Lucy Abraham

Psychometric validation of a sexual quality of life questionnaire for use in men with premature ejaculation or erectile dysfunction.

INTRODUCTION An instrument that can systematically capture the impact of sexual dysfunction on quality of life (QoL) in men is needed. AIMS To psychometrically validate a sexual QoL instrument for men (SQOL-M) with premature ejaculation (PE) or erectile dysfunction (ED). METHODS The main assessment populations were men participating in clinical trials of treatments for PE or ED. Men with PE had a confirmed intravaginal ejaculatory latency time of < or = 2 minutes in > or = 70% of attempts. Men with ED had a score of > 21 on the International Index of Erectile Function (IIEF). Confirmatory psychometric testing was conducted in further groups of men with PE. MAIN OUTCOME MEASURES The internal consistency, convergent and discriminant validity, test-retest reliability, and known-groups validity of the instrument were assessed. RESULTS An 11-item version of the SQOL-M was produced following factor analyses on men with either PE or ED. Psychometric testing showed no overlap between items and good item-total correlations. Factor analysis confirmed a one-factor solution. Excellent internal consistency was demonstrated, with a Cronbachs alpha of > or = 0.82 in all groups. In men reporting no change in their symptoms, the SQOL-M showed excellent test-retest reliability: the intraclass correlation coefficient was 0.77 for men with PE, and 0.79 for men with ED. Convergent validity was also good. In men with PE, the SQOL-M correlated with the satisfaction and distress domains of the Index of Premature Ejaculation. In men with ED, the SQOL-M correlated with the overall satisfaction domain of the IIEF. The measure also demonstrated excellent discriminant validity between men with PE or ED and men with no sexual dysfunction (P < 0.0001). CONCLUSIONS The SQOL-M instrument is a useful tool for evaluating sexual QoL in men with PE and ED.

Further evidence of the reliability and validity of the premature ejaculation diagnostic tool

This study details the further validation of the Premature Ejaculation Diagnostic Tool (PEDT), a five-item tool, developed to systematically apply the Diagnostic and Statistical Manual of Mental Disorders, revised version 4 (DSM-IV-TR), criteria in diagnosing presence or absence of premature ejaculation (PE). A total of 102 men completed the PEDT and were then interviewed by one of the seven clinical experts, who made a diagnosis of presence or absence of PE. The diagnoses from these two methods were compared to assess the convergent validity of PEDT. Retest reliability was also assessed, by men completing the PEDT a second time, approximately 2 weeks after the first administration. The level of agreement between clinical expert and PEDT diagnoses was very high (κ-statistic=0.80 (95% CI=0.68–0.92)), and retest reliability was very good – Intraclass correlation coefficient=0.88. In summary, the PEDT is extensively validated, self-report measure that can systematically assess DSM-IV-TR criteria to provide accurate diagnoses of PE/no-PE.

Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial.

ObjectiveThe effects of bazedoxifene (BZA)/conjugated estrogens (CE) on sleep and health-related quality of life (HRQoL) were evaluated in nonhysterectomized postmenopausal women who were enrolled in a randomized, double-blind, placebo- and active-controlled phase 3 trial. MethodsThe sleep/HRQoL substudy enrolled 459 women with bothersome moderate to severe vasomotor symptoms who were randomized to BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, BZA 20 mg, CE 0.45 mg/medroxyprogesterone acetate (MPA) 1.5 mg, or placebo for 1 year. On months 3 and 12, sleep parameters were evaluated using the Medical Outcomes Study sleep scale, and HRQoL was assessed using the Menopause-Specific Quality of Life (MENQOL) questionnaire. ResultsBZA/CE and CE/MPA significantly improved sleep and HRQoL compared with placebo. On month 3, most Medical Outcomes Study sleep parameter improvements with BZA/CE and CE/MPA versus placebo were not significant. On month 12, both BZA/CE doses and CE/MPA significantly improved time to fall asleep and sleep disturbance (P < 0.05 vs placebo); BZA 20 mg/CE 0.625 mg and CE/MPA also showed significant improvements in sleep adequacy and sleep problem indices I and II (P < 0.01 vs placebo). Both BZA/CE doses and CE/MPA significantly improved MENQOL vasomotor function score versus placebo at 3 and 12 months (P < 0.001). At 3 months, total MENQOL score was significantly improved with BZA 20 mg/CE 0.625 mg and CE/MPA versus placebo (P < 0.05); at 12 months, both BZA/CE doses and CE/MPA showed significant improvements (P < 0.001). ConclusionsSymptomatic postmenopausal women who are treated with BZA/CE for 1 year demonstrate significant improvements in sleep and HRQoL, similar to women treated with CE/MPA.

