Feasibility of Patient-Reported Outcomes Measurement Information System (PROMIS®) computerized adaptive tests in systemic lupus erythematosus outpatients.

Objective The aims of this study were to assess the feasibility of administering Patient-Reported Outcomes Measurement Information System (PROMIS®) computerized adaptive tests (CATs) to outpatients with systemic lupus erythematosus (SLE). Methods Adults with SLE were recruited during routine outpatient visits at an SLE Center of Excellence. Participants completed 14 PROMIS CATs and provided feedback on their experience. Differences in socio-demographic and clinical characteristics between participants and non-participants were evaluated. Results A total of 204 (86%) of 238 socioeconomically and racially diverse SLE patients completed PROMIS CATs. There were no significant differences between participants and non-participants. Time constraints were cited most frequently as reasons for non-participation. More than 75% of individuals submitted positive comments, including approval of the content and format of questions, and the survey's promotion of self-reflection. A minority of participants cited challenges, most often related to question phrasing (8%) and technical difficulties (6%). Conclusions The administration of PROMIS CATs was feasible and positively received in a diverse cohort of SLE outpatients. Neither socio-demographic nor disease characteristics were significant barriers to successful completion of PROMIS CATs. PROMIS CATs have great potential for efficiently measuring important patient-centered outcomes in routine clinical care of a wide range of SLE patients.

Physiology of female sexual function and dysfunction.

Female sexual dysfunction is age-related, progressive, and highly prevalent, affecting 30-50% of American women. While there are emotional and relational elements to female sexual function and response, female sexual dysfunction can occur secondary to medical problems and have an organic basis. This paper addresses anatomy and physiology of normal female sexual function as well as the pathophysiology of female sexual dysfunction. Although the female sexual response is inherently difficult to evaluate in the clinical setting, a variety of instruments have been developed for assessing subjective measures of sexual arousal and function. Objective measurements used in conjunction with the subjective assessment help diagnose potential physiologic/organic abnormalities. Therapeutic options for the treatment of female sexual dysfunction, including hormonal, and pharmacological, are also addressed.

Effect of sildenafil on subjective and physiologic parameters of the female sexual response in women with sexual arousal disorder.

Sexual dysfunction is a complaint of 30-50% of American women. Aside from hormone replacement therapy, there are no current FDA-approved medical treatments for female sexual complaints. The goal of this pilot study was to determine safety and efficacy of sildenafil for use in women with sexual arousal disorder (SAD). Evaluations were completed on 48 women with complaints of SAD. Physiologic measurements, including genital blood flow, vaginal lubrication, intravaginal pressure-volume changes, and genital sensation were recorded pre- and postsexual stimulation at baseline and following 100 mg sildenafil. Subjective sexual function was assessed using a validated sexual function inventory at baseline and following 6 weeks of home use of sildenafil. At termination of the study patients also completed an intervention efficacy index (FIEI). Following sildenafil, poststimulation physiologic measurements improved significantly compared to baseline. Baseline subjective sexual function complaints, including low arousal, low desire, low sexual satisfaction, difficulty achieving orgasm, decreased vaginal lubrication, and dyspareunia also improved significantly following 6 weeks home use of sildenafil. Sildenafil appears to significantly improve both subjective and physiologic parameters of the female sexual response. Double-blind, placebo-controlled studies are currently in progress to further determine efficacy of this medication for treatment of female sexual dysfunction complaints in different populations of women.

Pharmacotherapy or psychotherapy?: effective treatment for FSD related to unresolved childhood sexual abuse.

Childhood sexual abuse (CSA) is the form of sexual victimization most correlated with sexual dysfunction in adulthood (Atkeson, Calhoun, Resick, & Ellis, 1994; Sarwer & Durlak, 1996; Laumann, Paik, & Rosen, 1999). The goal of this study was to address the sexual ramifications of unresolved CSA and consider the effectiveness of vasoactive pharmacotherapy, specifically sildenafil, for the treatment of women with unresolved CSA. The sample included 35 women (mean age, 45 years) who presented to a sexual health clinic and who were not of childbearing potential. Of the sample 7 women (23%) had a history of unresolved CSA. Following a psychosexual history and medical evaluation, all women were treated with 100 mg of sildenafil, to be used over a 6-week period at home. When home doses were complete, participants filled out the FIEI, a valid and reliable 5-item questionnaire asking about sexual response post sildenafil. Parameters of sexual response included vaginal lubrication, amount and quality of sensation, satisfaction with intercourse, and ability to reach orgasm. Trends were calculated comparing women with and without unresolved CSA history. A minority of women with CSA responded positively to sildenafil.

