COMPREHENSIVE SYSTEMATIC REVIEW
全面系统评价

TRAINING PROGRAM
培训项目

MODULE 2: WORKBOOK

Conducting Systematic Reviews
of Quantitative Evidence
对定量证据进行系统评价

June 2021

Comprehensive Systematic Review
Training Program
综合系统评价培训计划

MODULE 2: WORKBOOK
Conducting Systematic Reviews of Quantitative Evidence
模块2：工作簿：对定量证据进行系统评价

Published by JBI, Adelaide, South Australia, Australia.
由澳大利亚南澳大利亚州JBIAdelaide出版。

© JBI 2021

This publication is copyright. Apart from any fair dealing for the purpose of private study, research, criticism or review as permitted under the Copyright Act, no part may be reproduced by any process or placed in computer memory without written permission. All enquiries should be made to JBI
本出版物受版权保护。除了《著作权法》允许的以私人研究、批评或电子观点为目的的任何公平交易外，未经书面许可，任何部分都不得由任何机构制作或放入计算机内存中。所有查询均应向JBI提出.

Contents

Activity 1: 4

Selecting the Appropriate Study Design 4
选择合适的研究设计 4

Activity 2: 5

Critical Appraisal of Experimental Studies 5
实验研究的批判性评价 5

Activity 3: 33

Critical Appraisal of Observational Studies 33
观察性研究的批判性评价 33

Activity 4: 69

Activity 5: 70

Interpreting Forest Plots 70
解释森林地块 70

Activity 6: 72

Knowledge Assessment 73
知识评估 73

Activity 1:

Selecting the Appropriate Study Design
选择合适的研究设计

What study design would be best suited to:
哪种研究设计最适合：

1. Measuring a clinical benefit on lung function from inhaled corticosteroids?
1. 衡量吸入皮质类固醇对肺功能的临床益处？

2. Measuring the relationship between lung cancer incidence and smoking?
2. 测量肺癌发病率与吸烟之间的关系？

3. Determining the prevalence of depression in a population?
3. 确定人群中抑郁症的患病率？

4. Observing and reporting a novel presentation of basal cell carcinoma?
4. 观察和报告基底细胞癌的新表现？

Activity 2:

Critical Appraisal of Experimental Studies
实验研究的批判性评价

Part 1:

This activity requires you to work in pairs. One member will read the study by Caldwell and Crane (2016), and the other will read the study by Croghan, et al. (2003) on page 7 and page 18 of this workbook. Critically appraise the papers using the checklist provided in the workbook.
此活动要求您两人一组工作。一名成员将阅读 Caldwell 和 Crane （2016） 的研究，另一名成员将阅读本工作簿第 7 页和第 18 页的 Croghan 等人 （2003） 的研究。使用工作簿中提供的清单批判性地评估论文。

Once complete, comment on the overall methodological quality of your designated paper.
完成后，对指定论文的整体方法学质量发表评论。

Part 2:

In your pairs, get one member to:
在您的配对中，让一名成员：

Login to JBI SUMARI.

Select the project that you created in Module 1 [The effectiveness of combination Nicotine Replacement Therapy versus single Nicotine Replacement Therapy on smoking cessation (Your Name)]
选择您在模块 1 [联合尼古丁替代疗法与单一尼古丁替代疗法对戒烟的有效性（您的姓名）] 中创建的项目]

Select [Overview] from the top menu bar.
从顶部菜单栏中选择[概览]。

Select [Participants].

