Tara Symonds

Sleep disturbance is a common experience in fibromyalgia (FM). The field lacks a sleep specific patient reported outcome (PRO) measure developed and validated in a FM population. The study objective is to gain an in-depth understanding of sleep in FM and to develop a PRO measure of it. Research involved the following stages: 1) A literature review conducted to identify key concepts associated with FM patient experience of sleep and PRO measures that have been used to assess this; 2) Qualitative interviews with therapeutic area experts; 3) Focus groups with FM patients who experienced sleep disturbance; 4) Development of a conceptual framework and the Fibromyalgia Sleep Diary (FMSD); and 5) Cognitive interviews with patients to explore content validity of the FMSD. The literature review and expert interviews supported sleep disturbance being an important aspect of the FM patient experience, and underscored the need for a new FM specific sleep PRO measure. Results from the focus groups demonstrated that FM patients experience sleep disturbances that they attribute to their FM symptoms, such as pain and stiffness, confirming the importance of understanding more about sleep changes. Aspects of sleep raised by FM patients included poor sleep quality and insufficient quantity including difficulty with falling asleep, getting comfortable, and staying asleep; restlessness; light sleep; not feeling rested upon awakening; and difficulty starting the day. Cognitive interview results showed that the 8-item FMSD, developed to reflect the concepts identified above, was relevant to FM patients with content that was interpreted as intended. The FMSD was developed in line with the recommendations of the FDA PRO guidance and ISPOR PRO Task Force. The qualitative evidence generated thus far strongly supports the content validity of the FMSD as a PRO measure of sleep disturbance in FM populations. Psychometric evaluation of the FMSD to demonstrate reliability, validity and sensitivity to change is recommended as a next step.

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. 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. 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. Psychometric analyses. 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. 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.

Introduction: Erectile dysfunction (ED) is the most common male sexual dysfunction and has a negative impact on masculinity and self-esteem. Phosphodiesterase type 5 inhibitors, including sildenafil, are the first-line treatment option for ED. Providing appropriate information regarding suitability for using sildenafil is important. Aim: The purpose of this study was to assess whether a broad spectrum of men could appropriately evaluate their suitability for 50-mg sildenafil after reviewing patient information materials. Main Outcome Measures: Patient information (Pack) on appropriate use of 50-mg sildenafil and patient information leaflet (PIL), a Web survey including demographics, self-assessed suitability for sildenafil use, and suitability screener. Methods: A randomly selected, population-representative Web-based panel of males in the UK was recruited for this study. Eligible men answered a brief sociodemographic questionnaire and then were presented with the Pack. If a participant desired additional information, he could also review the PIL. The participants then rated the Pack and PIL (if reviewed), self-assessed their suitability for sildenafil use, and completed a previously validated screener for suitability. Results: A total of 1,275 men aged 40 and above were included in these analyses; the mean age was 57.8 ± 9.9 years. A total of 1,054 men reported ED; 517 men (40.5%) deemed themselves suitable for sildenafil; 504 men (39.6%) deemed themselves unsuitable; and 254 (19.9%) were unsure. The concordance rate between screener-assessed suitability and self-assessed suitability was 70.9% (95% confidence interval [CI] = 68.1–73.7%). When accounting for men who would not take sildenafil even though they were suitable or would seek additional information from a healthcare professional prior to using sildenafil, the concordance rate was 84.2% (95% CI = 82.2–86.2%). Conclusion: The results of this study suggest that men in the general population are capable of using written sildenafil patient education materials to accurately assess their suitability for treatment with 50-mg sildenafil.

