Can an educational program optimize PDE5i therapy? A study of Canadian primary care practices
ABSTRACT Introduction. The importance of patient instructions, designed to optimize therapy with phosphodiesterase type 5 inhibitors for the treatment of erectile dysfunction (ED), has recently been demonstrated. Aim. To evaluate the impact of an educational program for new sildenafil users against usual ED management in Canadian primary care practices. Methods. This multicenter, 6-month cluster randomized prospective study was conducted across Canada in general practitioners' offices where sites were randomized to receive a treatment optimization program (TOP) tool at visit I (TOP sites) or not to receive the TOP tool (non-TOP sites) while continuing with usual practice. Study participants were men seeking medical attention for ED and who were sildenafil naive. The TOP tool consisted of a tear-off sheet, a brochure, and a video. Study drug was not provided to the patients. Sildenafil samples and prescriptions were dispensed as per usual care practices. Main Outcome Measures. The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used to determine treatment satisfaction at visit 2 (month 3) and visit 3 (month 6). Patient and physician satisfaction with the TOP tool was assessed using self-reported questionnaires. Results. The intent-to-treat (ITT) population consisted of 2,573 patients from 231 primary care sites. At visits 2 and 3, treatment satisfaction with sildenafil was high with almost 9 patients out of 10 satisfied with treatment. No significant statistical differences were observed in the EDITS scores between the TOP and the non-TOP groups at visits 2 and 3. More than 80% of the participants were satisfied or very satisfied with the video and the brochure. More than 8 out of 10 participating physicians (84%) would use the TOP tool in their current practice if available. Conclusions. TOP is a valuable and time-efficient ED management tool providing benefits to newly diagnosed ED patients and to their physicians.
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ABSTRACT: While the efficacy of sildenafil for the management of erectile dysfunction (ED) has been demonstrated in randomized clinical trials, few data exist on its effectiveness in a real-life setting. The objective of this study was to examine the treatment satisfaction and effectiveness with sildenafil in a real-life setting in Canada. A multicenter, prospective study, using an educational program aimed at optimizing sildenafil treatment, was conducted at 231 primary care sites across Canada. Patients who received their first prescription of sildenafil for ED within the usual practice of medicine were invited to participate in the study. Data were collected through patient self-administered questionnaires. The Sexual Health Inventory for Men (SHIM) questionnaire was used to determine the erectile function at baseline, month 3 and month 6. Treatment satisfaction at months 3 and 6 was assessed using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. The intent-to-treat population consisted of 2,573 patients. The mean age was 55 years (18 to 92 years). At baseline, the mean SHIM score was 11.9 with 21.7% of men having severe ED, 22.9% moderate ED, 36.5% mild-to-moderate ED, and 16.9% mild ED. At month 3, the mean SHIM score improved significantly to 18.0 (P < 0.0001) and 33.3% of patients had a SHIM score above 21 (no ED). At 6 months, the mean SHIM score was 18.7. At both months 3 and 6, approximately 89% of patients were satisfied with their treatment (i.e., EDITS score >or= 50), suggesting no attenuation of the satisfaction over the 6 months of use. The effectiveness of sildenafil in the management of ED was demonstrated in a large cohort of men treated in a primary care setting in this Canadian real-life study. Persistence with therapy and lack of attenuation over time among the vast majority of men was shown.Journal of Sexual Medicine 10/2007; 4(5):1414-21. DOI:10.1111/j.1743-6109.2007.00555.x · 3.15 Impact Factor
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ABSTRACT: Neither men with erectile dysfunction (ED) nor their physicians are willing to discuss sexual problem sufficiently. Written information material could facilitate a dialogue and encourage men to seek treatment. The central task of this article was to determine the effectiveness and acceptance of patient information material for sexual dysfunction. Through an information campaign, men received informational material. Eight thousand men also received a first survey, which asked about the intention to seek treatment and to discuss the sexual problem with a physician or partner. A second follow-up questionnaire, 3-6 months after the first one, asked for the implementation of these intentions. Descriptive and regression-based analyses were applied. Help-seeking behavior, subjective assessment of change in disease severity and partnership quality, satisfaction. Four hundred forty-three men participated in both surveys. Nearly 90% of them became active after reading the information material. More than half talked with their partner (57.8%) and a physician (65%), and one-third sought treatment (31.8%). Especially discussing the problem with the partner and receiving treatment improved erectile functioning and led to an increase in the quality of partnership (P </= 0.05). The initial intention to become active was a good predictor for completing an action. The main reasons for not becoming active were inhibitions to talk about ED (46.8%) and fear of a medical examination (27.7%). Overall, the results demonstrate that written information material is a useful resource for men with ED, because it evokes a high help-seeking behavior. It was perceived both to improve the sexual problem as well as to increase the quality of partnership. Providing such material in the medical practice may be an appropriate way to overcome inhibitions and to initiate dialogue with affected men. However, the results must be interpreted with caution because of possible motivationally driven self-selection bias.Journal of Sexual Medicine 03/2008; 5(2):436-47. DOI:10.1111/j.1743-6109.2007.00673.x · 3.15 Impact Factor
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ABSTRACT: Studies evaluating the effect of education on treatment success with phosphodiesterase type 5 (PDE5) inhibitor therapy in men with erectile dysfunction (ED) are limited. Additional education of the primary care physician (PCP) and the patient are thought to optimize the treatment of ED. To assess the impact of education of the PCP or of the patient in the treatment of ED with vardenafil relative to usual care. In this 12-week, open-label, multicenter, factorial-designed, cluster-randomized Canadian study, 1,029 patients with ED were enrolled into four different education groups: usual care, patient education, PCP education, and both PCP and patient education. All groups started on vardenafil 10 mg, with the option to titrate at weeks 4 and 8. The primary efficacy measure was the difference at week 4 last observation carried forward (LOCF) in the overall improvement in erectile function (EF) as measured by the Global Assessment Question (GAQ), while on background vardenafil, between those receiving education vs. those who did not. Other secondary assessments included responses to diary questions regarding penetration (sexual encounter profile, SEP2) and erection maintenance (SEP3), and to questionnaires regarding treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction [EDITS]). A total of 956 patients were included in the intent-to-treat population. Mean baseline International Index of Erectile Function-EF domain score was 13. GAQ response rates at week 4 LOCF were high (>80%) for all groups, regardless of the education given. Mean per patient SEP2 and SEP3 rates at week 12 LOCF were 86-89% and 79-83%, respectively. In an exploratory analysis, a positive relationship between GAQ responses and EDITS scores was observed (P < or = 0.0007). Vardenafil was generally well tolerated. In men with moderate ED, vardenafil led to high success rates and satisfaction regardless of the education given. The benefits of education for PCP and patients in Canada were possibly masked by a ceiling effect in this study population.Journal of Sexual Medicine 04/2008; 5(3):705-15. DOI:10.1111/j.1743-6109.2007.00716.x · 3.15 Impact Factor