Diagnosis, consultation, treatment, and impact of migraine in the US: Results of the OVERCOME (US) study.

OBJECTIVE: The ObserVational survey of the Epidemiology, tReatment and Care of MigrainE (OVERCOME; United States) study is a multicohort, longitudinal web survey that assesses symptomatology, consulting, diagnosis, treatment, and impact of migraine in the United States. BACKGROUND: Regularly updating population-based views of migraine in the United States provides a method for assessing the quality of ongoing migraine care and identifying unmet needs. METHODS: The OVERCOME (US) 2018 migraine cohort involved: (I) creating a demographically representative sample of US adults using quota sampling (n = 97,478), (II) identifying people with active migraine in the past year via a validated migraine diagnostic questionnaire and/or self-reported medical diagnosis of migraine (n = 24,272), and (III) assessing consultation, diagnosis, and treatment of migraine (n = 21,143). The current manuscript evaluated whether those with low frequency episodic migraine (LFEM; 0-3 monthly headache days) differed from other categories on outcomes of interest. RESULTS: Among the migraine cohort (n = 21,143), 19,888 (94.1%) met our International Classification of Headache Disorders, 3rd edition-based case definition of migraine and 12,905 (61.0%) self-reported a medical diagnosis of migraine. Respondents' mean (SD) age was 42.2 (15.0) years; 15,697 (74.2%) were women. Having at least moderate disability was common (n = 8965; 42.4%) and around half (n = 10,783; 51.0%) had consulted a medical professional for migraine care in the past year. Only 4792 (22.7%) of respondents were currently using a triptan. Overall, 8539 (40.4%) were eligible for migraine preventive medication and 3555 (16.8%) were currently using migraine preventive medication. Those with LFEM differed from moderate and high frequency episodic migraine and chronic migraine on nearly all measures of consulting, diagnosis, and treatment. CONCLUSION: The OVERCOME (US) 2018 cohort revealed slow but steady progress in diagnosis and preventive treatment of migraine. However, despite significant impact among the population, many with migraine have unmet needs related to consulting for migraine, migraine diagnosis, and getting potentially beneficial migraine treatment. Moreover, it demonstrated the heterogeneity and varying unmet needs within episodic migraine.

Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004-2014.

This study aimed to determine the prevalence of rheumatoid arthritis in the United States (US) adult insured population from 2004 to 2014. This was an observational, retrospective, cross-sectional study based on US administrative health insurance claims databases (Truven Health MarketScan® Research database and IMS PharMetrics Plus database). Trends in RA prevalence focusing on the 10-year period covering January 1, 2004-December 31, 2014 were analyzed using a validated algorithm for the identification of RA. Prevalence rates in the databases were determined and age- and gender-adjusted rates were projected to the US population in 2014. Analysis of data from the two databases indicated that the RA prevalence rate in commercially insured adult US population ranged from 0.41 to 0.54% from 2004 to 2014. The prevalence varied substantially by gender and age in each year and increased gradually across the years for most subgroups. In 2014, out of 31,316,902 adult patients with continuous enrollment in the Truven Health MarketScan® Research database, 157,634 (0.50%) patients met our criteria for RA. Similarly, out of 35,083,356 adult patients in the IMS PharMetrics Plus database, 139,300 (0.50%) patients met our criteria for RA. In 2014, the overall age-adjusted prevalence of RA ranged from 0.53 to 0.55% (0.29-0.31% for males and 0.73-0.78% for females). The prevalence of RA in the US appeared to increase during the period from 2004 to 2014, affecting a conservative estimate of 1.28-1.36 million adults in 2014.

Association of moderate to severe lower urinary tract symptoms with incident type 2 diabetes and heart disease.

