Initial and Follow-Up Evaluations of Integrated Psychological Services for Anxiety and Depression in a Safety Net Primary Care Clinic.

OBJECTIVE: Despite the recognized importance of integrated behavioral health, particularly in safety net primary care, its effectiveness in real world settings has not been extensively evaluated. This article presents 2 successive studies examining the effectiveness of integrated behavioral care in a safety net setting. METHOD: Study 1 compared the depression and anxiety scores of predominately low-income and minority patients who underwent brief interventions (N = 147) to those of patients from a demographically similar comparison clinic without integrated psychological services, matched on baseline levels of anxiety and depression and length of time between assessments (N = 139). Study 2 did not include a control group but served as a long-term follow-up assessment of anxiety and depression for a subset of 47 patients who finished treatment and could be reached by telephone within 6-18 months of their last session. RESULTS: Study 1 found that patients from the clinic with integrated psychology services experienced greater decreases in depression and anxiety scores than patients in the control clinic. These effects did not differ as a function of age, gender, or race. Study 2 found that patients continued to decline in depression and anxiety over time, with lower scores at the last session and even lower scores after longer-term follow-up ranging from 6 to18 months. These improvements remained significant when controlling for other interim mental health treatments. CONCLUSION: These results support the short- and long-term treatment effects of brief primary care behavioral interventions, further strengthening the case for integrated behavioral healthcare in safety net settings.

The Impact of Integrated Psychological Services in a Safety Net Primary Care Clinic on Medical Utilization.

OBJECTIVE: The integration of psychological and behavioral health services into safety net primary care clinics has been viewed as a step toward reducing disparities in mental health treatment and addressing behavioral factors in chronic diseases. Though it is posited that integrated behavioral health (IBH) reduces preventable medical costs, this premise has yet to be tested in a safety net primary care clinic. METHOD: Retrospective pre- and posttreatment analysis with quasi-experimental control group was constructed using propensity score matching. Participants included 1,440 adult patients at a safety net primary care clinic, 720 of whom received IBH services, and 720 of whom received medical treatment only. RESULTS: Analysis showed that rates of preventable inpatient utilization decreased significantly among IBH-treated patients compared to no change among control patients. CONCLUSION: IBH was associated with decreased rates of preventable inpatient visits. IBH may present opportunities to deliver improved holistic patient care while reducing unnecessary inpatient medical utilization.

The efficacy and tolerability of the ß3-adrenoceptor agonist mirabegron for the treatment of symptoms of overactive bladder in older patients.

INTRODUCTION: mirabegron is a ß3-adrenoceptor agonist developed for the treatment of symptoms of overactive bladder (OAB). As the prevalence of OAB increases with age, a prospective subanalysis of individual and pooled efficacy and tolerability data from three 12-week, randomised, Phase III trials, and of tolerability data from a 1-year safety trial were conducted in order to evaluate the efficacy and tolerability of mirabegron in subgroups of patients aged ≥65 and ≥75 years. METHODS: primary efficacy outcomes were change from baseline to final visit in the mean number of incontinence episodes/24 h and the mean number of micturitions/24 h. Tolerability was assessed by the incidence of treatment-emergent adverse events (TEAEs). RESULTS: over 12 weeks mirabegron 25 mg and 50 mg once-daily reduced the mean numbers of incontinence episodes and micturitions/24 h from baseline to final visit in patients aged ≥65 and ≥75 years. Mirabegron was well tolerated: in both age groups, hypertension and urinary tract infection were among the most common TEAEs over 12 weeks and 1 year. The incidence of dry mouth, a typical anticholinergic TEAE, was up to sixfold higher among the older patients randomised to tolterodine than any dose of mirabegron. CONCLUSIONS: these analyses have demonstrated the efficacy of mirabegron over 12 weeks and the tolerability of mirabegron over 12 weeks and 1 year in OAB patients aged ≥65 and ≥75 years, supporting mirabegron as a therapeutic option in older patients with OAB.

