QUADAS评分标准翻译稿件

蓝鱼o_0

1、病例谱是否包含了各种病例及易混淆的疾病病例？（疾病谱组成）
Was the spectrum of patients representative of the patients who will receive the test in practice?
是：纳入的病离谱能够代表临床实践中接受该检查的患者群
Studies should score "yes" for this item if you believe, based on the information reported or obtained from the study's authors, that the spectrum of patients included in the study was representative of those in whom the test will be used in practice.
否：研究招募的是健康对照组或已知患有目标疾病的患者组，或研究人群不符合事先界定何种病例谱
If you think that the population studied does not fit into what you specified as acceptable, the item should be scored as "no".
不清楚：信息不全，无法判断
If there is insufficient information available to make a judgement then it should be scored as "unclear".

2、研究对象的选择标准是否明确？（选择标准）
Were selection criteria clearly described?
是：研究提供如何选择受试者的所有信息
If you think that all relevant information regarding how participants were selected for inclusion in the study has been provided then this item should be scored as "yes".
否：研究的选择标准没有明确报告
If study selection criteria are not clearly reported then this item should be scored as "no".
不清楚：研究仅报告了部分选择标准，且现有的信息不足
In situations where selection criteria are partially reported and you feel that you do
not have enough information to score this item as "yes",then it should be scored as "unclear".

3、金标准是否能准确区分有病、无病状态？（金标准）
Is the reference standard likely to correctly classify the target condition?
是：金标准能够准确区分目标疾病后者已经是现有的最佳方法
If you believe that the reference standard is likely to correctly classify the target condition or is the best method available, then this item should be scored "yes".
否：金标准不太可能准确区分目标疾病
If you do not think that the reference standard was likely to have correctly classified the target condition then this item should be scored as "no".
不清楚：判断依据不足
If there is insufficient information to make a judgement then this should be
scored as "unclear".

4、金标准和待评价试验检测的间隔时间是否足够短，以避免出现疾病病情的变化？（疾病进展偏倚）
Is the time period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests?
是：A 进展速度快的疾病，金标准和诊断性试验的检测时间间隔约为数小时或数日；B 慢性病，疾病状态可能不会在一周、一个月甚至更长的时间内发生变化，这是虽然诊断性试验和金标准的检测时间间隔较长，但仍可以评价为“是”
For conditions that progress rapidly even a delay of several days may be important. For such conditions this item should be scored "yes" if the delay between
the performance of the index and reference standard is very short, a matter of hours or days. However, for chronic conditions disease status is unlikely to change in a week, or a month, or even longer. In such conditions longer
delays between performance of the index and reference standard may be scored as "yes".
否：金标准和诊断性试验的检测时间间隔太长，其间疾病状态可能已经发生变化
If you think the time period between the performance of the index test and the reference standard was sufficiently long that disease status may have changed between the performance of the two tests then this item should be
scored as "no".
不清楚：信息不足
If insufficient information is provided this should be scored as "unclear".

5、是否所有的样本或随机选择的样本均接受了金标准试验？（部分参照偏倚Partial verification biaswork-up bias, selection bias, or sequential ordering bias）
Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis
是：所有接受了诊断性试验的患者或随机选择的患者,均通过金标准证实其疾病状态
If it is clear from the study that all patients, or a random selection of patients, who received the index test went on to receive verification of their disease status using a reference standard then this item should be scored as "yes".
否：部分接受了诊断性试验的患者，没有通过金标准证证实其真实的疾病状态，且接受金标准检测的患者不是随机选择的
If some of the patients who received the index test did not receive verification of their true disease state, and the selection of patients to receive the reference standard was not random, then this item should be scored as "no".
This item should be scored as yes even if the reference standard was not the same for all patients. [详细解说请见下文]
不清楚：研究没有报告该信息
If this information is not reported by the study then it should be scored as "unclear".

6、是否所有病例无论待评价试验的结果如何，都接受了相同的金标准试验？（多重参照偏倚）
Did patients receive the same reference standard regardless of the index test result
是：患者通过相同的金标准证实了其真正的疾病状态
If it is clear that patients received verification of their true disease status using the same reference standard then this item should be scored as "yes".
否：部分患者通过另一种不同的金标准证实
If some patients received verification using a different reference standard this item
should be scored as "no".
不清楚：研究没有报告该信息
If this information is not reported by the study then it should be scored as "unclear".

