Self-Esteem And Relationship Questionnaire Research Articles

SCORING CORRESPONDENCE IN OUTCOMES RELATED TO ERECTILE DYSFUNCTION TREATMENT ON A 4-POINT SCALE (SCORE-4)

ABSTRACT Introduction The Erection Hardness Score (EHS), a validated single-item patient-reported outcome (PRO), may provide a simple method to capture erectile dysfunction (ED) symptoms and to monitor treatment outcome. Aim To map the relationship between the EHS, which was used as the anchor, and other validated PROs: International Index of Erectile Function (IIEF), Quality of Erection Questionnaire (QEQ), Sexual Experience Questionnaire (SEX-Q), and Self-Esteem and Relationship questionnaire (SEAR). Methods Data were from a trial of flexible-dose sildenafil (50 or 100 mg) in 209 men with ED. Main Outcome Measures A mixed-effects repeated-measures model with EHS as a categorical explanatory variable and each of the other PROs, as a separate dependent variable, was applied to analyze the longitudinal data from randomization to the end of the 10-week, double-blind, placebo-controlled phase and the 6-week open-label phase. EHS data, which were generated at each sexual encounter (event), were averaged per patient over the same recall period that preceded administration of the other PRO questionnaires. Results Scores on all domains of the IIEF and SEX-Q, as well as the SEAR total score and SEAR Sexual Relationship domain, discriminated on all EHS categories. The QEQ total score discriminated on all EHS categories except EHS 1 and EHS 2. Although the model did not impose any functional relationship between PRO score and EHS, an approximately linear relationship existed between the EHS and all other PROs, which was especially pronounced for those PROs that were more directly related to erectile quality or function. Conclusions The relationship between discrete EHS categories and PRO scores demonstrates the close correspondence of erectile hardness with erectile function (IIEF), erection quality (QEQ), overall sexual experience (SEX-Q), and ED-related psychosocial factors (SEAR) in men with ED. Cappelleri JC, Bushmakin AG, Symonds T, and Schnetzler G. S coring c orrespondence in o utcomes r elated to e rectile dysfunction treatment on a 4-point scale (SCORE-4). J Sex Med 2009;6:809–819.

Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension

To evaluate once-daily 100-mg sildenafil for the treatment of erectile dysfunction (ED) in men with ED and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). This was a 12-week, randomised, double-blind, placebo-controlled (DBPC) trial, with an 8-week open-label (OL) extension, in men > or = 45 years of age who scored < or = 25 on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and > or = 12 on the International Prostate Symptom Score. At DBPC end of treatment (EOT), the sildenafil group (n = 189, vs. placebo, n = 180) had improved EF (IIEF), improved emotional well-being [Self-Esteem And Relationship questionnaire (SEAR)], and greater treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction) (p < 0.0001). At OL EOT, IIEF and SEAR scores improved slightly in the group previously randomised to sildenafil (n = 168), but much more in the group previously randomised to placebo (N = 155), such that total improvement over the 20-week trial was comparable between the groups. Erections at baseline were hard enough for penetration on approximately half of occasions and lasted long enough for successful intercourse on less than one quarter of occasions, increasing at sildenafil DBPC and OL EOT to approximately 90% (penetration) and 80% (intercourse success) vs. 61% (penetration) and 39% (intercourse success) for DBPC placebo. At sildenafil DBPC and OL EOT, > or = 90% of men were taking sildenafil 100 mg. Sildenafil was generally well tolerated. In this trial of men with ED and BPH-associated LUTS, sildenafil treatment for ED was efficacious, effective and generally well tolerated.

