Article

Erectile Dysfunction Is Highly Prevalent in Men With Newly Diagnosed Inflammatory Bowel Disease

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Abstract

Background and Aims Cross-sectional studies on sexual function in men with inflammatory bowel disease (IBD) yield mixed results. Using a prospective incidence cohort, we aimed to describe sexual function at baseline and over time and to identify factors associated with impaired sexual function in men with IBD. Methods Men 18 years and older enrolled between April 2008 and January 2013 in the Ocean State Crohn’s and Colitis Area Registry (OSCCAR) with a minimum of 2 years of follow-up were eligible for study. Male sexual function was assessed using the International Index of Erectile Function (IIEF), a self-administered questionnaire that assesses 5 dimensions of sexual function over the most recent 4 weeks. To assess changes in the IIEF per various demographic and clinical factors, linear mixed effects models were used. Results Sixty-nine of 82 eligible men (84%) completed the questionnaire (41 Crohn’s disease, 28 ulcerative colitis). The mean age (SD) of the cohort at diagnosis was 43.4 (19.2) years. At baseline, 39% of men had global sexual dysfunction, and 94% had erectile dysfunction. Independent factors associated with erectile dysfunction are older age and lower physical and mental component summary scores on the Short Form Health Survey (SF-36). Conclusion In an incident cohort of IBD patients, most men had erectile dysfunction. Physicians should be aware of the high prevalence of erectile dysfunction and its associated risk factors among men with newly diagnosed IBD to direct multidisciplinary treatment planning.

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... 16,17 Even when the sexual dysfunction was broken down by age, those older than age 40 had a 15.7% rate of sexual dysfunction, still considerably lower than the rate of more than 80% found in our cohort. 16 On the other hand, a recently published study including 69 men with newly diagnosed IBD reported a 39% prevalence of sexual dysfunction, 18 which is half as prevalent compared to our cohort. Compared to our veteran cohort, this US cohort of patients with IBD is younger with a higher proportion of white subjects, a lower likelihood of being married, and none of the subjects were on thiopurines or biologics. ...
... A recent US multicenter study of men with recently diagnosed IBD reported a 94% prevalence of ED within 1 year of diagnosis, which is similar to the high prevalence in our cohort. 18 The authors reported no significant change in the IIEF scores over a 2-year period of follow-up, consistent with our findings of a persistently high prevalence of ED in our cohort of patients with IBD with a mean of 13 years of disease duration. ...
... 5,19 Rivière et al. 6 found an association between lower SIBDQ scores with sexual dysfunction and ED on univariate analysis; however, these did not remain significant on multivariate analysis. The recent study by Shmidt et al. 18 found an association between ED and lower scores on the Short Form Health Survey, consistent with poorer QOL, but there was no association with overall sexual dysfunction or any other subcategories of the IIEF survey. ...
Article
Background Aims of this study were to assess the prevalence of and risk factors for sexual dysfunction (SD) in male veterans with inflammatory bowel disease (IBD). Methods We collected IBD history, quality of life (QOL), and sexual function surveys. Results One hundred seventy-one men enrolled, mean age 50 years, 85% had SD, 92% had erectile dysfunction (ED). More severe ED (P = 0.0001), decreased sexual desire (P = 0.004), and decreased satisfaction (P = 0.001) were associated with poorer QOL. Biologic use was associated with increased SD; hypertension with a decrease in sexual desire. Conclusions SD and ED are highly prevalent and associated with poorer QOL.
... In this study, a relationship was found between depression and low sexual desire, ED, and low satisfaction [16]. In the study of Shmidt et al. [17], 69 patients with IBD were evaluated and it was found that 39% of the patients had global sexual dysfunction and 94% had ED. In this study, it was shown that ED is associated with advanced age and low physical and mental status scores. ...
... There are limited studies in the literature demonstrating the relationship between systemic inflammation and ED. Proinflammatory cytokines such as tumor necrosis factoralpha (TNF-α), interleukin-6 (IL-6) and interleukin-8 (IL-8) have been reported to increase in both ED and heart failure, which are known to be etiologically related [17]. It has been emphasized that the inflammatory markers act as important active agents in the development of ED. ...
Article
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Background and objective: Inflammatory bowel diseases (IBD) are chronic diseases involving the gastrointestinal system, including ulcerative colitis (UC) and Crohn’s disease (CD). Studies have shown a relationship between inflammatory bowel diseases and sexual dysfunction in men but it has been reported that this is due to surgery or the patient’s psychological state. In our study, we aimed to assess the impact of IBD on the sexual functioning of male patients who has no previous pelvic surgery by evaluating the depression status of the patients. Materials and methods: The 334 patients who were followed up in our gastroenterology outpatient clinic between January 2021 and March 2021 were included in the study and they were divided into 2 groups as with (n = 146) and without IBD (n = 188). None of the patients had a history of pelvic surgery or pelvic radiotherapy due to IBD or any other disease. The two groups were compared in terms of demographic data, comorbidities, sexual function, depression status and blood tests. International Index of Erectile Function (IIEF) was used in the evaluation of sexual functions, and the Beck Depression Inventory (BDI) was used in the evaluation of depression. Risk factors for erectile dysfunction (ED) were determined. Results: The mean Beck depression test scores of the two groups were found to be similar (p = 0.361). ED was detected in 52.7% of patients with IBD and 32.4% of patients without IBD (p < 0.0001). In multivariate regression analysis, age (p = 0.008), smoking (p < 0.001), presence of diabetes mellitus (p = 0.02) and presence of IBD (p < 0.001) were determined as independent risk factors for ED. Conclusion: Inflammatory bowel diseases can cause ED regardless of the pelvic surgery performed and the psychological status that occur in these patients.
... 12,14,31 However, a recent study that included 69 men newly diagnosed with IBD, 39% had a global SD, and 94% suffered from ED, using the IIEF. 32 A previous study found that 44% of men felt severely sexually compromised due to IBD, mainly in those with active disease. 33 Also, in men with IBD, a decrease in sexual desire was more frequent than in the general population. ...
Article
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Inflammatory bowel disease (IBD) is a chronic condition that globally affects the health of people who suffer from it, deteriorating their quality of life (QoL). An aspect rarely explored by healthcare providers is the influence of the disease on the sexual functioning of individuals. This discretion is mainly due to an unconscious resistance when asking our patients about their sexual functioning because of a lack of knowledge and skills to tackle this topic or disinterest on the part of professionals, and fear or shame on the part of patients. Sexual function is a constant concern in IBD patients that has been reflected in several studies, especially if we consider that the prevalence of sexual dysfunction (SD) in IBD is higher than that reported in the general population. The etiology of SD in patients with IBD remains unclear but is likely to be multifactorial, where biological, psychosocial, and disease-specific factors are involved. Currently, there are no formal recommendations in the IBD clinical guidelines on how to manage SD in these patients. The use of validated clinical scales could improve the detection of SD and allow the treatment of the underlying causes in order to improve the QoL of patients with IBD. This review aims to illustrate the different aspects involved in SD in IBD patients and the importance of the participation of a multidisciplinary team in the early detection and treatment of SD at different stages of the disease.
... Heart failure [34], atrial fibrillation [35], chronic obstructive pulmonary disease [36], osteoporosis [37], dementia [38], inflammatory bowel diseaese [39], and varicocele [40] have been associated with a higher incidence of ED in humans. Except for varicocele, our previous analyses supported a lower risk of all these morbidities among metformin users [6][7][8]11,12,15,16]. ...
Article
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Metformin is the first-line oral antidiabetic drug that shows multiple pleiotropic effects of anti-inflamation, anti-cancer, antiaging, anti-microbia, anti-atherosclerosis, and immune modulation. Metformin’s effects on men’s related health are reviewed here, focusing on reproductive health under subtitles of erectile dysfunction (ED), steroidogenesis and spermatogenesis; and on prostate-related health under subtitles of prostate specific antigen (PSA), prostatitis, benign prostate hyperplasia (BPH), and prostate cancer (PCa). Updated literature suggests a potential role of metformin on arteriogenic ED but controversial and contradictory effects (either protective or harmful) on testicular functions of testosterone synthesis and spermatogenesis. With regards to prostate-related health, metformin use may be associated with lower levels of PSA in humans, but its clinical implications require more research. Although there is a lack of research on metform’s effect on prostatitis, it may have potential benefits through its anti-microbial and anti-inflammatory properties. Metformin may reduce the risk of BPH by inhibiting the insulin-like growth factor 1 pathway and some but not all studies suggest a protective role of metformin on the risk of PCa. Many clinical trials are being conducted to investigate the use of metformin as an adjuvant therapy for PCa but results currently available are not conclusive. While some trials suggest a benefit in reducing the metastasis and recurrence of PCa, others do not show any benefit. More research works are warranted to illuminate the potential usefulness of metformin in the promotion of men’s health.
... Sexual dysfunction is found to be more common in inflammatory bowel disease (IDB) patients than in general population [5][6][7]. A study by Knowles and colleagues [5] in 74 IDB Australian patients showed that 53.9% of males and 83.6% of females stated lack of sexual interest. ...
