Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction (original) (raw)
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Development and Validation of the Quality of Erection Questionnaire
The Journal of Sexual Medicine, 2007
There are no psychometrically validated assessment tools designed to solely and specifically evaluate satisfaction with the quality of erections. Aim. To develop and psychometrically analyze the Quality of Erection Questionnaire (QEQ), a new patientreported measure developed to evaluate men's satisfaction with the quality of their erections. Methods. The questionnaire was developed through in-depth qualitative interviews of men with erectile dysfunction (ED) in the United States and Australia. An exploratory methodology study was conducted on 65 men with ED. Subsequently, the psychometric properties were confirmed in a larger dataset of 558 men with ED from two combined clinical trials. Main Outcome Measures. Identification of potential redundancy or outliers in items (Pearson inter-item correlations); exploratory factor analysis (unrotated and varimax rotated); internal consistency (Cronbach's alpha); convergent validity (Pearson correlation coefficients between the QEQ total score and domain scores of the International Index of Erectile Function); known-groups validity (ability of the QEQ scores to differentiate between ED severity groups); test-retest reliability (Pearson correlation coefficient). Results. The QEQ demonstrated excellent convergent and known-groups validity. Additional analysis demonstrated high internal consistency (Cronbach's alpha, 0.92). Item analysis demonstrated a unidimensional structure and suggested that satisfaction with hardness may be the key driver for satisfaction with overall quality of erections ( r = 0.8). The smaller exploratory study demonstrated good test-retest reliability ( r = 0.82). Conclusions. The QEQ is a six-item, patient-reported measure with a unidimensional structure, which produces a total score that may be transformed to a 0-100 scale. Psychometric analysis confirmed reliability and validity of the QEQ, which solely and specifically evaluates satisfaction of men with the quality of their erections. The QEQ is a potentially useful measure for monitoring and evaluating treatment in those who are bothered by, or concerned about, their erectile function. Porst H, Gilbert C, Collins S, Huang X, Symonds T, Stecher V, and Hvidsten K. Development and validation of the Quality of Erection Questionnaire. J Sex Med 2007;4:372-381.
Erection Quality Scale: Initial scale development and validation
Urology, 2004
Objectives. The Erection Quality Scale (EQS) is a new, self-report measure for assessing the quality of penile erections. It is intended to complement existing diagnostic and outcome measures (eg, International Index of Erectile Function, Sexual Encounter Profile) in both clinical practice and outcomes research in erectile dysfunction (ED). Methods. The initial phases of development and psychometric validation of the EQS are described. Specifically, qualitative research in patients and healthy men was used to generate relevant constructs. On the basis of the findings from these phases, and recommendations from an expert panel, seven constructs were selected for inclusion. Multiple items with different formats were drafted to measure each of the key constructs. An iterative process of cognitive testing, item revision, and item reduction was used to identify the 15 most appropriate items and their optimal response scales. This version of the scale was tested in a 200-subject discriminant validity study designed to gather data for a psychometric evaluation. Participants were classified into ED-untreated, ED-treated, and healthy control groups to evaluate the discriminant validity of the measure in men with different levels of erectile function. Results. The study results supported a robust single-factor structure, indicating that the EQS provides an overall index of erection quality. An intraclass correlation coefficient of 0.85 denotes adequate test-retest reliability. Furthermore, the EQS correlated well with existing measures and differentiated patients from the three ED classifications, a preliminary indication of discriminant validity. Conclusions. The findings presented provide evidence of the scale's potential utility for measuring erection quality in future studies. UROLOGY 64: 351-356, 2004.
International Journal of Impotence Research, 2003
A French quality of life questionnaire specific to erectile dysfunction (ED), 'QVS' for 'Questionnaire de Vie Sexuelle', has been developed. This paper describes its validation: item reduction and reliability (internal consistency and reproducibility), construct validity and criterion validity (clinical, discriminant and concurrent). The initial 40-item questionnaire was administered once to 316 ED and 117 control subjects, and twice (D0 and D7) to 104 ED and 29 control subjects. Item reduction gave a 27-item questionnaire with three scales (Sexual Life, Skills and Psychosocial Wellbeing) and four scores (one score for each scale and a Global Index). Psychometric analyses demonstrated the reliability and the validity of the QVS. The questionnaire was able to discriminate patients according to the presence or severity of ED. The Skills scale was the least sensitive. Analysis of responsiveness to change over time still needs to be addressed to consider the questionnaire as a fully validated instrument.
