Frances Quirk

Development of a sexual function questionnaire for clinical trials of female sexual dysfunction

OBJECTIVE To better evaluate efficacy in clinical trials of drugs as potential treatments for female sexual dysfunctions (FSD), a brief, multidimensional measure of female sexual function was developed. METHODS Data from semistructured interviews with 82 women with or without FSD, aged 19-65 years, generated a pool of 61 items that addressed aspects of female sexual function. On review by a panel, individual items were selected for face validity and clinical relevance. Thirty-one items were used as a sexual function questionnaire (SFQ-V1) in two multicenter, phase II clinical trials totaling 781 women with FSD. Normative data were generated from a sample of 201 women without FSD. RESULTS Factor analysis produced seven domains of female sexual function: desire, physical arousal-sensation, physical arousal-lubrication, enjoyment, orgasm, pain, and partner relationship. The internal consistency of the domains ranged from 0.65 to 0.91, and test-retest reliability ranged from 0.21 to 0.71 for Cohens weighted kappa and 0.42 to 0.78 for Pearsons correlation coefficient. There was a significant difference between the baseline mean SFQ domain scores of patients with FSD compared with those of women without FSD (p < 0.0001). End-of-study SFQ scores were significantly different for women who reported improvement vs. women who reported no improvement (p < 0.001). CONCLUSIONS The SFQ produced seven domains of female sexual function with excellent internal consistency, moderate to good reliability, excellent discriminant validity, and sensitivity. The results suggest that the SFQ may be a valuable new tool for evaluating and diagnosing subsets of FSD and, ultimately, for evaluating treatments of these disorders.

The role of cognitive impairment in general functioning in major depression

The association between cognitive performance and general functioning in depression is controversial. The present study evaluated the association between cognitive dysfunction and major depressive disorder (MDD, N=70) as compared with age- and gender-matched healthy controls (n=206) and its relationship to general functioning (physical and mental health quality of life, activities of daily living, and employment status) in participants with current MDD (n=26) and those with previous MDD only (n=44). Participants were assessed clinically using the Mini International Neuropsychiatric Interview (M.I.N.I.) for the depression groups and the Diagnostic Interview for Psychoses (DIP-DM) for the control group. Measures to evaluate cognition and quality of lifes comprised the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Short Form-36 Health Survey Questionnaire, and the Activities/Instrumental Activities of Daily Living (ADL/IADL); employment status was also assessed in MDD. The results showed that a) while individuals with current depression had worse cognitive performance in all domains than healthy controls, those individuals with previous depression had lasting cognitive impairments in the domains of immediate memory and attention as compared with healthy controls; b) individuals with current depression had lower scores in the visuospatial/constructional and attention domains and the total score than individuals with previous depression; c) individuals in the depression group as a whole who were currently unemployed had significantly lower scores in all domains (except attention) of cognitive function; d) cognitive function was not related to either physical or mental quality of life or impairments of activities of daily living (ADL, IADL); e) that unemployment in previous depression was related to poor cognitive function similar to those with current depression. The results indicate that MDD may have detrimental and lasting effects on cognitive performance partly related to poorer general functioning.

Development of a questionnaire on sexual quality of life in women

The Sexual Quality of Life–Female (SQOL-F) questionnaire has been developed to assess the impact of female sexual dysfunction (FSD) on a womans sexual quality of life. SQOL-F items were developed through interviews with 82 women. Three data sets from womens health surveys in the United Kingdom and the United States generated data for scale validation. The SQOL-F showed good psychometric properties: convergent validity, discriminant validity, and test-retest reliability. The SQOL-F is a valid instrument for assessing the impact of FSD on quality of life and as an adjunct in evaluating FSD in clinical trials. The SQOL-F sensitivity to changes in sexual function needs confirmation.