PURPOSE: Increasing evidence suggests a possible link between lower urinary tract symptoms and chronic illnesses. We determined whether lower urinary tract symptoms are associated with incident type 2 diabetes and heart disease in a population based study. MATERIALS AND METHODS: BACH is a population based epidemiological survey of urological symptoms. A multistage, stratified, cluster sample design was used to obtain a random sample of 4,144 men and women 30 to 79 years old at baseline. Median followup was 4.8 years between baseline (2002 to 2005) and followup (2006 to 2010). Type 2 diabetes and heart disease were assessed by self-report. Lower urinary tract symptoms were assessed by the AUA-SI, and voiding and storage subscores. Logistic regression was used to estimate the OR and 95% CI, and adjust for potential confounders. RESULTS: In participants with a body mass index of 30 kg/m(2) or greater the adjusted ORs for incident heart disease were 1.89 (95% CI 1.05, 3.39) for AUA-SI 8 or greater and 2.32 (95% CI 1.33, 4.05) for a storage score of 4 or greater. In participants with abdominal obesity the adjusted ORs for incident type 2 diabetes were 2.06 (95% CI 1.19, 3.55) for AUA-SI 8 or greater and 1.81 (95% CI 1.04, 3.15) for a storage score of 4 or greater. Lower urinary tract symptoms (AUA-SI 8 or greater) were also predictive of type 2 diabetes in men and women younger than 50 years (adjusted OR 2.37, 95% CI 1.18, 4.80). CONCLUSIONS: Longitudinal results of BACH suggest that lower urinary tract symptoms are a marker of increased risk for type 2 diabetes and heart disease in obese men and women. The increased risk in younger men and women suggests that lower urinary tract symptoms may be an indicator of impending disease.

Association of peripheral microvascular dysfunction and erectile dysfunction.

PURPOSE: Increasing evidence of a link between erectile dysfunction and cardiovascular disease suggests a shared vascular etiology with endothelial dysfunction as a plausible underlying biological mechanism. To our knowledge whether this association is different for large arterial endothelium compared to microvascular endothelium has not yet been established. We investigated the association of erectile dysfunction with macrovascular and microvascular endothelial function. MATERIALS AND METHODS: A sample of 390 men with a mean age of 55.5 years was recruited from the BACH survey, a population based survey of urological symptoms. Erectile dysfunction was assessed using IIEF-5. The percent of brachial artery flow mediated dilatation, a measure of macrovascular function, and hyperemic flow velocity in cm per second, a measure of microvascular function, were assessed by ultrasound. Linear regression was used to assess the association of erectile dysfunction and endothelial function, and adjust for potential confounders. RESULTS: Reactive hyperemia was lower in men with vs without erectile dysfunction (mean ± SE 97.1 ± 2.5 vs 106.0 ± 1.6 cm per second, p = 0.003). However, the difference in flow mediated dilatation between men with vs without erectile dysfunction was statistically nonsignificant (mean 6.6% ± 0.33% vs 7.2% ± 0.24%, p = 0.147). The association of erectile dysfunction with reactive hyperemia was attenuated but it remained statistically significant in men with moderate to severe erectile dysfunction (IIEF-5 less than 12) after adjusting for traditional cardiovascular risk factors (p = 0.038). CONCLUSIONS: These results provide evidence of greater microvascular than macrovascular endothelial dysfunction as a potential contributor to erectile dysfunction and an underlying mechanism linking erectile dysfunction and cardiovascular disease.

Erectile dysfunction as a marker for cardiovascular disease diagnosis and intervention: a cost analysis.

INTRODUCTION: Erectile dysfunction (ED) is a risk factor for cardiovascular disease (CVD). We examine the costs of screening men with ED for CVD risk factors and the cost savings of treating these at risk men. AIM: This study aims to evaluate the effect of screening men presenting with ED for CVD risk factors and to determine the cost effectiveness of this screening protocol. METHODS: The known incidence and prevalence of ED and CVD, the rate of undiagnosed CVD, and the effects of CVD treatment were used to model the change in prevalence of acute CVD events and ED as a function of the number of men with ED and CVD. The cost savings associated with reduction in acute cardiovascular (CV) events and ED prevalence was estimated over 20 years. MAIN OUTCOME MEASURES: Acute CVD event rate reduction and associated cost savings were modeled over 20 years. RESULTS: The relative risk of ED in men with CVD is 1.47 and the coprevalence of both ED and CVD was estimated at 1,991,520 men. Approximately 44% of men with CVD risk factors are unaware of their risk. If all men presenting with ED were screened for CVD, 5.8 million men with previously unknown CVD risk factors would be identified over 20 years, costing $2.7 billion to screen. Assuming a 20% decrease in CV events as a result of screening and treatment, 1.1 million cardiovascular events would be avoided, saving $21.3 billion over 20 years. Similarly, 1.1 million cases of ED would be treated, saving $9.7 billion. Together, the reduction in acute CVD and ED treatment cost would save $28.5 billion over 20 years. CONCLUSIONS: Screening for CVD in men presenting with ED can be a cost-effective intervention for secondary prevention of both CVD and, over the longer term, ED.

