GRADE evidence profile: should commercial serological tests be used as a replacement test for conventional tests such as smear microscopy in patients of any age suspected of having pulmonary tuberculosis?

Based on sample size = 8,318, sensitivity median = 64%, specificity median = 91%. The quality of evidence was rated as high (no points subtracted), moderate (one point subtracted), low (two points subtracted), or very low (>2 points subtracted) based on five factors: study limitations, indirectness of evidence, inconsistency in results across studies, imprecision in summary estimates, and likelihood of publication bias. For each outcome, the quality of evidence started at high when there were randomized controlled trials or high-quality observational studies (cross-sectional or cohort studies enrolling patients with diagnostic uncertainty) and at moderate when these types of studies were absent. No points were subtracted when there were negligible issues identified; one point was subtracted when there was a serious issue identified; two points were subtracted when there was a very serious issue identified in any of the criteria used to judge the quality of evidence. Points subtracted are in parentheses. Publication bias was rated as “not likely,” “likely,” or “very likely” [23].aWhat do these results mean given 10% or 30% disease prevalence among individuals being screened for TB?bOutcomes were ranked by their relative importance as critical, important, or of limited importance. Ranking helped to focus attention on those outcomes that were considered most important.cThe majority of studies lacked a representative patient population and were not blinded.dAlthough diagnostic accuracy is considered a surrogate for patient-important outcomes, we did not downgrade.eThere was considerable heterogeneity in study results.fWe did not pool accuracy estimates. The 95% CIs were wide for many individual studies. We did not downgrade as there were a large number of studies and we had already taken off two points for inconsistency.gData included in the review did not allow for formal assessment of publication bias using methods such as funnel plots or regression tests. Therefore, publication bias cannot be ruled out. It is prudent to assume some degree of publication bias as studies showing poor performance of serological tests were probably less likely to be published. No points were deducted.

基于样本量8,318，敏感度中位数达64%，特异性中位数达91%。证据质量根据五个因素进行评估：研究局限性、证据的间接性、研究结果的不一致性、总结估计的不精确性以及发表偏倚的可能性。证据质量被评定为高（无扣除分）、中等（扣除一分）、低（扣除两分）或非常低（扣除超过两分）。评分依据包括：研究局限性、证据的间接性、研究结果的不一致性、总结估计的不精确性以及发表偏倚的可能性。对于每个结果，当存在随机对照试验或高质量观察性研究（横断面研究或队列研究，纳入诊断不确定的患者）时，证据质量从高开始评定；当这些类型的研究不存在时，评定为中等。若发现可忽略的问题，则不扣除分数；若发现严重问题，则扣除一分；若在用于判断证据质量的标准中存在非常严重的问题，则扣除两分。扣除的分数用括号标注。发表偏倚被评定为“不太可能”、“可能”或“非常可能”[23]。考虑到接受结核病筛查的个人中10%或30%的疾病患病率，这些结果意味着什么？根据相对重要性对结果进行排序，将其分为关键、重要或有限重要。排序有助于集中关注被认为最重要的结果。大多数研究缺乏代表性的患者群体，且未进行盲法研究。尽管诊断准确性被视为患者重要结果的替代指标，但我们并未降低评级。研究结果存在显著的异质性。我们没有合并准确性估计。许多个别研究的95%置信区间较宽。由于有大量研究，并且我们已经因不一致性扣除了两分，因此我们没有进一步降低评级。综述中的数据不允许使用如漏斗图或回归测试等方法对发表偏倚进行正式评估。因此，无法排除发表偏倚的存在。考虑到表现不佳的血清学检测研究可能不太可能被发表，谨慎起见，应假定存在一定程度的研究发表偏倚。未扣除分数。