The RCPCH care pathway for food allergy in children: an evidence and consensus based national approach.

AIMS: The Royal College of Paediatrics and Child Health (RCPCH) Science and Research Department was commissioned by the Department of Health to develop national care pathways for children with allergies; food allergy is the second pathway. The pathways focus on defining the competences required to improve the equity of care received by children with allergic conditions. METHOD: The food allergy pathway was developed by a multidisciplinary working group and was based on a comprehensive review of the evidence. The pathway was reviewed by a broad group of stakeholders including the public and approved by the Allergy Care Pathways Project Board and the RCPCH Clinical Standards Committee. The National Institute of Health and Clinical Excellence simultaneously established a short guideline review of community practice for children with food allergy; close communication was established between the two groups. RESULTS: The results are presented in two sections: a pathway algorithm and the competences. The entry points are defined and the ideal pathway of care is described from initial recognition and confirmed diagnosis through to follow-up. CONCLUSIONS: The range of manifestations of food allergy/intolerance is much more diverse than hitherto recognised and diagnosis can be problematic as many patients do not have classical IgE mediated disease. The pathway provides a guide for training and development of services to facilitate improvements in delivery as close to the patient's home as possible. The authors recommend that this pathway is implemented locally by a multidisciplinary team with a focus on creating networks.

The RCPCH care pathway for children at risk of anaphylaxis: an evidence and consensus based national approach to caring for children with life-threatening allergies.

AIMS: Numerous studies have identified shortcomings in the management of children at risk of severe acute allergic reactions (anaphylaxis). The Science and Research Department at the Royal College of Paediatrics and Child Health (RCPCH) was commissioned by the Department of Health to develop competence based national care pathways for children with allergies. Anaphylaxis is the first completed pathway. METHODS: The anaphylaxis pathway was developed by a multidisciplinary working group, reviewed by a broad group of stakeholders and approved by the Allergy Care Pathways Project Board and the RCPCH Clinical Standards Committee. RESULTS: Pathway development is described under five headings: evidence review, mapping, external review, core knowledge documents and key recommendations. The full pathway can be downloaded from www.rcpch.ac.uk/allergy/anaphylaxis. This document describes the entry points and the ideal pathway of care from self-care through to follow-up. The five key recommendations focus on: (1) prompt administration of adrenaline by intramuscular injection; (2) referral to specialists with competence in paediatric allergies; (3) risk analysis; (4) provision of a self-management plan; and (5) suggested creation of a national anaphylaxis death register. CONCLUSIONS: We present the first national care pathway for anaphylaxis, which is based on a critique of published evidence, expert consensus and multi-stakeholder input including patient representation via the Anaphylaxis Campaign. The Project Board urges health professionals to work together across networks to improve care for children at risk of anaphylaxis, in particular during the period after an acute reaction. Additionally, the Project Board strongly recommends the funding of a national anaphylaxis register.

Sexual difficulties and help-seeking among mature adults in Australia: results from the Global Study of Sexual Attitudes and Behaviours.

BACKGROUND: The Global Study of Sexual Attitudes and Behaviours was a survey of 27 500 men and women in 29 countries. Here we report the sexual activity, the prevalence of sexual difficulties and related help-seeking behaviour among participants in Australia. METHODS: A telephone survey was conducted in Australia in 2001-2002, with interviews based on a standardised questionnaire. A total of 1500 individuals (750 men and 750 women) aged 40 to 80 years completed the survey. The questionnaire covered demographic information, overall health, and sexual behaviours, attitudes and beliefs. RESULTS: Overall, 83% of men and 74% of women had engaged in sexual intercourse during the 12 months preceding the interview, and 38% of all men and 29% of all women engaged in sexual intercourse more than once a week. Early ejaculation (23%), erectile difficulties (21%) and a lack of sexual interest (18%) were the most common male sexual difficulties. The most frequently reported female sexual difficulties were: lack of sexual interest (33%), lubrication difficulties (26%) and an inability to reach orgasm (25%). Older age was a significant predictor of male erectile difficulties and of lubrication difficulties in women. Only a minority of men and women had sought help for their sexual difficulty(ies) from a health professional. CONCLUSIONS: Many middle-aged and older adults in Australia report continued sexual interest and sexual activity. Several sexual difficulties are highly prevalent in this population, but those experiencing these difficulties rarely seek medical help. This may be because they do not perceive such difficulties as serious or sufficiently upsetting.

Importance of and satisfaction with sex among men and women worldwide: results of the global better sex survey.

