Background

For persons of childbearing potential prescribed isotretinoin, the iPLEDGE program requires use of 2 simultaneous methods of contraception or commitment to abstinence.

Objective

To model the relative effectiveness of a variety of contraception strategies for patients taking isotretinoin, including those that are acceptable according to iPLEDGE.

Methods

We performed a decision analysis modeling the estimated rate of pregnancy with various contraception strategies during a typical 6-month course of isotretinoin.

Results

Tier 1 contraception options (eg, subdermal hormonal implant, intrauterine devices) each had effectiveness of >99.5% alone. When combined with a secondary form of contraception, tier 2 contraception options (eg, depot medroxyprogesterone injections, combined oral contraceptives) each had effectiveness >99%.

Limitations

Sensitivity analyses were conducted to evaluate the impact of uncertain parameters on the results.

Conclusion

There may be opportunities to simplify iPLEDGE by recognizing the high effectiveness of tier 1 contraception options and increasing use of secondary forms of contraception among those using tier 2 contraception options as their primary form of contraception. Future studies are needed to understand the most effective strategies in clinical practice to prevent unintended pregnancy for patients taking isotretinoin to improve outcomes and provide patient-centered care.

中文翻译：

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简化iPLEDGE的避孕要求：决策分析。

背景

对于育有潜在处方异维A酸的人，iPLEDGE计划要求同时使用两种避孕或禁欲方法。

目的

为服用异维A酸的患者模拟各种避孕策略的相对有效性，包括那些根据iPLEDGE可接受的策略。

方法

我们进行了一项决策分析，该模型分析了典型的异维A酸6个月疗程中采用各种避孕策略的估计怀孕率。

结果

第1层避孕方法（例如，皮下激素植入物，子宫内避孕器）各自的有效性均> 99.5％。当与第二种避孕方式结合使用时，第2层避孕方法（例如，甲羟孕酮注射液，联合口服避孕药）的有效性均大于99％。

局限性

进行了敏感性分析，以评估不确定参数对结果的影响。

结论

认识到1级避孕方案的高效性并在使用2级避孕方案作为主要避孕方式的人群中增加使用次要避孕形式，可能有机会简化iPLEDGE。需要进一步的研究来了解临床实践中最有效的策略，以防止服用异维A酸的患者意外怀孕以改善结局并提供以患者为中心的护理。