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A content-based interpretation of a health status measure uses an item, along with its response choices, internal to the measure to understand the meaning of its scores. We applied a cumulative logit model to content-based interpretation of a validated self-esteem subscale (four items) for men with erectile dysfunction (score range: 0 to 100, where higher scores indicate a more favorable response). Data were obtained from a nontreatment cross-sectional study with 98 men with erectile dysfunction and 94 controls. The ordinal response item “I had good self-esteem” over the past 4 weeks (1 = Almost never/never, 2 = A few times, 3 = Sometimes, 4 = Most times, 5 = Almost always/Always) was regressed on the self-esteem subscale score to which the item belongs. The proportional odds assumption was not refuted (P = .085) and supported graphically. At relatively high self-esteem scores (65+), the estimated probability of reporting good self-esteem (ie, good self-esteem most of the time or almost always/always) was 68% or more. For a 10-point increase (eg, 65 to 75), the odds of reporting good self-esteem increased slightly more than threefold (3.2). A content-based interpretation using a cumulative logit model can increase sensitivity, enhance meaning, and provide succinct and simple interpretation to scores of a health status measure.

To estimate the minimal clinically meaningful improvement (MCMI) on the Self-Esteem And Relationship (SEAR) questionnaire. Using combined data from the 2 pivotal SEAR trials of men treated with sildenafil for erectile dysfunction (ED), MCMIs were estimated as the lower limit of the 2-sided 95% confidence intervals of SEAR mean change scores (from baseline to end of study) for 2 anchor groups: (1) men who improved 1 ED severity category on the Erectile Function domain of the International Index of Erectile Function, and (2) men who improved 5–60% (inclusive) on these erectile function scores. Both anchors gave comparable results. A 10-point MCMI was proposed because the estimates of 95% lower bounds centered on around 10 points for most SEAR components (Sexual Relationship, Confidence, Self-Esteem, Overall Score). An exception was the Overall Relationship whose 95% lower bounds were too low to recommend them as an MCMI. Two anchor-based approaches suggest that a change of about 10 points represents an MCMI on most components of the SEAR questionnaire.

Nonarteritic anterior ischemic optic neuropathy (NAION) has been reported rarely in men after taking sildenafil or other phosphodiesterase 5 inhibitors for erectile dysfunction (ED). The incidence of NAION in men receiving sildenafil treatment for ED was estimated using pooled safety data from global clinical trials and European observational studies. Based on clinical trial data in more than 13,000 men and on more than 35,000 patient-years of observation in epidemiologic studies, we estimated an incidence of 2.8 cases of NAION per 100,000 patient-years of sildenafil exposure. This is similar to estimates reported in general US population samples (2.52 and 11.8 cases per 100,000 men aged ≥50 years). The data cited herein do not suggest an increased incidence of NAION in men who took sildenafil for ED.

Objectives Research is lacking on the correlation between treatment satisfaction and confidence, self-esteem, and relationships for men receiving treatment for erectile dysfunction (ED). We sought to correlate scores between the validated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index and the validated Self-Esteem And Relationship (SEAR) questionnaire following treatment with sildenafil citrate (VIAGRA). Methods This study was based on an open-label, flexible-dose trial of 93 sildenafil-naive patients with ED. Pearson correlation coefficients between EDITS index and SEAR questionnaire scores, each of which can range from 0 to 100 (most favorable), were calculated at end of treatment (EOT). An analysis of covariance model was applied to associate changes from baseline to EOT in SEAR scores with EDITS score at EOT, controlling for baseline SEAR score. Results Significant and sizable Pearson's correlations between SEAR and EDITS scores ( P ≤ 0.0001; range: 0.49–0.84) were observed. A 10-point higher EDITS scores at EOT corresponded to a significant and tangible average improvement in SEAR scores from baseline to EOT ( P ≤ 0.0001; range: 6.6–8.7). Average SEAR scores at EOT were markedly different between patients with greater treatment satisfaction at EOT (EDITS score ≥ median EDITS score of 88.6; n = 50) and those with lesser treatment satisfaction at EOT (EDITS score Conclusions The data add to the validity of the SEAR questionnaire, suggest a tangible relationship between treatment satisfaction and psychosocial benefit among men with ED treated with sildenafil, and highlight the importance of assessing the psychosocial impact of ED in men undergoing treatment.