The use of the Female Intervention Efficacy Index (FIEI) as an immediate outcome measure of medical intervention to treat female sexual dysfunction.

Many medications used in the treatment of male erectile dysfunction are still in the experimental phases for use in women. Numerous pharmacological options for women presently under testing include the EROS-CTD clitoral therapy device (Berman et al., 1999b; Billups et al., 2001). In addition to the new medical developments for treating female sexual dysfunction, methods for evaluating sexual responses and efficacy of intervention are evolving as well.

Female neurogenic sexual dysfunction secondary to clitoral neuropathy.

We herein present several cases of female sexual dysfunction related in part to organic neurologic pathophysiology. These cases emphasize the role of the central and peripheral nervous systems in female sexual function.

Female sexual dysfunction.

The ideal approach to female sexual dysfunction would be a collaborative effort between therapists and physicians and would include a complete medical and psychosocial evaluation, and inclusion of the partner spouse in the evaluation and treatment process. Despite significant anatomic and embryologic parallels between men and women, the multifaceted nature of female sexual dysfunction clearly is distinct from that of the man. The clinician cannot approach female patients or their sexual function problems in the same fashion as in male patients. The context in which a woman experiences her sexuality is equally if not more important than the physiologic outcome she experiences, and these issues should be determined before beginning medical therapy or determining treatment efficacies.

Novel approaches to female sexual dysfunction.

Female sexual dysfunction is age-related, progressive and highly prevalent, affecting 30 - 50% of American women. While there are emotional and relational elements to sexual function, it has become increasingly evident that female sexual dysfunction can occur secondary to medical problems and has an organic basis. A plethora of different female sexual dysfunctions exist and in order to obtain a greater understanding of the possible treatments for these problems, it is essential to have a strong knowledge base of female pelvic anatomy, the neurogenic mediators of female sexual response, the impact of hormones on female sexual function and the aetiologies of female sexual dysfunction. Currently, there are potential therapeutic options for the treatment of female sexual dysfunction and these options include both hormonal and pharmacological therapy. However, therapeutic agents may not prove to be enough and the ideal approach to female sexual dysfunction is thus a collaborative effort between therapists and physicians, which should include a complete medical and psychosocial evaluation, as well as inclusion of the partner or spouse in the evaluation and treatment process.

Anatomy and physiology of female sexual function and dysfunction: classification, evaluation and treatment options.

Female sexual dysfunction is a significant age-related, progressive and highly prevalent problem that affects a substantial number of women in the United States. The female sexual response cycle is initiated by neurotransmitter-mediated vascular and nonvascular smooth muscle relaxation resulting in increased pelvic blood flow, vaginal lubrication, and clitoral and labial engorgement. These mechanisms are mediated by a combination of neuromuscular and vasocongestive events. Physiological impairments that interfere with the normal female sexual response bring about complaints associated with diminished sexual arousal, libido, vaginal lubrication, genital sensation, and ability to achieve orgasm. Therapy aimed at restoring hormone levels as well as genital blood flow will be discussed.

Clinical evaluation of female sexual function: effects of age and estrogen status on subjective and physiologic sexual responses.

INTRODUCTION: 30-50% of American women complain of sexual dysfunction. Aging, menopause, and a decline in circulating estrogen levels significantly increase the incidence of sexual complaints. Evaluation of physiologic components of the female sexual response has, in the past, been technically challenging and difficult to standardize. We describe methodology for evaluating physiologic and subjective components of the female sexual response in the clinical setting and determine the effects of age and estrogen status on them. METHODS: 48 women with complaints of sexual dysfunction were evaluated. Physiologic measurements include genital blood peak systolic velocity, vaginal pH, intravaginal pressure-volume changes (compliance), and genital vibratory perception thresholds. Measurements were recorded at baseline and following sexual stimulation. Baseline subjective sexual function was assessed using a Female Sexual Function Inventory. Age was then correlated with both physiologic and subjective sexual responses. RESULTS: Sexual stimulation resulted in increased mean genital blood peak systolic velocity, vaginal pressure-volume, and vaginal pH measurements (P < 0.05) in all women. Older women (ages 55-71 y) and menopausal women not on hormone replacement therapy had significantly lower physiologic response sexual complaints. Baseline subjective sexual function complaints included low arousal (67%), low desire (21%), difficulty achieving orgasm (92%), and pain or discomfort during and/or following intercourse (67%). CONCLUSIONS: Clinical evaluation of physiologic and subjective components of the female sexual response are possible using this comprehensive approach. Physiologic measurements were reproducible and easy to perform, and incidence and types of sexual complaints were assessed with the sexual function questionnaire. A comprehensive approach is necessary when evaluating female sexual dysfunction due to the significant emotional and relational factors that can contribute to the problem. This combined subjective/physiologic assessment may also prove useful when evaluating efficacy of pharmacotherapy in the future.