Outcome measurement in Female Sexual Dysfunction clinical trials: Review and recommendations

Abstract Defining and measuring Female Sexual Dysfunction (FSD) is a complex and challenging task. Several factors have confounded the theory and measurement of FSD including: the use of an inappropriate male paradigm; difficulty in capturing the complexity of womens sexual response; an evolving but presently untested nosology; and the relative independence between subjective and objective aspects of womens sexual response. Each of these factors have contributed to the difficulty in developing meaningful and valid endpoints for clinical trials. The Food and Drug Administrations (FDA) 2000 draft guidance document for female sexual dysfunction clinical trials recommended the use of daily diary measures as primary and self-administered questionnaires (SAQs) as secondary endpoints. Event logs or diary measures may be adequate for assessing aspects of male sexual performance (e.g., erectile function), or in other therapeutic areas with discrete and readily observable endpoints (e.g., incontinence). However, psychometric theory suggests that for female sexual dysfunction clinical trials, SAQ instruments may provide more sensitive and reliable measures of outcome. We offer an alternative set of recommendations in the hope that the FDA will reconsider its position and to serve as potential guidelines for non-industry sponsored research on female sexuality as well. First, we propose that SAQs be elevated from their current status as secondary endpoints to be considered as potential primary endpoints in clinical trials of FSD. Second, we recommend that depending on the trial design and intervention under study, either an SAQ or diary measure (typically one or the other, and not both), might serve as a primary endpoint in a clinical trial. Third, SAQs and diaries should be employed, analyzed and interpreted in their particular areas of strength. Diaries are most useful for enumerating events and/or counting frequencies. SAQs are superior at gathering subjective data related to womens sexual function. Fourth, we believe there is a theoretical basis for considering SAQs to be superior measurement tools compared to diaries in assessing sexual dysfunction in women. At present, however there is insufficient objective data to fully support this opinion. Conversely, we do not anticipate either theoretical or objective evidence to support the alternative hypothesis (that diaries are superior to SAQs). If this proves to be correct in the future, diary measures may no longer be considered as primary endpoints for FSD clinical trials. Finally, we recommend that the FDA and/or other regulatory agencies reconsider the emphasis given to the number of successful or satisfactory sexual events over time as primary endpoints because they do not definitively demonstrate whether there has or has not been any improvement in the FSD endpoint under study (e.g., sexual desire). Successful and satisfactory encounters represent an amalgam of subjective assessments that are too far removed from the essential FSD component.

Serum androgen levels in healthy premenopausal women with and without sexual dysfunction: part B: reduced serum androgen levels in healthy premenopausal women with complaints of sexual dysfunction

Androgen insufficiency has been associated with decreased libido and arousal in postmenopausal women, but rarely has been evaluated in healthy premenopausal women. In all, 32 healthy premenopausal women were enrolled in this study, 18 with one or more complaints of sexual dysfunction and 14 without. Assays of ovarian and adrenal androgens were measured before and after ACTH stimulation. The women with complaints of sexual dysfunction had significantly lower adrenal androgens than did the control women. There were no differences in the basal ovarian androgens or cortisol levels. After ACTH, both groups stimulated cortisol as well as adrenal and ovarian androgens. In conclusion, premenopausal women with complaints of sexual dysfunction had lower adrenal androgen precursors and testosterone than age-matched control women without such complaints. Further study is required to determine how lower adrenal androgens contribute to female sexual dysfunction.

The rising prevalence of comorbid obesity and eating disorder behaviors from 1995 to 2005

OBJECTIVE To measure the cooccurrence of obesity and eating disorder (ED) behaviors in the South Australian population and assess the change in level from 1995 to 2005. METHOD Two independent cross-sectional single stage interview based population surveys were conducted a decade apart. Self-reported height, weight, ED behaviors, and sociodemographics were assessed. Changes between the two time points were analyzed. RESULTS From 1995 to 2005 the population prevalence of comorbid obesity and ED behaviors increased from 1 to 3.5%. Comorbid obesity and ED behaviors increased more (prevalence odds ratio (POR) = 4.5; 95% confidence interval (CI) = 95% CI = [2.8, 7.4]; p < .001) than either obesity (POR = 1.6; 95% CI = [1.3, 2.0]; p < .001) or ED behaviors (POR = 3.1; 95% CI = [2.3, 4.1]; p < .001) alone. DISCUSSION Comorbid obesity and ED behaviors are an increasing problem in our society. Prevention and treatments efforts for obesity and EDs must consider and address this increasing comorbidity.