Erectile dysfunction (ED) is commonly associated with depressed mood and diminished quality of life (QoL), but few studies have investigated the causal associations involved. Therefore, we evaluated the correlation between several measures of mood, QoL, and sexual function in a retrospective analysis of a sample of depressed men (n=152), with ED enrolled in a clinical trial of sildenafil citrate (VIAGRA). Strong correlations were observed at baseline among measures of erectile function (EF), mood, and overall QoL. Significant treatment effects were observed on all three domains, with significant interactions between changes in mood and QoL. Based on multiple regression and path analysis, a model was developed in which EF changes were associated with improved mood and quality of sexual life, which resulted in improved partner satisfaction, family life, and overall life satisfaction. These data suggest that QoL changes associated with ED therapy may be mediated by changes in sexual function, mood, and family relationships.

Background: The Sexual Health Inventory for Men (SHIM) has been shown to possess favorable statistical properties in diagnosing the presence and severity of erectile dysfunction (ED). However, the SHIM has not been compared with patient self-assessment of ED. Objective: This article describes an independent-validation study examining the correlation and agreement between the SHIM and patient self-assessment of ED with respect to the severity of ED at baseline and after treatment, and in terms of change from baseline. Methods: The study population consisted of 247 male outpatients with ED participating in a multicenter, double-blind, placebo-controlled, flexible-dose (25–100 mg/d) Phase IIIb clinical trial in which they were randomized equally to sildenafil citrate or placebo. Patients assessed their degree of ED as severe, moderate, minimal/mild, or no problem at baseline and after 12 weeks of treatment. They also responded to the 5 questions on the SHIM, after which their degree of ED was calculated based on the SHIM total score. Results: In general, the SHIM and the single-item self-assessment question produced similar descriptive profiles of the severity of ED. Kendall τ-b correlations were 0.66 (95% CI, 0.58–0.74) at baseline, 0.86 (95% CI, 0.82–0.90) after treatment, and 0.72 (95% CI, 0.67–0.77) for change from baseline. Agreement between instruments, measured by the weighted κ statistic, mirrored the correlations at baseline and after treatment. As expected, both measures correlated moderately with improvement in erections and treatment satisfaction of both patient and partner. Conclusion: The moderate-to-high correlation and agreement between the SHIM and patient self-assessment of ED validate the SHIM for use in the diagnostic classification of ED severity.

To assess the efficacy and safety of Viagra (sildenafil citrate) in male outpatients with erectile dysfunction and patient and partner satisfaction with treatment using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS).A total of 247 patients with erectile dysfunction of broad-spectrum etiology were treated in a randomized, double-blind, parallel-group, multicenter study conducted at outpatient clinics. Patients receiving oral sildenafil (25, 50, and 100 mg) were compared with patients receiving placebo during a 12-week period. The principal efficacy measures were responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) on the International Index of Erectile Function and three global efficacy questions. Patient and partner satisfaction with treatment were assessed, for the first time, using the EDITS questionnaire.Efficacy scores for the International Index of Erectile Function questions and the global efficacy questions were significantly higher for patients receiving sildenafil than for those receiving placebo (P0.001). Both patients and partners receiving sildenafil also had significantly higher EDITS scores than those receiving placebo (P0.001). Adverse events were chiefly mild or moderate. Two patients receiving sildenafil and none receiving placebo discontinued treatment because of adverse events.Sildenafil was an effective, well-tolerated treatment for erectile dysfunction in an outpatient setting. Partner evaluations corroborated patient assessments. The results from the EDITS questionnaire indicated that after 12 weeks of receiving sildenafil both patients and partners reported higher levels of treatment satisfaction relative to placebo.