Article
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Patients with inflammatory bowel disease (IDB) may have higher levels of sexual dysfunction than the general population. We aimed to study the prevalence of sexual disorders in a sample of Brazilian male and female patients with IDB and its association with depression, epidemiological and clinical data. This was a cross sectional study of 192 individuals (40 females with IDB, 40 males with IDB and 112 healthy controls). Male patients and controls answered the IIEF-5 (International Index of Erectile Function-5) and female patients the FSFI (Female Sexual Function Index). Beck Depression Inventory-II was used to access depression. Epidemiological, clinical and treatment data was collected from medical charts. We found that male and female patients with IDB had more sexual dysfunction than controls. Age was the only factor, when considering the various demographics, depression, IDB type, and treatments, that was significantly associated with sexual dysfunction in IBD patients, and this pattern was only detected in males. Taking into account the multi-faceted nature of this disease and how IDB symptoms interfere with sexual functioning, a multidisciplinary approach may be useful to improve the quality of life of patients with IDB.
... Modified from Barbalho et al. (2016). (Toresson et al., 2019;Shmidt et al., 2019;Reddavide et al., 2018;Torella et al., 2018;Masnadi et al., 2018;Barbalho et al., 2019;Ghishan and Kiela, 2017). ...
... Finally, we agreed with the authors' comments that physicians should take into consideration the high prevalence of erectile dysfunction and the risk factors among men with new diagnosis of inflammatory bowel disease, and physicians should talk about sex problems with these men. 2,4 Therefore, affected men may have a chance to counsel about their sex problems. Interventions can help affected men to receive appropriate treatments for erectile dysfunction. ...
... Social desirability was assessed as currently recommended for cross-sectional studies with these characteristics. Most IBD patients (94%) had been diagnosed >2 years before, which reduces selection bias (as patients indicated their diagnosis as CD or UC) and also information bias (as the potential impact of recent diagnosis 32,33 was not evaluated). More importantly, we used an SQoL instrument that addresses the different components of sexual health. ...
Article
Background: The impact of inflammatory bowel disease (IBD) on sexual health is a leading concern among patients. Most studies focus on sexual dysfunction rather than patient-perceived sexual quality of life (SQoL). We aimed to assess SQoL in IBD patients compared with healthy controls. Methods: This is a multicenter, cross-sectional study of IBD patients (n = 575 with Crohn's disease and n = 294 with ulcerative colitis), compared with healthy controls (n = 398), that used an anonymous self-administered questionnaire. This multimodal questionnaire included sociodemographic data and 4 validated instruments: Short IBD Questionnaire, Social Desirability Scale, Sexual QoL Questionnaire-Male/Female, Nine-item Patient Health Questionnaire. Results: Inflammatory bowel disease patients reported lower SQoL (men: 77.29 vs 83.83; P < 0.001; women: 70.40 vs 81.63; P < 0.001) compared with controls. Among IBD patients, SQoL was positively correlated with health-related quality of life (HRQoL) and negatively correlated with depression symptoms. Perianal disease was associated with lower HRQoL and higher incidence of depression, but only impacted SQoL in men. In linear regression analysis for men, SQoL was associated with age, marital status, and depression (β, -2.101; 95% confidence interval [CI], -2.505 to -1.696; P < 0.001). In women, SQoL was associated with depression (β, -1.973; 95% CI, -2.313 to -1.632; P < 0.001) only. Conclusions: Patients with IBD had impaired SQoL compared with healthy controls. Age, widow status, and depression were independent predictors of SQoL in men with IBD, whereas in women depression was the only independent predictor. Emotional and self-esteem issues were the main concerns reported by IBD patients regarding sexual health.
... Social desirability was assessed as currently recommended for cross-sectional studies with these characteristics. Most IBD patients (94%) had been diagnosed >2 years before, which reduces selection bias (as patients indicated their diagnosis as CD or UC) and also information bias (as the potential impact of recent diagnosis 32,33 was not evaluated). More importantly, we used an SQoL instrument that addresses the different components of sexual health. ...
Article
Introduction The impact of sexuality and quality of life (QOL) is one of the main concerns of IBD. Despite the obvious relevance of this problem, knowledge of the extent of sexual dysfunction (SD) in IBD is limited. Aim of this study was to assess the prevalence of SD and erectile dysfunction (ED), QOL their predictors, and their age-related dynamic in IBD patients. Methods In this cross-sectional study 202 IBD patients [122 male, 80 female, 133 Crohn’s disease (CD), 69 ulcerative colitis (UC)] fulfilled International Index of Erectile Function (IIEF) or Female Sexual Functioning Index (FSFI). QOL was assessed using IBDQ-32 through bowel, systemic, emotional and social domains. Results Prevalence of SD in men was 18%, ED 30.3% and SD in women 75%. Low QOL was present in 34.6% without gender difference (p=0.253). In men SD and ED were highest among 21-30 years and raising after 51 years of age. In women SD was constantly highly prevalent, showing no decline over time. In multivariate analysis significant predictors of SD in men were CD phenotype, disease duration and emotional domain of IBDQ, of ED depression, emotional and bowel domain of IBDQ, and of SD in women emotional IBDQ domain. Conclusion Quality of sex life is a serious concern among IBD patients and is age related. Components that play a role in sexual functioning in IBD require more clarification and further development of screening and treatment guidelines for SD to provide better care in the IBD population.
Chapter
The gastrointestinal (GI) system is a large organ system responsible for regulating the digestive functions of the body. Different incidences of specific GI diseases between women and men suggest a possible role of sex hormones in the promotion or prevention of disease development. In order to manage specific GI symptoms and their related diseases, it is important to understand the mechanism by which a disease has developed and the role of sex and gender. Sex and gender differences are observed in liver disease, specifically liver lesions, gastrointestinal reflux disease, and inflammatory bowel disease. The aim of this chapter is to improve understanding of sex and gender differences in these specific diseases in order to help focus differential diagnosis and treatment.
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Background Erectile dysfunction (ED) is closely related to coronary heart disease (CHD). Apolipoprotein (Apo) A1, Apo B, and Apo A/Apo B are known to be predictive factors for CHD. They are not yet a definite laboratory marker for the diagnosis of ED in cardiology. Therefore, we investigated the association between Apo A1, Apo B, and Apo A/Apo B, and ED. Aim To investigate the association between Apo A, Apo B, and Apo A/Apo B and the severity of ED. Methods A total of 152 ED patients and 39 healthy control participants underwent a fasting blood draw to test for Apo A, Apo B, and Apo A/Apo B and a detailed laboratory examination. The International Erectile Function Index (IIEF-5) was used to determine the severity of ED. Receiver operating characteristic (ROC) curve analysis was performed to identify the cutoff values for Apo A, Apo B, and Apo A/Apo B. Each questionnaire was completed before any diagnosis was made or treatment performed. Outcomes Several lipid profile indicators (Apo A, Apo B, Apo A/Apo B, lipoprotein (a), free fatty acids, and total cholesterol) were studied, along with several questionnaires. Results In our study, the number of patients with no ED, mild ED, mild-to-moderate ED, and moderate-to-severe ED were 39 (20.4%), 58 (30.4%), 36 (18.8%), and 58 (30.4%), respectively. Apo A and Apo A/Apo B were significantly reduced in patients with more severe ED (P = .037 and P < .001, respectively), while Apo B was significantly increased in patients with more severe ED (P = .002). According to the ROC curve, Apo A/Apo B had a medium diagnostic value for risk of ED with an AUC of 0.743 (95% CI: 0.68–0.80). For moderate-to-severe ED, 3 apolipoprotein indexes, including Apo B, Apo A, and Apo A/Apo B had medium diagnostic performance with AUCs of 0.759 (95% CI: 0.66–0.84), 0.703 (95% CI: 0.60–0.79), and 0.808 (95% CI: 0.72–0.88), respectively. Clinical implications Our results can inform cardiologists in the assessment of ED in patients with CHD. Strengths and limitations This study is the first to investigate the association between apolipoprotein and ED in China. The major limitations are that our sample size was too small to have matched controls without ED for different Apo levels. Conclusion Our results showed that Apo B, Apo A, and Apo A/Apo B can be used as markers to evaluate the risk of ED and that these proteins play an important role in the etiology of ED. Li X, Li D. The Suggestive Effect of Apo A, Apo B, and Apo A/Apo B on Erectile Dysfunction. J Sex Med 2020;XX:XXX–XXX.
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Half of patients with inflammatory bowel disease (IBD) are men, yet less attention has been focused on their sexual issues despite higher rates of sexual dysfunction and infertility than the general population. Depression and IBD disease activity are the most consistently reported risk factor for sexual dysfunction among men with IBD. Methotrexate and sulfasalazine have been rarely associated with impotence. Sulfasalazine reversibly reduces male fertility. No other medications used in IBD significantly affect fertility in humans. There is no increase in adverse fetal outcomes among offspring of fathers with IBD. Patients with IBD seem to be at a higher risk for prostate cancer; therefore, screening as recommended for high-risk patients should be considered.
