Improvement of tuberculosis case detection and reduction of discrepancies between men and women by simple sputum-submission instructions: a pragmatic randomised controlled trial
Improvement of tuberculosis case detection and reduction of discrepancies between men and women by simple sputum-submission instructions: a pragmatic randomised controlled trial
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DOI：
10.1016/s0140-6736(07)60916-7
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发表时间：
2007-06-09
期刊：
影响因子：
168.9
通讯作者：
Godfrey-Faussett, Peter
中科院分区：
文献类型：
--
作者：
Khan, Mishal Sameer;Dar, Osman;Godfrey-Faussett, Peter
背景：在一些情况下，怀疑患有结核病的妇女比男性更不可能检测出涂片阳性。女性提交的劣质痰标本可能是造成两性差异的原因之一。我们进行了一项实用的随机对照试验，以评估提交痰液说明对女性患者的影响。方法对2005年5月至7月在巴基斯坦拉瓦尔品第联邦结核病中心就诊的1494名女性和1561名男性疑似结核病患者进行随机分组，根据流行做法，在提交标本前接受痰液提交指导，或在没有具体指导的情况下提交标本。在纳入的患者中，133例（4%）拒绝参与。主要结果测量是指导和非指导妇女涂片阳性的比例。意向治疗分析是在治疗分配的基础上进行的。本研究已注册国际标准随机对照试验，注册号为34123170。接受指导的女性比对照组更有可能检测出涂片阳性（风险比1.63 [95% Cl 1.19-2.22]）。指导与较高的痰检阳性病例检出率（对照组为58例[8%]，干预组为95例[13%]；p=0.002）、唾液点提交减少（p=0.003）以及清晨带回标本的妇女人数增加（p=0.02）相关。在男性中，检查说明对涂片阳性比例或标本质量没有显著影响。在拉瓦尔品第联邦结核病中心，女性涂片阳性率低于男性，主要是由于提交的标本质量差。通过提供简短的指导，妇女的涂片阳性大大增加。提交痰液指南可能是一种极具成本效益的干预措施，可改善痰检阳性病例的发现，并缩小低收入国家结核病控制方面的性别差异。
Background In several settings, women with suspected tuberculosis are less likely to test smear positive than are men. Submission of poor-quality sputum specimens by women might be one reason for the difference between the sexes. We did a pragmatic randomised controlled trial to assess the effect of sputum-submission instructions on female patients.Methods 1494 women and 1561 men with suspected tuberculosis attending the Federal Tuberculosis Centre in Rawalpindi, Pakistan, were randomly assigned between May and July, 2005 either to receive sputum-submission guidance before specimen submission or to submit specimens without specific guidance, according to prevailing practice. Of enrolled patients, 133 (4%) declined to participate. The primary outcome measure was the proportion of instructed and non-instructed women testing smear positive. Intention-to-treat analysis was undertaken on the basis of treatment allocation. This study is registered with the International Standard Randomised Controlled Trial number 34123170.Findings Instructed women were more likely to test smear positive than were controls (Risk ratio 1.63 [95% Cl 1.19-2.22]). Instructions were associated with a higher rate of smear-positive case detection (58 [8%] in controls vs 95 [13%] in the intervention group; p=0.002), a decrease in spot-saliva submission (p=0.003), and an increase in the number of women returning with an early-morning specimen (p=0.02). In men, instructions did not have a significant effect on the proportion testing smear positive or specimen quality.Interpretation In the Federal Tuberculosis Centre in Rawalpindi, lower smear positivity in women than in men was mainly a function of poor-quality specimen submission. Smear positivity in women was increased substantially by provision of brief instructions. Sputum-submission guidance might be a highly cost-effective intervention to improve smear-positive case detection and reduce the disparity between the sexes in tuberculosis control in low-income countries.