诊断性临床研究报告规范-——STARD规范解读

章节与主题

项目

 解释

On page

TITLE/ABSTRACT/
KEYWORDS
题目摘要关键词

1

Identify the article as a study of diagnostic accuracy (recommend MeSH heading 'sensitivity and specificity').
确定文章为诊断性研究，推荐用MESH主题词作为关键词

INTRODUCTION
前言

2

State the research questions or study aims, such as estimating diagnostic accuracy or comparing accuracy between tests or across participant groups.
描述研究目的或问题，如评估诊断准确性或比较不同诊断方法之间的差异，或比较不同人群间差异

METHODS

Participants
受试者

3

The study population: The inclusion and exclusion criteria, setting and locations where data were collected.
研究人群：纳入与排除标准，数据收集的背景和地点

4

Participant recruitment: Was recruitment based on presenting symptoms, results from previous tests, or the fact that the participants had received the index tests or the reference standard?
受试者招募：基于症状表现，既往检查结果或是受试已接受过待测检测，或初步检测，或金标准检测的结果。

5

Participant sampling: Was the study population a consecutive series of participants defined by the selection criteria in item 3 and 4? If not, specify how participants were further selected.
抽样：研究人群是否根据条目3，4中的选择标准确定序列？如果否，请描述如何确定样本？

6

Data collection: Was data collection planned before the index test and reference standard were performed (prospective study) or after (retrospective study)?
数据收集：在指标检查和参考标准检查之前（前瞻性）还是之后（回顾性）

Test methods
检查方法

7

The reference standard and its rationale.
参考标准及其原理

8

Technical specifications of material and methods involved including how and when measurements were taken, and/or cite references for index tests and reference standard.
相关资料与方法的技术说明，包括何时和怎样进行测量的，和/或引用参考文献说明指标检查和参考标准检查

9

Definition of and rationale for the units, cut-offs and/or categories of the results of the index tests and the reference standard.
指标检查和参考标准检查的结果（单位），临床界和/或分类的标准

10

The number, training and expertise of the persons executing and reading the index tests and the reference standard.
执行和读取指标检查和参考检查的人员的数量，培训及其专业技能

11

Whether or not the readers of the index tests and reference standard were blind (masked) to the results of the other test and describe any other clinical information available to the readers.
执行和读取指标检查和参考标准检查的人员是否采用盲法？描述其它可获取的临床资料

Statistical methods
统计

12

Methods for calculating or comparing measures of diagnostic accuracy, and the statistical methods used to quantify uncertainty (e.g. 95% confidence intervals).
计算和比较诊断性的方法，以及不确定性的定量统计方法，如95%CI

13

Methods for calculating test reproducibility, if done.
如果已做，计算检查可重复性的方法。

RESULTS

Participants
受试者

14

When study was performed, including beginning and end dates of recruitment.
研究何时完成，包括受试者招募的起止时间

15

Clinical and demographic characteristics of the study population (at least information on age, gender, spectrum of presenting symptoms).
研究人群的临床特征和人口学特征（如年龄，性别，疾病谱等）

16

The number of participants satisfying the criteria for inclusion who did or did not undergo the index tests and/or the reference standard; describe why participants failed to undergo either test (a flow diagram is strongly recommended).
符合纳入标准，参与了或未参与指标检查和/或参考检查的人数，说明为什么这些患者没有参与任一检查（推荐画出流程图）

Test results
检查结果

17

Time-interval between the index tests and the reference standard, and any treatment administered in between.
从指标检查到参考标准检查间的时间间隔，及在此期间是否给予任何治疗

18

Distribution of severity of disease (define criteria) in those with the target condition; other diagnoses in participants without the target condition.
在出现了目标情况的受试者中描述疾病的严重程度分布状况，以及未出现目标情况的受试者中说明其它诊断

19

A cross tabulation of the results of the index tests (including indeterminate and missing results) by the results of the reference standard; for continuous results, the distribution of the test results by the results of the reference standard.
指标检查结果（包括不确定和丢失的结果）和参考标准检查结果的四格表。以及为了进一步检查而获得的检查结果分布和参考标准检查结果的四格表

20

Any adverse events from performing the index tests or the reference standard.
在进行指标检查和参考标准检查过程中，是否出现不良事件

Estimates
评估

21

Estimates of diagnostic accuracy and measures of statistical uncertainty (e.g. 95% confidence intervals).
诊断准确性的评估及统计学不确定性的衡量

22

How indeterminate results, missing data and outliers of the index tests were handled.
指标检查的不确定性结果，丢失结果（失访结果），以及异常值的处理情况

23

Estimates of variability of diagnostic accuracy between subgroups of participants, readers or centers, if done.
如果已做，评估诊断准确性在受试者的不同亚组间，不同结果判读者间，以及不同中心间的变异情况。

24

Estimates of test reproducibility, if done.    
如果已做，评估检查的可重复性。

DISCUSSION
讨论

25

Discuss the clinical applicability of the study findings.
讨论研究结果的临床适用性