A feasibility study comparing pharmacist and physician recommendations for sildenafil treatment.

INTRODUCTION: In Europe, pharmacists may be an important first point of contact for men with erectile dysfunction (ED) asking for advice and treatment. AIM: To determine if European community pharmacists could appropriately recommend suitability for supply of sildenafil 50 mg for the treatment of ED. METHODS: For this cross-sectional, observational study, the current Summary of Product Characteristics was adapted to create a study drug information sheet for use in a pharmacy setting in which, for certain patients, supply is not suitable and referral to a physician is recommended. After training and with use of a guidance questionnaire, pharmacists assessed the suitability of supply of sildenafil 50 mg for men presenting to their pharmacy. Men with self-reported ED who were not currently using a phosphodiesterase type 5 inhibitor were recruited. Within 7 days of the pharmacist-patient interaction, a physician with experience in the management of ED telephoned the subject to assess suitability. If there was discordance between the pharmacist and physician recommendations, the case was independently reassessed by a physician specialist in sexual medicine. MAIN OUTCOME MEASURES: The primary end point was the concordance rate (with 95% confidence intervals) between pharmacist and physician recommendations. Rates were weighted by country sample sizes. RESULTS: Concordance (95% confidence interval) was 0.70 (0.66-0.74) between pharmacist and physician recommendation, indicating agreement in 70% of cases, and was 0.90 (0.86-0.94) between pharmacist and physician specialist in sexual medicine. Furthermore, if the cases in which the pharmacist did not put subjects at risk (i.e., gave an acceptable recommendation) are assessed, the success rate is 83.5% (79.6-87.4%) and 92.8% (90.1-95.5%), respectively. CONCLUSION: Pharmacists were accurate in providing suitable treatment recommendation, generally not recommending sildenafil for men without ED and recommending physician assessment when there was any question about cardiovascular health, other comorbidity, or co-medication.

The ability of men to assess their suitability to take a phosphodiesterase type 5 inhibitor: an assessment of the comprehension of patient information materials.

INTRODUCTION: Erectile dysfunction is a treatable condition that affects a large proportion of men. Most men do not seek medical help for their ED because of embarrassment or social stigma that may lead some men to self-treat. AIM: To evaluate men's ability to self-assess their suitability for 50 mg sildenafil use after reviewing patient information materials. MAIN OUTCOME MEASURES: Patient rating of patient information materials, self-assessment of suitability for sildenafil use, and clinician assessment of sildenafil suitability. METHODS: Men in the UK were recruited through newspaper, radio, and internet advertisements. Eligible men reviewed the 50 mg sildenafil patient information materials (packaging materials and patient information leaflet) at the in-person visit and then completed a survey to rate the materials and self-assess their suitability for sildenafil use. A clinician, blinded to the participant's ED status and self-assessed sildenafil suitability, then conducted a one-on-one interview to assess the participant's ED status and suitability for sildenafil treatment. The primary analysis was the concordance of self-assessed suitability versus clinician-assessed suitability. RESULTS: The initial study phase included 113 generally healthy men, mean age 40.2 ± 13.1 years. The second phase included 70 men with comorbid prostate or cardiac conditions, mean age 60.7 ± 7.8 years. The 183 men rated the patient information materials as easy to understand; few participants reported problems understanding the materials, and many participants learned new information. The concordance rate between clinician-assessed suitability and self-assessed suitability was 73.9% (95% confidence interval [CI] = 66.7-81.2%). When accounting for men who would not take sildenafil even though they were suitable or would seek additional information from a healthcare professional prior to using sildenafil, the concordance rate was 90.1% (95% CI = 85.8-94.4%). CONCLUSION: The results of this UK study suggest that men are capable of using written sildenafil patient education materials to accurately assess their suitability for treatment with 50 mg sildenafil.

Development and evaluation of an educational interactive CD-ROM for teens with cancer.

BACKGROUND: Cancer is the number one disease killer of children and adolescents in North America. For adolescents, this diagnosis comes at a particularly vulnerable stage. Educating adolescents with cancer from diagnosis through treatment teaches and empowers them. Increasing evidence shows that these adolescents want more information. Few educational tools exist for young cancer patients; none are interactive; therefore, a CD-ROM was developed to meet this need. PROCEDURE: Animation, voiceover, music, videos, and games were combined to develop a comprehensive multimedia CD-ROM to teach 12- to 18-year-olds with solid tumors about their disease, treatment, coping skills, and late effects in an interactive and non-threatening way. The CD-ROM was evaluated in a pre-post design with 65 subjects recruited from four pediatric oncology centers randomized to the CD-ROM or a "Handbook" containing analogous information. Pre-post questionnaires measured coping strategies, health locus of control, quality of life, cancer knowledge, and self-efficacy; post-test variables also included acceptability and use by teens, their families, and healthcare professionals. RESULTS: Teens receiving the CD-ROM were significantly more likely to increase their internal locus of control scores; however, no significant differences were observed on other measures, attributable in part to the study sample size. Among teens, acceptability was higher in the CD-ROM versus the Handbook group, but not different between the two parent groups. Pediatric oncology healthcare providers gave positive feedback on the CD-ROM. CONCLUSIONS: This CD-ROM is an innovative and engaging educational tool--the first portable interactive product with access on demand for adolescents with solid tumors.