Sleep related problems and urological symptoms: testing the hypothesis of bidirectionality in a longitudinal, population based study.

PURPOSE: We evaluate the bidirectional association between urological symptoms (urinary incontinence, lower urinary tract symptoms and nocturia) and sleep related variables. MATERIALS AND METHODS: Data were obtained from a prospective cohort study of 1,610 men and 2,535 women who completed baseline (2002 to 2005) and followup (2006 to 2010) phases of the BACH (Boston Area Community Health) Survey, a population based random sample survey. Sleep restriction (5 hours or less per night), restless sleep, sleep medication use and urological symptoms were assessed by self-report. Urinary incontinence was defined as weekly leakage or moderate/severe leakage, lower urinary tract symptoms (overall, obstructive, irritative) were defined by the AUA-SI (American Urological Association symptom index) and nocturia was defined as urinary frequency 2 or more times per night. RESULTS: At the 5-year followup 10.0%, 8.5% and 16.0% of subjects newly reported lower urinary tract symptoms, urinary incontinence and nocturia, respectively, and 24.2%, 13.3% and 11.6% newly reported poor sleep quality, sleep restriction and use of sleep medication, respectively. Controlling for confounders, the odds of urological symptoms developing were consistently increased for subjects who reported poor sleep quality and sleep restriction at baseline, but only baseline nocturia was positively associated with incident sleep related problems at followup. Body mass index, a potential mediator, reduced selected associations between sleep and incident urinary incontinence and irritative symptoms, but C-reactive protein did not. CONCLUSIONS: These data suggest that self-reported sleep related problems and urological symptoms are linked bidirectionally, and that body mass index may be a factor in the relationship between sleep and the development of urological symptoms.

Treatment status and progression or regression of lower urinary tract symptoms in a general adult population sample.

PURPOSE: We report progression and regression of lower urinary tract symptoms in a population based cohort by race/ethnicity, gender, age and lower urinary tract symptom medication use. MATERIALS AND METHODS: The BACH (Boston Area Community Health) Survey enrolled 5,502 participants 30 to 79 years old of black, Hispanic or white race/ethnicity. The 5-year followup interviews were completed by 1,610 men and 2,534 women for a conditional response rate of 80%. Population weighted estimates of lower urinary tract symptoms severity were assessed using the AUASI (American Urological Association symptom index) and analyzed using multivariate models. RESULTS: Symptom progression (increase in AUASI score of 3 or more points) was reported by 21% to 33% of participants and regression (decrease 3 or greater) by 30% to 44% of participants, most commonly women and Hispanic participants. Age and higher body mass index were associated with progression (p <0.01), but not with regression. Lower urinary tract symptom medication use at baseline only was associated with improved symptoms scores 5 years later (multivariate adjusted OR 3.10, 95% CI 1.28-7.51, compared to nonusers), whereas using medication at baseline and followup was associated with similar rates of progression and regression as observed among participants not using lower urinary tract symptom medication at either point. CONCLUSIONS: Lower urinary tract symptoms persisted at followup for approximately half of the population experiencing symptoms at baseline, including many men and women using lower urinary tract symptom medications. However, overall lower urinary tract symptom medication use and surgical treatment appeared beneficial for symptom control at 5-year followup. Age and body mass index were associated with symptom worsening, and Hispanic ethnicity was associated with greater symptom fluctuation. Clinicians should consider the higher likelihood of lower urinary tract symptom progression for older or heavier patients, and monitor responsiveness to lower urinary tract symptom medication.