Urology, 1997
Objectives. To develop a brief, reliable, self-administered measure of erectile function that is cross-culturally valid and psychometrically sound, with the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. Methods. Relevant domains of sexual function across various cultures were identified via a literature search of existing questionnaires and interviews of male patients with erectile dysfunction and of their partners. An initial questionnaire was administered to patients with erectile dysfunction, with results reviewed by an international panel of experts. Following linguistic validation in 10 languages, the final 15-item questionnaire, the International Index of Erectile Function (IIEF), was examined for sensitivity, specificity, reliability (internal consistency and testretest repeatability), and construct (concurrent, convergent, and discriminant) validity. Results. A principal components analysis identified five factors (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction) with eigenvalues greater than 1.0. A high degree of internal consistency was observed for each of the five domains and for the total scale (Cronbach's alpha values of 0.73 and higher and 0.91 and higher, respectively) in the populations studied. Test-retest repeatability correlation coefficients for the five domain scores were highly significant. The IIEF demonstrated adequate construct validity, and all five domains showed a high degree of sensitivity and specificity to the effects of treatment. Significant (P values -0.0001) changes between baseline and post-treatment scores were observed across all five domains in the treatment responder cohort, but not in the treatment nonresponder cohort. Conclusions. The IIEF addresses the relevant domains of male sexual function (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), is psychometrically sound, and has been linguistically validated in l 0 languages. This questionnaire is readily self-administered in research or clinical settings. The IIEF demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. UROLOGY 49: 822-830, 1997.
The ED-EQoL: The development of a new quality of life measure for patients with erectile dysfunction
Quality of Life Research, 2000
Purpose: To identify the important issues which have an impact on the quality of life (QoL) of men suffering from erectile dysfunction (ED) and to generate a new ED-specific QoL questionnaire ready to undergo further psychometric testing. Methods: QoL issues relating to ED were generated through in-depth qualitative interviews of 29 patients, literature review and consultation with other healthcare professionals. The issues were formulated into a questionnaire, which was piloted using 40 patients with ED and subsequently refined using well-established principles of questionnaire development. Results: The qualitative interviews revealed numerous psychosocial problems associated with ED, which were operationalised into a 40-item questionnaire. Pilot testing allowed the questionnaire to be reduced to a manageable 15-item final questionnaire while maintaining face and content validity and the potential to discriminate between men with varying degrees of affected QoL. This questionnaire had a Cronbach's a of 0.94. Conclusions: A new EDspecific QoL measure has been developed using appropriate methodology. Qualitative techniques identified a range of psychosocial morbidity in men with ED, leading to a simple but robust instrument with face and content validity. This questionnaire, Erectile Dysfunction -Effect on quality of life (ED-EQoL), has now undergone psychometric testing for validity and reliability.
Responsiveness and Minimum Important Differences for the Erection Quality Scale
The Journal of Urology, 2007
We evaluated the responsiveness and treatment sensitivity of the Erection Quality Scale, and provided further psychometric validation of this scale. Materials and Methods: An 8-week, placebo controlled, randomized clinical trial investigating the efficacy and safety of vardenafil in patients with erectile dysfunction was performed. The Erection Quality Scale, together with a number of other patient and partner questionnaires, was administered at a screening visit, at baseline, and weeks 4 and 8 of treatment. Erection Quality Scale responsiveness was investigated by evaluating treatment induced changes and modeling using ANCOVA. Internal consistency, convergent and discriminant validity, and minimum important difference of the Erection Quality Scale were also assessed. Results: Efficacy evaluations demonstrated that the Erection Quality Scale was sufficiently responsive to differentiate the treatment benefits of vardenafil compared with placebo. Internal consistency for the Erection Quality Scale total score was similar across visits, with values high enough to suggest reliability of items included in the scale. Discriminant validity of the Erection Quality Scale total score was demonstrated, with a high correlation with the erectile function domain of the International Index of Erectile Function (0.88, p Ͻ0.0001) and negligible correlations with clinical measures assumed to be unrelated to erection quality. All Erection Quality Scale total score comparisons substantially exceeded the 5-point minimum important difference estimate. Conclusions: The Erection Quality Scale was responsive and internally consistent, and demonstrated convergent and discriminant validity. Furthermore, this instrument provided a unique contribution to the measurement of erection quality compared to the International Index of Erectile Function. This study provides strong evidence supporting the use of the Erection Quality Scale in clinical trials.