7、金标准试验是否独立于待评价试验（即待评价试验不包含在金标准中）？（混合偏倚）
Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard
是：诊断性试验不是金标准组成部分
If it is clear from the study that the index test did not form part of the reference standard then this item should be scored as "yes".
否：诊断性试验是金标准组成部分
If it appears that the index test formed part of the reference standard then this item should be scored as "no".
不清楚：研究没有报告该信息
If this information is not reported by the study then it should be scored as "unclear"

8、待评价试验的操作是否描述得足够清楚且可进行重复？（待评价试验的实施）
Was the execution of the index test described in sufficient detail to permit replication of the test?
9、金标准试验的操作是否描述的足够清楚且可以进行重复？（金标准的实施）
Was the execution of the reference standard described in sufficient detail to permit its replication?

是：研究报告或引用了足够的信息保证诊断性试验的可重复性
If the study reports sufficient details or citations to permit replication of the index test and reference standard then these items should be scored as "yes".
否：研究未报告或引用了足够的信息保证诊断性试验的可重复性
In other cases these items should be scored as "no".
不清楚：进描述了待评价试验实施过程的部分细节，没有足够的证据将该条目评价为“是”
In situations where details of test performance are partially reported and you feel that you do not have enough information to score this item as "yes", then it should be scored as "unclear".

10、待评价试验的结果判读是否是在不知晓金标准试验结果的情况下进行的？（试验解读偏倚）
Were the index test results interpreted without knowledge of the results of the reference standard?
11、金标准试验的结果判读是否是在不知晓待评价试验结果的情况下进行的？（金标准解读偏倚）
Were the reference standard results interpreted without knowledge of the results of the index test?

是：研究明确指出，待评价试验的结果判读是在不知晓金标准试验结果的情况下进行的
If the study clearly states that the test results (index or reference standard) were interpreted blind to the results ofthe other test then these items should be scored as "yes".
否：情况并非“是”
If this does not appear to be the case they should be scored as "no".
不清楚：研究没有报告该信息
If this information is not reported by the study
then it should be scored as "unclear".

12、当解释试验结果时可获得的临床资料是否与实际应用中可获得的临床资料一致?（临床解读偏倚）*
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?
是：临床实际判读试验时，通常都能够获取临床资料且判读待评价试验时也能够获取类似的资料；临床实际判读试验时，不能够获取临床资料且判读待评价试验时也能够获取类似的资料
If clinical data would normally be available when the test is interpreted in practice and similar data were available when interpreting the index test in the study then this item should be scored as "yes". Similarly, if clinical data would not be available in practice and these data were not available when the index test results were interpreted then this item should be scored as "yes"
否：情况并非“是”
If this is not the case then this item should be scored as "no".
不清楚：研究没有报告该信息
If this information is not reported by the study then it should be scored as "unclear".

13、是否报告了难以解释/中间试验结果？（难以解释的试验结果）
Were uninterpretable/ intermediate test results reported?
是：在研究报告中铭刻清楚地判断包括，难以解释的/不确定的/中间试验的结果在所有实验结果中都已经报告
If it is clear that all test results, including uninterpretable/indeterminate/intermediate are reported then this item should be scored as "yes".
否：若事实上已经出现了这样的结果，但研究没有报告
If you think that such results occurred but have not been reported then this item should be scored as "no".
不清楚：若无法确定是否所有的的实验结果均已报告
If it is not clear whether all study results have been reported then this item should be scored as "unclear".

14、对退出研究的病例是否进行解释？（退出病例）
Were withdrawals from the study explained?
是：在研究报告中铭刻清楚地判断进入研究的所有话者的情况均已报告，如受试者的流程图
If it is clear what happened to all patients who entered the study, for example if a flow diagram of study participants is reported, then this item should be scored as "yes".
否：若发现进入研究的部分患者并没有完成研究，既没有接受待评价试验和金标准的检测，且研究报告没有对这些患者作出说明
If it appears that some of the participants who entered the study did not complete the study, i.e. did not receive both the index test and reference standard, and these patients were not accounted for then this item should be scored as
"no".
不清楚：无法确定是否进入研究的所有患者都都作出了说明
If it is not clear whether all patients who entered the study were accounted for then this item should be scored as "unclear".