Sexual dysfunction in partners of men with premature ejaculation

Research in partners of men with erectile dysfunction suggests that a womans sexual difficulties can be contingent on her partners sexual dysfunction. However, little research has been conducted in partners of men with other sexual dysfunctions, such as premature ejaculation (PE). We evaluated 139 partners of men diagnosed with having PE and 89 age-matched women whose partners did not have any sexual dysfunction. Results showed that 77.7% of PE partners had at least one sexual dysfunction, compared to 42.7% of the control group. Further research needs to be undertaken to investigate the temporal relationship between sexual dysfunctions in both partners.

The bladder pain/interstitial cystitis symptom score: development, validation, and identification of a cut score.

BACKGROUND There is a need to develop a self-report measure that reliably identifies moderate to severe bladder pain syndrome (BPS) patients for inclusion into clinical trials to assess the efficacy of new BPS treatments. OBJECTIVE To develop and validate a patient-reported symptom-based instrument, the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS), for clinical trial eligibility of BPS patients. DESIGN, SETTING, AND PARTICIPANTS Stage 1: Qualitative concept elicitation (CE) interviews were conducted with BPS patients in France (n=12), Germany (n=12), and the United States (US) (n=20), and overactive bladder (OAB) (n=10) patients in the US for comparison. Stage 2: Cognitive debriefing (CD) interviews were performed with US BPS patients (n=20). Stage 3: An observational study with 99 BPS, 99 OAB, and 100 healthy participants in the US was used to perform item reduction, identify cut scores, and validate the measure. A cut score was defined using logistic regression and receiver operating characteristic curves. Psychometric properties, including test-retest reliability, were assessed. MEASUREMENTS In addition to the BPIC-SS, the Pelvic Pain and Urgency/Frequency Patient Symptom Scale, the Interstitial Cystitis Symptom Index, a Clinician Global Impression of Severity, and a Patient Global Impression of Change were included in the observational study. RESULTS AND LIMITATIONS In CE, reported symptoms were bladder pain, persistent urge to urinate, and high urinary frequency. In CD, 13 items were deleted, and 15 were retained. Based on validation analyses, qualitative findings, and clinical relevance, the instrument was reduced to eight items that had strong sensitivity (0.72) and specificity (0.86) with a cut score ≥19 to determine clinical trial inclusion. Psychometric properties were strong. CONCLUSIONS The BPIC-SS is a reliable, valid, and appropriate questionnaire to select BPS/interstitial cystitis patients for clinical trials.