The relationship of life stressors, mood disorder, and health care utilization in primary care patients referred for integrated behavioral health services.

Exposure to stressful life events, mood disorder, and health care utilization were evaluated in 102 low-income, primarily minority patients receiving behavioral health and medical services at a safety-net primary care clinic. Exposure to major stressors was far higher in this sample than in the general population, with older patients having lower stress scores. Proportions of patients who met the criteria for clinical depression and anxiety were higher than in normative samples of primary care patients. Stress exposure was higher in the patients who met the criterion for clinical anxiety but was unrelated to clinical depression. Contrary to expectation, anxiety, depression, or stress exposure was not related to service utilization. Latter findings are discussed in terms of the influence of the provision of behavioral health services, the highly skewed distribution of major stressor scores, and the likely greater influence of individual differences in minor stressor exposure on utilization in this population.

Evaluation of integrated psychological services in a university-based primary care clinic.

Primary care is increasingly moving toward integration of psychological services; however few studies have been conducted to test the efficacy of such an integrated approach. This paper presents a program evaluation of psychological services provided by doctoral trainees in clinical and counseling psychology within a primary care clinic at an urban academic medical center. It includes: (1) a description of the program, including types of patients served, their presenting problems, and treatments administered and; (2) evidence of the impact of behavioral health services on primary care patients' emotional adjustment and progress on behavioral goals. Intake and follow-up measures of depression, anxiety, smoking, insomnia, chronic pain, and weight loss were collected on 452 adult patients (mean age = 52; 59 % African-American; 35 % uninsured) who were provided brief interventions (mean visits = 2.2) over a 16-month period. Although conclusions are limited by the lack of a control or comparison group, preliminary findings indicate that the integrated behavioral health services provided were effective. Implications and future directions are discussed.

Results of a randomized phase III trial of mirabegron in patients with overactive bladder.

PURPOSE: Many patients with overactive bladder discontinue pharmacotherapy due to suboptimal efficacy or side effects. Mirabegron, a ß3-adrenoceptor agonist, may offer an effective and well tolerated alternative treatment for overactive bladder. MATERIALS AND METHODS: A randomized, double-blind, placebo controlled trial was conducted in the United States and Canada. After a 2-week placebo run-in period, adults with overactive bladder symptoms for 3 or more months were randomized 1:1:1 to receive placebo, 50 or 100 mg mirabegron once daily for 12 weeks. Efficacy data were collected via patient completed diaries and quality of life assessments. Co-primary efficacy end points were changes from baseline to final visit in mean number of incontinence episodes per 24 hours and micturitions per 24 hours. Key secondary micturition and incontinence end points were also evaluated. Safety assessments included treatment emergent adverse events, laboratory assessments, vital signs, electrocardiograms and post-void residual volume. RESULTS: Compared to placebo, 50 and 100 mg mirabegron groups demonstrated statistically significantly greater mean decreases (95% CI) from baseline for incontinence episodes (-1.13 [-1.35, -0.91], -1.47 [-1.69, -1.25] and -1.63 [-1.86, -1.40]) and micturitions (-1.05 [-1.31, -0.79], -1.66 [-1.92, -1.40] and -1.75 [-2.01, -1.48]) per 24 hours (p <0.05). Significant improvements in all key secondary end points were observed for both mirabegron doses vs placebo. The incidence of frequently reported treatment emergent adverse events (hypertension, urinary tract infection, headache, nasopharyngitis) was similar in the mirabegron and placebo groups. Dry mouth was reported for 1.5%, 0.5% and 2.1% of patients in the placebo, 50 and 100 mg mirabegron groups, respectively. CONCLUSIONS: Once daily mirabegron in a 50 or 100 mg dose is an effective treatment for overactive bladder symptoms with a low occurrence of side effects.

Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study.

