Fajardo-Bernal Luisa, Aponte-Gonzalez Johanna, Vigil Patrick, Angel-Müller Edith, Rincon Carlos, Gaitán Hernando G, Low Nicola
Clinical Research Institute, Faculty of Medicine, Universidad Nacional de Colombia, KR 30 45 03, Bogota, Colombia.
Cochrane Database Syst Rev. 2015 Sep 29;2015(9):CD011317. doi: 10.1002/14651858.CD011317.pub2.
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most frequent causes of bacterial sexually transmitted infections (STIs). Management strategies that reduce losses in the clinical pathway from infection to cure might improve STI control and reduce complications resulting from lack of, or inadequate, treatment.
To assess the effectiveness and safety of home-based specimen collection as part of the management strategy for Chlamydia trachomatis and Neisseria gonorrhoeae infections compared with clinic-based specimen collection in sexually-active people.
We searched the Cochrane Sexually Transmitted Infections Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS on 27 May 2015, together with the World Health Organization International Clinical Trials Registry (ICTRP) and ClinicalTrials.gov. We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.
Randomized controlled trials (RCTs) of home-based compared with clinic-based specimen collection in the management of C. trachomatis and N. gonorrhoeae infections.
Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We contacted study authors for additional information. We resolved any disagreements through consensus. We used standard methodological procedures recommended by Cochrane. The primary outcome was index case management, defined as the number of participants tested, diagnosed and treated, if test positive.
Ten trials involving 10,479 participants were included. There was inconclusive evidence of an effect on the proportion of participants with index case management (defined as individuals tested, diagnosed and treated for CT or NG, or both) in the group with home-based (45/778, 5.8%) compared with clinic-based (51/788, 6.5%) specimen collection (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.60 to 1.29; 3 trials, I² = 0%, 1566 participants, moderate quality). Harms of home-based specimen collection were not evaluated in any trial. All 10 trials compared the proportions of individuals tested. The results for the proportion of participants completing testing had high heterogeneity (I² = 100%) and were not pooled. We could not combine data from individual studies looking at the number of participants tested because the proportions varied widely across the studies, ranging from 30% to 96% in home group and 6% to 97% in clinic group (low-quality evidence). The number of participants with positive test was lower in the home-based specimen collection group (240/2074, 11.6%) compared with the clinic-based group (179/967, 18.5%) (RR 0.72, 95% CI 0.61 to 0.86; 9 trials, I² = 0%, 3041 participants, moderate quality).
AUTHORS' CONCLUSIONS: Home-based specimen collection could result in similar levels of index case management for CT or NG infection when compared with clinic-based specimen collection. Increases in the proportion of individuals tested as a result of home-based, compared with clinic-based, specimen collection are offset by a lower proportion of positive results. The harms of home-based specimen collection compared with clinic-based specimen collection have not been evaluated. Future RCTs to assess the effectiveness of home-based specimen collection should be designed to measure biological outcomes of STI case management, such as proportion of participants with negative tests for the relevant STI at follow-up.
沙眼衣原体（CT）和淋病奈瑟菌（NG）是细菌性性传播感染（STIs）最常见的病因。减少从感染到治愈的临床路径中损失的管理策略可能会改善性传播感染的控制，并减少因治疗不足或缺乏治疗而导致的并发症。
评估与门诊标本采集相比，家庭标本采集作为沙眼衣原体和淋病奈瑟菌感染管理策略一部分的有效性和安全性。
2015年5月27日，我们检索了Cochrane性传播感染组专业注册库、Cochrane对照试验中心注册库（CENTRAL）、MEDLINE、EMBASE和LILACS，以及世界卫生组织国际临床试验注册平台（ICTRP）和ClinicalTrials.gov。我们还手工检索了会议论文集，联系了试验作者，并查阅了检索到的研究的参考文献列表。
在沙眼衣原体和淋病奈瑟菌感染管理中，比较家庭标本采集与门诊标本采集的随机对照试验（RCTs）。
三位综述作者独立评估试验是否纳入，提取数据并评估偏倚风险。我们联系研究作者获取更多信息。我们通过协商一致解决任何分歧。我们使用Cochrane推荐的标准方法程序。主要结局是索引病例管理，定义为检测、诊断并在检测呈阳性时接受治疗的参与者数量。
纳入了10项试验，涉及10479名参与者。对于家庭标本采集组（45/778，5.8%）与门诊标本采集组（51/788，6.5%）相比，索引病例管理参与者比例（定义为检测、诊断并接受CT或NG或两者治疗的个体）的影响，证据尚无定论（风险比（RR）0.88，95%置信区间（CI）0.60至1.29；3项试验，I² = 0%，1566名参与者，中等质量）。任何试验均未评估家庭标本采集的危害。所有10项试验均比较了检测个体的比例。完成检测的参与者比例结果具有高度异质性（I² = 100%），未进行合并。我们无法合并各研究中检测参与者数量的数据，因为各研究中的比例差异很大，家庭组为30%至96%，门诊组为6%至97%（低质量证据）。家庭标本采集组检测呈阳性的参与者数量（240/2074，11.6%）低于门诊标本采集组（179/967，18.5%）（RR 0.72，95% CI 0.61至0.86；9项试验，I² = 0%，3041名参与者，中等质量）。
与门诊标本采集相比，家庭标本采集在沙眼衣原体或淋病奈瑟菌感染的索引病例管理水平上可能相似。与门诊标本采集相比，家庭标本采集导致检测个体比例增加，但阳性结果比例较低抵消了这一增加。与门诊标本采集相比，家庭标本采集的危害尚未评估。未来评估家庭标本采集有效性的随机对照试验应设计为测量性传播感染病例管理的生物学结局，如随访时相关性传播感染检测呈阴性的参与者比例。