An assessment of patient-reported outcomes for men with erectile dysfunction: Pfizer's perspective
International Journal of Impotence Research, 2008
Patient-reported outcomes (PROs) for men with erectile dysfunction (ED) have blossomed in the published literature and at professional conferences. These outcomes have been central to study the science of ED itself and to evaluate efficacy of treatment for men with ED. In this review article we highlight and distinguish among seven key PROs: the International Index of Erectile Function, for sexual function including erectile function; the Sexual Health Inventory for Men (SHIM), for diagnosis of ED; the Quality of Erection Questionnaire, for satisfaction with quality of erections; the Erectile Dysfunction Inventory of Treatment Satisfaction, for personal evaluation of treatment received; the Self-Esteem And Relationship questionnaire, for emotional well-being; the Erection Hardness Score (EHS), for targeting erection hardness and the Sexual Experience Questionnaire, for erection (both function and quality), individual satisfaction and couples satisfaction. Depending on the purpose of the investigation, all seven PROs have merit for use in clinical trials and at least deserve consideration in clinical practice. The SHIM and the EHS, given their aims and brevity, deserve special consideration in clinical practice. As a unit these seven PROs complement and supplement each other. Which ones to choose in a particular undertaking depends on the objective or purpose of a given study. These PROs acknowledge that sexual dysfunction and its treatment have multiple dimensions. Each of these instruments represents a significant contribution to sexual medicine research and, when used judiciously and appropriately, can help to provide optimal patient care and management.
International Journal of Impotence Research, 2006
To determine whether the results of the self-reported International Index of Erectile Function (IIEF) to assess erectile function can overestimate the degree of erectile impairment. A total of 32 consecutive patients seeking treatment for erectile dysfunction (ED) at a urologist's office were evaluated by completion of the erectile function domain of the IIEF. Nocturnal penile tumescence testing using the Rigiscan (Timm Medical Technologies Inc., USA) was performed in these patients after completion of the IIEF. The median IIEF-6 score was 9 of 30 (range, 1-25; mean, 11/30). Rigiscan results were abnormal in six patients (19%), normal in 25 patients (78%), and unable to interpret in one patient (3%). IIEF-6 scores were subdivided by severity along with Rigiscan results. There was no correlation between age, IIEF score, or Rigiscan results. In conclusion, the IIEF is a useful tool and is helpful for follow-up of a patient to evaluate efficacy of treatments for ED, but should not replace objective testing to diagnose the quality of ED.
Journal of Sexual Medicine, 2009
The validated Quality of Erection Questionnaire (QEQ) evaluates satisfaction with erection quality. Aim. To collate QEQ data, including correlations between QEQ outcomes and outcomes assessing emotional well-being, treatment satisfaction, and erection hardness after sildenafil citrate treatment. Methods. In four trials, men older than 18 years and with erectile dysfunction, a stable sexual partner, and no recent phosphodiesterase type 5 inhibitor use were randomized to double-blind flexible-dose sildenafil or placebo (1:1 ratio) for 6 or 10 weeks (two trials), fixed-dose 50 mg, 100 mg, and placebo (1:1:1 ratio) for 8 weeks (one trial), and 50 mg and 100 mg (1:1 ratio) for 4 weeks after 4 weeks of single-blind sildenafil 50 mg. Exclusion criteria included recent significant cardiovascular disease, use of nitrates, nitric oxide donors, cytochrome P450 3A4 inhibitors, or other erectile dysfunction treatment, and sildenafil hypersensitivity or previous severe or serious treatment-related adverse event.
Urology, 1999
Objectives. To develop Patient and Partner versions of a psychometrically sound questionnaire, the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), to assess satisfaction with medical treatments for erectile dysfunction. Methods. Treatment satisfaction differs from treatment efficacy as it focuses on a person's subjective evaluation of treatment received. Twenty-nine items representing the domain of treatment satisfaction for men and 20 representing partner satisfaction were generated. Two independent samples of 28 and 29 couples completed all items at two points in time. Spearman rank-order correlations were derived to assess test-retest reliability and couple coefficients of validity. Internal consistency coefficients were calculated for both Patient and Partner versions and a content validity panel was used to analyze content validity. Results. Only items that met all the following criteria were selected to comprise the final questionnaires: (a) range of response four or more out of five; (b) test-retest reliability greater than 0.70; (c) ratings by at least 70% of the content validity panel as belonging in and being important for the domain; and (d) significant correlation between the subjects' and partners' responses. Eleven patient items met criteria and formed the Patient EDITS; five partner items met criteria and formed the Partner EDITS. Scores on the two inventories were normally distributed with internal consistencies of 0.90 and 0.76, respectively. Test-retest reliability for the Patient EDITS was 0.98; for the Partner EDITS, it was 0.83. Conclusions. Reliability and validity were well established, enabling the EDITSs to be used to assess satisfaction with treatment modalities for erectile dysfunction and to explore the impact of patient and partner satisfaction on treatment continuation. UROLOGY 53: [793][794][795][796][797][798][799] 1999. © 1999, Elsevier Science Inc. All rights reserved.