INTRODUCTION: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) commonly coexist in aging men. Tadalafil, a phosphodiesterase type 5 inhibitor approved for treating ED, is currently being evaluated for treating BPH-LUTS. AIMS: This multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH-LUTS in men with both conditions during 12 weeks of double-blinded therapy. METHODS: Men were ≥ 45 years old, sexually active, and experiencing ED for ≥ 3 months and BPH-LUTS for >6 months. Randomization (baseline) followed a 4-week placebo lead-in; changes from baseline were assessed via analysis of covariance and compared to placebo. A gatekeeping procedure controlled for multiple comparisons of co-primary and key secondary measures at end point (last post-baseline observation). MAIN OUTCOME MEASURES: The co-primary measures were the International Index of Erectile Function-erectile function (IIEF-EF) domain and International Prostate Symptom Score (IPSS) score; key secondary measures were the Sexual Encounter Profile Question 3 (SEP Q3) and BPH Impact Index (BII). Treatment-emergent adverse events, serious adverse events, orthostatic vital signs, clinical laboratory and uroflowmetry parameters, and postvoid residual volume were assessed. RESULTS: Tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF-EF domain scores (both P < 0.001) vs. placebo (N = 200) at end point. For IPSS, improvements were significant with tadalafil 5 mg (P < 0.001), but not 2.5 mg, for observations from 2 weeks through end point (least-squares mean ± standard error change from baseline at end point, placebo -3.8 ± 0.5, tadalafil 2.5 mg -4.6 ± 0.4, and 5 mg -6.1 ± 0.4). Tadalafil 5 mg significantly improved SEP Q3 and BII (P < 0.001). Overall, tadalafil was well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters. CONCLUSIONS: Tadalafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated.

The interpersonal process in tissue donation requests with "undecided" next of kin.

CONTEXT: Although recent studies have demonstrated that tissue requesters' behavior during conversations about tissue donation affects consent rates, the link between requesters' behavior and consent rates remains unclear. OBJECTIVE: To examine whether positive/collaborative requester behaviors elicit complementary behaviors from next of kin who were initially undecided about their willingness to donate their deceased family member's tissues. DESIGN: -Audio recordings of requests were coded to assess for interpersonal behavior of each interactant. SETTING: Audio recordings were gathered from a national sample of tissue banks. PARTICIPANTS: One hundred and two requester-next-of-kin dyads, consisting of 102 relatives and 53 requesters. MAIN OUTCOME MEASURES: Tissue requester and next-of-kin affiliation and interpersonal control were assessed. Tissue requesters' persuasion, confirmation (eg, approval, empathy, reassurance) and disapproval, as well as next-of-kin approval and disapproval, were examined. RESULTS: Tissue requesters and next of kin tended to match one another on affiliation and complement one another on interpersonal control. "Key topics," which may affect the next of kin's decision, are discussed in only about one-third of requests. Next of kin were less affiliative and more disapproving when requesters were also more disapproving. Interpersonal behavior of the tissue requester, such as affiliation, statements of disapproval, and persuasion, as well as discussion of key topics, was a significant predictor of the interpersonal behavior of the next of kin. CONCLUSIONS: Positive requester behaviors elicited a positive response from undecided next of kin. Because many next of kin have limited knowledge about tissue donation before the request, the communication process may affect the next of kin's perceptions of donation and thus affect the likelihood of consent. Findings could potentially inform communication skills training for tissue requesters; future research could examine effects of such training on consent rates.

Changes in peak urinary flow and voiding efficiency in men with signs and symptoms of benign prostatic hyperplasia during once daily tadalafil treatment.

