDD = Hypoactive Sexual Desire Disorder; No FSD = no Female Sexual Dysfunction; Other FSD = Female Sexual Arousal Disorder and/or Female Orgasmic Disorder.

  3. Menopausal status was determined by STRAW criteria [8].

No. subjects511424
Mean age ± SD (years)36.8 ± 9.633.4 ± 8.535.8 ± 10.9
Race   
 White35 (68.6)11 (78.6)17 (70.8)
 Black13 (25.5)3 (21.4)6 (25.0)
 White Hispanic3 (5.9)0 (0)1 (4.2)
Menopausal status   
 Premenopausal38 (74.5)11 (78.6)19 (79.2)
 Perimenopausal10 (19.6)3 (21.4)4 (16.7)
 Postmenopausal3 (5.9)0 (0)1 (4.2)
Marital status   
 Married32 (62.7)11 (78.6)11 (45.8)
 Living together12 (23.5)1 (7.1)6 (25.0)
 Dating7 (13.7)2 (14.3)7 (29.2)

Validation of the DSDS

The diagnoses made using the standard diagnostic interview and DSDS agreed in 224 out of 263 cases, indicating that the DSDS had a diagnostic accuracy of 85.2% (Table 4). Of the 165 subjects with a diagnosis of HSDD by standard diagnostic interview, 138 were diagnosed with HSDD by the DSDS. Thus, the DSDS had a sensitivity of 0.836 (95% CI: 0.771, 0.889). Of the 98 subjects diagnosed as not having HSDD by the standard diagnostic interview, 86 were diagnosed as not having HSDD by the DSDS. Thus, the DSDS had a specificity of 0.878 (95% CI: 0.796 to 0.935). In total, 150 subjects had a diagnosis of HSDD by DSDS, of whom 138 (92%) were also diagnosed as having HSDD by standard diagnostic interview.

Table 4.  Diagnosis of Hypoactive Sexual Desire Disorder by the Decreased Sexual Desire Screener (DSDS) and standard diagnostic interview (N = 263)
DSDSStandard diagnostic interviewTotal
YesNo
  1. HSDD includes both primary HSDD (main or only form of FSD) and secondary HSDD as diagnosed by the standard diagnostic interview.

Yes13812150
No2786113
Total16598263

A secondary analysis showed that eliminating the fifth question (factors to be ruled out), and considering only the first four questions (factors to be ruled in), increased the point estimate of sensitivity slightly from 0.836 to 0.884 (95% CI: 0.826, 0.928) but impaired specificity somewhat from 0.878 to 0.775 (95% CI: 0.681, 0.851).

Subject and Clinician Debriefing

The five DSDS questions were well understood by the subset of 89 women who took part in the debriefing exercise, with 76 (85.4%) able to understand all five questions. The numbers of subjects who understood questions 1 to 5 were 84 (94.4%), 86 (96.6%), 87 (97.8%), 89 (100%), and 85 (95.5%), respectively. Of the five DSDS questions, question 1 was cited the most frequently (five cases, 5.6%) as not understood; in four cases, this was because the phrase “in the past” was considered too vague. Three subjects (3.4%) each had comments on questions 2 and 3. Two subjects commenting on question 2 cited its failure to give a time frame. No two comments on question 3 were similar. The only other comments made by more than one subject was “define current,” or an alternative phrasing, “what time period are you looking for?” which were applied once each to questions 5B, 5C, and 5D.

Non-expert clinician debriefing showed that the overwhelming majority of non-expert clinicians considered the five DSDS questions adequate to diagnose HSDD; they indicated that they could use the DSDS to rule in or rule out HSDD in 92.9% (235/253) of subjects who completed the DSDS. A total of 32 comments were received in respect to the five questions, of which eight (3.2%) applied to question 5D and six (2.4%) to question 1. The remaining questions had three or fewer comments each (<1.2%). With respect to question 5D, clinicians expressed the view that either more explicit questions about arousal and orgasm were needed, or that positive answers about arousal, orgasm, and/or pain made it difficult to determine which diagnosis was primary and which was secondary. However, the DSDS was designed only to determine whether a woman has HSDD, and not to determine whether the HSDD is primary (main or only form of FSD) or secondary. With respect to question 1, this was cited as inadequate by some non-expert clinicians because “in the past” was considered too vague (three cases, 1.2%); the question could not be answered without further elicitation (two cases, 0.8%); or the question's applicability if lack of desire is lifelong lacks relevance (one case, 0.4%). The only other comment to be cited in more than one debriefing (>0.4%) was in respect of question 5G, for which work was cited in two debriefings (0.8%) as a cause of loss of sexual interest.