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Background: Aspects of sexual health, which can be adversely affected by chronic disease, have been inadequately explored in inflammatory bowel disease (IBD). Aims: We evaluated patient-reported interest in sexual activity and satisfaction with sex life in a large cohort of IBD patients. Methods: We conducted a cross-sectional study within the Crohn's and Colitis Foundation Partners Internet cohort. Sequential participants completed a 6-question supplemental online survey to examine sexual interest and satisfaction using the Patient-Reported Outcome Measurement Information System®(PROMIS®) Sexual Function and Satisfaction measures. One-sample t tests were used to compare interest and satisfaction scores to general population norms. Results: Among 2569 individuals, 1639 had Crohn's disease (CD), 930 had ulcerative colitis (UC) or indeterminate colitis, and 71% were women. Mean PROMIS scores for sexual interest were comparable to the general US population in men (CD: 49 and UC: 48 vs. population mean 50) and women (CD: 41 and UC: 40 vs. population mean 42). However, sexual satisfaction scores were lower than the US population in men (CD: 48 and UC: 48 vs. 51) and women (CD: 47 and UC: 46 vs. 49), p < 0.01 for both. Older age, disease activity, depression, anxiety, and pain were associated with lower interest and satisfaction and lowered IBD-specific quality of life. Conclusions: IBD patients in a large online survey had similar levels of sexual interest but decreased sexual satisfaction compared to the general population. Exploring these sexual health domains during clinical encounters can aid in improving IBD quality of life.
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A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
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Health status assessment for persons with chronic illness includes not only symptoms, but also an appraisal of the psychosocial concomitants of illness. In this national study of persons with inflammatory bowel disease (IBD), we standardized a disease-specific 25-item measure of perceived health status: the Rating Form of IBD Patient Concerns (RFIPC). Factor analysis yielded four indices: a) impact of disease (e.g., being a burden, loss of energy, loss of bowel control); b) sexual intimacy; c) complications of disease (e.g., developing cancer, having surgery, dying early); and d) body stigma (e.g., feeling dirty or smelly). A higher level of IBD concerns was associated with greater disease severity, female gender, and lower educational status. When controlling for these factors, as well as disease type and age, we found that concerns about: a) impact of disease was positively associated with poorer perception of health and well-being, greater psychological distress (SCL-90), and poorer daily function (Sickness Impact Profile) (p less than 0.0001); b) sexual intimacy was related to poorer psychologic function (p less than 0.01); and c) complications of disease was related to several measures of poorer daily function (p less than 0.0001 to 0.01). This standardized measure of the worries and concerns of persons with IBD may be used in clinical care and research to evaluate the effects of interventions on IBD patient outcomes.
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Relevant information for clinical decision-making in a wide spectrum of diseases includes the extent to which sexual function is intact, how important it is to preserve sexual capacity and whether waning sexual function causes distress. Little information is available on elderly men. We aimed to obtain this basic information. Radiumhemmet's Scale of Sexual Function was posted to 435 randomly selected men aged 50–80 years. Assessments included sexual desire, erectile capacity, orgasm and ejaculation and to what extent waning sexual function distressed the men. The questions were answered anonymously. Information was obtained from 319 men (73%). Of these, 83% stated that sex was ‘very important’, ‘important’ or a ‘spice to life’. Physiological potency for men aged 50–59, 60–69 and 70–80 amounted to 97%, 76% and 51% respectively. Among the oldest men (70–80 years), 46% reported orgasm at least once a month. Over 80% of all men who reported some level of erection stated that it was of importance to them to maintain the present level of erection stiffness. Most men who reported waning sexual function (compared with their youth) stated that this distressed them. Sex is important to elderly men. Even among the 70–80-year-olds, an intact sexual desire, erection and orgasm are common and it is considered important to preserve them. Sexual function should be considered in the clinical assessment of elderly men.
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Depressed men commonly have erectile dysfunction, and men with erectile dysfunction are frequently depressed. Since the etiologic and modulatory relationships between depression and erectile dysfunction have been poorly characterized, a 12-week, randomized, double-blind, placebo-controlled trial was conducted at 20 urologic clinics to evaluate the effects of sildenafil treatment in men with erectile dysfunction and mild-to-moderate comorbid depressive illness. Men (N=152, mean age=56 years) with erectile dysfunction for > or =6 months (mean=5.7 years), a DSM-IV diagnosis of depressive disorder not otherwise specified, and a Hamilton Depression Rating Scale score > or =12 (mean at baseline=16.9) were randomly assigned to flexible-dose treatment with sildenafil citrate or matching placebo. Interviewer-rated and self-report instruments were used to assess changes in sexual function, depressive symptoms, and quality of life. Conservative criteria were used to classify erectile dysfunction treatment response and nonresponse. Sildenafil was strongly associated with erectile dysfunction treatment response. Fifty-eight men met the conservative criteria for response (48 given sildenafil, 10 given placebo), and 78 men did not respond (18 given sildenafil, 60 given placebo). Mean decreases of 10.6 and 2.3 in Hamilton depression scale scores were seen in treatment responders and nonresponders, respectively; 76% of treatment responders showed a > or =50% decline in Hamilton depression scale score versus 14% of nonresponders. Quality of life was similarly improved in treatment responders. Sildenafil is efficacious for erectile dysfunction in men with mild-to-moderate depressive illness. Improvement of erectile dysfunction is associated with marked improvement in depressive symptoms and quality of life.
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The Global Study of Sexual Attitudes and Behaviors (GSSAB) is an international survey of various aspects of sex and relationships among adults aged 40-80 y. An analysis of GSSAB data was performed to estimate the prevalence and correlates of sexual problems in 13,882 women and 13,618 men from 29 countries. The overall response rate was modest; however, the estimates of prevalence of sexual problems are comparable with published values. Several factors consistently elevated the likelihood of sexual problems. Age was an important correlate of lubrication difficulties among women and of several sexual problems, including a lack of interest in sex, the inability to reach orgasm, and erectile difficulties among men. We conclude that sexual difficulties are relatively common among mature adults throughout the world. Sexual problems tend to be more associated with physical health and aging among men than women.
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Background: Data on fertility rates and medication safety in men with inflammatory bowel disease (IBD) are limited. The aim of this study was to evaluate whether there is a seminal alteration in patients with IBD and, if so, to evaluate the mechanisms that may play a role according to what has been described in the literature. Its secondary aim was to evaluate the impact on male sexual function of IBD. Methods: Multicenter, cross-sectional, case series study comparing men with IBD and control subjects. Semen analysis was performed according to the recommendations of World Health Organization. The impact on male sexual function was evaluated with the International Index of Erectile Function questionnaire. Results: On multivariate analysis, patients with Crohn's disease had lower sperm concentrations compared with those with ulcerative colitis (median [interquartile range], 34.5 [19.2-48] versus 70 [34.5-127.5], P = 0.02) and lower seminal zinc levels (mean ± SD, 1475 ± 235 μmol/L versus 2221 ± 1123 μmol/L, P = 0.04). Patients with Crohn's disease on anti-tumor necrosis factor treatment had better progressive motility (mean ± SD, 56.7 ± 17.7 versus 35.1 ± 22.1, P = 0.01) and sperm morphology (14.4 ± 7.1 versus 7.6 ± 4.9, P = 0.04) than those who were not on anti-tumor necrosis factor. Regarding sexual function, no significant differences were found across patients with IBD and control subjects. Conclusions: Men with Crohn's disease showed a trend toward poorer semen quality than those with ulcerative colitis. Treatment with anti-tumor necrosis factor drugs does not seem to be associated with poor sperm quality. In patients in clinical remission, male sexual function is not affected by IBD.
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Introduction: Emerging work has shown erectile dysfunction (ED) to be an important indicator of cardiovascular risk via its shared pathophysiology. Yet limited research has examined if a direct relationship between ED and mortality risk exists. Aim: The purpose of this brief report was to better define the relationship between ED and mortality risk. Methods: Prevalent ED was assessed with the question: "How would you describe your ability to get and keep an erection adequate for satisfactory intercourse?" Participant data from the population-based 2003-2004 National Health and Nutrition Examination Survey (NHANES) was linked to death certificates from the National Death Index for mortality assessment. Main outcome measures: Increased risk of premature all-cause mortality among those with ED (vs. those without). Results: Of 1,790 adult men providing complete data (age range: 20-85 years; mean = 45.4 year), with 557 having ED, over a 93-month follow-up, 244 deceased over this time. After adjustments, those with ED (vs. those without) had a 70% increased risk of premature all-cause mortality (hazards ratio = 1.70; 95% confidence interval; 1.01-2.85; P = 0.04). Conclusions: ED is associated with increased premature mortality risk. The present findings have major public health and clinical implications in that ED is a strong indicator of premature mortality. Therefore, patients with ED should be screened and possibly treated for complications that may increase the risk of premature death. Loprinzi PD and Nooe A. Erectile dysfunction and mortality in a national prospective cohort study. J Sex Med **;**:**-**.