It is advantageous to combine international regime and global policy approaches to employment. Sources of the relative ineffectiveness of regional and global employment policy are found primarily in conflicting missions of intergovernmental organizations, ideological conflicts and the inadequate resources and powers of such organizations. Employment suffers from the existence of higher economic and human rights priorities in virtually all international policy arenas. Although evolutionary progress can be expected in the present regime structure, fundamental change will require truly global policies in a more highly developed regime that integrates economic and human rights principles and goals. Given the severe social costs of unemployment and underemployment throughout much of the world, effective international responses might well have been expected long before the 1980s. Thus employment would seem a likely addition to such "global policy" problems as nuclear proliferation, economic development, human rights, ocean resources, pollution, and telecommunications which are currently being addressed by international institutions (Soroos, 1986). Yet the global response has, thus far, been surprisingly limited. The problem of wisespread unemployment meets virtually all the criteria that Soroos, in his introductory essay, suggests may trigger international treatment of a major problem and at least some of his criteria for considerations of the problem as "global" (Soroos, 1986: 64-72). Unemployment may involve relationships between two or more countries and the problem may spill over national boundaries. It is also manifest in the international community as a whole, at least of each principal state or region, and is a domestic problem that is "common to many, if not all, countries" (Soroos, 1986: 20). It is doubtful, however, whether unemployment and underemployment in foreign countries has been a "special interest" of the international community, as has been the case with such serious human rights violations as apartheid in South Africa. The strongest cases for such recognition can be made for the periods from about 1944-48, and for the second half of the 1970s. The "Declaration of Philadelphia," adopted by the 1944 International Labour Conference, was a strong call for "effective international and national action" on behalf of full employment in the context of the memory of the Great Depression and the strong sense of international solidarity resulting from military victory (International Labour Organization, 1944: 623). This era culminated in the inclusion of the right to work (employment) in the 1948

To evaluate the body mass index (BMI) and lower urinary tract symptom (LUTS) severity on treatment response to sildenafil in men with erectile dysfunction (ED) and moderate to severe LUTS associated with benign prostatic hyperplasia.A post hoc analysis of data from a 12-week, double-blind, placebo-controlled study of sildenafil (50 mg once daily titrated to 100 mg once daily) was conducted. The BMI categories were obese (or = 30 kg/m(2)), overweight (or = 25 to30 kg/m(2)), and normal weight (25 kg/m(2)). ED was defined as a score ofor = 25 on the erectile function domain of the International Index of Erectile Function, and LUTS was defined by an International Prostate Symptom Score ofor = 12. The maximal urinary flow rate was determined by uroflowmetry.Patients receiving sildenafil (n = 189) had a significant improvement in the erectile function domain scores of the International Index of Erectile Function (P.0001 vs placebo, n = 180), which did not vary across BMI groups. A greater improvement in LUTS score was observed with sildenafil compared with placebo for men with severe LUTS (-8.6 vs -2.4, P.0001) than in men with moderate LUTS (-3.6 vs -1.7, P = .06). Also, the improvement in LUTS scores was significant (Por = .02) for men taking sildenafil independent of BMI (obese, -8.9 vs -5.4; overweight, -7.3 vs -3.2; normal weight, -7.1 vs -0.84). No difference was found among the treatment groups in the change from baseline maximal urinary flow rate across all LUTS and BMI categories (range 4.5 to -4.2 mL/s).The results of our study have shown that daily dosing with sildenafil improved ED and LUTS independent of baseline LUTS severity or BMI.

OBJECTIVE: Although contraindicated, there are situations when a patient who has recently taken a phosphodiesterase 5 inhibitor (e.g., sildenafil) might need intravenous nitroglycerin (NTG) treatment. This study determined if, and at what dose, intravenous NTG could be administered safely to men with coronary artery disease who had recently ingested sildenafil. DESIGN: Double-blind, placebo-controlled, randomized, crossover trial. SETTING: Four clinical practice sites in Canada, Scotland, and the United States. PATIENTS: A total of 34 men (>or=35 yrs) with a history of angina pectoris and coronary artery disease (>50% stenosis of at least one coronary artery), most of whom were taking antihypertensives. INTERVENTIONS: Sildenafil (100 mg) or placebo (single dose; crossover after 3-7 days) followed 45 mins later by escalating doses of intravenous NTG (160 microg/min maximum). MEASUREMENTS AND MAIN RESULTS: After sildenafil, there were slightly greater maximum (supine) blood pressure decreases and heart rate increases (e.g., 4 to 6 mm Hg [systolic] and

We investigated the effect of early sildenafil dose optimization and personalized instructions on sexual intercourse success in 1109 men beginning sildenafil therapy for erectile dysfunction. In phase 1 (4 weeks), patients followed the instructions contained in the sildenafil (50 mg) sample pack and had 1.4 sexual intercourse attempts per week with 82% success. Patients (17%) had a second intercourse attempt (80% successful): 58% occurred within 4 h, 20% within 5-8 h, and 22% within 9-24 h of the first attempt. In phase 2 (4 weeks), sildenafil was adjusted as needed (53% to 100 mg, and 2% to 25 mg), and investigators provided personalized instructions to facilitate patient success. Sexual intercourse attempts increased to 1.7 per week, with 91% success, and 18% were followed by a second attempt, of which 91% were successful. Most patients requested the 100-mg dose, which helped improve sexual intercourse frequency, flexibility and success.