Female sexual dysfunction: anatomy, physiology, evaluation and treatment options.

It has been estimated that up to 76% of women, depending upon their age, have complaints of sexual dysfunction, including decreased libido, vaginal dryness, pain with intercourse, decreased genital sensation and difficulty or inability to achieve orgasm. Female sexual dysfunction is a significant problem that affects the quality of life of many women. This review addresses the etiologies and incidence of female sexual complaints, as well as new findings in the evaluation and treatment of female sexual dysfunction.

Vasculogenic female sexual dysfunction: vaginal engorgement and clitoral erectile insufficiency syndromes.

The first phase of the female sexual response, associated with neurotransmitter-mediated vascular smooth muscle relaxation, results in increased vaginal lubrication, wall engorgement and luminal diameter as well as increased clitoral length and diameter. Specific physiologic impairments of vasculogenic female sexual dysfunction include vaginal engorgement and clitoral erectile insufficiency syndromes. These syndromes exist when during sexual stimulation abnormal arterial circulation into the vagina or clitoris, usually from atherosclerotic vascular disease, interferes with normal vascular physiologic processes. Clinical symptoms may include delayed vaginal engorgement, diminished vaginal lubrication, pain or discomfort with intercourse, diminished vaginal sensation, diminished vaginal orgasm, diminished clitoral sensation or diminished clitoral orgasm. An animal model of this syndrome, with significant physiologic responses between the control and the atherosclerotic pelvic nerve stimulated hemodynamic responses, is discussed. Non-atherosclerotic, traumatic vascular disease of the ilio-hypogastric-pudendal arterial bed from pelvic fractures or blunt perineal trauma may also result in diminished vaginal/clitoral arterial blood flow following sexual stimulation. Diagnostic studies assessing the hemodynamic integrity of the ilio-hypogastric-pudendal arterial bed to the vagina and clitoris and new oral/topical pharmacologic strategies for enhancing vaginal/clitoral blood flow in patients with vasculogenic female sexual dysfunction are discussed. There is a growing body of evidence that women with sexual dysfunction will commonly have physiologic abnormalities, such as vasculogenic female sexual dysfunction, contributing to their overall sexual health problems.

Effect of estrogen withdrawal on nitric oxide synthase expression and apoptosis in the rat vagina.

OBJECTIVES: The physiology of the female sexual response and its molecular mediators remain poorly understood. Nitric oxide (NO) is synthesized in neurons and is a potent relaxor of vascular and nonvascular smooth muscle. In this study, we hypothesize that vaginal atrophy and declining sexual function during menopause may be NO dependent. Using the rat as an experimental model, we examined the expression and topologic localization of vaginal NO synthase (NOS) and the concomitant induction of apoptosis under normal and estrogen-depleted conditions. METHODS: Thirty rats were categorized into six groups on the basis of phase of the estrous cycle or estrogen status after oophorectomy. The expression and cellular localization of NOS was examined in frozen sections using specific antibodies against neuronal (N-NOS) and endothelial NOS (E-NOS). Apoptotic cells were identified in situ using the terminal transferase technique (TUNEL). Trichome staining was performed in all specimens to determine smooth muscle/collagen ratios. RESULTS: N-NOS immunoreactivity was localized to nerve fibers supplying vaginal smooth muscle, perivascular nerve plexuses, and lamina propria. E-NOS was localized to vascular endothelium and perivascular smooth muscle fibers. Both E-NOS and N-NOS expression in intact cycling animals was highest during proestrous and lowest during metestrous. After oophorectomy, levels of both N-NOS and E-NOS declined substantially compared with those of intact animals, and there was a parallel induction of apoptosis. Estrogen withdrawal also resulted in increased vaginal atrophy, intramural collagen accumulation, and perivascular wall thickening, as identified by trichome staining. Estrogen replacement resulted in a significant increase in E-NOS and N-NOS expression, as well as diminished apoptosis and vaginal atrophy. CONCLUSIONS: This cellular distribution of NOS in the rat vagina suggests that NO may modulate both vaginal blood supply and vaginal smooth musculature. Estrogen appears to play a critical role in concomitantly regulating vaginal NOS expression and apoptosis in nerves, smooth muscle, vascular endothelium, and epithelium of the rat vagina. These findings may have significant clinical implications for the pathophysiology of postmenopausal female sexual dysfunction.

