Novák Annoesjka, de la Loge Christine, Abetz Linda
N.V. Organon, Oss, The Netherlands.
Pharmacoeconomics. 2004;22(4):245-56. doi: 10.2165/00019053-200422040-00003.
To validate an acceptability questionnaire for NuvaRing, a new combined contraceptive vaginal ring.
A 21-item questionnaire was developed covering: ease of ring use, ease of package use, clarity of instructions, sexual comfort, cycle-related characteristics, compliance and satisfaction. A total of 2145 women completed the questionnaire after 3, 6 or 13 cycles of NuvaRing use. The psychometric properties and predictive value of the questionnaire were assessed using cycle 3 data (n = 1950). The quality of completed questionnaires, item content analysis, construct validity, internal consistency reliability, known groups validity and predictive validity were evaluated.
Excluding non-ordinal items, 0.6% of the data were missing. Principal component analysis of 15 ordinal items indicated that two hypothesised dimensions ('ease of package use' and 'clarity of instructions') were consistently linked and so were combined into a single 'ease of comprehension' scale. Item convergent validity (the degree of correlation between an item and its own scale) was 100% for 'ease of ring use' (r = 0.44) and 'satisfaction' (r = 0.58), 83% for 'ease of comprehension' (r = 0.25-0.62) and 67% (r = 0.38-0.54) for 'sexual comfort', but 0% for 'cycle-related characteristics' (r = 0.31). Item discriminant validity (the degree to which an item correlates with its own scale compared with other scales) was >/=96% for all dimensions. Internal consistency reliability was acceptable for all dimensions (adjusted Cronbach's alpha coefficient >0.70). Satisfaction was higher than in the complementary groups for respondents who had no adverse events, chose NuvaRing as the best method of contraception or completed the study; this indicated good known groups validity. Low satisfaction with the method was a good predictor of early discontinuation after cycle 3, indicating that the questionnaire had good predictive validity.
The acceptability questionnaire has good psychometric properties and can predict early discontinuation of the NuvaRing vaginal ring method of contraception.
验证一种针对新型复方避孕阴道环NuvaRing的可接受性调查问卷。
编制了一份包含21个条目的问卷，内容涵盖：环的使用便捷性、包装使用便捷性、说明清晰度、性舒适度、与月经周期相关的特征、依从性和满意度。共有2145名女性在使用NuvaRing 3个、6个或13个周期后完成了问卷。使用第3周期的数据（n = 1950）评估问卷的心理测量特性和预测价值。对完成问卷的质量、条目内容分析、结构效度、内部一致性信度、已知群组效度和预测效度进行了评估。
排除非有序条目后，0.6%的数据缺失。对15个有序条目的主成分分析表明，两个假设维度（“包装使用便捷性”和“说明清晰度”）始终相关，因此合并为一个“易于理解”量表。“环的使用便捷性”（r = 0.44）和“满意度”（r = 0.58）的条目收敛效度（一个条目与其自身量表之间的相关程度）为100%，“易于理解”为83%（r = 0.25 - 0.62），“性舒适度”为67%（r = 0.38 - 0.54），但“与月经周期相关的特征”为0%（r = 0.31）。所有维度的条目区分效度（一个条目与其自身量表相比与其他量表的相关程度）均≥96%。所有维度的内部一致性信度均可接受（调整后的Cronbach's alpha系数>0.70）。对于没有不良事件、选择NuvaRing作为最佳避孕方法或完成研究的受访者，满意度高于互补组；这表明已知群组效度良好。对该方法的低满意度是第3周期后提前停用的良好预测指标，表明该问卷具有良好的预测效度。
该可接受性调查问卷具有良好的心理测量特性，能够预测NuvaRing阴道环避孕方法的早期停用情况。