Introduction. Erectile dysfunction (ED) can significantly impact a man's relationships and well-being. Aim. We assessed changes in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction in men with ED using the validated Self-Esteem And Relationship questionnaire (SEAR). Methods. This was a 12-week, double-blind, placebo-controlled, flexible-dose (25, 50, 100 mg, as needed) interna- tional study of sildenafil in men ≥18 years of age in Mexico, Brazil, Australia, and Japan. Main Outcome Measures. The primary study outcome was change in self-esteem from baseline to the end of treatment. Secondary study measures were changes in other SEAR components, International Index of Erectile Function (IIEF) domains, percentage of intercourse attempts that were successful, and the response to a global efficacy question at the end of treatment. Results. Patients were well balanced for age and duration of ED (placebo = 149 and sildenafil = 151). Compared with placebo, sildenafil significantly improved self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction (P < 0.0001). The psychosocial measures of well-being assessed with the SEAR were positively correlated (range 0.60-0.86, P < 0.0001) with erectile function, the frequency of achieving erections that allowed satisfactory sexual intercourse, the percentage of successful sexual intercourse attempts, and global treatment efficacy. Conclusions. Significant improvements in self-esteem, confidence, sexual relationship satisfaction, and overall rela- tionship satisfaction after treatment of ED with sildenafil were consistent among countries. These data suggest a substantial cross-cultural improvement in well-being after successful treatment of ED with sildenafil. Althof S, O'Leary M, Cappelleri J, Hvidsten K, Stecher V, Glina S, King R, and Siegel R. Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: Results from an international, multi-center, double-blind, placebo-controlled trial. J Sex Med 2006;3:521-529.

Introduction Erectile dysfunction (ED) can negatively impact psychosocial measures of a patient's sexual life. Aim To evaluate self‐esteem, confidence, and relationships in men with ED, before and after treatment with sildenafil citrate (Viagra®), with reference to controls without ED. Methods Sildenafil‐naive patients with ED were enrolled in a 10‐week, open‐label, flexible‐dose (25 mg, 50 mg, or 100 mg) trial of sildenafil. In a separate study, men without ED who did not take sildenafil also completed the Self‐Esteem And Relationship (SEAR) questionnaire. In addition to traditional statistical testing, equivalency testing was applied to compare the ED group, before and after treatment, with the control group and to examine whether the ED group improved to normative ranges on the SEAR questionnaire after treatment (within half a standard deviation of the normative or control group mean). Main Outcome Measures Baseline and end‐of‐treatment responses on psychosocial aspects of ED were measured with the validated SEAR. Results Mean SEAR scores between subjects with ED (N = 93, mean age 55.0 years) at baseline and control subjects without ED (N = 94, mean age 52.5 years) were statistically different from zero and not statistically equivalent. Conversely, mean SEAR scores between ED subjects after treatment and control subjects were statistically equivalent and not statistically different from zero. Conclusions The results indicate that sildenafil is associated with normalization of relationships, confidence, and self‐esteem in men with ED. Cappelleri JC, Bell SS, Althof SE, Siegel RL, and Stecher VJ. Comparison between sildenafil‐treated subjects with erectile dysfunction and control subjects on the Self‐Esteem And Relationship questionnaire. J Sex Med 2006;3:274–282.

Development and validation of a patient-reported measure of psychosocial variables in men with erectile dysfunction (ED) is described. Literature review, focus groups, and medical specialists identified 86 potential items. Redundant, ambiguous, or low item-to-total correlation items were removed. Data from 98 men reporting diagnosed ED and 94 controls assisted in final item selection and psychometric evaluation. Treatment responsiveness was evaluated in 93 men with ED in a 10-week open-label trial of sildenafil citrate (Viagra®). The 14 chosen items resolved into two domains: Sexual Relationship (eight items) and Confidence (six items), the latter comprising Self-Esteem (four items) and Overall Relationship (two items) subscales. The resulting Self-Esteem And Relationship (SEAR) questionnaire demonstrated validity and reliability. The intervention study demonstrated responsiveness to beneficial treatment with significant improvement in scores (P=0.0001). The SEAR questionnaire possesses strong psychometric properties that support its validity and reliability for measuring sexual relationship, confidence, and particularly self-esteem.