In Europe, pharmacists may be an important first point of contact for men with erectile dysfunction (ED) asking for advice and treatment. To determine if European community pharmacists could appropriately recommend suitability for supply of sildenafil 50 mg for the treatment of ED. For this cross-sectional, observational study, the current Summary of Product Characteristics was adapted to create a study drug information sheet for use in a pharmacy setting in which, for certain patients, supply is not suitable and referral to a physician is recommended. After training and with use of a guidance questionnaire, pharmacists assessed the suitability of supply of sildenafil 50 mg for men presenting to their pharmacy. Men with self-reported ED who were not currently using a phosphodiesterase type 5 inhibitor were recruited. Within 7 days of the pharmacist-patient interaction, a physician with experience in the management of ED telephoned the subject to assess suitability. If there was discordance between the pharmacist and physician recommendations, the case was independently reassessed by a physician specialist in sexual medicine. The primary end point was the concordance rate (with 95% confidence intervals) between pharmacist and physician recommendations. Rates were weighted by country sample sizes. Concordance (95% confidence interval) was 0.70 (0.66-0.74) between pharmacist and physician recommendation, indicating agreement in 70% of cases, and was 0.90 (0.86-0.94) between pharmacist and physician specialist in sexual medicine. Furthermore, if the cases in which the pharmacist did not put subjects at risk (i.e., gave an acceptable recommendation) are assessed, the success rate is 83.5% (79.6-87.4%) and 92.8% (90.1-95.5%), respectively. Pharmacists were accurate in providing suitable treatment recommendation, generally not recommending sildenafil for men without ED and recommending physician assessment when there was any question about cardiovascular health, other comorbidity, or co-medication.

Erectile dysfunction is a treatable condition that affects a large proportion of men. Most men do not seek medical help for their ED because of embarrassment or social stigma that may lead some men to self-treat. To evaluate men's ability to self-assess their suitability for 50 mg sildenafil use after reviewing patient information materials. Patient rating of patient information materials, self-assessment of suitability for sildenafil use, and clinician assessment of sildenafil suitability. Men in the UK were recruited through newspaper, radio, and internet advertisements. Eligible men reviewed the 50 mg sildenafil patient information materials (packaging materials and patient information leaflet) at the in-person visit and then completed a survey to rate the materials and self-assess their suitability for sildenafil use. A clinician, blinded to the participant's ED status and self-assessed sildenafil suitability, then conducted a one-on-one interview to assess the participant's ED status and suitability for sildenafil treatment. The primary analysis was the concordance of self-assessed suitability versus clinician-assessed suitability. The initial study phase included 113 generally healthy men, mean age 40.2 ± 13.1 years. The second phase included 70 men with comorbid prostate or cardiac conditions, mean age 60.7 ± 7.8 years. The 183 men rated the patient information materials as easy to understand; few participants reported problems understanding the materials, and many participants learned new information. The concordance rate between clinician-assessed suitability and self-assessed suitability was 73.9% (95% confidence interval [CI] = 66.7-81.2%). When accounting for men who would not take sildenafil even though they were suitable or would seek additional information from a healthcare professional prior to using sildenafil, the concordance rate was 90.1% (95% CI = 85.8-94.4%). The results of this UK study suggest that men are capable of using written sildenafil patient education materials to accurately assess their suitability for treatment with 50 mg sildenafil.

Introduction: Men may choose to bypass the healthcare system to obtain a phosphodiesterase type 5 inhibitor (PDE5i). Aim: Evaluate the characteristics and purchasing patterns of men obtaining a PDE5i without prior healthcare professional (HCP) interaction. Main Outcome Measures: Prior HCP interaction, defined as having a prescription for any PDE5i, having a PDE5i sample from a physician, or buying the PDE5i in a retail pharmacy; and erectile dysfunction (ED, the Massachusetts Male Aging Study single-item question) were assessed. A multivariate regression analysis determined predictive factors for PDE5i purchase without prior HCP interaction. Methods: A Web-based observational study was conducted in the United Kingdom, Germany, and Italy. Results: Of the 11,899 participants, 1,252 (10.5% [95% CI, 10.0–11.1%]) reported PDE5i use in the last 6 months. PDE5is were obtained without prior HCP interaction by 403 users (32.3% [95% CI, 29.6–34.8%]); 65.5% of them had ED. Overall prevalence of men using PDE5is without HCP interaction was 3.0% (95% CI, 2.6–3.5%), 4.1% (95% CI, 3.5–4.6%), and 2.8% (95% CI, 2.1–3.5%) for men aged 18–34, 35–50, and >50 years, respectively (P = 0.0045). Predictive factors for obtaining a PDE5i without prior HCP interaction were embarrassment to speak to a physician (P = 0.0009) and the perception that this would be the cheapest way to get the medicine (P = 0.03). Conclusions: Based on these findings, it can be estimated that approximately 6 million men in Europe might currently bypass the healthcare system to obtain a PDE5i. In addition to the risks associated with use of PDE5is from uncontrolled sources, because most of these men have ED, they also miss the opportunity for important health information or medical follow-up. HCPs should actively address ED and offer treatment to discourage men from seeking uncontrolled sources of ED medicines.