Steinberg E P, Holtz P M, Sullivan E M, Villar C P
Covance Health Economics and Outcomes Services Inc., Washington, DC 20005-3934, USA.
Fertil Steril. 1998 Apr;69(4):617-23. doi: 10.1016/s0015-0282(97)00566-9.
To critically appraise the content of the American Society for Reproductive Medicine (ASRM)/Society for Reproductive Technology (SART) Registry.
English-language literature review.
PATIENT(S): Women undergoing treatment with assisted reproductive technology (ART).
INTERVENTION(S): Current ART treatments, including IVF, GIFT, zygote intrafollopian transfer (ZIFT), oocyte micromanipulation, and cryopreserved embryo transfers.
MAIN OUTCOME MEASURE(S): Compliance with clinical practice guidelines, and casemix-adjusted rates of live delivery, clinical pregnancy, ectopic pregnancy, miscarriage, birth defects, implantation, fertilization, and retrieval.
RESULT(S): Outcomes should be adjusted for variation in patient characteristics known to affect prognosis, including maternal age, the duration of infertility, the presumed cause(s) of infertility, the patient's prior history of treatment for infertility, and diethylstilbestrol exposure. Outcome rates should be reported using the patient as the denominator, as well as cycle, retrieval, and transfer. The statistical significance of observed differences in events rates should be indicated. Because widely accepted clinical practice guidelines related to performance of ART procedures are not available, compliance with practice guidelines cannot currently be assessed.
CONCLUSION(S): Reports based on ASRM/SART Registry data can be enhanced by refined casemix adjustment, assessing outcome rates per patient, as well as per component of ART procedure, and by providing an indication of the statistical significance of observed differences in event rates. In addition, a critical appraisal of available evidence related to particular aspects of infertility management would help clarify the areas in which there is an evidentiary basis for formulation of practice guidelines, as well as topics requiring additional clinical research.
严格评估美国生殖医学学会（ASRM）/生殖技术学会（SART）登记处的内容。
英文文献综述。
接受辅助生殖技术（ART）治疗的女性。
当前的ART治疗方法，包括体外受精（IVF）、配子输卵管内移植（GIFT）、合子输卵管内移植（ZIFT）、卵母细胞显微操作以及冷冻胚胎移植。
符合临床实践指南情况，以及经病例组合调整后的活产率、临床妊娠率、异位妊娠率、流产率、出生缺陷率、着床率、受精率和取卵率。
应针对已知会影响预后的患者特征差异进行结果调整，这些特征包括产妇年龄、不孕持续时间、推测的不孕原因、患者既往的不孕治疗史以及己烯雌酚暴露情况。结果率应以患者为分母进行报告，同时也应按周期、取卵和移植情况报告。应指出观察到的事件率差异的统计学显著性。由于目前尚无关于ART程序操作的广泛接受的临床实践指南，因此目前无法评估对实践指南的依从性。
通过完善病例组合调整、评估每位患者以及ART程序各组成部分的结果率，并指明观察到的事件率差异的统计学显著性，可增强基于ASRM/SART登记处数据的报告。此外，对不孕管理特定方面的现有证据进行严格评估将有助于明确哪些领域有制定实践指南的证据基础，以及哪些主题需要进一步的临床研究。
