全科医疗中不孕症初始管理的开放获取输卵管评估（OATS试验）：一项实用的整群随机对照试验
Open Access Tubal aSsessment for the initial management of infertility in general practice (the OATS trial): a pragmatic cluster randomised controlled trial.
作者信息
Wilkes Scott, Murdoch Alison, Steen Nick, Wilsdon John, Rubin Greg
机构信息
Centre for Primary and Community Care, School of Health Natural and Social Sciences, University of Sunderland, Sunderland.
出版信息
Br J Gen Pract. 2009 May;59(562):329-35. doi: 10.3399/bjgp09X420590.
BACKGROUND
GPs investigate approximately half of all infertile couples with semen analysis and endocrine blood tests. For assessment of tubal status, hysterosalpingography (HSG) is recommended as a first-line investigation for women not known to have comorbidities.
AIM
To test whether providing GPs with open access to HSG results in infertile couples progressing to a diagnosis and management plan sooner than with usual management.
DESIGN OF STUDY
A pragmatic cluster randomised controlled trial.
SETTING
Seventy-one of 173 general practices in north-east England agreed to participate.
METHOD
A total of 670 infertile couples presented to 33 intervention practices and 25 control practices over a 2-year period. Practices allocated to the intervention group had access to HSG for those infertile women who fulfilled predefined eligibility criteria. The primary outcome measure was the interval between presentation to the GP and the couple receiving a diagnosis and management plan.
RESULTS
An annual incidence of 0.8 couples per 1000 total population equated to each GP seeing an average of one or two infertile couples each year. Open access HSG was used for 9% of all infertile women who presented to the intervention practices during the study period. The time to reach a diagnosis and management plan for all infertile couples presenting was not affected by the availability of open access HSG (Cox regression hazard ratio = 0.9, 95% confidence interval [CI] = 0.7 to 1.1). For couples who reached a diagnosis and management plan, there was a non-significant difference in time to primary outcome for intervention versus control practices (32.5 weeks versus 30.5 weeks, mean difference 2.2 weeks, 95% CI = 1.6 to 6.1 weeks, P = 0.1). The intracluster correlation coefficient was 0.03 across all practices.
CONCLUSION
Providing GPs with open access to HSG had no effect on the time taken to reach a diagnosis and management plan for couples with infertility.
背景
全科医生（GPs）对大约一半的不孕夫妇进行精液分析和内分泌血液检查。对于输卵管状况的评估，子宫输卵管造影术（HSG）被推荐作为对已知无合并症女性的一线检查方法。
目的
测试为全科医生提供开放获取子宫输卵管造影术（HSG）的机会是否会使不孕夫妇比常规管理更快地进入诊断和管理计划阶段。
研究设计
一项实用的整群随机对照试验。
研究地点
英格兰东北部173家全科诊所中的71家同意参与。
方法
在两年期间，共有670对不孕夫妇前往33家干预诊所和25家对照诊所就诊。分配到干预组的诊所可以为符合预定义资格标准的不孕女性进行子宫输卵管造影术（HSG）检查。主要结局指标是从向全科医生就诊到夫妇接受诊断和管理计划的时间间隔。
结果
每1000总人口中每年有0.8对夫妇的发病率相当于每位全科医生每年平均接诊一到两对不孕夫妇。在研究期间，前往干预诊所就诊的所有不孕女性中，有9%使用了开放获取的子宫输卵管造影术（HSG）。开放获取子宫输卵管造影术（HSG）的可用性并未影响所有前来就诊的不孕夫妇达成诊断和管理计划的时间（Cox回归风险比 = 0.9，95%置信区间[CI] = 0.7至1.1）。对于达成诊断和管理计划的夫妇，干预诊所和对照诊所在主要结局时间上无显著差异（32.5周对30.5周，平均差异2.2周，95%CI = 1.6至6.1周，P = 0.1）。所有诊所的组内相关系数为0.03。
结论
为全科医生提供开放获取子宫输卵管造影术（HSG）的机会对不孕夫妇达成诊断和管理计划所需的时间没有影响。
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