Relationships between Hispanic ethnicity and attitudes and beliefs toward herbal medicine use among older adults.

BACKGROUND: Little is known about the underlying intentions to use herbal medicines among Hispanic older adults. Understanding these intentions is critical to the provision of effective counseling. OBJECTIVES: The objectives were to (1) identify predictors of the intention to use herbal medicines for health problems in the next 6 months among Hispanic and non-Hispanic older adults using the Theory of Planned Behavior (TPB); and (2) compare their beliefs underlying significant predictors of intention with use herbal medicines for health problems in the next 6 months. METHODS: Using a cross-sectional research design, data were collected via self-administered questionnaires from convenience samples at a Senior Health Clinic and a Veterans Affairs Hospital outpatient pharmacy. Study subjects were community dwelling adults aged 65 years and older and able to complete the survey in English. Multiple regression analysis was used to identify the significant predictors of intention to use herbal medicines in the TPB within each ethnicity. Independent t tests were used to compare the beliefs underlying the significant predictors of intention with use herbal medicines across the 2 groups. RESULTS: For both Hispanic (N=80) and non-Hispanic (N=171) patients, attitudes toward using herbal medicines was the only significant predictor of the intention to use herbal medicines in the next 6 months (Hispanics, Adj. R(2)=0.59, beta=0.78, P<.001; non-Hispanics, Adj. R(2)=0.57, beta=0.66, P<.001). The magnitude of the beta coefficients did not differ significantly between the 2 ethnicities. Compared with non-Hispanics, Hispanics believed that herbal medicines are cheaper, have fewer side effects, work better, and are more convenient to use than other medicines. CONCLUSIONS: Understanding ethnic differences in behavioral beliefs underlying attitudes toward the use of herbal medicines can help pharmacists and other health care professionals in educating and formulating appropriate counseling strategies specific to older patients of different ethnicities.

Correlations with satisfaction measures in men treated with phosphodiesterase inhibitors for erectile dysfunction.

This literature review examined the relationship of erectile function to patient satisfaction. Published correlation coefficients (r values) were sought between patient-reported outcomes (PROs; i.e., instruments/questionnaires) assessing erection or erectile function and PROs assessing individual sexual satisfaction, satisfaction in the context of the couple or relationship, or satisfaction with erection. The U.S. National Library of Medicine's PubMed database was searched for English-language, randomized, double-blind, placebo-controlled trials of treatment with a phosphodiesterase type 5 inhibitor in men with erectile dysfunction (ED) who were not selected for any concomitant disease. Trials that reported correlations between an ED-specific and psychometrically validated PRO for an erection/erectile function concept and for a selected satisfaction concept were included. All correlations were positive, with almost all r values >.50. The positive relationship between results on erection/erectile function PROs and results on satisfaction PROs is probably reinforced bidirectionally such that improved erection/erectile function improves satisfaction, which further improves erection and/or erectile function.

Risk of impaired renal function after colonoscopy: a cohort study in patients receiving either oral sodium phosphate or polyethylene glycol.

OBJECTIVES: We aimed to evaluate frequency, predictors, and monitoring of renal dysfunction related to the use of oral sodium phosphates for colonoscopy in clinical practice. METHODS: Cohort study using clinical records and electronic patient information from the Henry Ford Health System, Detroit, MI. We identified patients undergoing colonoscopy using sodium phosphate or polyethylene glycol (PEG), and estimated the risk of renal impairment associated with bowel preparation and other risk factors. RESULTS: Out of 7,897 patients, 6,833 had used sodium phosphate; 1,617 patients had renal dysfunction within 12 months prior to colonoscopy and 3,928 patients had no creatinine measurement within 12 months prior to or 6 months postcolonoscopy. Among the remaining 2,352 patients, 88 had incident renal dysfunction (glomerular filtration rate [GFR]<60 mL/min) after colonoscopy. The relative risk (RR) estimate for renal dysfunction comparing sodium phosphate with PEG was 1.13 (95% CI 0.58-2.23) without adjustment, and 1.14 (95% CI 0.55-2.39) after multivariate adjustment. Significant univariate risk factors were age>or=65 yr, African-American race, low baseline GFR, hypertension, and use of angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-renin blockers, or thiazide diuretics. CONCLUSIONS: In patients without preexisting renal disease, the risk of renal impairment after colonoscopy appears to be similar between sodium phosphate and PEG users. Sodium phosphate use in patients with preexisting renal disease is not recommended, but common in clinical practice. Sodium phosphate should not be used in patients with preexisting serious renal disease, adequate hydration should be assured in all patients, and renal function should be monitored before and after colonoscopy in those at risk of renal dysfunction.