Discussion

Although expert diagnosis involving an extensive clinical interview is considered the gold standard for diagnosing HSDD according to DSM-IV-TR criteria, it is time-consuming, poorly accessible, and there is no universally accepted instrument to diagnose subjects (with HSDD) [1].

The DSDS was designed to be a simplified questionnaire that could be used by a non-expert clinician to reliably diagnose HSDD in pre-, peri-, and postmenopausal women complaining of decreased sexual desire and associated personal distress. The questions included in the DSDS were selected not only to rule in HSDD according to DSM-IV-TR criteria, but also to rule out the most frequent clinically relevant conditions.

As the results of this validation study have shown, the DSDS can be considered an appropriately sensitive and specific brief diagnostic procedure for generalized acquired HSDD. When the DSDS is completed by subjects and then reviewed with a non-expert clinician, the diagnosis has a high level of validity when compared with the diagnosis of an expert clinician using an extensive clinical interview. The estimated sensitivity of the DSDS was 84% and its specificity 88%, with agreement between the DSDS and the standard diagnostic interview in about 85% of cases. The sensitivity and specificity rates in this study are quite similar, suggesting that the balance between these parameters is optimized. Since the DSDS is to be used for the diagnosis of generalized acquired HSDD in women who seek help from a clinician for sexual problems and not for screening of general populations, the balance of sensitivity and specificity seen in this study is essential. A secondary analysis showed that eliminating question 5 (about factors to be ruled out) from the DSDS, and considering only the first four questions (about factors to be ruled in), increased the point estimate of sensitivity slightly but impaired specificity somewhat. Thus, further simplification of the DSDS seems counterproductive for an instrument to be used in general practice. Entry criteria in this validation study were broad, but this study did not investigate whether the DSDS can be used to diagnose HSDD in women who are not in a stable, monogamous, heterosexual relationship.

Of the 150 patients diagnosed with HSDD by the DSDS, 92% were also diagnosed with HSDD by the standard diagnostic interview. Although the latter gives an estimate of positive predictive value, it is not a valid one since the subjects enrolled in this study were not a random sample from the population and the prevalence of HSDD in this population is not representative of the prevalence of HSDD in the general population. By contrast, the estimates of sensitivity and specificity are independent of prevalence.

To determine whether the DSDS questions were applicable to the study population, debriefing was undertaken with both subjects and non-expert clinicians. Subjects were asked if they understood the questions, while non-expert clinicians were asked if the questions were adequate for diagnostic purposes. Results of the debriefing interviews were positive; 85% of subjects understood every question and did not comment, and although virtually all the non-expert clinicians using the DSDS considered themselves non-experts in diagnosing FSD, almost all considered the DSDS questions adequate to diagnose HSDD once they had used the instrument. Positive judgments from the non-expert clinicians about the adequacy of the questions were supported by the accuracy of the diagnoses they made using the DSDS compared with diagnoses made by expert clinicians using the standard diagnostic interview. No changes were made to any of the DSDS questions following debriefing, but a statement to clarify the term “in the past” was added to the clinician's instructions. “In the past” forms the basis of question 1 of the DSDS and is designed to establish the contextual subtype of FSD, i.e., if a woman's level of sexual desire and interest had been good and satisfying “in the past,” then her HSDD would be considered acquired rather than lifelong.

Traditionally, diagnosis of HSDD has been the domain of clinicians with expert knowledge of FSD, thereby limiting access to treatment for women with complaints of decreased sexual desire and associated personal distress. Growing recognition of the prevalence and impact of FSD has increased demand for more rapid means of diagnosing sexual problems in women, including HSDD, which is the most commonly reported form of FSD [9]. Validation data for two screeners for HSDD have recently been published [10,11]. However, the validation studies for both instruments were performed in postmenopausal women only and neither tool rules out any of the confounding factors that may cause HSDD-like symptoms [10,11].