Longitudinal changes in high-density lipoprotein cholesterol and cardiovascular events in older adults.

OBJECTIVE: While low high-density lipoprotein cholesterol (HDL-C) is associated with increased risk of cardiovascular (CV) events, there are limited data evaluating the association of longitudinal change in HDL-C with CV event risk in older populations. The aim of this study was to examine the association between within-subject changes in HDL-C levels and CV events in an older population. DESIGN: Observational cohort study. PATIENTS: 1293 men and 1422 women age ≥50 years, with ≥2 consecutive HDL measurements, and no prior CVD as part of Framingham Offspring Study. MEASUREMENTS: A clinical CV event was defined as the first occurrence of any of the following: coronary heart disease (coronary death, myocardial infarction, coronary insufficiency and angina), cerebrovascular event, peripheral artery disease or heart failure. RESULTS: Median total follow-up time across subjects was 9·6 years. Change in HDL-C was evaluated as between-exam (approximately 3·5 years) percentage change in HDL-C, categorized as ≥10% decrease, <10% change (stable) and ≥10% increase. Crude and adjusted sex-specific Cox hazards regression models with change in HDL-C as a time-dependent covariate quantified the association with CV events. Mean baseline age of the analysis sample was 53 years. There were 233 and 111 CV events among men and women, respectively. Change in HDL-C was not significantly associated with CVD incidence in men or women, without or with adjustment for confounders including baseline HDL-C or use of relevant medications. CONCLUSION: In conclusion, relatively short-term (3·5 years) changes in HDL-C levels do not affect CV events in men and women.

Population-based patterns of prescription androgen use, 1976-2008.

PURPOSE: Prescription testosterone (T) has limited approved medical indications and is a controlled substance in Canada. Utilization studies in other Westernized countries have revealed sharp increases in T use in recent years. We examined medical use of androgens, including T, over a ≥30-year period among adult (18+) men in a population-based study set in a Canadian juridisdiction of universal health care. METHODS: Analyses were based on data from electronic records of dispensed prescriptions during 1976-2008 in Saskatchewan, Canada. All formulations of androgens listed in the provincial formulary (oral and injectable) were included. We examined demographics of users, androgen types used, switching patterns, and trends in the annual rate of use over time. RESULTS: There were 11 521 androgen users who were followed for an average of 11.8 years. Overall, 11 types of androgens were used, and there were 86 812 dispensing events. The mean age at first use was 56.4 years (median: 58). Men had 7.5 prescription dispensing events on average (median: 2). The most commonly used formulations were methyl-T (36.2% of users) followed by T-enanthate (32.5%), T-cypionate (22.3%), and T-undecanoate (20.0%). Most users (82%) did not switch among androgen types. The annual rate of use varied substantially over time, with a marked increase observed from 1994 to 1999 and a decrease from 2000 to 2008. CONCLUSIONS: Androgen users were largely middle aged and had relatively few dispensings. We hypothesize that observed secular trends in androgen use may align with drug treatment pattern changes for erectile dysfunction, including the advent of phosphodiesterase type 5 inhibitors.

The 20-year public health impact and direct cost of testosterone deficiency in U.S. men.