Behaviour of medical students in seeking mental and physical health care: exploration and comparison with psychology students

Context  Doctors are often reluctant to seek health care through the usual channels and tend to self‐diagnose and prescribe. Medical students learn attitudes and values from clinician role models and may also adopt behaviour patterns that lead them to seek help for physical and mental health problems from informal sources.

Barriers to Help-Seeking in Young Women With Eating Disorders: A Qualitative Exploration in a Longitudinal Community Survey

Few with eating disorders (EDs) access evidence-based treatments. We conducted a prospective exploration of help-seeking by 57 community women with bulimic-type EDs using the Framework approach of familiarization, identifying themes, indexing, charting and mapping and interpretation. The mean age of the sample was 33 years. Results found women sought help for concerns regarding perceived (over) weight rather than for eating, although many women would have welcomed questions from professionals regarding eating behaviours. Empathy, providing information and hope were considered important features of health professionals to provide a positive experience of help-seeking. Specific personal barriers to treatment included low motivation, fear of stigma, and cost. Greater clinician and community awareness of and action on these issues would likely help close “the gap” for effective help-seeking by those with EDs.

SOME DEVELOPMENTS ON THE INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF)

This manuscript covers two complementary topics. For both topics, data from clinical studies and control samples were used. The first topic provides an overview of the development and validation of the International Index of Erectile Function (IIEF), a 15-item questionnaire, for male erectile and sexual function. A principal components analysis revealed five factors (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF demonstrated reliability, validity, and sensitivity and specificity with regard to treatment effect. The second topic presents, among men who reported having had sexual intercourse, the methodology and results on the evaluation of the erectile function (EF) domain of the IIEF, which has a range of scores from 6–30 for these men, as a diagnostic tool to help discriminate between men with and without erectile dysfunction (ED). For a prevalence rate of ED equal to 0.5 in a clinical population, the Classification and Regression Trees program gave a cutoff score of 25: men with EF scores of 25 or less were retrospectively classified as having ED, while those with scores above 25 were classified as not having ED (sensitivity = 0.97, specificity = 0.88). The IIEF has been developed and validated as a scale that is reliable, brief, self-administered, and psychometrically sound. Its EF domain showed desirable diagnostic properties. More research is encouraged in this area.

Serum androgen levels in healthy premenopausal women with and without sexual dysfunction: Part A. Serum androgen levels in women aged 20-49 years with no complaints of sexual dysfunction.

Androgen insufficiency is a recognized cause of sexual dysfunction in men and women. Age-related decrements in adrenal and gonadal androgen levels also occur naturally in both sexes. At present, it is unclear if a womans low serum androgen level is a reflection of the expected normal age-related decline or indicative of an underlying androgen-deficient state. We studied premenopausal women with no complaints of sexual dysfunction to help define a normal female androgen profile. In all, 60 healthy, normally menstruating women, ages 20–49 y, were studied. The Abbreviated Sexual Function Questionnaire was administered along with a detailed interview. Radioimmunoassay measurements of morning serum testosterone (T), free testosterone (fT), dehydroepiandrosterone-sulfate (DHEAS), sex hormone-binding globulin (SHBG), and free androgen index (FAI) were measured during days 8–15 of the menstrual cycle. In women 20–49 y old without complaints of sexual dysfunction, serum androgen levels exhibit a progressive stepwise decline. Comparing values obtained in women age 20–29 y to those obtained in women 40–49 y, specific hormone decrements were DHEAS 195.6–140.4 μg/dl, serum T 51.5–33.7 ng/dl, fT 1.51–1.03 pg/ml. SHBG did not change significantly in women in this age group. The FAI reflected the age-related decrease in female androgen levels. The framework for the development of a female androgen profile in women with no complaints of sexual dysfunction has been established, and an age-related decrease in testosterone and its adrenal precursor, DHEAS, has been demonstrated. The FAI mirrors these decreases and its usefulness in clinical practice is confirmed. A precipitous decline in all androgens occurs after the decade of the 20s, yet SHBG does not show a significant change throughout the premenopausal years.