OBJECTIVE: To determine, by post hoc analysis, the effects of tadalafil (a long-acting phosphodiesterase 5 inhibitor) on peak urinary flow (Q(max)), bladder capacity, voiding efficiency and the obstructive symptoms of benign prostatic hyperplasia (BPH) in men with lower urinary tract symptoms secondary to BPH (BPH-LUTS), compared with placebo. PATIENTS AND METHODS: After a 4-week placebo run-in period, 1058 men with BPH-LUTS were randomly allocated to receive once daily treatment with placebo or tadalafil (2.5, 5, 10, or 20 mg) for 12 weeks. Uroflowmetry, postvoid residual volume (PVR), and BPH symptom score measurements were assessed throughout the trial. RESULTS: Increases in Q(max) were numerically greater for tadalafil (2.5, 5, 10, and 20 mg with percentage changes of 15%, 16%, 17%, 22%, respectively) vs placebo (12%), but did not reach statistical significance. Age, baseline Q(max), erectile dysfunction history, sexual activity, and previous alpha-blocker therapy significantly influenced the Q(max) response. Tadalafil was not associated with significant changes in PVR. Tadalafil had its greatest effects on bladder capacity and voiding efficiency in men with a Q(max) of <10 mL/s at baseline, but these changes were not significantly different from placebo responses. Tadalafil treatment significantly improved the IPSS obstructive subscores (tadalafil 2.5, 5, 10, 20 mg with percentage changes of 24%, 31%, 33%, 33%, respectively) vs placebo (13%). CONCLUSIONS: Once daily tadalafil did not significantly change Q(max) or voiding efficiency compared with placebo in men with BPH-LUTS, although there were dose-dependent improvements. No subgroups were identified where tadalafil or placebo treatment had a deleterious effect on Q(max). Despite these minimal changes in uroflowmetric measures, tadalafil was associated with clinically meaningful and statistically significant improvements in the obstructive symptoms of BPH.

Roles of sex and ethnicity in procurement coordinator--family communication during the organ donation discussion.

CONTEXT: Interpersonal relations with health care providers influence families' decisions to consent to solid-organ donation. However, previous research has been based on retrospective interviews with donation-eligible families and has not directly examined the interpersonal interactions between families and organ procurement coordinators. OBJECTIVE: To increase understanding of the interpersonal interaction between procurement coordinators and families during the organ donation discussion, with special attention to the influence of the sex and race of the procurement coordinator and the race of the potential donor's family. DESIGN: A descriptive study in which standardized patients portrayed family members interacting with actual procurement coordinators in simulated donation request scenarios. SETTING AND PARTICIPANTS: Thirty-three videotaped interactions between standardized patients and 17 procurement coordinators involving 2 different scenarios depicting deceased donation were evaluated. MAIN OUTCOME MEASURES: Video recordings were rated by independent coders. Coders completed the Impact Message Inventory-Form C, the Participatory Style of Physician Scale, and the Siminoff Communication and Content and Affect Program-Global Observer Ratings scale. RESULTS AND CONCLUSIONS: African American procurement coordinators, particularly African American women, were rated as more controlling and work-oriented than white procurement coordinators. Male procurement coordinators were more affiliative with the white family than the African American family, whereas female procurement coordinators were slightly less affiliative with the white family. African American procurement coordinators expressed more positive affect when interacting with the African American family than the white family, whereas the opposite was true for white procurement coordinators. Research is needed to cross-validate these exploratory findings and further examine cultural mistrust between procurement coordinators and families of ethnic minorities, especially given the negative attitudes of many minorities toward donation.

Psychological factors associated with response to maxillofacial injury and its treatment.

