Khan Mishal Sameer, Dar Osman, Sismanidis Charalambos, Shah Karam, Godfrey-Faussett Peter
London School of Hygiene and Tropical Medicine, London, UK.
Lancet. 2007 Jun 9;369(9577):1955-60. doi: 10.1016/S0140-6736(07)60916-7.
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.
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.
Instructed women were more likely to test smear positive than were controls (Risk ratio 1.63 [95% CI 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.
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.
在多个地区，疑似结核病的女性痰涂片阳性检测率低于男性。女性提交质量不佳的痰标本可能是导致性别差异的一个原因。我们进行了一项实用随机对照试验，以评估痰标本提交指导对女性患者的影响。
2005年5月至7月，在巴基斯坦拉瓦尔品第的联邦结核病中心，1494名疑似结核病的女性和1561名男性被随机分配，一组在提交标本前接受痰标本提交指导，另一组按照常规做法在无特定指导的情况下提交标本。登记的患者中有133人（4%）拒绝参与。主要结局指标是接受指导和未接受指导的女性痰涂片阳性检测率。根据治疗分配进行意向性分析。本研究已在国际标准随机对照试验编号34123170注册。
接受指导的女性比对照组更有可能痰涂片呈阳性（风险比1.63[95%置信区间1.19 - 2.22]）。指导与更高的涂片阳性病例检出率相关（对照组为58例[8%]，干预组为95例[13%]；p = 0.002），唾液标本提交减少（p = 0.003），以及清晨标本返回的女性数量增加（p = 0.02）。在男性中，指导对痰涂片阳性检测率或标本质量没有显著影响。
在拉瓦尔品第的联邦结核病中心，女性痰涂片阳性率低于男性主要是由于标本提交质量差。提供简短指导可大幅提高女性的痰涂片阳性率。痰标本提交指导可能是一种极具成本效益的干预措施，可提高涂片阳性病例检出率，并减少低收入国家结核病控制中的性别差异。