Add the name and email address of the other member of your pair and select [Invite]. A message should appear at the top of the screen notifying you that the person was successfully invited.
添加配对中其他成员的姓名和电子邮件地址，然后选择[邀请]。屏幕顶部应显示一条消息，通知您此人已成功受邀。

Check the [Privileged Author] option corresponding to their name.
选中与其姓名相对应的[特权作者]选项。

Select [Studies] from the top menu bar.
从顶部菜单栏中选择[研究]。

You will see the studies that you imported from Module 1. You should have 4 studies included ready to be screened at the ‘Full Text’ stage following the Module 1 activity. Please select [Include] for the study by Caldwell (2016) and Croghan (2003) under the ‘Full Text Screening’ box. This needs to be done by both members of the pair.
您将看到从模块 1 导入的研究。您应该有 4 项研究准备好在模块 1 活动后的“全文”阶段进行筛选。请在“全文筛选”框下选择 [包括] Caldwell （2016） 和 Croghan （2003） 的研究。这需要由这对成员的两个成员完成。

Select [Appraisal] from the top menu bar.
从顶部菜单栏中选择[评估]。

The other member of your pair can then:
然后，您配对中的另一名成员可以：

Check their email and accept the invitation to join the project.
检查他们的电子邮件并接受加入项目的邀请。

Login to JBI SUMARI and enter the project titled with their partner’s name.
登录 JBI SUMARI 并输入标题为其合作伙伴名称的项目。

Select [Appraisal] from the top menu bar.
从顶部菜单栏中选择[评估]。

Both members can then:
然后，两个成员都可以：

Select [Start] for the paper you read (Caldwell and Crane [2016] or Croghan, et al. [2003])
为您阅读的论文选择[开始]（Caldwell and Crane [2016]或Croghan等人[2003]）

Enter your appraisal results from your workbook into JBI SUMARI.
将工作簿中的评估结果输入到 JBI SUMARI 中。

Select [Include].
选择[包括]。

Select [Save].

Select [Back].

Repeat the same process for the paper you did not read using fake responses and select [Include].
使用虚假回复对未阅读的论文重复相同的过程，然后选择[包括]。

One member of the team must then compare the results of the appraisals for each paper and make a final decision:
然后，团队的一名成员必须比较每篇论文的评估结果并做出最终决定：

Select the final [Start] for the Caldwell and Crane (2016) paper.
选择 Caldwell and Crane （2016） 论文的最终 [开始]。

The responses of each member will be shown. A final decision will need to be made for any results that are different. Choose a final response for all differences and select [Include].
将显示每个成员的回答。对于任何不同的结果，都需要做出最终决定。选择所有差异的最终响应，然后选择[包括]。

Select [Save].

Select [Back].

Repeat the same process for Croghan, et al. (2003).
对Croghan等人（2003）重复相同的过程。

JBI Critical Appraisal Checklist for Randomized Controlled Trials
JBI随机对照试验的批判性评估清单

Reviewer      Date
审稿人日期      

Author  Caldwell and Crane (2016)  Year  Record Number
作者 Caldwell and Crane （2016） 年份记录编号  

Overall appraisal:  Include ☐  Exclude ☐  Seek further info ☐
总体评价： 包括 ☐ 排除 ☐ 寻求更多信息 ☐

Comments (Including reason for exclusion)
评论（包括排除原因）

JBI Critical Appraisal Checklist for Randomized Controlled Trials
JBI随机对照试验的批判性评估清单

Reviewer      Date
审稿人日期      

Author  Croghan, et al. (2003)  Year  Record Number
作者 Croghan， et al. （2003） 年份记录编号  

Overall appraisal:  Include ☐  Exclude ☐  Seek further info ☐
总体评价： 包括 ☐ 排除 ☐ 寻求更多信息 ☐

Comments (Including reason for exclusion)
评论（包括排除原因）

Explanation for the critical appraisal tool for RCTs
对随机对照试验的关键评估工具的解释

Answers: Yes, No, Unclear, or Not Applicable
答案：是、否、不清楚或不适用

Was true randomization used for assignment of participants to treatment groups?
是否使用真正的随机化将受试者分配到治疗组？