PURPOSE: This study evaluated symptoms of acute stress disorder (ASD), satisfaction with appearance postsurgery, and satisfaction with care in patients with maxillofacial injury at their first postsurgical physician visit. To determine the best predictors of patients' ASD symptoms and satisfaction, data also were obtained on the patients' strategies for coping with the stress of the injury, on the patients' and doctors' interpersonal appraisals of each other, and on the doctors' participatory behavior during the visits. PATIENTS AND METHODS: A total of 47 patients who had sustained traumatic maxillofacial injury requiring emergency medical/surgical treatment were administered self-report measures immediately before and after their first postsurgical visit 10 to 12 days after trauma exposure. Doctors completed self-report measures after the visit and evaluated the patients' severity of injury. RESULTS: Patients experienced high levels of ASD in the short-term period after surgery. Use of emotion-focused strategies by patients to cope with stress was associated with more ASD symptoms but better satisfaction with facial appearance. The more severely injured patients were less satisfied with their appearance and were viewed by their doctors as being more interpersonally controlling during the postsurgical visit. CONCLUSIONS: Closer attention by doctors to patients' interpersonal behavior may aid in early identification of those patients with maxillofacial injury who may experience longer-term social problems related to their altered facial appearance.

Relationship of interpersonal behaviors and health-related control appraisals to patient satisfaction and compliance in a university health center.

OBJECTIVE: The authors' aim was to evaluate patient-provider relationships in a college health center. PARTICIPANTS: Eighty student patients and their health-care providers. METHODS: Patients completed a measure of perceived health competence before a consultation and measures of provider participatory behavior and interpersonal behavior before and after the consultation. They evaluated their satisfaction with care and compliance after the consultation and again 2 weeks later. Providers completed measures of their participatory behavior and patients' interpersonal behavior after the consultation. RESULTS: Patients preferred to be well informed and to have their preferences taken into account, and generally felt competent at managing their own health affairs. They indicated they obtained the high level of participation they desired. Patients desired and actually experienced friendly and submissive providers. Degree of match between patients' desired and actual level of involvement in their care was associated with greater satisfaction. A greater match between the extent to which they desired the provider to be affiliative and the provider's actual affiliative behavior was associated with more satisfaction. No variables were predictive of patient compliance. CONCLUSION: The authors discuss results in terms of the influence of situational factors characteristic of a college health center.

Mindfulness, burnout, and effects on performance evaluations in internal medicine residents.

PURPOSE: Burnout has been documented at high levels in medical residents with negative effects on performance. Some dispositional qualities, like mindfulness, may protect against burnout. The purpose of the present study was to assess burnout prevalence among internal medicine residents at a single institution, examine the relationship between mindfulness and burnout, and provide preliminary findings on the relation between burnout and performance evaluations in internal medicine residents. METHODS: Residents (n = 38) completed validated measures of burnout at three time points separated by 2 months and a validated measure of dispositional mindfulness at baseline. Program director end-of-year performance evaluations were also obtained on 22 milestones used to evaluate internal medicine resident performance; notably, these milestones have not yet been validated for research purposes; therefore, the investigation here is exploratory. RESULTS: Overall, 71.1% (n = 27) of the residents met criteria for burnout during the study. Lower scores on the "acting with awareness" facet of dispositional mindfulness significantly predicted meeting burnout criteria χ2(5) = 11.88, p = 0.04. Lastly, meeting burnout criteria significantly predicted performance on three of the performance milestones, with positive effects on milestones from the "system-based practices" and "professionalism" domains and negative effects on a milestone from the "patient care" domain. CONCLUSION: Burnout rates were high in this sample of internal medicine residents and rates were consistent with other reports of burnout during medical residency. Dispositional mindfulness was supported as a protective factor against burnout. Importantly, results from the exploratory investigation of the relationship between burnout and resident evaluations suggested that burnout may improve performance on some domains of resident evaluations while compromising performance on other domains. Implications and directions for future research are discussed.

Optimal matches of patient preferences for information, decision-making and interpersonal behavior: evidence, models and interventions.