INTRODUCTION: Testosterone deficiency (TD) imposes a substantial public health burden in the U.S. We modeled the costs associated with TD-related sequelae including cardiovascular disease (CVD), diabetes mellitus (DM), and osteoporosis-related fractures (ORFs). AIM: To quantify the incremental cost burden imposed by TD's cardiometabolic sequelae. METHOD: Incidence, prevalence, and mortality of these conditions were collected for men ages 45-74 from six national databases and large cross-sectional studies. Relative risk (RR) rates were determined for these sequelae in patients with T < 300 ng/dL. The prevalence of TD was determined for this cohort of men. MAIN OUTCOME MEASURES: Adjusted incidence and prevalence were determined. Annual costs for the three TD-related sequelae were inflated at a real rate of 3% for 20 years. RESULTS: Actual and adjusted (normalized for T deficiency) rates of CVD, DM, and ORFs in U.S. men aged 45-74 assuming a TD prevalence of 13.4% were calculated. We determined that, over a 20-year period, T deficiency is projected to be involved in the development of approximately 1.3 million new cases of CVD, 1.1 million new cases of DM, and over 600,000 ORFs. In year 1, the attributed cost burden of these diseases was approximately $8.4 billion. Over the entire 20-year period, T deficiency may be directly responsible for approximately $190-$525 billion in inflation-adjusted U.S. health care expenditures. CONCLUSION: TD may be a significant contributor to adverse public health. Further study is needed to definitively describe the whether TD is a modifiable risk factor for CVD, DM, and ORFs. This may represent an opportunity for nationwide public health initiatives aimed at preventive care.

The role of initial success rates and other factors in determining reliability of outcomes of phosphodiesterase inhibitor therapy for erectile dysfunction: a pooled analysis of 17 placebo-controlled trials of tadalafil for use as needed.

INTRODUCTION: Reliability of successful outcomes in men with erectile dysfunction (ED) on phosphodiesterase type 5 inhibitors is an important aspect of patient management. AIMS: We examined reliability of successful outcomes in a large integrated dataset of randomized tadalafil trials. MAIN OUTCOME MEASURES: Success rates, time to success, subsequent success after first success, and probability of success were analyzed based on Sexual Encounter Profile questions 2 and 3. METHODS: Data from 3,254 ED patients treated with tadalafil 10 mg (N = 510), 20 mg (N = 1,772), or placebo (N = 972) were pooled from 17 placebo-controlled studies. RESULTS: Tadalafil patients had significantly higher first-attempt success rates vs. placebo. This effect was consistent across most subgroups; however, patients with severe ED experienced a greater response to tadalafil than patients with mild-moderate ED. Approximately 80% of patients achieved successful penile insertion within two attempts with either tadalafil dose and successful intercourse within eight attempts for tadalafil 10 mg and four attempts for tadalafil 20 mg. However, approximately 70% of tadalafil-treated patients achieved successful intercourse even by the second attempt. Subsequent success rates were higher for patients with first-attempt success (81.5% for 10 mg and 86.1% for 20 mg vs. 66.2% for placebo, P < 0.001) vs. patients with later initial success (53.2% for 10 mg and 56.4% for 20 mg vs. 39.9% for placebo, P < 0.001). Among patients treated with tadalafil, intercourse success rates at early attempts were similar to rates at later attempts (i.e., attempts 5 and 10 vs. 25), although insertion success rates were significantly lower earlier in treatment. CONCLUSIONS: The findings affirm the reliability of successful outcomes with tadalafil treatment and that first-attempt success is a critical factor affecting subsequent outcomes. The results further show that even among men who did not succeed on first attempt, a substantial proportion will have successful outcomes if treatment is maintained.

Registry of Hypogonadism in Men (RHYME): design of a multi-national longitudinal, observational registry of exogenous testosterone use in hypogonadal men.

OBJECTIVE: Despite the prevalence of hypogonadism (HG) and widespread use of testosterone therapy, little is known about the safety/effectiveness of long-term testosterone use. The Registry of Hypogonadism in Men (RHYME) is a multi-national patient registry assessing prostate health and other outcomes associated with testosterone treatment in men. DESIGN: Observational patient disease registry. METHODS: RHYME is a non-interventional disease registry with longitudinal data collection on a large sample (N = 999) of well-characterized, hypogonadal men aged 18 years or older. The Registry will prospectively evaluate male patients diagnosed with HG, who have not previously been treated with testosterone therapy. Key design features include: (1) broad inclusion/exclusion criteria, (2) standardized central laboratory hormone assays, (3) independent adjudication of prostate biopsies and mortalities, (4) standard of care treatment, (5) comprehensive medical record and questionnaire data at six months and annually post-enrollment and (6) adequate statistical power for assessing prostate endpoints at 36 months. RESULTS: A total of 25 clinical sites in six European countries (Germany, Italy, the Netherlands, Spain, Sweden and the United Kingdom) have completed recruitment for the study. Recruitment was initiated in May 2009, and completed in December 2011. Data collection is ongoing with a minimum of two years of follow-up on all patients.