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Despite the fact that the inflammatory bowel diseases (IBD) and their treatments may affect physical appearance, the effect of IBD on body image is poorly understood. The aims of this study were to determine whether body image dissatisfaction (BID) changes over time in patients with IBD and to examine the demographic and disease-related variables associated with decreased body image. Adults aged 18 and above in the Ocean State Crohn's and Colitis Area Registry with at least 2 years of follow-up were eligible for this study. All patients were enrolled within 6 months of IBD diagnosis and followed prospectively. BID was assessed using a modified version of the Adapted Satisfaction With Appearance questionnaire. Total Adapted Satisfaction With Appearance scores and 2 subscores were calculated. To assess for changes over time, general linear models for correlated data were used for continuous outcomes, and generalized estimating equations were used for discrete outcomes. Two hundred seventy-four patients were studied. BID was found to be stable over time among men and women with IBD despite overall improvements in disease activity. No differences were found in BID according to IBD subtype. Female gender, greater disease activity, higher symptom burden, longer duration of steroid use, dermatologic and musculoskeletal manifestations of IBD, and ileocolonic disease location among patients with Crohn's disease were associated with greater BID. Greater BID was associated with lower health-related quality of life. BID remains stable in an incident cohort of IBD despite improved disease activity and is associated with lower health-related quality of life.
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Basics Introduction The problem of missing data Concepts of MCAR, MAR and MNAR Simple solutions that do not (always) work Multiple imputation in a nutshell Goal of the book What the book does not cover Structure of the book Exercises Multiple imputation Historic overview Incomplete data concepts Why and when multiple imputation works Statistical intervals and tests Evaluation criteria When to use multiple imputation How many imputations? Exercises Univariate missing data How to generate multiple imputations Imputation under the normal linear normal Imputation under non-normal distributions Predictive mean matching Categorical data Other data types Classification and regression trees Multilevel data Non-ignorable methods Exercises Multivariate missing data Missing data pattern Issues in multivariate imputation Monotone data imputation Joint Modeling Fully Conditional Specification FCS and JM Conclusion Exercises Imputation in practice Overview of modeling choices Ignorable or non-ignorable? Model form and predictors Derived variables Algorithmic options Diagnostics Conclusion Exercises Analysis of imputed data What to do with the imputed data? Parameter pooling Statistical tests for multiple imputation Stepwise model selection Conclusion Exercises Case studies Measurement issues Too many columns Sensitivity analysis Correct prevalence estimates from self-reported data Enhancing comparability Exercises Selection issues Correcting for selective drop-out Correcting for non-response Exercises Longitudinal data Long and wide format SE Fireworks Disaster Study Time raster imputation Conclusion Exercises Extensions Conclusion Some dangers, some do's and some don'ts Reporting Other applications Future developments Exercises Appendices: Software R S-Plus Stata SAS SPSS Other software References Author Index Subject Index
Article
Introduction Data suggest that ED is still an underdiagnosed and undertreated condition. In addition, it seems that men with ED are unsatisfied about their relationship with their physician and with the available drugs. Aim The study aims to identify health-related characteristics and unmet needs of patients suffering from erectile dysfunction (ED) in big 5 European Union (EU) nations (France, Germany, Italy, Spain, and UK). Methods Data were collected from the 2011 5EU National Health and Wellness-Survey on a population of 28,511 adult men (mean age: 47.18; SD 16.07) and was focused on men (5,184) who self-reported ED in the past 6 months. In addition, the quality of life (QoL) and work productivity/activity were explored. Main Outcome Measures Health-related QoL (HRQoL) and work productivity were measured with SF-12v2 and WPAI validated psychometric tools. Results One in every 20 young men (age 18–39) across 5EU experienced ED in the past 6 months. About half of men (2,702/5,184; [52%]) with ED across all ages did not discuss their condition with their physician. Interestingly, among those men who did discuss their condition with their physician, 68% (1,668/2,465) do not currently use medication. These findings were more evident in the age group of 18–39 years. Only 48% (2,465/5,184) had a closer relationship with their physician, suggesting that this quality of relationship may be unsatisfactory. Compared with controls, ED patients have a significantly higher intrapsychic and relational psychopathological comorbid burden and relevant decreasing in HRQoL, with a significantly higher impairment on work productivity/activity. Conclusion Data suggest that there is a need for a new therapeutic paradigm in ED treatment which images the achievement of a new alliance between physician and patient. Hence, alternative drug delivery strategies may reduce the psychological and social impact of this disease. Jannini EA, Sternbach N, Limoncin E, Ciocca G, Gravina GL, Tripodi F, Petruccelli I, Keijzer S, Isherwood G, Wiedemann B, and Simonelli C. Health-related characteristics and unmet needs of men with erectile dysfunction: A survey in five European countries. J Sex Med 2014;11:40–50.
Article
Context Erectile dysfunction is common in men with diabetes.Objective To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes.Design A multicenter, randomized, double-blind, placebo-controlled, flexible dose-escalation study conducted May through November 1996.Setting Patients' homes and 19 clinical practice centers in the United States.Patients A total of 268 men (mean age, 57 years) with erectile dysfunction (mean duration, 5.6 years) and diabetes (mean duration, 12 years).Interventions Patients were randomized to receive sildenafil (n=136) or placebo (n=132) as needed, but not more than once daily, for 12 weeks. Patients took the study drug or placebo 1 hour before anticipated sexual activity. The starting dose of sildenafil citrate was 50 mg, with the option to adjust the dose to 100 mg or 25 mg based on efficacy and tolerability, to be taken as needed.Main Outcome Measures Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events.Results Two hundred fifty-two patients (94%) completed the study (131/136 in the sildenafil group, 121/132 in the placebo group). By intention-to-treat analysis, at 12 weeks, 74 (56%) of 131 patients in the sildenafil group reported improved erections compared with 13 (10%) of 127 patients in the placebo group (P<.001). The proportion of men with at least 1 successful attempt at sexual intercourse was 61% (71/117) for the sildenafil group vs 22% (25/114) for the placebo group (P<.001). Adverse events related to treatment were reported for 22 (16%) of 136 patients taking sildenafil and 1 (1%) of 132 patients receiving placebo. The most common adverse events were headache (11% sildenafil, 2% placebo), dyspepsia (9% sildenafil, 0% placebo), and respiratory tract disorder (6% sildenafil, 2% placebo), predominantly sinus congestion or drainage. The incidence of cardiovascular adverse events was comparable for both groups (3% sildenafil, 5% placebo).Conclusion Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes. Figures in this Article Diabetes mellitus affects an estimated 15.7 million people in the United States, including 7.5 million men, with type 2, non–insulin-dependent, diabetes accounting for 90% to 95% of the diagnosed cases and type 1, insulin-dependent, diabetes accounting for 5% to 10%.1 A common complication of diabetes in men is erectile dysfunction (ED), defined by the National Institutes of Health Consensus Panel on Impotence as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual activity.2 The prevalence of ED of any degree in men aged 40 to 70 years was estimated to be 52% in the Massachusetts Male Aging Study (MMAS), with a prevalence of 25% for moderate ED and 10% for complete ED (ie, no erections).3 The prevalence of ED is age dependent, with the rate of complete ED increasing from 5% among men aged 40 years to 15% among those aged 70 years.3 Erectile dysfunction in men with diabetes is often associated with diabetic neuropathy and peripheral vascular disease.4- 5 It occurs at an earlier age in men with diabetes than in men in the general population,6- 7 and several studies have demonstrated a high prevalence (35% to 75%) of ED with diabetes.6,8- 10 In men with treated diabetes in the MMAS, the age-adjusted prevalence of complete ED (no erections) was 28%, which was approximately 3 times higher than the prevalence of complete ED observed in the entire sample of men (10%).3 Penile erection is a hemodynamic event dependent on the relaxation of smooth muscle cells and arteries of the corpus cavernosum.11 Relaxation of corpus cavernosal smooth muscle is mediated by nitric oxide–induced cyclic 3‘, 5‘-guanosine monophosphate (cGMP) formation.12- 14 In response to sexual stimuli, nonadrenergic, noncholinergic nerves and endothelial cells of the arterioles in the penis release nitric oxide, which induces smooth muscle relaxation via stimulation of guanylate cyclase and the production of cGMP. Subsequently, cGMP is hydrolyzed by cGMP-specific phosphodiesterase type 5 (PDE5), the predominant PDE isozyme of the corpus cavernosum.15 Sildenafil citrate is an orally active and selective inhibitor of PDE5. When sexual stimulation causes local release of nitric oxide, sildenafil enhances the effect of nitric oxide on the corpus cavernosum by increasing the levels of cGMP in this tissue. Sildenafil is rapidly absorbed following oral administration, has an onset of action within 25 to 60 minutes after dosing,15 and has a plasma half-life of approximately 4 hours. Sildenafil has been shown to be an effective and well-tolerated treatment in patients with ED of various etiologies.16 The purpose of the present study was to assess the efficacy and safety of sildenafil in the treatment of ED in men with diabetes. In a pilot study of 21 men with ED and diabetes, treatment with sildenafil improved erectile function, as assessed by penile plethysmography in a clinic setting.17 This study evaluated sildenafil in a larger population of men with ED and diabetes in a home setting, which reflects the situation encountered in clinical practice.