OBJECTIVE: A comprehensive review was conducted of the theoretical and empirical work that addresses the preference-match strategy in physician-patient communication. METHODS: Searches were conducted on Medline, PsychINFO, InFoTrac One File Plus, Sociological Abstracts, and Dissertation Abstracts through 2004. The following keywords were used: patient preferred and received information; patient preferred and actualized treatment decision-making; patient-physician beliefs in shared decision-making; patient-physician match, fit, or concordance; reciprocal relationship or mutuality; doctor-patient affiliation, control, relationship; match/fit between patient and physician in affiliation, control, or relationship. RESULTS: Findings revealed varying degrees of support for the positive effects of matching patients' preferred levels of information, decisional control, and consultative interpersonal behavior. CONCLUSIONS: Findings justify not only continued but expanded research efforts in this area that would incorporate recommended changes in research design and implementation. PRACTICE AND RESEARCH IMPLICATIONS: Assessment strategies and match interventions are discussed that, if evidence continues to be supportive, might routinely optimize patient-physician encounters toward more positive outcomes. Methodological guidelines are suggested that can improve future preference-match studies of the patient-physician interaction. Practitioners need to consider adoption of patient-match assessment and intervention strategies in addition to recent exclusive concentrations on patient-centered and shared decision-making approaches.

Erectile response to vardenafil in men with a history of nonresponse to sildenafil: a time-from-dosing descriptive analysis.

BACKGROUND: The efficacy and tolerability of vardenafil hydrochloride in men with erectile dysfunction (ED) and a history of nonresponse to sildenafil citrate have previously been reported. OBJECTIVE: The aim of this descriptive analysis was to assess the efficacy and tolerability of vardenafil at various times after dosing in men with ED and a history of nonresponse to sildenafil and who chose to attempt sexual intercourse between 0.25 and 6 hours after dosing with vardenafil. METHODS: This analysis used data from a previously published 12-week, prospective, randomized, double-blind, flexible-dose, placebo-controlled study conducted at 41 hospitals and outpatient clinics across Australia, Europe, Asia, and North America. In that study, men with ED and sildenafil nonresponse, defined using 6 rigorous criteria (including nonresponse to the highest recommended dose, 100 mg/d) were assigned to receive vardenafil 10 mg or placebo QD. At study weeks 4 and 8, patients in both groups were given the option to maintain the 10-mg/d dose, or have the dose titrated to 5 or 20 mg/d. The present analysis used data from patient diaries completed daily, which included information concerning attempts at sexual intercourse, time from dosing to attempt, penetration, and maintenance of erection sufficient for successful intercourse. At week 12, diary data were categorized into time intervals (in hours) after dosing. For each interval, the per-patient success rate was based on the total number of attempts made in that interval. Comparative statistics were not performed on the time-interval analysis. Tolerability was monitored throughout the study. Data concerning the primary end point were reported previously. RESULTS: A total of 463 men were enrolled, of whom 457 were included in the safety analysis (vardenafil, n = 231; placebo, n = 226) and 454 in the intent-to-treat analysis (vardenafil, n = 229; placebo, n = 225; mean age, 60.1 vs 59.0 years; mean body mass index, 28.7 vs 28.0 kg/m2). Six patients were excluded from the safety analysis (2 patients did not use study medication [placebo group], postbaseline safety data unavailable in 4 patients [2 in each study group]). Men receiving vardenafil had numerically greater penetration and completion success rates compared with those receiving placebo at all time intervals. Penetration success rates were numerically higher with vardenafil compared with placebo as early as within 0.25 hour after dosing (62% vs 30%); efficacy continued beyond 6 hours after dosing in 77% and 50% of patients, respectively. Similarly, vardenafil-treated patients had numerically greater completion success rates compared with those receiving placebo at 0.25 hour (53% vs 12%) and beyond 6 hours after dosing (70% vs 24%). The most common drug-related adverse events in the vardenafil and placebo groups were flushing (7% vs 1%), headache (6% vs 2%), and nasal congestion (5% vs <1%). CONCLUSIONS: This descriptive analysis suggests that erection sufficient for penetration and intercourse completion was achieved within 0.25 hour and lasted for >6 hours after dosing with vardenafil 10 mg in these men with mostly moderate to severe ED and a history of nonresponse to sildenafil and who chose to make attempts during those intervals. The drug was generally well tolerated.