Racial and socioeconomic disparities in sleep and chronic disease: results of a longitudinal investigation.

OBJECTIVES: Sleep problems appear to differentially affect racial minorities and people of lower socioeconomic status (SES). These population subgroups also have higher rates of many debilitating diseases such as obesity, type 2 diabetes mellitus (T2DM), hypertension, coronary heart disease, stroke, and mortality. Considering the presence of social disparities in sleep and chronic disease, this research aims to assess the role of sleep disparities in the incidence of obesity, T2DM, hypertension, and/or cardiovascular disease (CVD). DESIGN: The Boston Area Community Health (BACH) Survey is a population-based random-sample cohort of 5502 participants aged 30-79. Sleep restriction (< or = 5 hours/night) and restless sleep were assessed at baseline. Health status was ascertained at baseline and approximately 5 years later among 1610 men and 2535 women who completed follow-up. SETTING: Participants completed an in-person, home visit, interview at baseline (2002-2005) and follow-up (2006-2010). PARTICIPANTS: Boston, Massachusetts residents (2301 men, 3201 women) aged 30-79 years from three racial groups (1767 Black, 1876 Hispanic, 1859 White) participated in the BACH Survey. RESULTS: There were significant differences in the prevalence of sleep-related problems at baseline by both race and SES as well as significant disparities in the incidence of T2DM, high blood pressure and cardiovascular disease at follow-up. Restless sleep was associated with an increased risk of obesity, T2DM, and CVD. However, we found that sleep does not mediate social disparities in health outcomes. CONCLUSIONS: Results from the BACH Survey confirm large social disparities in health outcomes as well as large social disparities in short sleep duration and restless sleep. However, sleep did not appear to mediate the relationship between race, SES, and health disparities.

Do low testosterone levels contribute to ill-health during male ageing?

Testosterone regulates male sexual development and body composition. In adult men, testosterone levels exhibit a gradual decline with increasing age. Whether it is age per se or health and behaviour related factors that are responsible for this decline, and the implications thereof for subsequent health remain controversial. Observational studies report associations of lower testosterone levels with poorer health outcomes in ageing men, including frailty, reduced sexual activity, insulin resistance and cardiovascular events and mortality. However, outcome data from randomised clinical trials of testosterone are limited, and are lacking for major endpoints such as cardiovascular events. The risks and benefits of testosterone intervention in older men require further clarification. This article will review the role of testosterone in men, discuss epidemiological and interventional data illuminating its potential role to preserve health during male ageing, consider the limitations of the evidence base and implications for clinical practice, and explore future directions for research in this topical area.

Non steroidal anti-inflammatory drug use and levels of oestrogens and androgens in men.

OBJECTIVE: Studies suggest that regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) may lower oestrogen levels in women. However, no large, population-based studies have assessed NSAID/hormone associations in men. Our objective was to examine the association between use of prescription and over-the-counter NSAIDs, and levels of oestrogens and androgens in men. DESIGN: The Boston Area Community Health Survey, an observational survey with initial data collection in 2002-2005. PATIENTS: A total of 1766 men who provided a blood sample and data on recent analgesic use. MEASUREMENTS: Adjusted geometric mean levels of androgens, oestrogens, SHBG, LH and FSH for each category of NSAID use and the per cent difference in hormone levels for users vs nonusers. RESULTS: There was no significant association between prescription/over-the-counter NSAID use and any hormone examined after adjustment for potential confounders. For example, geometric mean testosterone levels were 13·8, 13·6 and 14·2 nM in nonusers, prescription users and over-the-counter NSAID users, respectively; the corresponding levels for estradiol were 80·3, 70·4 and 79·9 pM. In stratified analyses, however, prescription NSAID use was associated with lower testosterone, estradiol and estrone levels in obese men and lower testosterone and dehydroepiandrosterone sulphate levels in inactive men. CONCLUSIONS: While overall these data do not provide strong support for an association between NSAID use and hormone levels in men, prescription NSAIDs may decrease levels of certain oestrogens and androgens in obese and inactive men.

