Pfizer Inc, Groton, CT, USA.
Pfizer Inc, New York, NY, USA.
J Sex Med. 2018 May;15(5):732-740. doi: 10.1016/j.jsxm.2018.03.078.
Patient-reported outcomes, such as the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index, are essential for successful evaluation and treatment of patients with erectile dysfunction.
To enrich interpretation of the EDITS index score and to complement the existing 0 to 100 scoring.
This supplemental analysis evaluated EDITS questionnaire data (11 items; index score range = 0-100; higher scores indicate more treatment satisfaction) after completion of an 8-week double-blinded trial of 279 men 18 to 65 years old with erectile dysfunction randomized to sildenafil 100 mg, sildenafil 50 mg, or placebo. Response options for each EDITS item were grouped into "success" (the 2 most satisfied or favorable responses) and "no success" (the remaining 3 responses). The binary response (success or no success) for each item was expressed as a function of overall EDITS score in a simple logistic regression model with all treatments combined.
Odds ratios and success probabilities (using Wald χ tests) were calculated for specified point differences and total EDITS index scores, respectively.
EDITS index score increases corresponded with significant increases in odds of success in different EDITS aspects (P < .0001 for all comparisons). For instance, a 10-point EDITS index score difference was associated with odds ratios of 11.3, 42.0, 17.7, and 6.8 for overall treatment satisfaction, treatment meeting expectations, satisfaction with treatment quickness, and satisfaction with how long treatment lasts, respectively. For a given EDITS index score, likelihood of success was determined for different aspects of treatment satisfaction. For example, a mean EDITS index score of 78 (sildenafil 100 mg; SD = 18) corresponded to 96%, 88%, 94%, and 88% chances of success for the 4 EDITS items referenced earlier, respectively. Corresponding probabilities for a mean EDITS index score of 50 (placebo; SD = 18) were 3%, less than 0.1%, 1%, and 4%, respectively.
Interpretation of the EDITS index score can be augmented using key aspects of treatment satisfaction as reported by the patient.
This analysis used a well-established anchor-based approach to interpret EDITS index scores. The methodology used and corresponding results are appropriate for clinical practice and clinical trial settings. Limitations include data evaluation only for the Patient EDITS and not the complementary Partner EDITS and use of data from a clinical trial enrolling a well-defined patient population only in stable relationships.
These results enable a meaningful interpretation of EDITS index scores, facilitating decision making by stakeholders for better-informed health care choices. Cappelleri JC, Tseng L-J, Stecher V, Goldstein I. Enriching the Interpretation of the Erectile Dysfunction Inventory of Treatment Satisfaction: Characterizing Success in Treatment Satisfaction. J Sex Med 2018;15:732-740.
患者报告的结果,如治疗满意度的勃起功能障碍量表(EDITS)指数,对于成功评估和治疗勃起功能障碍患者至关重要。
丰富 EDITS 指数评分的解释,并补充现有的 0 到 100 的评分。
本补充分析评估了 EDITS 问卷数据(11 项;指数评分范围为 0-100;评分越高表示治疗满意度越高),该数据来自一项为期 8 周的、279 名年龄在 18 至 65 岁之间的勃起功能障碍男性的双盲试验,这些男性被随机分配接受西地那非 100mg、西地那非 50mg 或安慰剂治疗。EDITS 每个项目的回答选项分为“成功”(最满意或最有利的两个回答)和“不成功”(其余 3 个回答)。使用所有治疗方法的简单逻辑回归模型,将每个项目的二进制(成功或不成功)反应表示为整体 EDITS 评分的函数。
EDITS 指数评分的增加与不同 EDITS 方面的成功几率增加相对应(所有比较的 P<0.0001)。例如,EDITS 指数评分差异 10 分与总体治疗满意度、治疗符合预期、治疗迅速满意度和治疗持续时间满意度的成功几率比值分别为 11.3、42.0、17.7 和 6.8。对于给定的 EDITS 指数评分,可以确定不同治疗满意度方面的成功可能性。例如,西地那非 100mg 组平均 EDITS 指数评分为 78(SD=18),分别对应 4 个 EDITS 项目的成功率为 96%、88%、94%和 88%,而安慰剂组平均 EDITS 指数评分为 50(SD=18),相应的成功率分别为 3%、小于 0.1%、1%和 4%。
使用患者报告的治疗满意度关键方面可以补充 EDITS 指数评分的解释。
本分析使用了一种成熟的基于锚定的方法来解释 EDITS 指数评分。所使用的方法和相应的结果适用于临床实践和临床试验环境。局限性包括仅评估患者的 EDITS,而不是互补的伴侣 EDITS,并且仅使用稳定关系中定义明确的患者人群的临床试验数据。
这些结果使 EDITS 指数评分的解释更加有意义,为利益相关者做出更好的知情医疗保健选择提供了决策支持。Cappelleri JC、Tseng L-J、Stecher V、Goldstein I。丰富治疗满意度勃起功能障碍量表的解释:确定治疗满意度方面的成功。性医学杂志 2018;15:732-740。