The risk factors associated with erectile dysfunction (ED) overlap extensively with risk factors associated with cardiovascular disease and include age, diabetes, hypertension, smoking, and hypercholesterolemia (1,2). This suggests a common pathophysiological basis that is likely to be the vascular endothelium and the nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) signaling pathway. ED is more prevalent and severe in patients with hypertension than in the general population (3) and can be a predictor of cardiovascular disease (1,4).

This study was an evaluation of whether sildenafil citrate is effective for the treatment of erectile dysfunction in men taking concomitant serotonin-reuptake-inhibiting antidepressants.A retrospective subanalysis of combined data from 10 phase II/III double-blind, placebo-controlled, fixed- and flexible-dose trials (12-26 weeks) identified a group of men with erectile dysfunction receiving 5 to 200 mg/day of sildenafil (N=65) or placebo (N=33) and concomitant serotonin-reuptake-inhibiting antidepressants. Efficacy was measured by responses to questions from the International Index of Erectile Function on ability to achieve erection, ability to maintain erection, ejaculation frequency, orgasm frequency, and sexual desire.Patients with erectile dysfunction receiving sildenafil and concomitant serotonergic antidepressants had significantly greater improvements in ability to achieve and maintain an erection, frequency of ejaculation, and orgasm frequency than did patients receiving placebo, without increased sexual desire.Sildenafil significantly improved erectile dysfunction in patients taking concomitant serotonergic antidepressants.

To the Editor: Geelen and coworkers1 reported 6% to 15% increases in action potential duration in guinea pig hearts exposed to supratherapeutic concentrations (30 μmol/L) of sildenafil. They observed that high concentrations (IC50, 100 μmol/L) inhibited the rapid component of the delayed rectifier K+ current in Chinese hamster ovary and HEK293 cells transfected with human ether-a-go-go-related gene (HERG). Their interpretation that this could lead to adverse cardiovascular effects in humans is unfounded. Sildenafil inhibits the human PDE5 enzyme in vitro by 50% at a concentration of 3.5 nmol/L,2 which is nearly 30 000 times below the level required to block HERG by 50%. Sildenafil is 96% protein-bound, with a peak free plasma concentration after the maximum recommended therapeutic dose (100 mg) of 40 nmol/L,3 which is 2500 times lower than the concentration required to inhibit HERG by 50%. Because sildenafil is metabolized primarily via CYP3A4, the authors imply that during coadministration with CYP3A4 inhibitors (eg, erythromycin), sildenafil plasma levels could rise by 20-fold. However, sildenafil has a high oral bioavailability (≈40%), which limits the extent that coadministered drugs can raise …

Objectives. To assess the validity of severity classes on the erectile function (EF) domain of the International Index of Erectile Function by determining their relationship with the self-assessment of EF, before and after treatment, in an independent cohort of patients. Methods. Two hundred forty-seven men with clinically diagnosed erectile dysfunction (ED) and in a stable heterosexual relationship were enrolled in a randomized, double-blind, multicenter, placebo-controlled, parallel-group, 12-week, flexible-dose study. Patients assessed their degree of ED as severe, moderate, minimal/mild, or no problem at baseline and after treatment. They also responded to the six questions of the EF domain, with the total score indicating the following degrees of ED: severe, EF score 1 to 10; moderate, EF score 11 to 16; mild to moderate, EF score 17 to 21; mild, EF score 22 to 25; and no ED, EF score 26 to 30. Descriptive profiles of the two diagnostic instruments were compared. The correlations between the instruments were evaluated with Kendall’s tau-b at baseline, after treatment at 12 weeks, and at change from baseline. Results. The two measures gave generally similar descriptive profiles of ED severity. The correlations were 0.65 (95% confidence interval 0.57 to 0.73) at baseline, 0.86 (95% confidence interval 0.83 to 0.89) after 12 weeks of treatment, and 0.73 (95% confidence interval 0.67 to 0.79) at change from baseline. Conclusions. The moderate-to-high correlation between the patients’ self-assessment of EF and the EF domain of the International Index of Erectile Function provides a validation of this domain for the reliable diagnostic classification of ED severity.