Article
Background Sexuality is important when assessing quality of life (QoL), which is often disturbed in inflammatory bowel disease (IBD). However, sexuality is not addressed in most QoL questionnaires. Aims To evaluate the prevalence and predisposing factors of sexual dysfunction among IBD patients, and their own perception. Methods A postal survey was conducted in IBD patients 25–65 years of age from two tertiary centres. Patients were asked to provide a control of the same gender and age without IBD. The questionnaire assessed patient perception of the impact of IBD on their sexuality, and also allowed calculation of the Erectile Function International Index or the Female Sexual Function Index. Results A total of 355 patients and 200 controls were available for the final analysis. Both groups were comparable except for a higher proportion of individuals who had been treated for depression among patients. Half of the female and one-third of the male patients considered that both sexual desire and satisfaction worsened after IBD diagnosis. As compared to controls, both men and women with IBD showed significantly lower scores in sexual function indexes, but a higher prevalence of sexual dysfunction was only noticed among women. Independent predictors of sexual dysfunction among IBD patients were the use of corticosteroids in women, and the use of biological agents, depression and diabetes in men. Conclusions Sexuality is often disturbed in IBD patients, particularly among women. Many factors seem to contribute to worsened intimacy. Sexuality should be considered when QoL is assessed in these patients.
Article
BACKGROUND Although fatigue is a common symptom among cancer patients, it is also a common experience in the general, healthy population. Its universality has made it difficult to appreciate whether the fatigue experienced by patients with cancer is distinguishable from the fatigue experienced by the general population. Because the etiology of fatigue is multifactorial, it also has been difficult to appreciate fully the relative contribution of anemia to cancer-related fatigue.METHODS To address this issue, responses to a brief, standardized set of 13 questions from the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System were compared across three groups: anemic cancer patients (n = 2369 patients), nonanemic cancer patients (n = 113 patients), and the general United States population (n = 1010 persons).RESULTSFatigue scores of the anemic cancer patients (at both baseline and upon completion of anemia therapy) were significantly worse compared with the scores of nonanemic cancer patients that, in turn, were worse compared with the scores of the general United States population (P < 0.001). Score distributions were quite distinct for these three groups. Within the group of anemic cancer patients, the degree of anemia (mild, moderate, or severe) also was predictive of the degree of fatigue (P < 0.001), although the distributions were not dramatically distinct.CONCLUSIONS Although anemia is clearly a factor that contributes to the severity of disease-related fatigue among cancer patients, hemoglobin levels explain only part of the difference compared with fatigue among the general United States population. The distinct distributions of fatigue scores of anemic cancer patients compared with the general United States population and the substantial sample sizes of these two groups enabled a discriminant analysis approach that allowed the differentiation of anemic cancer patients from the general population with high sensitivity (0.92) and reasonable specificity (0.69). Thus, although fatigue is a symptom most anyone can relate to, the fatigue of cancer patients, particularly those who are anemic, is decidedly worse. Interventions targeting this common and life-disrupting symptom likely would be of considerable value to patients with cancer. Cancer 2002;94:528–38. © 2002 American Cancer Society.
Article
Aliment Pharmacol Ther 2011; 34: 1328–1336 Background Many patients with ulcerative colitis (UC) and Crohn’s disease (CD) complain of significant fatigue. To date, no instrument to measure fatigue has been validated in a US inflammatory bowel disease (IBD) population. Aim To determine the reliability and validity of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale in IBD. Methods A total of 209 patients with IBD completed the 13 items of the FACIT-F, alongside laboratory testing and disease activity assessment. Internal consistency was measured by Cronbach’s alpha; test–retest reliability by the intraclass correlation coefficient (ICC); validity by the correlation of the FACIT-F score with C-reactive protein (CRP) erythrocyte sedimentation rate (ESR), haematocrit (HCT) and disease activity as measured by the Harvey-Bradshaw Index (HBI; CD) and Simple Clinical Colitis Activity Index (SCCAI; UC). Results The mean ± SD FACIT-F score was 38.9 ± 11.0 overall (CD 38.6 ± 11.3; UC 39.4 ± 10.6). Cronbach’s alpha was 0.94. The ICC for first and repeat FACIT-F scores assessed within 180 days without change in disease state was 0.81 (CD 0.78; UC 0.87). FACIT-F scores were lower in patients with active symptoms (CD 4.6 points, 95% CI 2.4–6.9, P < 0.001; UC 8.5 points, 95% CI 5.5–11.4, P < 0.001). In UC, FACIT-F scores were correlated with ESR (−0.76, 95% CI −0.89 to −0.50), CRP (−0.72, 95% CI −0.88 to −0.43) and HCT (0.53, 95% CI 0.22–0.74). Conclusion The FACIT-F scale is a reliable and valid instrument for measuring fatigue in IBD.
Article
To assess the validity and reliability of the fatigue subscale of the Functional Assessment of Chronic Illness Therapy (FACIT-F), a 6-item subset from the thrombocytopenia subscale of the Functional Assessment of Cancer Therapy (FACT-Th6) and the Short Form-36 Version 2 (SF-36v2) in 2 clinical trials of the thrombopoietin receptor agonist eltrombopag in chronic immune thrombocytopenia (ITP) patients. In the 6-month, RAndomized placebo-controlled ITP Study with Eltrombopag (RAISE; n = 197), the FACIT-F, FACT-Th6, and SF-36v2 were administered at baseline, day 43, weeks 14 and 26, or early withdrawal. In the ongoing open-label extension study, Eltrombopag EXTENDed Dosing Study (EXTEND; n = 154), measures were administered at baseline, at the beginning of each stage, and at permanent discontinuation of study medication. FACIT-F, FACT-Th6, and SF-36v2 demonstrated acceptable internal consistency reliability (i.e., all Cronbach's alphas >0.70) and test-retest reliability (all intraclass correlation coefficients >0.70). Construct validity was supported by moderate (0.35 < r < 0.50) to strong (r > 0.50) inter-measure correlations for baseline and change scores. A small to medium magnitude of effect was captured by the FACIT-F and FACT-Th6 among patients who experienced sustained platelet responses. Results provide support for the validity, reliability, and responsiveness of the FACIT-F, FACT-Th6, and SF-36v2 in chronic ITP patients.
Article
Sexuality is a complex aspect of the human being's life and is more than of only the sexual act. Normal sexual functioning consists of sexual activity with transition through the phases from arousal to relaxation with no problems, and with a feeling of pleasure, fulfillment and satisfaction. Rheumatic diseases may affect all aspects of life including sexual functioning. The reasons for disturbing sexual functioning are multifactorial and comprise disease-related factors as well as therapy. In rheumatoid arthritis and ankylosing spondylitis patients, pain and depression could be the principal factors contributing to sexual dysfunction. On the other hand, in women with Sjögren's syndrome, systemic lupus erythematosus and systemic sclerosis sexual dysfunction is apparently most associated to vaginal discomfort or pain during intercourse. Finally, sexual dysfunction in patients with fibromyalgia could be principally associated with depression, but the characteristic symptoms of fibromyalgia (generalized pain, stiffness, fatigue and poor sleep) may contribute to the occurrence of sexual dysfunction. The treatment of sexual dysfunction will depend on the specific patient's symptoms, however, there are some general recommendations including: exploring different positions, using analgesics drug, heat and muscle relaxants before sexual activity and exploring alternative methods of sexual expression. This is a systemic review about the impact of several rheumatic diseases on sexual functioning. There are no previous overviews about this topic so far.
Article
The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. Our objectives were to assess the PHQ-8 as a depression measure in a large, epidemiological population-based study, and to determine the comparability of depression as defined by the PHQ-8 diagnostic algorithm vs. a PHQ-8 cutpoint > or = 10. Random-digit-dialed telephone survey of 198,678 participants in the 2006 Behavioral Risk Factor Surveillance Survey (BRFSS), a population-based survey in the United States. Current depression as defined by either the DSM-IV based diagnostic algorithm (i.e., major depressive or other depressive disorder) of the PHQ-8 or a PHQ-8 score > or = 10; respondent sociodemographic characteristics; number of days of impairment in the past 30 days in multiple domains of health-related quality of life (HRQoL). The prevalence of current depression was similar whether defined by the diagnostic algorithm or a PHQ-8 score > or = 10 (9.1% vs. 8.6%). Depressed patients had substantially more days of impairment across multiple domains of HRQoL, and the impairment was nearly identical in depressed groups defined by either method. Of the 17,040 respondents with a PHQ-8 score > or = 10, major depressive disorder was present in 49.7%, other depressive disorder in 23.9%, depressed mood or anhedonia in another 22.8%, and no evidence of depressive disorder or depressive symptoms in only 3.5%. The PHQ-8 diagnostic algorithm rather than an independent structured psychiatric interview was used as the criterion standard. The PHQ-8 is a useful depression measure for population-based studies, and either its diagnostic algorithm or a cutpoint > or = 10 can be used for defining current depression.