The differences between participants included in compared groups constitute a threat to the internal validity of a study exploring causal relationships. If participants are not allocated to treatment and control groups by random assignment, there is a risk that the allocation will be influenced by the known characteristics of the participants, and these differences between the groups may distort the comparability of the groups. A true random assignment of participants to the groups means that a procedure is used that allocates the participants to groups purely based on chance, not influenced by the known characteristics of the participants. Examine the details about the randomization procedure used for allocation of the participants to study groups. Was a true chance (random) procedure used? For example, was a list of random numbers used? Was a computer-generated list of random numbers used?
比较组中参与者之间的差异对探索因果关系的研究的内部有效性构成了威胁。如果参与者没有通过随机分配分配到治疗组和对照组，则分配可能会受到参与者已知特征的影响，并且组之间的这些差异可能会扭曲组的可比性。将参与者真正随机分配到组意味着使用一种程序，该程序纯粹基于偶然性将参与者分配到组中，不受参与者已知特征的影响。检查有关用于将参与者分配到研究组的随机化程序的详细信息。是否使用了真正的机会（随机）程序？例如，是否使用了随机数列表？是否使用了计算机生成的随机数列表？

Was allocation to groups concealed?
是否隐瞒了对组的分配？

If those allocating participants to the compared groups are aware of which group is next in the allocation process, that is, treatment or control, there is a risk that they may deliberately and purposefully intervene in the allocation of patients by preferentially allocating patients to the treatment group or to the control group. This may distort the implementation of the allocation process indicated by the randomization and, therefore, the results of the study may be distorted. Concealment of allocation (allocation concealment) refers to procedures that prevent those allocating patients from having knowledge prior to allocation of which treatment or control is next in the allocation process. Check the details about the procedure used for allocation concealment. Was an appropriate allocation concealment procedure used? For example, was central randomization used? Were sequentially numbered, opaque, and sealed envelopes used? Were coded drug packs used?
如果那些将参与者分配到比较组的人知道哪个组是分配过程中的下一个组，即治疗组或对照组，则存在他们可能通过优先将患者分配到治疗组或对照组来故意和有目的地干预患者分配的风险。这可能会扭曲随机化所指示的分配过程的实施，因此研究结果可能会被扭曲。隐瞒分配（分配隐瞒）是指阻止分配患者的人在分配之前知道分配过程中的下一个治疗或控制的程序。检查有关用于分配隐藏的过程的详细信息。是否使用了适当的分配隐藏程序？例如，是否使用中心随机化？是否使用了按顺序编号、不透明和密封的信封？是否使用了编码药包？

Were treatment groups similar at the baseline?
治疗组在基线时相似吗？

The differences between participants included in compared groups constitute a threat to the internal validity of a study exploring causal relationships. If there are differences between participants included in compared groups, there is a risk of selection bias. If there are differences between participants included in the compared groups perhaps the “effect” cannot be attributed to the potential “cause” (the examined intervention or treatment). It may be plausible that the “effect” can be explained by the differences between participants, that is, by selection bias. Check the characteristics reported for participants. Are the participants from the compared groups similar with regards to the characteristics that may explain the effect even in the absence of the “cause,” for example, age, severity of the disease, stage of the disease, co-existing conditions, and so on? Check the proportions of participants with specific relevant characteristics in the compared groups. Check the means of relevant measurements in the compared groups (pain scores, anxiety scores, etc). [Note: Do NOT only consider the P-value for the statistical testing of the differences between groups with regards to the baseline characteristics.]
比较组中参与者之间的差异对探索因果关系的研究的内部有效性构成了威胁。如果比较组中的参与者之间存在差异，则存在选择偏倚的风险。如果被比较组中的参与者之间存在差异，则“效果”可能无法归因于潜在的“原因”（检查的干预或治疗）。“效果”可以通过参与者之间的差异来解释，即选择偏差，这可能是合理的。检查为参与者报告的特征。即使没有“原因”，来自比较组的参与者在可能解释效果的特征方面是否相似，例如年龄、疾病严重程度、疾病阶段、共存条件等？检查比较组中具有特定相关特征的参与者的比例。检查比较组中相关测量值（疼痛评分、焦虑评分等）的均值。[注意：不要只考虑 P 值来统计测试组间在基线特征方面的差异。