As men age, the incidence of both benign prostatic hyperplasia (BPH) and hypertension increases. Concomitant occurrence of these conditions also increases with age, and the 2 are frequently encountered together in primary care practice. In addition, many patients with hypertension require1 antihypertensive agent to adequately control blood pressure. In a multicenter, community-based, 8-week, uncontrolled, open-label study, we evaluated doxazosin, a selective alpha1-adrenergic-receptor antagonist, in 491 patients with concomitant symptomatic BPH (American Urological Association [AUA] symptom scoreor =12) and hypertension, some previously untreated and some with inadequately controlled hypertension (systolic blood pressure 120-179 mm Hg or diastolic blood pressure [DBP] 80-109 mm Hg) despite taking 1 or 2 antihypertensive agents. Patients were allocated to 1 of 4 groups at baseline according to their diastolic blood pressure (control was considered DBP90 mm Hg) and whether they had received antihypertensive medication before the study. Thus the 4 groups were treated/well-controlled, treated/poorly controlled, untreated/hypertensive, and untreated/normotensive. In all patient groups, doxazosin therapy significantly improved AUA total symptom and bothersomeness scores and BPH-specific indices of health status and interference with activities (P0.001). Significant improvements in BPH symptoms were observed with doxazosin, regardless of whether initial symptoms were moderate or severe (P0.001). Clinically important blood pressure lowering occurred only in the patient groups in which blood pressure had been elevated at baseline. Patients whose blood pressure was poorly controlled at baseline, either without or with treatment (predominantly with angiotensin-converting enzyme inhibitors or calcium channel blockers), achieved adequate blood pressure control (reduction to140/90 mm Hg) with the addition of doxazosin. Similar improvements in blood pressure and BPH symptoms were seen in both older (or =65 years) and younger (45 to 64 years) patients, and doxazosin was well tolerated by both groups. The most frequent treatment-related adverse event was dizziness (13.0% of patients); however, patients classified the dizziness as mild in approximately 75% of reports, and severe dizziness was reported by only 2 patients (0.4%). Doxazosin is an effective antihypertensive agent when used in combination with agents from other antihypertensive classes in patients with poorly controlled hypertension and BPH, and is also successful as monotherapy for controlling both BPH and hypertension in patients with mild to moderate hypertension.

To present the results of a pooled analysis of three double-blind, placebo-controlled studies of doxazosin in benign prostatic hyperplasia (BPH). Heterogeneous symptom and bother score data collected using different symptom indices were transformed to enable a comparison of the data and to conduct a pooled, in-depth analysis.Urinary flow rates, and symptom and bother score data were shown by analysis of covariance methods to give consistent estimates of the efficacy of doxazosin across different studies, thus confirming the validity of pooling the results. Prior to analysis, symptom and bother score data were transformed so that all scales started from zero (least symptoms or bother) and were expressed as a percentage of the maximum score.Doxazosin produced a significantly greater improvement than placebo in peak urinary flow rate (P = 0.0017), symptom severity (P0.0001), and bother caused by symptoms (P0.0001). Stratification showed that a greater improvement was obtained during doxazosin treatment by those with more severe symptoms at baseline (P = 0.0001). Stratification by age showed that age did not affect the capacity to benefit from treatment. Analysis of the pooled peak flow-rate data showed that doxazosin produced a consistently greater increase in flow compared with placebo. Doxazosin was well tolerated, with 10% of patients having withdrawn due to adverse events versus 4% with placebo (P0.05).Doxazosin is well tolerated and effective in the treatment of BPH. Pooling of data has enabled more extensive and robust conclusions to be drawn than was possible for each one of the individual three studies.

For more than a decade the international community has made efforts to promote approaches to the prevention and control of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (HIV/AIDS) pandemic that are both effective and highly respectful of individual rights especially the rights of persons infected or considered to be at high risk of infection. This effort has proceeded globally and regionally as well as at the national and local levels. Although the outcome in relation to respect for rights has been far better than many public health and human rights advocates had feared few analysts or officials believe that governments have been doing enough to modify their practices in such areas as entry restrictions at national borders mandatory testing of various groups implementation of a right to medical treatment and protection of persons with AIDS against discrimination. The reasons for the apparent failures to protect rights are myriad and have roots at the local national regional and global levels. This article seeks to extend our understanding of such factors and suggests cultural economic biomedical social and political reasons for the failures. This article also considers why most of the leading international public health and human rights organizations have been less than fully effective in their efforts to promote rights together with effective HIV/AIDS prevention and control. The article then seeks to combine the analyses of these factors with a close look at the policies advanced in a wide array of documents and statements that intergovernmental organizations (IGOs) and international nongovernmental organizations (NGOs) have issued since 1983. This effort is shaped in part by a series of interviews conducted by the author between 1992 and 1994 as well as by many of the seminal interpretative works of scholars in diverse disciplines. (excerpt)