Article
300 patients with inflammatory bowel disease (IBD) were randomly selected from the community-based register held in Leicester. They were invited to participate in a study investigating personal problems of patients with IBD. 188 patients agreed to participate and were subsequently sent a previously validated questionnaire. A similar questionnaire was sent to buddy controls of similar age, sex and background (n = 76) as well as matched controls drawn at random from general practitioner lists (n = 46). Details sought included demographic data, patients' perception of their disease severity, data relating to treatment, family history, fertility, frequency of sexual intercourse and the effect IBD had on personal relationships. 150 questionnaires were returned from patients (response rate 80%) and 122 from controls. The reliability of a randomly selected group of questionnaires was assessed by direct interview 4 months after the main study (n = 20). There were no demographic differences between the patient and control groups (age: t = 0.67, ns; duration of marriage: t = 0.92, and marital status/number with a regular partner: chi 2 = 14, 12 d.f., p = 0.3). Dyspareunia was commoner amongst patients (n = 15, 38%) than controls (n = 7, 18%), although this was not statistically significant (z = 2.6). There was no significant difference in the overall frequency of sexual intercourse amongst patient and control groups (chi 2 = 12.78, 12 d.f.), even when comparing those with infrequent or no sexual intercourse (chi 2 = 6.98, 4 d.f.) The reliability of these results was confirmed after 4 months when there was no difference in responses in the re-interviewed group.(ABSTRACT TRUNCATED AT 250 WORDS)
Article
The widespread use of standardized health surveys is predicated on the largely untested assumption that scales constructed from those surveys will satisfy minimum psychometric requirements across diverse population groups. Data from the Medical Outcomes Study (MOS) were used to evaluate data completeness and quality, test scaling assumptions, and estimate internal-consistency reliability for the eight scales constructed from the MOS SF-36 Health Survey. Analyses were conducted among 3,445 patients and were replicated across 24 subgroups differing in sociodemographic characteristics, diagnosis, and disease severity. For each scale, item-completion rates were high across all groups (88% to 95%), but tended to be somewhat lower among the elderly, those with less than a high school education, and those in poverty. On average, surveys were complete enough to compute scales scores for more than 96% of the sample. Across patient groups, all scales passed tests for item-internal consistency (97% passed) and item-discriminant validity (92% passed). Reliability coefficients ranged from a low of 0.65 to a high of 0.94 across scales (median = 0.85) and varied somewhat across patient subgroups. Floor effects were negligible except for the two role disability scales. Noteworthy ceiling effects were observed for both role disability scales and the social functioning scale. These findings support the use of the SF-36 survey across the diverse populations studied and identify population groups in which use of standardized health status measures may or may not be problematic.
Article
Quality of life (QOL), a subjective index of health perception and function, embraces physical, social, and emotional performance but has not had a prominent role in clinical trials of inflammatory bowel disease (IBD). To test the robustness of the Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific QOL index, this study assessed its validity, reliability, and responsiveness during a multicenter trial. Three hundred five patients with stable Crohn's disease received cyclosporin or placebo for 18 months. IBDQ and dimensional scores (bowel, social, systemic, and emotional) were correlated with disease activity (Crohn's disease activity index [CDAI] and Harvey-Bradshaw index). Concordance of IBDQ scores was tested in 280 stable subjects. Linear regression evaluated change in IBDQ scores over time. IBDQ scores correlated highly with CDAI (r = -0.67; P < 0.0001). The reliability coefficient for IBDQ score was 0.70 vs. 0.66 for CDAI and 0.55 for Harvey-Bradshaw index. Regression line slopes of IBDQ scores were significantly different in patients who deteriorated from those who remained stable ([b] < 0.15; P < 0.0001). QOL scores were lower in patients who required surgery. The IBDQ is a valid reliable assessment tool that reflects important changes in the health status of patients with IBD. The IBDQ is a robust measure of therapeutic efficacy and should be used in future clinical trials in IBD.
Article
This paper reports the development and validation of a questionnaire assessing fatigue and anemia-related concerns in people with cancer. Using the 28-item Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire as a base, 20 additional questions related to the symptoms and concerns of patients with anemia were developed. Thirteen of these 20 questions dealt with fatigue, while the remaining 7 covered other concerns related to anemia. Using semi-structured interviews with 14 anemic oncology patients and 5 oncology experts, two instruments were produced: The FACT-Fatigue (FACT-F), consisting of the FACT-G plus 13 fatigue items, and the FACT-Anemia (FACT-An), consisting of the FACT-F plus 7 nonfatigue items. These measures were, in turn, tested on a second sample of 50 cancer patients with hemoglobin levels ranging from 7 to 15.9 g/dL. The 41-item FACT-F and the 48 item FACT-An scores were found to be stable (test-retest r = 0.87 for both) and internally consistent (coefficient alpha range = 0.95-0.96). The symptom-specific subscales also showed good stability (test-retest r range = 0.84-0.90), and the Fatigue subscale showed strong internal consistency (coefficient alpha range = 0.93-0.95). Internal consistency of the miscellaneous nonfatigue items was lower but acceptable (alpha range = 0.59-0.70), particularly in light of their strong relationship to patient-rated performance status and hemoglobin level. Convergent and discriminant validity testing revealed a significant positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and a predicted lack of relationship with social desirability. The total scores of both scales differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < 0.0001). The 13-item Fatigue subscale of the FACT-F and the 7 nonfatigue items of the FACT-An also differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < or = 0.001). The FACT-F and FACT-An are useful measures of quality of life in cancer treatment, adding more focus to the problems of fatigue and anemia. The Fatigue Subscale may also stand alone as a very brief, but reliable and valid measure of fatigue.
Article
To develop a brief, reliable, self-administered measure of erectile function that is cross-culturally valid and psychometrically sound, with the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. Relevant domains of sexual function across various cultures were identified via a literature search of existing questionnaires and interviews of male patients with erectile dysfunction and of their partners. An initial questionnaire was administered to patients with erectile dysfunction, with results reviewed by an international panel of experts. Following linguistic validation in 10 languages, the final 15-item questionnaire, the international index of Erectile Function (IIEF), was examined for sensitivity, specificity, reliability (internal consistency and test-retest repeatability), and construct (concurrent, convergent, and discriminant) validity. A principal components analysis identified five factors (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction) with eigenvalues greater than 1.0. A high degree of internal consistency was observed for each of the five domains and for the total scale (Cronbach's alpha values of 0.73 and higher and 0.91 and higher, respectively) in the populations studied. Test-retest repeatability correlation coefficients for the five domain scores were highly significant. The IIEF demonstrated adequate construct validity, and all five domains showed a high degree of sensitivity and specificity to the effects of treatment. Significant (P values = 0.0001) changes between baseline and post-treatment scores were observed across all five domains in the treatment responder cohort, but not in the treatment nonresponder cohort. The IIEF addresses the relevant domains of male sexual function (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), is psychometrically sound, and has been linguistically validated in 10 languages. This questionnaire is readily self-administered in research or clinical settings. The IIEF demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction.
Article
Erectile dysfunction is common in men with diabetes. To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes. A multicenter, randomized, double-blind, placebo-controlled, flexible dose-escalation study conducted May through November 1996. Patients' homes and 19 clinical practice centers in the United States. A total of 268 men (mean age, 57 years) with erectile dysfunction (mean duration, 5.6 years) and diabetes (mean duration, 12 years). Patients were randomized to receive sildenafil (n = 136) or placebo (n = 132) as needed, but not more than once daily, for 12 weeks. Patients took the study drug or placebo 1 hour before anticipated sexual activity. The starting dose of sildenafil citrate was 50 mg, with the option to adjust the dose to 100 mg or 25 mg based on efficacy and tolerability, to be taken as needed. Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events. Two hundred fifty-two patients (94%) completed the study (131/136 in the sildenafil group, 121/132 in the placebo group). By intention-to-treat analysis, at 12 weeks, 74 (56%) of 131 patients in the sildenafil group reported improved erections compared with 13 (10%) of 127 patients in the placebo group (P<.001). The proportion of men with at least 1 successful attempt at sexual intercourse was 61 % (71/ 117) for the sildenafil group vs 22% (25/114) for the placebo group (P<.001). Adverse events related to treatment were reported for 22 (16%) of 136 patients taking sildenafil and 1 (1%) of 132 patients receiving placebo. The most common adverse events were headache (11% sildenafil, 2% placebo), dyspepsia (9% sildenafil, 0% placebo), and respiratory tract disorder (6% sildenafil, 2% placebo), predominantly sinus congestion or drainage. The incidence of cardiovascular adverse events was comparable for both groups (3% sildenafil, 5% placebo). Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes.
