Brock Gerald, Carrier Serge, Casey Richard, Tarride Jean-Eric, Elliott Stacey, Dugré Hélène, Rousseau Catherine, D'Angelo Pina, Defoy Isabelle
Department of Urology, St. Joseph's Healthcare, London, Ontario, Canada.
J Sex Med. 2007 Sep;4(5):1404-13. doi: 10.1111/j.1743-6109.2007.00549.x. Epub 2007 Jul 18.
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.
To evaluate the impact of an educational program for new sildenafil users against usual ED management in Canadian primary care practices.
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 1 (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 naïve. 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.
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.
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.
TOP is a valuable and time-efficient ED management tool providing benefits to newly diagnosed ED patients and to their physicians.
旨在优化5型磷酸二酯酶抑制剂治疗勃起功能障碍（ED）的患者指导的重要性最近已得到证实。
评估针对新使用西地那非的患者开展的教育项目对加拿大初级医疗实践中常规ED管理的影响。
这项多中心、为期6个月的整群随机前瞻性研究在加拿大各地的全科医生办公室进行，研究地点被随机分为在第1次就诊时接受治疗优化项目（TOP）工具（TOP组）或不接受TOP工具（非TOP组），同时继续常规诊疗。研究参与者为因ED寻求医疗帮助且未使用过西地那非的男性。TOP工具包括一张可撕下的纸、一本小册子和一段视频。未向患者提供研究药物。西地那非样本和处方按照常规护理做法发放。
使用治疗满意度勃起功能障碍量表（EDITS）问卷来确定在第2次就诊（第3个月）和第3次就诊（第6个月）时的治疗满意度。使用自我报告问卷评估患者和医生对TOP工具的满意度。
意向性分析（ITT）人群包括来自231个初级医疗地点的2573名患者。在第2次和第3次就诊时，对西地那非的治疗满意度较高，每10名患者中近9名对治疗满意。在第2次和第3次就诊时，TOP组和非TOP组之间的EDITS评分未观察到显著统计学差异。超过80%的参与者对视频和小册子满意或非常满意。超过十分之八的参与医生（84%）表示如果有TOP工具，会在当前诊疗中使用。
TOP是一种有价值且省时的ED管理工具，对新诊断的ED患者及其医生都有益处。
