Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial.
Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial.
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DOI：
10.1016/j.ajog.2016.08.033
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发表时间：
2017-02
影响因子：
9.8
通讯作者：
Hart C
中科院分区：
文献类型：
--
作者：
Hubacher D;Spector H;Monteith C;Chen PL;Hart C
避孕有效性的测量结合了技术和使用者相关因素。观察性研究表明，与短效可逆避孕药相比，长效可逆避孕药的有效性更高。选择长效可逆避孕药的女性可能与选择短效可逆避孕药的女性在关键方面有所不同，而这些差异可能是长效可逆避孕药的高效性的原因。建议更广泛地使用长效可逆避孕药，但在通常选择短效避孕方法的人群中，缺乏可接受性和成功使用的科学证据。该研究的目的是减少测量避孕有效性的偏差，并更好地分离长效可逆避孕相对于短效可逆避孕在预防意外怀孕方面的独立作用。我们进行了一项部分随机的患者偏好试验，招募了 18-29 岁寻求短效方法（药丸或注射剂）的女性。同意随机分组的参与者被分配到以下两类中的一类：长效可逆避孕或短效可逆避孕。拒绝随机分组但同意在观察队列中进行随访的女性选择了她们喜欢的方法。在随机化下，参与者选择该类别中的一种特定方法并免费获得，而偏好队列中的参与者则以通常的方式支付避孕费用。对参与者进行前瞻性随访，以测量方法继续和 12 个月时意外怀孕的主要结局。 Kaplan-Meier 技术用于估计方法连续概率。方法开始后应用意向治疗原则来比较意外怀孕的发生率。我们还根据产品的满意度来衡量可接受性。在 916 名参与者中，43% 选择随机，57% 选择偏好选项。 12 个月时完全失访率 <2%。 12 个月方法持续概率为 63.3%（95% 置信区间，58.9–67.3）（偏好短效可逆避孕）、53.0%（95% 置信区间，45.7–59.8）（随机短效可逆避孕）和 77.8%（95% 置信区间，71.0–83.2） （随机长效可逆避孕）（涉及随机组的主要比较中 P < .001）。 12 个月累积意外怀孕概率为 6.4%（95% 置信区间，4.1–8.7）（偏好短效可逆避孕药）、7.7%（95% 置信区间，3.3–12.1）（随机短效可逆避孕药）和 0.7%（95% 置信区间，0.0–4.7）（随机长效可逆避孕）（比较随机组时 P = .01）。在仅涉及短效可逆避孕使用者的二次比较中，与随机组相比，偏好组的继续概率较高 (P = .04)。然而，短效可逆避孕随机组和短效可逆避孕偏好组的意外怀孕率在统计上相当 (P = .77)。 78% 的随机长效可逆避孕药使用者对他们的初始方法感到满意/中立，而随机短效可逆避孕药使用者的这一比例为 89% (P < .05)。然而，在 12 个月时继续使用该方法的人中，所有组都同样快乐/中立 (>90%)。即使在开始或继续短效可逆避孕的典型女性群体中，长效可逆避孕也被证明是高度可接受的。开始一年后，随机接受长效可逆避孕药的女性的继续率很高，因此与使用短效可逆避孕药的女性相比，能够更好地防止意外怀孕；这些发现归因于最初的技术，而不是经常使有效性观察估计产生偏差的潜在因素。两个短效可逆避孕组的相似模式经历为随机组和常规护理偏好组之间的普遍性提供了桥梁。增加自愿采用长效可逆避孕药的好处可能会惠及比以前想象的更广泛的人群。
Measures of contraceptive effectiveness combine technology and user-related factors. Observational studies show higher effectiveness of long-acting reversible contraception compared with short-acting reversible contraception. Women who choose long-acting reversible contraception may differ in key ways from women who choose short-acting reversible contraception, and it may be these differences that are responsible for the high effectiveness of long-acting reversible contraception. Wider use of long-acting reversible contraception is recommended, but scientific evidence of acceptability and successful use is lacking in a population that typically opts for short-acting methods. The objective of the study was to reduce bias in measuring contraceptive effectiveness and better isolate the independent role that long-acting reversible contraception has in preventing unintended pregnancy relative to short-acting reversible contraception. We conducted a partially randomized patient preference trial and recruited women aged 18–29 years who were seeking a short-acting method (pills or injectable). Participants who agreed to randomization were assigned to 1 of 2 categories: long-acting reversible contraception or short-acting reversible contraception. Women who declined randomization but agreed to follow-up in the observational cohort chose their preferred method. Under randomization, participants chose a specific method in the category and received it for free, whereas participants in the preference cohort paid for the contraception in their usual fashion. Participants were followed up prospectively to measure primary outcomes of method continuation and unintended pregnancy at 12 months. Kaplan-Meier techniques were used to estimate method continuation probabilities. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also measured acceptability in terms of level of happiness with the products. Of the 916 participants, 43% chose randomization and 57% chose the preference option. Complete loss to follow-up at 12 months was <2%. The 12 month method continuation probabilities were 63.3% (95% confidence interval, 58.9–67.3) (preference short-acting reversible contraception), 53.0% (95% confidence interval, 45.7–59.8) (randomized short-acting reversible contraception), and 77.8% (95% confidence interval, 71.0–83.2) (randomized long-acting reversible contraception) (P < .001 in the primary comparison involving randomized groups). The 12 month cumulative unintended pregnancy probabilities were 6.4% (95% confidence interval, 4.1–8.7) (preference short-acting reversible contraception), 7.7% (95% confidence interval, 3.3–12.1) (randomized short-acting reversible contraception), and 0.7% (95% confidence interval, 0.0–4.7) (randomized long-acting reversible contraception) (P = .01 when comparing randomized groups). In the secondary comparisons involving only short-acting reversible contraception users, the continuation probability was higher in the preference group compared with the randomized group (P = .04). However, the short-acting reversible contraception randomized group and short-acting reversible contraception preference group had statistically equivalent rates of unintended pregnancy (P = .77). Seventy-eight percent of randomized long-acting reversible contraception users were happy/neutral with their initial method, compared with 89% of randomized short-acting reversible contraception users (P < .05). However, among method continuers at 12 months, all groups were equally happy/neutral (>90%). Even in a typical population of women who presented to initiate or continue short-acting reversible contraception, long-acting reversible contraception proved highly acceptable. One year after initiation, women randomized to long-acting reversible contraception had high continuation rates and consequently experienced superior protection from unintended pregnancy compared with women using short-acting reversible contraception; these findings are attributable to the initial technology and not underlying factors that often bias observational estimates of effectiveness. The similarly patterned experiences of the 2 short-acting reversible contraception cohorts provide a bridge of generalizability between the randomized group and usual-care preference group. Benefits of increased voluntary uptake of long-acting reversible contraception may extend to wider populations than previously thought.