50 years with Down syndrome: A longitudinal study.

BACKGROUND: A population sample of people with Down syndrome, studied from infancy, has now been followed up at the age of 50 years. From the original sample of 54, there were 27 still in the study at the age of 50, all but four of the losses resulting from deaths. METHODS: Intelligence and language skills were tested and daily living skills assessed. Memory/cognitive deterioration was examined using two test instruments. Other aspects of the people's lives were examined via carers' reports. RESULTS: Scores on verbal tests showed little change. Those on a non-verbal test, on self-help skills and on both memory tests showed some decline, even when the scores of those already suffering from dementia were discounted. CONCLUSIONS: At the age of 50, those not already diagnosed with dementia showed some decline on most tests. While this may include scores of people who subsequently develop dementia, it may also reflect the normal ageing process in this population.

'I was just so different': The experiences of women diagnosed with an autism spectrum disorder in adulthood in relation to gender and social relationships.

Existing literature exploring autism spectrum disorders within female populations predominantly utilises quantitative methodology. A limited number of small-scale, qualitative studies have explored the experiences of adolescent girls with autism spectrum disorder, but adult women have remained largely unheard. This study aims to broaden the stories told within autobiographical literature and empower those within the wider community of women with autism spectrum disorder. In doing so, it seeks to extend existing conceptualisations of experience to include socially and culturally located factors. A qualitative methodology was adopted, utilising multi-stage narrative analysis. Seven semi-structured interviews with women who received a diagnosis in adulthood were conducted. Recruitment spanned community mental health services, an inpatient service and a community support group. From the women's diverse experiences and stories emerged two broad categories related to gender identity and social relationships. The findings are discussed in relation to existing constructs of autism in women.

Ageing and dementia in a longitudinal study of a cohort with Down syndrome.

BACKGROUND: A population sample of people with Down syndrome has been studied from infancy and has now been followed up again at age 47 years. METHODS: Intelligence and language skills were tested and daily living skills assessed. Memory/cognitive deterioration was examined using two test instruments. RESULTS: Scores on verbal tests of intelligence changed little. Those on a non-verbal test, on self-help skills and on both memory tests showed some decline, even when the scores of those already suffering from dementia were discounted. CONCLUSIONS: At age 47, scores on most tests of even the majority of the cohort (i.e. those not definitely diagnosed with dementia) showed some decline. While this includes the scores of people who may subsequently develop dementia, it may also reflect the normal ageing process in this population.

Does training improve understanding of core concepts in cognitive behaviour therapy by people with intellectual disabilities? A randomized experiment.

BACKGROUND: People with intellectual disabilities (ID) experience similar or even higher rates of mental health problems than the general population and there is a need to develop appropriate treatments. Cognitive behaviour therapy (CBT) is effective for a wide range of disorders in the general population. However, there is some evidence that people with ID may lack the cognitive skills needed to take part in CBT. AIMS: To test if people with ID can learn skills required for CBT, specifically the ability to distinguish between thoughts, feelings, and behaviours and to link thoughts and feelings (cognitive mediation). METHOD: A randomized independent groups design was used to examine the effect of training in CBT on two tasks measuring CBT skills. Thirty-four adults with ID were randomly allocated to the experimental condition (N=18) or to the control condition (N=16). CBT skills were assessed blind at baseline and after the intervention. RESULTS: The training led to significant improvements in participants' ability to link thoughts and feelings, and this skill was generalized to new material. There was no effect of training on participants' ability to distinguish amongst thoughts, feelings, and behaviours. People with ID can, therefore, learn some skills required for CBT. This implies that preparatory training for CBT might be useful for people with ID. The results might be applicable to other groups who find aspects of CBT difficult.

Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt.

INTRODUCTION: Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy. AIM: Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED. METHODS: Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function) who had received < or =6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg). MAIN OUTCOME MEASURES: Efficacy, tolerability, treatment satisfaction, and other end points were measured at baseline and/or the end of the double-blind and open-label phases and compared between placebo and sildenafil initiated at doses of 50 and 100 mg. RESULTS: Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and 100 mg compared with placebo. At the end of DBPC treatment, 56% of men on the 100-mg dose felt no anxiety about the next intercourse attempt compared with 39% in the 50-mg group (odds ratio 2.03; P = 0.0197). Changes in functional scores from baseline were not statistically significant with the 100-mg dose compared with the 50-mg dose in the DBPC. Measures of treatment satisfaction and sexual experience significantly favored the 100-mg dose compared with the 50-mg dose in the DBPC. There was no increase in adverse events with the higher dose. CONCLUSIONS: Sildenafil at 50 mg or 100 mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Sildenafil 100 mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the 50-mg dose.

Quality of erections in men treated with flexible-dose sildenafil for erectile dysfunction: multicenter trial with a double-blind, randomized, placebo-controlled phase and an open-label phase.