Tadalafil improved erectile function at twenty-four and thirty-six hours after dosing in men with erectile dysfunction: US trial.

In a previous study assessing tadalafil for the treatment of erectile dysfunction (ED), tadalafil 20 mg was shown to improve erectile function for up to 36 hours vs placebo. This study sought to demonstrate the effectiveness of both 10- and 20-mg tadalafil vs placebo at 2 prespecified assigned times of 24 and 36 hours postdosing. This double-blind, placebo-controlled, parallel-group study randomized 483 men with ED into 6 groups according to a combination of treatment (placebo, tadalafil 10 or 20 mg) and assigned time (24 or 36 hours) for intercourse attempts. Patients were stratified by baseline ED severity based on Erectile Function Domain scores. The study had 4 phases: a 4-week run-in (no ED medication taken); a 2- to 4-week equilibration (dosing as needed); a 4- to 6-week assessment; and a 6-month open-label extension. During the assessment phase, men took a total of 4 doses of study medication, each dose separated by more than or equal to 7 days. Efficacy was measured as the mean per-patient percentage of successful intercourse attempts (Sexual Encounter Profile Diary Question 3: SEP3) during the assessment phase. Men taking either 10- or 20-mg tadalafil had a significant increase in SEP3 from baseline scores vs placebo at both 24 hours (P = .038 and <.001 for 10 and 20 mg, respectively) and 36 hours (P < .001 for both doses) postdose. The mean per-patient percentages of successful intercourse attempts for the 24-hour time point were 41.8%, 55.8%, and 67.3% for placebo and tadalafil 10 and 20 mg, respectively; for the 36-hour time point, the mean per-patient percentages were 32.8%, 56.2%, and 61.9% for placebo and tadalafil 10 and 20 mg, respectively. The most common treatment-emergent adverse events were headache, back pain, dyspepsia, and nasopharyngitis. Both 10- and 20-mg tadalafil improved erectile function for up to 36 hours postdosing in men with ED of varied severity.

Optimism, satisfaction with needs met, interpersonal perceptions of the healthcare team, and emotional distress in patients' family members during critical care hospitalization.

BACKGROUND: Families of critical care patients experience high levels of emotional distress. Access to information about patients' medical conditions and quality relationships with healthcare staff are high-priority needs for these families. OBJECTIVES: To assess satisfaction with needs met, signs and symptoms of acute stress disorder, interpersonal perception of healthcare staff, level of optimism, and the relationships among these variables in patients' family members. METHODS: Family representatives of 40 patients were administered a brief version of the Critical Care Family Needs Inventory, the Acute Stress Disorder Scale, the Brief Symptom Inventory, the Impact Message Inventory, and the Life Orientation Test shortly after admission of the patients to the intensive care unit and after discharge. RESULTS: Levels of dissociative symptoms associated with acute stress disorder were elevated in family members just after admission but decreased significantly after discharge. Needs the families thought were least satisfactorily cared for after admission involved lack of information. Interpersonally, attending physicians were viewed as more controlling than bedside nurses at admission; nurses were viewed as more affiliative than physicians both at admission and after discharge. At admission, higher optimism of the family members was strongly related to greater satisfaction with needs met, to perceptions of affiliation from physicians, and to perceptions of not being controlled by physicians. CONCLUSIONS: More interpersonal contact with medical staff can help meet the information needs of patients' families. Nurses may aid in families' adjustment by fostering a sense of optimism in family members and encouraging them to participate in the patients' care.

A randomized, double-blind, multicenter comparison of gatifloxacin versus ciprofloxacin in the treatment of complicated urinary tract infection and pyelonephritis.