INTRODUCTION: It is now increasingly recognized that sexual health is important to overall good health and well-being. AIM: The Global Better Sex Survey (GBSS) explored the sexual aspirations and unmet needs of men and women worldwide. MAIN OUTCOME MEASURES: Participant responses to survey questions. METHODS: Data were collected during 2005 in 27 countries by phone, door-to-door, and street-intercept interview. Data were weighted by demographic characteristics to accurately reflect the general population of each country. RESULTS: Of the 12,563 respondents (men = 6,291, women = 6,272), 46% of men and 48% of women were younger than 40 years, 41% were 40-59 years, and 11% were 60 years or older. Nearly all men (91%) and women (94%) were married, living with a partner, or in a relationship. All aspects of sex (intercourse, foreplay, orgasm, attraction to partner) were important to men and women. Nearly half (48%) of men surveyed reported some degree of erectile dysfunction (ED). A significant proportion of men (65%) were not very satisfied with their erection hardness (63% of women were not very satisfied with their partner's erection hardness). An association existed between satisfaction with erection hardness and satisfaction with sex life, love and romance, and overall health. Only 7% of men reported using a prescription medication for ED. However, 74% of men were willing to take medication to improve their erections if they thought they had ED; 64% of women would support such a decision. CONCLUSIONS: The GBSS reports the sexual needs and desires of men and women worldwide. Erectile function and the effect of ED on aspects of the sexual experience emerged as the most pressing concerns among male participants.

Evaluating the sexual experience in men: validation of the sexual experience questionnaire.

INTRODUCTION: The absence of a single brief measure that assesses function and health-related quality of life (HRQoL) hinders evaluation of the sexual experience in men with erectile dysfunction (ED). AIM: To psychometrically analyze the Sexual Experience Questionnaire (SEX-Q). METHODS: Two data sets were studied. A randomized, double-blind, placebo-controlled trial of flexible-dose sildenafil for ED treatment provided the final clinical trial data set (213 men enrolled, 4 of whom did not receive treatment) and the interim clinical trial data set (190 men screened and 165 men enrolled). The survey data set consisted of 902 respondents to a U.S. community health survey, of whom two-thirds had ED and one-third did not. MAIN OUTCOME MEASURES: Quality and distribution of responses, comparative fit, item-level discriminant testing, internal consistency (Cronbach alpha), test-retest reliability (intraclass correlation coefficient), known-groups validity (vs. International Index of Erectile Function [IIEF] ED severity groups), convergent validity (Pearson correlation coefficients with scores on the IIEF, Self-Esteem and Relationship [SEAR] questionnaire, and Quality of Erection Questionnaire [QEQ]), responsiveness, and clinically important difference (CID). RESULTS: The original 15 items were reduced to 12 items in three domains (erection, individual satisfaction, and couple satisfaction), which demonstrated good quality responses for all items; a strong factor structure; excellent internal consistency; good test-retest reliability; clear known-groups validity across the severity groups; moderate to strong convergent validity against the IIEF, SEAR, and QEQ; and high treatment responsiveness. The estimated CID ranged from 16.0 to 22.3 across domains. CONCLUSIONS: The SEX-Q is the first questionnaire to solely and exclusively combine functional and HRQoL concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience, making it a potentially useful measure for clinical trial research.

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

PURPOSE: To estimate the minimal clinically meaningful improvement (MCMI) on the Self-Esteem And Relationship (SEAR) questionnaire. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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: results of two double-blind, placebo-controlled trials.

BACKGROUND: Men with erectile dysfunction (ED) often have low self-esteem, confidence, and sexual relationship satisfaction. OBJECTIVE: 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. DESIGN: 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. PATIENTS: Men > or = 18 years old with ED. MEASUREMENTS: 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. RESULTS: 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. CONCLUSIONS: 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.

INTRODUCTION: Erectile dysfunction (ED) can significantly impact a man's relationships and well-being. AIM: 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). METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.

Sexual activity, sexual disorders and associated help-seeking behavior among mature adults in five Anglophone countries from the Global Survey of Sexual Attitudes and Behaviors (GSSAB).

We conducted a telephone survey during 2001-2002 to investigate sexual behavior, sexual dysfunction, and related help-seeking behavior in five Anglophone countries. In total, 5,998 individuals (2,992 men and 3,006 women) aged 40-80 years in the United States, Canada, the United Kingdom, Australia, and New Zealand completed the survey. The majority of subjects were sexually active, and although many men and women had experienced sexual dysfunctions, few had sought medical care for these dysfunctions. Further investigation is required to determine whether national differences in the prevalence of sexual dysfunctions are due to genetic predisposition, health factors, cultural perception or socioeconomic situation.