Sexual Function Questionnaire: Further Refinement and Validation

INTRODUCTION The Sexual Function Questionnaire (SFQ) is a self-report outcome measure of female sexual function. It has recently been refined to create a 28-item version (SFQ28) including the addition of a new arousal-cognitive domain. AIM This study aimed to validate the SFQ28 in female sexual arousal disorder (FSAD) and hypoactive sexual desire disorder (HSDD) populations and to develop a screening cut-score for the arousal-cognitive domain. METHODS Women with FSAD (n=222) and HSDD (n=114) and 303 women without female sexual dysfunction (FSD) completed the SFQ28, the Female Sexual Distress Scale (FSDS), and the Sexual Quality of Life-Female (SQOL-F) at a clinic visit. Retests were performed within FSD groups only (FSAD: n=92, HSDD: n=183), using postal questionnaires 7-14 days later. The optimal cut-score for the arousal-cognitive domain was based on diagnostic tests of sensitivity and specificity from a receiver operating characteristic curve. MAIN OUTCOME MEASURES Psychometric analyses. RESULTS The factor analysis confirmed the domain structure of the SFQ28. The SFQ28 demonstrated excellent internal consistency, test retest reliability and known groups validity, and good convergent validity with the FSDS and SQOL-F for all domains except pain. The sensitivity/specificity analysis determined a screening cut-score of 5 for the arousal-cognitive domain. CONCLUSION Given the replication of the psychometric data and the cut-scores for each domain, the SFQ28 is a robust measure that can be used in women with either FSAD or HSDD.

Psychometric Validation of Gender Nonspecific Sexual Confidence and Sexual Relationship Scales in Men and Women

INTRODUCTION The Sexual Confidence Scale (SCS) and the Sexual Relationship Scale (SRS) are two new measures designed for use by men and women across sexual dysfunction groups. The SCS assesses how confident an individual feels as a sexual partner, while the SRS assesses feelings that an individual has about their sexual relationship with their partner. AIM To conduct item reduction and psychometric validation of the SCS and SRS instruments. METHODS To validate the new measures, 104 men with premature ejaculation (PE), 101 men with erectile dysfunction (ED) and 106 women with female sexual arousal disorder (FSAD) took part in the study. One hundred and one males and 53 females without sexual dysfunction also completed the measures. MAIN OUTCOME MEASURES The internal consistency, convergent, and discriminant validity, test-retest reliability and known-groups validity of the instruments were assessed. RESULTS The number of items in each scale was reduced following standard item reduction analyses and reference to the conceptual framework. Factor analysis confirmed a one-factor solution for the SCS and a two-factor solution for the SRS. Internal consistency was good, with cronbachs alpha >or=0.7 across the groups for both the SCS and SRS. Excellent test-retest reliability and ability to discriminate between men and women with and without sexual dysfunction were also demonstrated for both scales. Correlations with the Sexual Quality of Life Questionnaire (SQOL) ranged from 0.48 to 0.80 indicating good convergent validity. CONCLUSIONS The SCS and the SRS are reliable and valid instruments in men with PE or ED and in women with FSAD. These modules may be used either as stand-alone measures or, preferably, in conjunction with the SQOL to provide a complete assessment of sexual quality of life.

Relationship between changes in vasomotor symptoms and changes in menopause-specific quality of life and sleep parameters.

Objective:This study characterizes and quantifies the relationship of vasomotor symptoms (VMS) of menopause with menopause-specific quality of life (MSQOL) and sleep parameters to help predict treatment outcomes and inform treatment decision-making. Methods:Data were derived from a 12-week randomized, double-blind, placebo-controlled phase 3 trial that evaluated effects of two doses of conjugated estrogens/bazedoxifene on VMS in nonhysterectomized postmenopausal women (N = 318, mean age = 53.39) experiencing at least seven moderate to severe hot flushes (HFs) per day or at least 50 per week. Repeated measures models were used to determine relationships between HF frequency and severity and outcomes on the Menopause-Specific Quality of Life questionnaire and the Medical Outcomes Study sleep scale. Sensitivity analyses were performed to check assumptions of linearity between VMS and outcomes. Results:Frequency and severity of HFs showed approximately linear relationships with MSQOL and sleep parameters. Sensitivity analyses supported assumptions of linearity. The largest changes associated with a reduction of five HFs and a 0.5-point decrease in severity occurred in the Menopause-Specific Quality of Life vasomotor functioning domain (0.78 for number of HFs and 0.98 for severity) and the Medical Outcomes Study sleep disturbance (7.38 and 4.86) and sleep adequacy (−5.60 and −4.66) domains and the two overall sleep problems indices (SPI: 5.17 and 3.63; SPII: 5.82 and 3.83). Conclusions:Frequency and severity of HFs have an approximately linear relationship with MSQOL and sleep parameters—that is, improvements in HFs are associated with improvements in MSQOL and sleep. Such relationships may enable clinicians to predict changes in sleep and MSQOL expected from various VMS treatments.

Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene.

OBJECTIVE Describe the effects of conjugated estrogens/bazedoxifene (CE/BZA), a new treatment for vasomotor symptoms (VMS) and osteoporosis prevention, on menopause-specific quality of life (MSQOL) across different patient population types in phase 3 clinical trials. DESIGN MSQOL was prospectively evaluated in 4 randomized, double-blind, placebo-controlled studies. The populations studied included healthy, non-hysterectomized postmenopausal women with symptomatic VMS or vulvar-vaginal atrophy (VVA) and general postmenopausal women (eligible regardless of symptoms). Menopause-specific Quality of Life (MENQOL) questionnaire total and domain scores for CE 0.625 mg/BZA 20mg and CE 0.45 mg/BZA 20mg were evaluated and compared with established thresholds for clinically important differences (CID). RESULTS Significant improvements compared with placebo were found with both CE/BZA doses in MENQOL vasomotor domain (-0.61 to -2.23 over 3-24 months) and total scores (-0.24 to -0.94) in the general and symptomatic VMS/VVA populations. Significant improvement compared with placebo in sexual domain (-0.11 to -0.72) was observed with the higher dosage for all populations, and with the lower dosage in the VVA (-0.71 at month 3) and general populations (-0.4 at months 12 and 24). Improvements in vasomotor domain exceeded the CID with both doses in symptomatic VMS populations and with the higher dosage in women with symptomatic VVA; for total MENQOL, the CID was exceeded with the higher dose in symptomatic VMS populations. CONCLUSIONS CE/BZA significantly improved overall and vasomotor-related MSQOL across populations of postmenopausal women with varying baseline symptom statuses. Women with greater menopausal symptoms at baseline were more likely to experience clinically meaningful changes.

Qualitative cross-cultural exploration of vaginal bleeding/spotting symptoms and impacts associated with hormone therapy in post-menopausal women to inform the development of new patient-reported measurement tools

OBJECTIVES To understand the vaginal bleeding/spotting experiences of postmenopausal (PM) women taking estrogen plus progestin therapies (EPT) and develop measures to assess these symptoms and their impact on womens daily lives in four countries. DESIGN (1) Concept elicitation interviews were conducted with PM women in the US (n=14), Italy (n=15), Mexico (n=15) and China (n=15) to explore vaginal bleeding/spotting symptoms associated with EPT. The Post-Menopausal Bleeding Questionnaire (PMBQ) was also debriefed to evaluate understanding and comprehensiveness. (2) Based on concept elicitation, a single item electronic daily diary was developed and the PMBQ modified to form a 12-item impact measure. (3) The measures were pilot-tested and then cognitively debriefed with US women receiving EPT. All qualitative data was subject to thematic analysis. MAIN OUTCOME MEASURES The Vaginal Bleeding/Spotting Daily Diary, (VBS-DD) and Post-Menopausal Bleeding Impact Questionnaire (PMBIQ) were developed in this study. RESULTS Concept elicitation identified vaginal bleeding and spotting as important symptoms for women taking EPT, impacting their emotional wellbeing, social life, ability to move freely, clothing and sexual activity. Based on pilot testing and cognitive debriefing, women demonstrated good understanding of the VBS-DD and the PMBQ was reduced to 10 items due to conceptual redundancy. CONCLUSIONS Women taking EPT in the US, China, Mexico and Italy reported vaginal bleeding/spotting symptoms that have a detrimental impact on their quality of life. Two new measures were developed to assess the severity and impact of vaginal bleeding/spotting specific to EPT. This work highlights the need for EPT-related symptoms to be a part of treatment decision-making.