BACKGROUND: Gatifloxacin is a fluoroquinolone antibiotic with a broad spectrum of in vitro and in vivo activity against the gram-negative and gram-positive pathogens frequently implicated in urinary tract infections (UTIs). OBJECTIVE: This study compared the clinical and bacteriologic efficacy and tolerability of gatifloxacin versus ciprofloxacin in adult patients with complicated UTIs or pyelonephritis. METHODS: In this double-blind, multicenter, randomized, comparative study, patients were treated with either gatifloxacin 400 mg once daily or ciprofloxacin 500 mg twice daily for 7 to 10 days. Bacteriologic eradication (by quantitative urine culture) and clinical efficacy rates were assessed at a test-of-cure visit (5 to 9 days and 4 to 11 days posttreatment, respectively) and at an extended follow-up visit (29-42 days and 25-50 days posttreatment, respectively). RESULTS: A total of 372 adults were randomized to treatment, 189 to gatifloxacin and 183 to ciprofloxacin. The most commonly isolated pretreatment pathogens (n = 292) were Escherichia coli (53%) and Klebsiella pneumoniae (13%). Pathogen eradication rates for complicated UTIs were 92% and 83% with gatifloxacin and ciprofloxacin, respectively (95% CI, -4.1% to 24.5%); for pyelonephritis, the respective rates were 92% and 85% (95% CI, -20% to 37%). Clinical response rates of >90% were observed in both treatment groups among patients with complicated UTIs as well as those with pyelonephritis. Sustained eradication rates were 76% (64/84) with gatifloxacin and 66% (52/79) with ciprofloxacin. Both drugs were well tolerated, with the most common adverse events in both treatment groups being nausea, dizziness, diarrhea, and vomiting. CONCLUSIONS: Gatifloxacin is comparable to ciprofloxacin based on clinical efficacy and bacteriologic eradication rates for the treatment of complicated UTIs or pyelonephri- tis and is associated with a low incidence of clinically significant adverse events.

Integrating measurement of control and affiliation in studies of physician-patient interaction: the interpersonal circumplex.

Following a brief overview and commentary on the physician-patient communication literature, this article summarizes and evaluates research on the relationship between physician-patient control (dominant-submissive) and affiliation (friendly hostile) behaviors as they relate to medical outcomes. Findings for both verbal and nonverbal control and affiliation measures are included. The interpersonal circumplex (together with the important interactional principles that it incorporates) is then introduced as an heuristic guide for future medical interaction research. The circumplex was constructed as a conceptual and empirical model to integrate the numerous studies that have established control and affiliation as universal dimensions of human interpersonal behavior and relationships. Next, the small group of studies that have applied circumplex inventories to analyses of practitioner-patient transactions are reviewed with emphasis on their strengths and unique aspects of their findings. The concluding section enumerates advantages and innovations that the interpersonal circumplex and its measures can provide to facilitate more heuristic studies of physician-patient interactions.

Appraisal of Desire for Control over Healthcare: Structure, Stability, and Relation to Health Locus of Control and to the 'Big Five' Personality Traits.

This study addressed the question of whether the traditional tripartite distinction between cognitive, decisional and behavioral control is meaningful as applied to desire for healthcare control. Subscales of the Krantz Health Opinion Survey and the Autonomy Preference Index were administered to 680 undergraduates along with the Multidimensional Health Locus of Control Scales and the NEO-FFI Five-Factor Inventory. These measures were readministered to 523 of these subjects approximately seven weeks later. Confirmatory factor analysis of the data indicated that desire for healthcare control is best conceptualized as having three separate components. Desire for information was clearly unrelated to either desire for behavioral or decisional control; however the latter two forms of control, which are indicative of more active engagement by the individual, overlapped to a moderate degree. The three-factor model was stable over time and the component factors (particularly desire for decisional and behavioral control) were also stable. No strong relationships were found between the component factors and measures of health locus of control or the basic personality trait dimensions measured by the NEO, suggesting that the factors represent largely situation-specific traits. Findings were discussed in terms of how they may have been influenced by variability in the instruments that were used to measure the separate desire for healthcare control components, and in terms of the need for criterion-related validational work especially in the crucial area of decisional control.