Clinically meaningful improvement on the Self-Esteem And Relationship questionnaire in men with erectile dysfunction

To estimate the minimal clinically meaningful improvement (MCMI) on the Self-Esteem And Relationship (SEAR) questionnaire. Using combined data from the 2 pivotal SEAR trials of men treated with sildenafil for erectile dysfunction (ED), MCMIs were estimated as the lower limit of the 2-sided 95% confidence intervals of SEAR mean change scores (from baseline to end of study) for 2 anchor groups: (1) men who improved 1 ED severity category on the Erectile Function domain of the International Index of Erectile Function, and (2) men who improved 5-60% (inclusive) on these erectile function scores. Both anchors gave comparable results. A 10-point MCMI was proposed because the estimates of 95% lower bounds centered on around 10 points for most SEAR components (Sexual Relationship, Confidence, Self-Esteem, Overall Score). An exception was the Overall Relationship whose 95% lower bounds were too low to recommend them as an MCMI. Two anchor-based approaches suggest that a change of about 10 points represents an MCMI on most components of the SEAR questionnaire.

Self-esteem, confidence, and relationships in men treated with sildenafil citrate for erectile dysfunction

Men with erectile dysfunction (ED) often have low self-esteem, confidence, and sexual relationship satisfaction. We evaluated the impact of sildenafil citrate and its generalizability across cultures on self-esteem, confidence, and sexual relationship satisfaction in men with ED using the Self-Esteem And Relationship (SEAR) questionnaire. Pooled analysis of 2 double-blind, placebo-controlled, flexible-dose trials of sildenafil with identical protocols: 1 was conducted in the United States and the other in Mexico, Brazil, Australia, and Japan. Men > or = 18 years old with ED. The impact of treatment on psychosocial factors associated with ED was determined by patient responses to the SEAR questionnaire. Erectile function was determined using the International Index of Erectile Function (IIEF) and a global efficacy question. Successful sexual intercourse attempts were derived from event logs of sexual activity. Treatment effect sizes were calculated for all study outcomes. Compared with patients who received placebo (n = 274), patients who received sildenafil (n = 279) reported significantly greater improvements (P < .0001) in self-esteem, confidence, sexual relationship satisfaction, and in all sexual function domains of the IIEF. Treatment effect sizes were large (range, 0.7 to 1.2) for all SEAR components, and improvement in psychosocial measures showed moderate to high correlations (range, 0.50 to 0.83, P < .0001) with improvement in erectile function, percentage of successful intercourse attempts, and global efficacy. In men with ED from 5 different nations, sildenafil produced substantial improvements in self-esteem, confidence, and sexual relationship satisfaction. Improvements in these psychosocial factors were observed crossculturally and correlated significantly and tangibly with improvements in erectile function.

Sildenafil Citrate Improves Self‐Esteem, Confidence, and Relationships in Men with Erectile Dysfunction: Results from an International, Multi‐Center, Double‐Blind, Placebo‐Controlled Trial

Erectile dysfunction (ED) can significantly impact a man's relationships and well-being. We assessed changes in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction in men with ED using the validated Self-Esteem And Relationship questionnaire (SEAR). This was a 12-week, double-blind, placebo-controlled, flexible-dose (25, 50, 100 mg, as needed) international study of sildenafil in men > or =18 years of age in Mexico, Brazil, Australia, and Japan. The primary study outcome was change in self-esteem from baseline to the end of treatment. Secondary study measures were changes in other SEAR components, International Index of Erectile Function (IIEF) domains, percentage of intercourse attempts that were successful, and the response to a global efficacy question at the end of treatment. Patients were well balanced for age and duration of ED (placebo = 149 and sildenafil = 151). Compared with placebo, sildenafil significantly improved self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction (P < 0.0001). The psychosocial measures of well-being assessed with the SEAR were positively correlated (range 0.60-0.86, P < 0.0001) with erectile function, the frequency of achieving erections that allowed satisfactory sexual intercourse, the percentage of successful sexual intercourse attempts, and global treatment efficacy. Significant improvements in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction after treatment of ED with sildenafil were consistent among countries. These data suggest a substantial cross-cultural improvement in well-being after successful treatment of ED with sildenafil.