Minimal clinically important differences in the vaginal insertion and successful intercourse items of the sexual encounter profile.

INTRODUCTION: Despite adoption of the successful vaginal insertion (Q2) and intercourse (Q3) items of the sexual encounter profile (SEP) as end points in clinical trials, there are no objective data on what constitute minimal clinically important differences (MCIDs) in these items. AIM: The objective was to estimate the MCID for SEP Q2 and Q3. METHODS: Using data from 17 randomized, controlled trials of the phosphodiesterase type 5 inhibitor tadalafil, we estimated MCIDs for the SEP using anchor-based approaches. The 17 studies included 3,345 patients treated for 12 weeks. The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 weeks on the following question: "Over the past 4 weeks, when you attempted sexual intercourse how often was it satisfactory for you?" MCIDs were developed using analysis of variance- and receiver operating characteristic (ROC)-based methods in a subset of studies (N = 11) by comparing patients with and without minimal improvement (N = 863). MCIDs were validated in the remaining six studies (N = 377). MAIN OUTCOME MEASURES: The main outcome measures of this study are SEP Q2 and Q3. RESULTS: Using the ROC-based approach, the MCID for SEP Q2 was 21.4%, with estimated sensitivity of 0.55 and specificity of 0.73; the MCID for SEP Q3 was 23.0%, with estimated sensitivity of 0.72 and specificity of 0.78. MCIDs for SEP Q2/Q3 varied significantly (P < 0.001) according to baseline erectile dysfunction (ED) severity. MCIDs distinguished between patients in the validation sample classified as no change or minimally improved in each ED etiology, ED duration, and age group, but less well across geographic regions. CONCLUSIONS: The contextualization of treatment-related changes into clinically relevant terms is essential to understanding treatment efficacy, interpreting results across studies, and for effective patient management. Overall, there was a better balance between sensitivity and specificity of the MCIDs using the ROC-based approach for the SEP intercourse success item than for the vaginal insertion item.

Serum 25-hydroxyvitamin D concentration and physical function in adult men.

OBJECTIVE: Recent reports suggest that vitamin D status influences musculoskeletal health; yet, there are limited data in adult men. This study investigated whether serum 25-hydroxyvitamin D [25(OH)D] concentration was associated with lean body mass, muscle strength and physical performance in men. DESIGN: Population-based, observational survey. PARTICIPANTS: 1219 black, Hispanic and white randomly selected men aged 30-79 years from the Boston Area Community Health/Bone Survey. MEASUREMENTS: Lean body mass by dual-energy X-ray absorptiometry, hand grip strength, a composite physical function score (chair stand and walking speed), 25(OH)D, parathyroid hormone (PTH), testosterone, age, race, body mass index, socioeconomic status, education, smoking, arthritis, self-reported health, calcium intake, physical activity. RESULTS: The distributions of serum 25(OH)D quartiles differed by race/ethnicity, education and smoking status. After adjustment for multiple lifestyle factors, serum 25(OH)D was not related to lean body mass, grip strength or the composite physical function score (all P>0.20). There was no variation in the associations between 25(OH)D level and outcomes by race/ethnicity. The relationship between PTH and the outcomes revealed similar results. CONCLUSION: In this population-based sample of adult men with a broad age range, there was no association between serum 25(OH)D concentration and lean body mass, muscle strength and physical function after controlling for multiple lifestyle factors.

The NERI Hypogonadism Screener: psychometric validation in male patients and controls.