INTRODUCTION: Erectile dysfunction (ED) impacts erection hardness and compromises quality of life. AIM: Assess erection hardness and its correlation with sexual function, emotional well-being, and satisfaction (erection quality, intercourse, sex life, sexual relationship, and treatment). METHODS: Men with ED were randomized to double-blind, flexible-dose sildenafil (25, 50, or 100 mg) or placebo (6 weeks) with open-label extension (6 weeks). MAIN OUTCOME MEASURES: Erection Hardness Score (EHS), Quality of Erection Questionnaire (QEQ), International Index of Erectile Function (IIEF), Self-Esteem And Relationship (SEAR) questionnaire, and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). RESULTS: A total of 307 men (mean [range] age, 45 [18-55] years) were randomized to sildenafil (N = 154) or placebo (N = 153). At the end of double-blind treatment, occasions with EHS 3 (hard enough for penetration but not completely hard) or 4 (completely hard) had increased by 40% +/- 3% for sildenafil vs. 11% +/- 3% for placebo (least squares mean +/- standard error; P < 0.0001); the estimated percentage of occasions with EHS 4 was 58% (95% CI, 52-65%) vs. 14% (95% CI, 10-19%) (odds ratio, 8.5; P < 0.0001). There was greater improvement in mean QEQ, IIEF, and SEAR scores (P < 0.0001), and more men were satisfied with sildenafil treatment (EDITS Index score >50: 90% vs. 49%). QEQ, IIEF, SEAR, and EDITS outcomes correlated positively with EHS 3 or 4, and with EHS 4 alone and were highest (no overlap of 95% CI vs. other EHS subgroups) in the subgroup with most frequent EHS of 4. CONCLUSIONS: In the group of men with ED treated with sildenafil, it was estimated that completely hard erections were achieved on 58% (95% CI, 52-65%) of occasions. Improvement in function, emotional well-being, and satisfaction was greatest in men with completely hard erections and correlated positively with other measures of hardness.

Development and validation of the quality of erection questionnaire.

INTRODUCTION: 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 patient-reported 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.

Quality of erection questionnaire correlates: change in erection quality with erectile function, hardness, and psychosocial measures in men treated with sildenafil for erectile dysfunction.

INTRODUCTION: The validated Quality of Erection Questionnaire (QEQ) is a six-question, patient-reported outcome measure for comprehensively evaluating satisfaction with the quality of erections in terms of hardness, onset, and duration, which can be used to develop and monitor individualized treatment goals. AIMS: To further validate the QEQ by determining responsiveness/sensitivity to change in erectile function, erection hardness grade, and psychosocial outcomes in men treated with sildenafil for erectile dysfunction (ED). METHODS: This open-label, noncomparative, multicenter trial of sildenafil (50 or 100 mg as needed for 10 weeks) enrolled men with ED who were in a stable, sexual relationship for at least 6 months. Previous phosphodiesterase type 5 inhibitor use must have been no more than 6 doses ever and no doses more recently than the previous 4 weeks. MAIN OUTCOME MEASURES: The baseline to week 10 change in the QEQ total score and its correlations with the end-of-treatment Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) score and with changes in: (i) International Index of Erectile Function (IIEF) domain scores; (ii) Self-Esteem And Relationship (SEAR) questionnaire component scores; and (iii) the frequency of erections graded hard enough for penetration (grade 3) or completely hard (grade 4) on the event log Erectile Hardness Grading Scale. RESULTS: The mean +/- standard deviation transformed QEQ total score tripled from 22.0 +/- 21.1 to 69.9 +/- 35.9 (P < 0.0001), and correlated positively with the end-of-treatment EDITS index score (r = 0.71) and with changes in IIEF domain scores (r = 0.29-0.86), SEAR component scores (r = 0.37-0.78), and the percentage of occasions that grade 3 or 4 erections were achieved (r = 0.66). CONCLUSIONS: The brief, easy-to-administer QEQ is responsive to the benefits of sildenafil treatment of men for ED and has convergent validity with measures of clinical and psychosocial outcomes.

Impact of erectile dysfunction on confidence, self-esteem and relationship satisfaction after 9 months of sildenafil citrate treatment.

PURPOSE: The first double-blind, placebo controlled trial in the United States of the Self-Esteem And Relationship questionnaire revealed that treatment with sildenafil citrate improves erectile function and measures of quality of life in men with erectile dysfunction. We investigated long-term improvement, and correlations between improved erectile function and confidence, self-esteem and sexual relationship satisfaction in men with erectile dysfunction. MATERIALS AND METHODS: This was a 36-week open label extension of the double-blind, placebo controlled trial. The blind was not broken. Patients were 18 years or older with clinically diagnosed erectile dysfunction. Erectile function was assessed using the International Index of Erectile Function. Self-esteem, confidence and relationship satisfaction were assessed using the Self-Esteem And Relationship questionnaire. Correlations were determined using Pearson's product moment coefficients. RESULTS: A total of 204 participants were enrolled in the open label extension, including 108 on placebo and 96 on sildenafil. In men who received placebo in the double-blind, placebo controlled phase mean erectile function scores and self-esteem, confidence and relationship satisfaction scores were increased significantly at week 36 of the open label extension (p < 0.0001). Men who received sildenafil in the double-blind, placebo controlled phase maintained high scores in the open label extension. Correlations between improved erectile function, and self-esteem, confidence and relationship satisfaction were strong and positive (p < 0.0001). CONCLUSIONS: Open label extension sildenafil after double-blind, placebo controlled placebo significantly improved erectile function, self-esteem, confidence and relationship satisfaction. Following an initial 12 weeks of double-blind, placebo controlled sildenafil therapy for erectile dysfunction improvements were sustained an additional 9 months. Positive correlations between erectile function, and self-esteem, confidence and relationship satisfaction suggest that improved erectile quality can improve long-term psychosocial quality of life.