Correlation of improved erectile function and rate of successful intercourse with improved emotional well-being assessed with the Self-Esteem And Relationship questionnaire in men treated with sildenafil for erectile dysfunction and stratified by age

ABSTRACTBackground: The quality of life consequences of erectile dysfunction (ED) include depression, anxiety, and loss of self-esteem. The Self-Esteem And Relationship (SEAR) questionnaire is a validated, patient-administered, psychometric instrument specific to ED.Objective: To determine correlations between erectile function (EF), intercourse success, and emotional well-being measured with the SEAR questionnaire in men treated with sildenafil citrate for ED and stratified by age (< 50 years, 50–65 years, and > 65 years).Research design and methods: This was an open-label, flexible-dose trial of sildenafil (25, 50 and 100 mg) administered for 10 weeks to 382 men with ED (mean ± SD age, 55 ± 13 years; mean ED duration, 4 years), which was conducted at 62 centers in the United States.Main outcome measures: Analysis (by intent-to-treat, n = 368) of the change from baseline to the week‐10 endpoint in the SEAR questionnaire Self-Esteem subscale, the intercourse success rate (percent of occasions at which an erection that lasted long enough for successful intercourse was achieved), and their correlation.Results: For the overall population, there was mean ± SD improvement ( p < 0.0001, paired t‐tests) in the Self-Esteem subscale (56 ± 25 to 79 ± 22) and intercourse success rate (21 ± 30% to 70 ± 36%), which showed positive correlation ( p < 0.0001). Secondary outcomes (i.e., EF domain of the International Index of Erectile Function; event log frequency of erection hard enough for sexual intercourse and of ejaculation/orgasm) also improved ( p < 0.0001) and correlated positively with the SEAR Self-Esteem subscale and Sexual Relationship domain ( p < 0.05 for all correlations). All 10 correlations were positive ( p < 0.05) in men aged 50 to 65 years, eight were positive in men aged > 65 years, and six were positive in men aged < 50 years. The most common treatment-related adverse events were mild-to-moderate headache (12% of patients), vasodilatation (7%), and rhinitis (4%).Conclusions: Men treated with sildenafil for ED demonstrated improved erectile function and an increased intercourse success rate, which correlated positively with improvement in SEAR measures of self-esteem and sexual relationship.

Comparison Between Sildenafil‐Treated Subjects with Erectile Dysfunction and Control Subjects on the Self‐Esteem And Relationship Questionnaire

Erectile dysfunction (ED) can negatively impact psychosocial measures of a patient's sexual life. To evaluate self-esteem, confidence, and relationships in men with ED, before and after treatment with sildenafil citrate (Viagra), with reference to controls without ED. Sildenafil-naïve patients with ED were enrolled in a 10-week, open-label, flexible-dose (25 mg, 50 mg, or 100 mg) trial of sildenafil. In a separate study, men without ED who did not take sildenafil also completed the Self-Esteem And Relationship (SEAR) questionnaire. In addition to traditional statistical testing, equivalency testing was applied to compare the ED group, before and after treatment, with the control group and to examine whether the ED group improved to normative ranges on the SEAR questionnaire after treatment (within half a standard deviation of the normative or control group mean). Baseline and end-of-treatment responses on psychosocial aspects of ED were measured with the validated SEAR. Mean SEAR scores between subjects with ED (N = 93, mean age 55.0 years) at baseline and control subjects without ED (N = 94, mean age 52.5 years) were statistically different from zero and not statistically equivalent. Conversely, mean SEAR scores between ED subjects after treatment and control subjects were statistically equivalent and not statistically different from zero. The results indicate that sildenafil is associated with normalization of relationships, confidence, and self-esteem in men with ED.