Sigmoid colon carcinoma metastatic to prostate.

Although primary prostatic carcinoma is very common, prostatic metastasis is unusual. We describe a unique example of prostatic metastasis from noncontiguous colon cancer, after presumed curative resection of the primary tumor. Potential mechanisms of metastasis are examined in the context of clinical and histopathologic evidence. A possible role is proposed for early transrectal ultrasound examination in diagnosis of patients with unexplained urologic symptoms after resection of colorectal cancer.

Pharmacy-based antimicrobial-monitoring service.

A pharmacy-based antimicrobial-monitoring service at a university teaching hospital is described. The service was developed and implemented by the pharmacy department in 1987. Antimicrobial drugs that can be misused, that are expensive, or for which bacterial resistance is a concern were targeted. When a pharmacist receives an order for a targeted antimicrobial, an antimicrobial-monitoring card is completed. Monitored drugs meeting approved criteria are dispensed as ordered. When the antimicrobial does not meet the criteria, the pharmacist contacts the physician and suggests an alternative. If the alternative is not accepted, the infectious diseases service is contacted and then informs the pharmacy department about the status of the drug. The agent is dispensed if no response is received within two hours. Qualified staff pharmacists rotate through the position of antimicrobial pharmacist, whose responsibilities include reviewing antimicrobial use throughout the hospital, checking relevant laboratory test results, and recommending adjustments to regimens. From July 1989 to June 1990, 3546 orders for monitored antimicrobials were reviewed; of these, 86% met the criteria, 9% did not meet the criteria but were approved, 2% were for drugs that were replaced by alternative therapies, 1% were for agents that were dispensed because the pharmacist was not contacted, and 2% represented medical staff overrides or drugs dispensed inappropriately. Pharmacist and physician compliance with the monitoring policy has been high. A positive, constructive, and educational relationship exists between pharmacists and physicians vis-à-vis the service. A pharmacy-based antimicrobial-monitoring service has been accepted by pharmacists and physicians and appears to be having a positive impact on prescribing habits.

Vancomycin pharmacokinetics in burn patients and intravenous drug abusers.

The pharmacokinetics of vancomycin were evaluated in 34 patients (10 burn patients, 14 intravenous drug abusers [IVDA], and 10 controls). Multiple serum samples were drawn following a 1-h vancomycin infusion at steady state over an 8- to 12-h dosing interval. Pharmacokinetic parameters were derived by noncompartmental analysis. There were no significant differences among the groups with respect to age, weight, serum creatinine, volume of distribution, or protein binding. Burn patients had a significantly higher creatinine clearance than did IVDA or controls. Vancomycin clearances averaged 142.8, 98.0, and 67.7 ml/min in burn patients, IVDA, and controls, respectively. The renal clearance of vancomycin was also higher in burn patients than in the other groups. IVDA tended to have a higher vancomycin clearance (31% higher) than did controls, but the difference was not statistically significant. Vancomycin clearance was much higher in burn patients requiring dosage individualization and close monitoring. A considerable amount of vancomycin was eliminated through renal tubular secretion, making dosage predictions based on creatinine clearance more difficult. Further work with IVDA will be needed to determine if they represent a group requiring aggressive vancomycin dosages.

A field test of the TIME patient simulation model.

The Technological Innovations in Medical Education (TIME) Project has created an interactive videodisc patient-simulation model that provides faculty with a new method for patient-centered teaching in the medical school classroom. The TIME model is designed to be controlled by a professor in the classroom setting, and incorporates voice recognition technology and video dramatization to create a believable patient encounter. Under the auspices of the Lister Hill National Center for Biomedical Communications, National Library of Medicine, where the Project originated in 1983, three medical schools participated in a field test of this "high-tech" model. Six faculty members made ten classroom presentations of two TIME simulations to 306 second-year medical students. The principal finding was that, in a group setting, a large majority of the students at all three schools became individually committed to the care and management of the simulated patient. They acted as if the patient's problems were real and left the session feeling as though they had interacted with an actual person. Therefore, in terms of simulating a real patient, the TIME patient-simulation model was validated, providing the basis for the development of new patient-centered methods to teach and test medical students in the classroom setting. The Project has been at the Georgetown University School of Medicine, where the model is being introduced into the existing curriculum, since 1988. It is currently being used as a part of the final examination for second-year students and in discussion-group settings for fourth-year students in the internal medicine clerkship. A field test is also under way using the TIME model to assess the clinical performance of third-year students.