The DSDS represents a new approach to the diagnosis of HSDD. Instead of using rating scales and applying cut-off values that would require validation in every population, it uses simple, universally applicable yes/no questions, including questions that enable the clinician to rule out common confounding diagnoses, with no requirement for additional forms.

The DSDS is not a self-screener validated for self-diagnosis. Question 5 asks the woman to assess whether her HSDD has been caused by certain factors, e.g., drugs or stress. Self-assessment of the cause of sexual problems may be inherently biased; thus, the DSDS requires use by a clinician who learns the patient's history and incorporates it into determining a diagnosis. However, using only the first four questions of the DSDS, which are expected to require only the patient's input, still provides an accurate diagnosis for most patients (point estimate of sensitivity, 0.884; of specificity, 0.775). Thus, it appears that DSDS questions 1–4 may be useful as a self-screener, subject to confirmation of the diagnosis by a clinician who has discussed the elements of question 5 with the patient.

Conclusions

The results of this prospective multicenter study have shown that the DSDS is an appropriately sensitive and specific brief instrument for the diagnosis of generalized acquired HSDD in women, independent of menopausal status. The DSDS provides a simple method for practicing clinicians who are not experts in the field of FSD to make an accurate diagnosis of generalized acquired HSDD and thus identify those women who might benefit from treatment. The DSDS should have outstandingly general and stable applicability because it relies on simple yes-or-no answers rather than graded ratings, eliminating the need for cut-off scores that might be population-specific.

Conflict of Interest: Anita Clayton: Grants—BioSante Pharmaceuticals, Inc., Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Novartis Pharmaceuticals, Pfizer, Inc., Sanofi-Aventis, Wyeth; Advisory Board Fee/Consultant Fee—Boehringer-Ingelheim, Bristol-Myers Squibb, Concert Pharmaceuticals, Eli Lilly and Company, Fabre-Kramer Pharmaceuticals, GlaxoSmithKline, Novartis Pharmaceuticals, Pfizer, Inc., PGxHealth, Sanofi-Aventis, Wyeth; Speaker's Bureau/Honorarium—Eli Lilly and Company, Pfizer, Inc., Wyeth; Royalties/copyright—Ballantine Books/Random House, Guilford Publications, Healthcare Technology Systems, Inc.

Evan Goldfischer: Principal Investigator— Boehringer Ingelheim, Pfizer, Eli Lilly and Company, GSK, Sanofi, Astellas, Ferring, Tap, GP Pharma; Speaker—Pfizer, Eli Lilly and Company, Astellas, GlaxoSmithKline; Consultant—BI, Astellas.

Irwin Goldstein: Consultant—Alagin Research, Aperture; Ad Board—Boehringer Ingelheim, Johnson & Johnson, Medtronic, Plethora Solutions, Vivus; Speaker—Auxilium, Bayer, BioSante, Coloplast, Eli Lilly, Pfizer, Timm Medical; Grant—Pfizer; Contract—Boehringer Ingelheim.

Leonard DeRogatis: Consultant—Boehringer Ingelheim.

Diane J. Lewis-D'Agostino: Employee of Boehringer Ingelheim.

Robert Pyke: Employee of Boehringer Ingelheim.

Statement of Authorship

Category 1

  • (a)Conception and DesignAnita H. Clayton; Diane J. Lewis-D'Agostino; Robert Pyke
  • (b)Acquisition of DataAnita H. Clayton; Diane J. Lewis-D'Agostino
  • (c)Analysis and Interpretation of DataAnita H. Clayton; Evan R. Goldfischer; Irwin Goldstein; Leonard DeRogatis; Diane J. Lewis-D'Agostino; Robert Pyke

Category 2

  • (a)Drafting the ArticleAnita H. Clayton; Robert Pyke
  • (b)Revising It for Intellectual ContentAnita H. Clayton; Evan R. Goldfischer; Irwin Goldstein; Leonard DeRogatis; Diane J. Lewis-D'Agostino; Robert Pyke

Category 3

  • (a)Final Approval of the Completed ArticleAnita H. Clayton; Evan R. Goldfischer; Irwin Goldstein; Leonard DeRogatis; Diane J. Lewis-D'Agostino; Robert Pyke

Ancillary