Validación de la versión española del cuestionario SEAR (Self-Esteem And Relationship Questionnaire) para varones con disfunción eréctil

The aim was to validate the Spanish version of the Self-Esteem and Relationship Questionnaire (SEAR), specific for patients with erectile dysfunction (ED), and based on the concept of self-esteem, for use in research and clinical practice in Spain. Observational, prospective, multisite, study comparing patients with ED (IIEF questionnaire score < 26 points), with a score (3/4) 16 points in the Self-Esteem domain of the SEAR questionnaire and undergoing treatment with sildenafil (group A), and healthy control subjects without ED. Patients with ED were assessed at baseline and after 3 months' treatment. Among 586 evaluable subjects (504 patients with ED and 82 health subjects) the questionnaire showed: a) adequate feasibility with a percentage of patients without response < 5%; b) adequate reliability with Cronbach alpha coefficients for the total and all domains (Sexual-Relationship, Confidence, Self-Esteem, and Overall-Relationship), of SEAR questionnaire, respectively: 0.92, 0.89, 0.84, 0.75, and 0.82 un patients, and 0.86, 0.80, 0.73, 0.56 and 0.74 un healthy subjects; c) adequate discriminatory validity between patients and healthy subjects (Mann-Whitney test, p < 0.0001), and between patients with vaying degrees of ED (Kruskall-Wallis test, p < 0.05); d) adequate convergent/divergent validity (correlations > 0.5 with the IIEF questionnaire and r > 0.3 and < 0.5 with Mental Health domain score of SF-12 questionnaire); e) adequate construct validity, obtaining 2 domains: Sexual-Relationship, and Confidence, and f) adequate sensitivity to clinical changes (SES: 2.1/SRM: 1.5/SEM: 4.4/MID: 13.1). Mark scores were estimated. The Spanish version of the SEAR questionnaire showed adequate and similar psychometric properties to those shown with the original English version.

Development and validation of the Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction.

Development and validation of a patient-reported measure of psychosocial variables in men with erectile dysfunction (ED) is described. Literature review, focus groups, and medical specialists identified 86 potential items. Redundant, ambiguous, or low item-to-total correlation items were removed. Data from 98 men reporting diagnosed ED and 94 controls assisted in final item selection and psychometric evaluation. Treatment responsiveness was evaluated in 93 men with ED in a 10-week open-label trial of sildenafil citrate (Viagra). The 14 chosen items resolved into two domains: Sexual Relationship (eight items) and Confidence (six items), the latter comprising Self-Esteem (four items) and Overall Relationship (two items) subscales. The resulting Self-Esteem And Relationship (SEAR) questionnaire demonstrated validity and reliability. The intervention study demonstrated responsiveness to beneficial treatment with significant improvement in scores (P=0.0001). The SEAR questionnaire possesses strong psychometric properties that support its validity and reliability for measuring sexual relationship, confidence, and particularly self-esteem.

Treatment responsiveness of the Self-Esteem And Relationship questionnaire in erectile dysfunction

Objectives To determine the treatment responsiveness of the disease-specific Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction. Methods The SEAR questionnaire was administered at baseline and at the end of the study in 93 patients with erectile dysfunction enrolled in a 10-week, open-label, flexible-dose (50-mg sildenafil, adjustable to 25 mg or 100 mg) trial. Changes from the baseline score were analyzed using the paired t test. The correlation between the changes from baseline on the SEAR questionnaire and the Erectile Function domain of the International Index of Erectile Function was examined. Results Significant and meaningful differences ( P = 0.0001) from baseline were observed in the two primary domains (Sexual Relationship and Confidence) and the two Confidence domain subscales (Self-Esteem and Overall Relationship). The magnitude of the change was quite high for most aspects (Sexual Relationship, effect size [ES] = 1.6; Confidence, ES = 1.0; Self-Esteem, ES = 1.1) and moderate for one (Overall Relationship, ES = 0.6). Changes in Erectile Function domain score correlated moderately with changes in the SEAR domain and subscale scores (Sexual Relationship, r = 0.69; Confidence, r = 0.48; Self-Esteem, r = 0.47; and Overall Relationship, r = 0.35; P ≤0.001). Conclusions The SEAR questionnaire is responsive to effective treatment of erectile dysfunction. These data suggest that the SEAR questionnaire is a valid instrument for detecting psychosocial gains from beneficial intervention.