Division of Allergy and Infectious Diseases, Department of Medicine and Department of Global Health, University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.
Department of Biostatistics, Vanderbilt University, Nashville, TN, USA.
BMC Med. 2021 Aug 13;19(1):178. doi: 10.1186/s12916-021-02043-z.
Preventing unintended pregnancies is paramount for women living with HIV (WLHIV). Previous studies have suggested that efavirenz-containing antiretroviral therapy (ART) reduces contraceptive effectiveness of implants, but there are uncertainties regarding the quality of the electronic medical record (EMR) data used in these prior studies.
We conducted a retrospective, cohort study of EMR data from 2011 to 2015 among WLHIV of reproductive age accessing HIV care in public facilities in western Kenya. We validated a large subsample of records with manual chart review and telephone interviews. We estimated adjusted incidence rate ratios (aIRRs) with Poisson regression accounting for the validation sampling using inverse probability weighting and generalized raking.
A total of 85,324 women contributed a total of 170,845 women-years (w-y) of observation time; a subset of 5080 women had their charts reviewed, and 1285 underwent interviews. Among implant users, the aIRR of pregnancy for efavirenz- vs. nevirapine-containing ART was 1.9 (95% CI 1.6, 2.4) using EMR data only and 3.2 (95% CI 1.8, 5.7) when additionally using both chart review and interview validated data. Among efavirenz users, the aIRR of pregnancy for depomedroxyprogesterone acetate (DMPA) vs. implant use was 1.8 (95% CI 1.5, 2.1) in EMR only and 2.4 (95% CI 1.0, 6.1) using validated data.
Pregnancy rates are higher when contraceptive implants are concomitantly used with efavirenz-containing ART, though rates were similar to leading alternative contraceptive methods such as DMPA. Our data provides policymakers, program staff, and WLHIV greater confidence in guiding their decision-making around contraceptive and ART options. Our novel, 3-phase validation sampling provides an innovative tool for using routine EMR data to improve the robustness of data quality.
对于感染艾滋病毒的女性（WLHIV）来说，预防非意愿妊娠至关重要。既往研究表明，含依非韦伦的抗逆转录病毒治疗（ART）会降低植入物的避孕效果，但对于这些既往研究中使用的电子病历（EMR）数据的质量存在不确定性。
我们对 2011 年至 2015 年间在肯尼亚西部公立医疗机构接受艾滋病毒护理的生育年龄 WLHIV 的 EMR 数据进行了回顾性队列研究。我们通过手动图表审查和电话访谈对大量记录进行了验证。我们使用逆概率加权和广义耙式分级法，根据验证抽样，通过泊松回归估计了校正发病率比（aIRR）。
共有 85324 名妇女共提供了 170845 名妇女年（w-y）的观察时间；其中 5080 名妇女的病历得到了审查，1285 名妇女接受了访谈。在植入物使用者中，仅使用 EMR 数据时，依非韦伦与奈韦拉平 ART 相比，妊娠的 aIRR 为 1.9（95%CI 1.6，2.4），而当同时使用图表审查和访谈验证数据时，aIRR 为 3.2（95%CI 1.8，5.7）。在依非韦伦使用者中，仅在 EMR 中，醋酸甲羟孕酮（DMPA）与植入物使用相比，妊娠的 aIRR 为 1.8（95%CI 1.5，2.1），而使用验证数据时，aIRR 为 2.4（95%CI 1.0，6.1）。
当同时使用含依非韦伦的 ART 时，避孕植入物的妊娠率更高，尽管与 DMPA 等主要替代避孕方法的妊娠率相似。我们的数据为政策制定者、项目工作人员和 WLHIV 提供了更大的信心，以指导他们在避孕和 ART 选择方面做出决策。我们新颖的 3 阶段验证抽样为使用常规 EMR 数据提高数据质量的稳健性提供了创新工具。
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