Article
Erectile dysfunction is a common condition in men with cardiovascular disease, probably as a result of shared factors that impair hemodynamic mechanisms in the penile and ischemic vasculature. Sildenafil citrate, an orally active, selective inhibitor of phosphodiesterase type 5 (PDE5), has demonstrated excellent efficacy and safety profiles in men with erectile dysfunction of various etiologies. Sildenafil administration is contraindicated in patients who are taking nitrates or nitric oxide donors. This retrospective subanalysis of data from double-blind, placebo-controlled studies assessed the efficacy (9 studies) and safety (11 studies) of sildenafil in patients with erectile dysfunction and ischemic heart disease who were not taking nitrates. Of 3,672 patients randomized to receive sildenafil (5-200 mg) or placebo for 4-24 weeks in 11 double-blind, placebo-controlled studies, 357 (10%) reported a history (past or present) of ischemic heart disease and were not taking nitrates. Efficacy was assessed using end-of-treatment responses to Question 3 (ability to achieve an erection) and Question 4 (ability to maintain an erection) of the International Index of Erectile Function (IIEF), scores for the 5 domains of male sexual function assessed by the IIEF (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), and responses to a global efficacy question ("Did the treatment improve your erections?"). The responses to the 2 IIEF questions were graded on a scale of 1 (almost never or never) to 5 (almost always or always), with a score of 0 indicating no attempt at sexual intercourse. At the end of treatment, the mean scores for Question 3 and Question 4 of the IIEF for patients with erectile dysfunction and ischemic heart disease were significantly higher for the sildenafil group than for the placebo group (p <0.0001). Mean end-of-treatment scores for the IIEF domains also demonstrated significant increases for sildenafil-treated patients compared with those receiving placebo (p <0.05). At the end of treatment, improved erections were reported by 70% of patients who received sildenafil and by 20% of those in the placebo group p <0.0001). For the sildenafil group, the incidences of the most common adverse events (headache 25%, flushing 14%, and dyspepsia 12%) for patients with ischemic heart disease were similar to those in patients without this concomitant illness (21%, 15%, and 10%, respectively). Moreover, the overall incidence of cardiovascular adverse events other than flushing was comparable in patients with and without ischemic heart disease for both treatment groups. Since there is a degree of cardiac risk associated with sexual activity, clinicians should consider the patient's cardiovascular status before initiating any treatment for erectile dysfunction. Physicians should be aware that patients with underlying cardiovascular disease could be adversely affected by the vasodilator effects of sildenafil, especially in combination with sexual activity. The results of the present subanalysis indicate that oral sildenafil significantly improves erectile function and is well tolerated in patients with erectile dysfunction and ischemic heart disease who are not taking nitrate therapy.
Article
Erectile dysfunction is a common complication of spinal cord injury. This double-blind, placebo-controlled, two-way crossover study assessed the efficacy and safety of oral sildenafil in men with erectile dysfunction caused by traumatic spinal cord injury. A total of 178 men (mean age, 38 years) received placebo or sildenafil 1 hour before sexual activity for 6 weeks; after a 2-week washout period, the men received the alternate treatment for 6 weeks. The 50-mg starting dose could be adjusted to 100 or 25 mg based on efficacy and tolerability. Efficacy was assessed by using global efficacy questions, the International Index of Erectile Function (IIEF), and a patient log of erectile activity. Of 143 men with residual erectile function at baseline, 111 (78%) reported improved erections and preferred sildenafil to placebo. For all men (including those who reported no residual erectile function at baseline), 127 of 168 (76%) reported improved erections and preferred sildenafil to placebo. For all men, 132 of 166 (80%) reported that sildenafil improved sexual intercourse compared with 17 of 166 men (10%) reporting improvement with placebo. IIEF questions assessing the ability to achieve and maintain erections and satisfaction with sexual intercourse demonstrated significant improvement with sildenafil. Sildenafil was well tolerated, with a low rate of discontinuation because of treatment-related adverse events (2% vs 1% for placebo). Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction caused by spinal cord injury.
Article
To evaluate the erectile function (EF) domain of the International Index of Erectile Function (IIEF) as a diagnostic tool to discriminate between men with and without erectile dysfunction (ED) and to develop a clinically meaningful gradient of severity for ED. One thousand one hundred fifty-one men (1035 with and 116 without ED) who reported attempting sexual activity were evaluated using data from four clinical trials of sildenafil citrate (Viagra) and two control samples. The statistical program Classification and Regression Trees was used to determine optimal cutoff scores on the EF domain (range 6 to 30) to distinguish between men with and without ED and to determine levels of ED severity on the EF domain using the IIEF item on sexual intercourse satisfaction. For a 0.5 prevalence rate of ED, the optimal cutoff score was 25, with men scoring less than or equal to 25 classified as having ED and those scoring above 25 as not having ED (sensitivity 0.97, specificity 0.88). Sensitivity analyses revealed a robust statistical solution that was well supported with different assumed prevalence rates and several cross-validations. The severity of ED was classified into five categories: no ED (EF score 26 to 30), mild (EF score 22 to 25), mild to moderate (EF score 17 to 21), moderate (EF score 11 to 16), and severe (EF score 6 to 10). Substantial agreement was shown between these predicted and "true" classes (weighted kappa 0.80). The EF domain possesses favorable statistical properties as a diagnostic tool, not only in distinguishing between men with and without ED, but also in classifying levels of ED severity. Clinical validation with self-rated assessments of ED severity is warranted.
Article
The existence of a sexual problem as the subjective evaluation of sexual function was assessed with a simple questionnaire. Those questioned were patients undergoing dialysis treatment (n = 400) or with a functioning renal transplant (RTx; n = 300) and both men and women in the general Dutch population (n = 591). In the Dutch control population, 8.7% of the men and 14.9% of the women reported a sexual problem, showing a significant gender difference but unrelated to age. In patients, the prevalence of a sexual problem was significantly greater (hemodialysis, men, 62.9%; women, 75.0%; peritoneal dialysis, men, 69.8%; women, 66.7%; renal transplantation, men, 48.3%; women, 44.4%). In RTx recipients, sexual problems were significantly less prevalent than in patients undergoing dialysis (P < 0.001). Only in male patients was an association between prevalence of a sexual problem and age found. The results of the simple questionnaire were sufficiently validated when 102 of 104 patients confirmed their responses in a subsequent structured interview. This study shows that the prevalence of sexual problems in patients undergoing renal replacement therapy is high and clinically relevant.
Article
Men with cardiovascular disease (CVD) are more likely to have erectile dysfunction (ED) than the general population, as both conditions share risk factors and some drugs used to treat CVD may induce ED as a side-effect. This study was undertaken to assess the efficacy and safety of sildenafil citrate for the treatment of ED in men with CVD who were receiving treatment with beta-blockers and/or angiotensin-converting enzyme inhibitors and/or calcium-channel blockers, but not nitrates. Treatment with sildenafil was associated with significant increases in the mean end-of-treatment scores for the questions from the International Index of Erectile Function that assess the ability to achieve and maintain erections (p = 0.0001). Furthermore, 71% of patients taking sildenafil reported improved erections compared with 24% taking placebo (p = 0.0001). This study also showed that sildenafil was well tolerated in patients with CVD and ED. Besides flushing, no treatment-related cardiovascular adverse events were noted for sildenafil.
Article
Controlled trials have demonstrated the efficacy of sildenafil for "mixed etiology" erectile dysfunction, but this may not be the case if there is underlying pelvic parasympathetic nerve damage. We aimed to determine the efficacy of sildenafil after rectal excision for rectal cancer and inflammatory bowel disease. Patients with erectile dysfunction after rectal excision were randomly assigned in a double-blind manner to sildenafil or placebo groups. After unblinding, placebo patients crossed over to open sildenafil. Primary end points were improvement in erectile function on a global efficacy question and erectile function questionnaire scores. Secondary end points were frequency and severity of side effects. Thirty-two patients were randomly assigned, and two dropped out before randomization. Fourteen received sildenafil, and 18 received placebo. Eleven (79 percent) of 14 responded to sildenafil, on global efficacy assessment, compared with 3 (17 percent) of 18 taking placebo (mean difference, 61.9 percent; 95 percent confidence interval, 34.4 to 89.4 percent; P = 0.0009). Sildenafil improved both erectile function domain scores (mean difference, 13.3; 95 percent confidence interval, 7.9 to 18.7; P = 0.0001) and total International Index of Erectile Function scores (mean difference, 30.6; 95 percent confidence interval, 18.7 to 42.6; P < 0.0001) from pretreatment baseline scores. Placebo did not produce improvement in either erectile function (mean difference, 1.7; 95 percent confidence interval, -0.8 to 4.2; P = 0.16) or total International Index of Erectile Function scores (mean difference, 5; 95 percent confidence interval, -1.1 to 11.1; P = 0.1). Ten (100 percent) of 10 crossover patients not responding to placebo did respond to sildenafil (difference, 100 percent; P < 0.0001). Sildenafil improved both erectile function domain scores (mean difference, 16.8; 95 percent confidence interval, 9.7 to 24; P = 0.002) and total International Index of Erectile Function scores (mean difference, 29.5; 95 percent confidence interval, 15.8 to 43.2; P = 0.003) from precrossover baseline scores. Seven (50 percent) of 14 patients on sildenafil compared with 4 (22 percent) of 18 on placebo experienced side effects (difference, 28 percent; 95 percent confidence interval, -4.4 to 60.4 percent; P = 0.14), 91 percent of which were mild and well tolerated. Sildenafil completely reverses or satisfactorily improves postproctectomy erectile dysfunction in 79 percent of patients. Side effects are usually mild and well tolerated. The damage incurred by the pelvic nerves after proctectomy, less profound than after prostatectomy, is likely to result in a partial parasympathetic nerve lesion.