OBJECTIVE: Hypogonadism (HG) is a clinical disorder consisting of reduced testosterone (T) levels and characteristic signs and symptoms of low T. Current instruments used to assess hypogonadal symptoms in men lack adequate measurement properties. To present data on the quantitative validation of a new self-report instrument (HG Screener) developed to identify men with symptoms of HG. DESIGN: This is a psychometric validation study conducted at 16 clinical sites across the Unites States. Subjects completed two visits separated by 2-4 weeks. PATIENTS: One hundred and thirty-one men (82 hypogonadal patients with total T≤10·4 nmol/l and 49 controls with total T>10·4 nmol/l) aged 21-75 years were enrolled. MEASUREMENTS: Self-reported assessments including the HG Screener (at both visits) along with seven validated questionnaires. RESULTS: The results of a factor analysis identified five functional factors or domains. The resulting instrument contains 25 items consisting of 18 functional items in five core domains (sexual function, mood, memory, sleep function and fatigue) and seven physical symptom items. Overall, the new instrument was found to have strong psychometric properties, including acceptable discriminant, construct and content validity, as well as good internal consistency and test-retest reliability. CONCLUSIONS: A new screening tool (HG Screener) for identifying men with HG has been developed and validated according to FDA standards. This new instrument possesses acceptable psychometrics and is available for clinical or research use.

Correlates of PDE5i use among subjects with erectile dysfunction in two population-based surveys.

INTRODUCTION: Erectile dysfunction (ED) is thought to affect some 150 million men worldwide, but many men with ED symptoms do not seek treatment. Existing surveys suggest that men with severe ED and who report support from their partners are more likely to receive treatment than were others. Less is known, however, concerning the influence of sociomedical factors such as income and body composition on receipt of treatment. AIM: The aim of this study was to determine the importance of socioeconomic status, comorbidities, and body composition on receipt of treatment for ED symptoms. METHODS: We used data on 638 men enrolled in the Boston Area Community Health (BACH) survey reporting ED symptoms and/or treatment for ED as evidenced by phosphodiesterase type 5 inhibitor (PDE5i) use. Logistic regression was employed to assess the relative strength of association between receipt of treatment and socioeconomic factors, body mass index, and medical factors. A replication of these results was then provided via a parallel model using the 2004 follow-up of the Men's Attitudes to Life Events and Sexuality (MALES). MAIN OUTCOME MEASURE: In BACH, ED was deemed present if a subject scored 16 points or fewer on the five-item International Index of Erectile Function or reported PDE5i use. In MALES, presence of ED was indicated by use of a validated single question querying ED severity. RESULTS: Controlling for age, body composition and other factors, increased household income, availability of a sexual partner, and provider diagnosis of high blood pressure were positively associated with treatment seeking via the use of PDE5i therapy in BACH. Results on data available in MALES produced similar results for household income and partner availability. CONCLUSION: These data provide evidence that financial disadvantage may present a barrier to treatment of ED, an increasingly important sentinel marker of the cardiovascular and overall health among aging men.

Physical function and health-related quality-of-life in a population-based sample.

BACKGROUND. It is of interest to understand whether impaired physical function is associated with health-related quality-of-life (HRQOL). We examined upper and lower body physical function and its relationship with two domains of HRQOL among men. METHODS. We conducted a population-based observational study of musculoskeletal health among Boston, MA residents, the Boston Area Community Health/Bone Survey. Participants were 1219 randomly-selected Black, Hispanic, and White males (30-79 years). Upper body function was measured using hand grip strength, while lower body function was measured by combining a timed walk and a chair stand test. HRQOL was measured using the physical (PCS-12) and mental health (MCS-12) component scores of the SF-12. Multivariate linear regression models were used to estimate the association between poor function and HRQOL. RESULTS. There was a significant association of poor upper body physical function with the MCS-12 (ß coefficient: -4.12, p = 0.003) but not the PCS-12 (ß coefficient: 0.79, p = 0.30) compared to those without poor function. Those with poor lower body physical function had significantly lower PCS-12 scores (ß: -2.95, p = 0.007), compared to those without poor function, but an association was not observed for MCS-12 scores. CONCLUSIONS. Domains of physical function were not consistently related to domains of HRQOL.