Members of the public expect to receive efficient and appropriate medical care if they become acutely ill or injured while in or around a hospital. Our institution became aware of the need for an organized system to respond to such emergencies involving patients, visitors, local community residents, and hospital employees, both inside the hospital and on the grounds surrounding the building. A search of the literature did not provide information regarding such a response; a survey of surrounding hospitals revealed no such plan in effect in other institutions. We therefore designed a plan to be superimposed onto our existing system for responding to in-house cardiac and respiratory arrests ("codes"). The results after one and one-half years appear encouraging. We recommend the establishment of such an emergency response system in all health care institutions.

Response to Tomsak, R. PDE5 inhibitors and permanent visual loss ( Int J Impot Res 2005; 17 : 547–549)

A young girl was brought to the emergency department because her tongue became entrapped while she was drinking from an aluminum soft-drink can. A dental drill was used to remove the can. The tongue was observed for 48 hours, during which an ischemic area recovered spontaneously.

Important new survey findings show the American public's restrictive approach to the First Amendment rights of people who express deviant views to be moderating over the last two decades. This mellowing is backed up by parallel findings of major liberalizing of the consensus in other areas, notably equality and sexual freedom. Liberalization has been limited in such areas as criminal justice and separation of church and state. Post-McCarthy and post-Watergate developments are credited, along with educational progress, with much of the advance. Reduced value consensus and a growing sense of self-interest in civil liberties seem to have contributed to the trends in support of civil liberties.

This study was performed to evaluate the effect of citric acid cavity cleanser on the human dental pulp when applied to freshly cut dentin. Treatment of cavities with citric acid cavity cleanser, also used as an etchant, before restoration with zinc oxide-eugenol cement, was toxic to the human dental pulp in comparison to sham-treated controls. The cleanser caused a significantly ( P s .01) greater intensity and incidence ( P s .01) of inflammation. The added insult from cleanser pretreatment caused destruction of the odontoblast processes within the cut dentinal tubules, and an increase in diameter of the tubules. These effects on dentin and odontoblasts probably contributed to the observed increase in adverse pulp responses.

The concept of human rights has expanded steadily since the close of the Second World War, and various, mostly Western, academic experts and national government representatives have opposed efforts to give priority to rights other than political and civil ones (Donnelly, 1981). Others defend, at least in part, efforts to incorporate and emphasize such claimed solidarity rights as self-determination, state control over natural resources, economic and social development, peace, and environmental protection into the body of fundamental human rights (Alston, 1981, p. 104; Falk, 1981, pp. 185–94). Intermediate between political-civil and solidarity rights stand largely welfare rights incorporated into the earliest United Nations human rights instruments, many of these reframed as ‘basic human needs’ to better relate them to the Third World context (Trubeck, 1984).

This is an exploration of the sources of social and economic rights proclaimed in major twentieth century international human rights instruments. Efforts are made to explore particular sources of such rights and state duties in order to reconsider certain widely supported propositions. One of the propositions examined in this paper is the idea that something termed "social rights" evolved from the late nineteenth century as part of an expanding conception of national citizenry. The late British social historian, T. H. Marshall, has had incomparable influence on the literature concerning human rights through his thesis of a three-stage development of the rights of citizens, this ending with the emergence of social rights.' Marshall's work draws rather sharp lines between such rights, identified with the availability of social protection programs to every citizen as a matter of legal right and earlier approaches to social protection that were based on means tests, programs that "had little direct effect on social inequality" and that were "not woven into the fabric of citizenship."2 A second issue that is addressed is the relationship between centuries old paternalistic ideas about the socioeconomic welfare of the poor which led to programs designed to promote social protection at the national level and current interpretations of internationally prescribed social and economic rights. Did the organized international community, during the quarter century following World War II, seek to go beyond paternalistic conceptions that focus on the duties of states rather than rights of the individuals? Or, alternatively, did that community merely prescribe a lowest common denominator of state duties in the name of human rights?