Article
The objectives of the study were to characterize male sexual functioning as related to age in community-dwelling older men. In 1989, a random sample of men aged 40-79 y (n=2115) without prior prostate surgery, prostate cancer, or other conditions known to affect voiding function (except benign prostatic hyperplasia) was invited (55% agreed) to participate in the Olmsted County Study of Urinary Symptoms and Health Status Among Men. In 1996, a previously validated male sexual function questionnaire was administered to the cohort. The questionnaire has 11 questions measuring sexual drive (two questions); erectile function (three) and ejaculatory function (two), as well as assessing problems with sex drive, erections, or ejaculation (three); and overall satisfaction with sex life (one). Each question is scored on a scale of 0-4, with higher scores indicating better functioning. Cross-sectional age-specific means (+/-s.d.) for drive, erections, ejaculation, problems, and overall satisfaction declined from 5.2 (+/-1.5), 9.8 (+/-2.5), 7.4 (+/-1.4), 10.7 (+/-2.2), and 2.6 (+/-1.0), respectively, for men in their 40s to 2.4 (+/-1.6), 3.3 (+/-3.4), 3.6 (+/-3.2), 7.7 (+/-3.8), and 2.1 (+/-1.2) for men 70 y and older (all P<0.001). The cross-sectional decline in function with age was not constant, with age-related patterns differing by domain. The percentage of men reporting erections firm enough to have intercourse in the past 30 days declined from 97% (454/468) among those in their 40s to 51% (180/354) among those in their 80s (P&<0.001). In age-adjusted analyses, men reporting regular sexual partners had statistically significantly higher levels of sex drive, erectile function, ejaculatory function, and overall satisfaction than those who did not report regular sexual partners. Sexual drive, erectile functioning, ejaculatory functioning, and overall sexual satisfaction in men show somewhat differing cross-sectional patterns of decline with advancing age. Active sexual functioning is maintained well into the 80s in a substantial minority of community-dwelling men.
Article
The Global Study of Sexual Attitudes and Behaviors (GSSAB) investigated various aspects of sex and relationships among 27,500 men and women aged 40-80 years. Here, we report help-seeking behaviours for sexual problems in this population. A questionnaire was administered using the accepted survey method in each country. Although almost half of all sexually active respondents had experienced at least one sexual problem, less than 19% of them (18.0% of men and 18.8% of women) had attempted to seek medical help for their problem(s). The most frequent action taken by men and women was to talk to their partner (39%). Only 9% of men and women had been asked about their sexual health by a doctor in a routine visit during the past 3 years. Although sexual problems are highly prevalent, few men and women seek medical help for these problems. Overall, men and women show similar help-seeking behaviours.
Article
This study validated a brief measure of fatigue in rheumatoid arthritis (RA), the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. The FACIT Fatigue was tested along with measures previously validated in RA: the Multidimensional Assessment of Fatigue (MAF) and Medical Outcomes Study Short-Form 36 (SF-36) Vitality. The sample included 636 patients with RA enrolled in a 24 week double blind, randomized clinical trial (RCT) of adalimumab versus placebo. The FACIT Fatigue showed good internal consistency (alpha = 0.86 to 0.87), strong association with SF-36 Vitality (r = 0.73 to 0.84) and MAF (r = -0.84 to -0.88), and the ability to differentiate patients according to clinical change using the American College of Rheumatology (ACR) response criteria (ACR 20/50/70). Psychometric performance of the FACIT Fatigue scale was comparable to that of the other 2 fatigue measures. A minimally important difference in FACIT Fatigue change score of 3-4 points was confirmed in a separate sample of 271 patients with RA enrolled in a second double blind RCT of adalimumab versus placebo. The FACIT Fatigue is a brief, valid measure for monitoring this important symptom and its effects on patients with RA.
Article
To determine if men with systemic sclerosis (SSc) are at increased risk of developing erectile dysfunction (ED) compared to men with rheumatoid arthritis (RA), and to investigate the temporal relationship of ED related to rheumatologic disease. Men with SSc identified from the practices of 2 rheumatologists were age matched to men with RA and were sent a standardized, validated questionnaire (SHIM IIEF-5) to assess ED and related factors. The questionnaire also addressed information on the subject's overall health and rheumatic disease status. The response rate was 50% (48% in SSc and 55% in RA), thus 43 with SSc and 23 with RA were included. The mean age of respondents was 53 yrs +/- 1.34 (SEM), (range 34 to 83). No statistical differences were found for marital status, alcohol or drug use, or past/present smoking. Men with scleroderma weighed less than men with RA (p < 0.004) and were more likely to have Raynaud's phenomenon (p < 0.0001), and to have fewer biological children (2.0 +/- 0.2 vs 2.7 +/- 0.2, p < 0.01). The prevalence of erectile dysfunction was 81% (SSc) and 48% (RA), (relative risk for SSc vs RA: 4.77; 95% CI: 1.55, 14.66; p < 0.005). In subjects who had ED, 78% (both SSc and RA) reported it occurring after disease onset. Men with SSc noted their ED began 2.7 +/- 1.2 (mean +/- SEM) years after their disease was diagnosed, and similarly, men with RA noted their ED began 3.3 +/- 2.2 years after disease diagnosis, p = 0.82. Eighty-six percent of patients with SSc had Raynaud's phenomenon (RP) compared to 19% RA, p < 0.0001. Eighty percent of subjects with RP (SSc + RA) had ED versus 50% of men without RP, p < 0.01. In RA subjects with RP (n = 4), 75% had experienced ED, versus 39% of RA without RP, p = 0.18. Possible confounding factors for ED were examined including smoking, hypertension, diabetes, and steroid use; all except self-reported history of nerve damage (p < 0.0005) and diabetes (p < 0.02) were insignificant for predicting the likelihood of increased ED. Patients with SSc were not more likely than RA to have experienced nerve damage (p = 0.25), or diabetes (p = 0.19). ED occurs frequently in SSc, is more common than in RA, and occurs on average 3 years after disease onset. RP appears to be associated with ED in both SSc and RA, but is not necessarily an independent risk factor for ED in SSc alone.
Article
Sexual problems as a result of inflammatory bowel diseases (IBDs) play an important role in patients' worries and concerns. We aimed to evaluate sexual function in men and women with IBD relative to healthy controls. A random sample of the national patients organization was surveyed (n = 1000). Age- and sex-matched friends were used as controls; in addition, controls were selected from a large health insurance cohort. Sexual function was evaluated using the Erectile Index of Erectile Function, and the Brief Index of Sexual Function in Women; impaired function was defined as a score less than -1 on a z-normalized scale. The results are reported as age-adjusted odds ratios with 95% confidence intervals based on conditional logistic regression. The response rate was 41% in cases. Overall, 153 male and 181 female matched pairs were available for analysis. The proportion of patients who were married, had a partner, and were sexually active were similar between cases and controls. Depression was the most important determinant of impaired sexual function. Men with IBD in remission or mild activity had similar Erectile Index of Erectile Function scores as compared with controls. Comorbidity and antihypertensive therapy impacted on single subscores. Women with IBD showed impaired function irrespective of disease activity as compared with healthy controls. Results in women varied by type of control. High socioeconomic status was a protective factor for several subscores in women. Depression is the most important determinant of low sexual function.
Article
Problems with intimacy and sexual performance are among the major concerns of patients with inflammatory bowel disease (IBD). This study was performed to identify disease-related factors associated with low sexual function in men. Consecutive patients were surveyed using a standardized questionnaire. A random sample from the national patients' organization was also included. Low sexual function was defined as a score < -1 on a z-normalized scale of the International Index of Erectile Function. Results are presented as adjusted odds ratios (ORs) with 95% confidence interval (CI) based on multiple logistic regression. 280 questionnaires were available for analysis. Scores were similar between the groups and compared with general population means, with the exception of sexual desire. Of the clinical group, 44% felt severely compromised sexually due to their IBD. Erectile function was particularly sensitive to somatic problems (disease activity, OR 2.5, 95% CI: 1.3-4.9; diabetes, OR 7.0, 95% CI: 1.4-35.0). The influence of depressive mood was restricted to aspects of satisfaction (sexual satisfaction, OR 2.3, 95% CI 1.1-4.9; overall satisfaction OR 3.7, 95% CI: 1.7-8.3). Sexual function was relatively better with longer disease duration and was not affected by the long-term severity of the disease.
Fatigue in cancer patients compared with fatigue in the general united states population
  • D Cella
  • JS Lai
  • CH Chang