Were participants blind to treatment assignment?
受试者是否对治疗分配不知情？

If participants are aware of their allocation to the treatment group or to the control group, there is the risk that they may behave differently and respond or react differently to the intervention of interest or to the control intervention compared to the situations when they are not aware of treatment allocation. Therefore the results of the study may be distorted. Blinding of participants is used in order to minimize this risk. Blinding of the participants refers to procedures that prevent participants from knowing which group they are allocated to. If blinding of participants is used, participants are not aware if they are in the group receiving the treatment of interest or if they are in any other group receiving the control interventions. Examine the details reported in the article about the blinding of participants with regards to treatment assignment. Was an appropriate blinding procedure used? For example, were identical capsules or syringes used? Were identical devices used? Be aware of different terms used, blinding is sometimes also called masking.
如果参与者知道他们被分配到治疗组或对照组，那么与他们不知道治疗分配的情况相比，他们可能会表现出不同的行为，对感兴趣的干预或对照干预的反应或反应不同。因此，研究结果可能会被歪曲。使用参与者盲法以尽量减少这种风险。参与者盲法是指阻止参与者知道他们被分配到哪个组的程序。如果对参与者使用盲法，参与者不知道他们是否在接受感兴趣治疗的组中，或者他们是否在接受对照干预的任何其他组中。检查文章中报告的有关参与者在治疗分配方面的盲法的详细信息。是否使用了适当的盲法程序？例如，是否使用了相同的胶囊或注射器？是否使用了相同的设备？请注意使用的不同术语，盲法有时也称为掩蔽。

Were those delivering treatment blind to treatment assignment?
那些提供治疗的人是否对治疗任务视而不见？

If those delivering treatment are aware of participants’ allocation to the treatment group or to the control group, there is the risk that they may behave differently with the participants from the treatment group and the participants from the control group. They may treat them differently, compared to situations when they are not aware of treatment allocation, and this may influence the implementation of the compared treatments, and the results of the study may be distorted. Blinding of those delivering treatment is used in order to minimize this risk. Blinding of those delivering treatment refers to procedures that prevent those delivering treatment from knowing which group they are treating. Those delivering treatment are not aware if they are treating the group receiving the treatment of interest or if they are treating any other group receiving the control interventions. Examine the details reported in the article about the blinding of those delivering treatment with regards to treatment assignment. Is there any information in the article about those delivering the treatment? Were those delivering the treatment unaware of the assignments of participants to the compared groups?
如果提供治疗的人知道参与者被分配到治疗组或对照组，那么他们可能会对治疗组的参与者和对照组的参与者表现出不同的行为。与他们不知道治疗分配的情况相比，他们可能会以不同的方式对待他们，这可能会影响比较治疗的实施，并且研究结果可能会被扭曲。对提供治疗的人进行盲法是为了将这种风险降到最低。对接受治疗的人进行盲法是指阻止接受治疗的人知道他们正在治疗哪个群体的程序。那些提供治疗的人不知道他们是否正在治疗接受感兴趣治疗的群体，或者他们是否正在治疗接受对照干预的任何其他群体。检查文章中报告的有关治疗分配的治疗人员失明的细节。文章中是否有任何关于提供治疗的人的信息？那些提供治疗的人是否不知道参与者被分配到比较组？

Were outcomes assessors blind to treatment assignment?
结果评估者是否对治疗分配视而不见？

If those assessing the outcomes are aware of participants’ allocation to the treatment group or to the control group, there is the risk that they may behave differently with the participants from the treatment group and the participants from the control group compared to the situations when they are not aware of treatment allocation. Therefore, there is the risk that the measurement of the outcomes may be distorted and the results of the study may be distorted. Blinding of outcomes assessors is used in order to minimize this risk. Examine the details reported in the article about the blinding of outcomes assessors with regards to treatment assignment. Is there any information in the article about outcomes assessors? Were those assessing the treatment’s effects on outcomes unaware of the assignments of participants to the compared groups?
如果评估结果的人知道受试者被分配到治疗组或对照组，那么与不知道治疗分配的情况相比，他们与治疗组的参与者和对照组的参与者的行为可能会有所不同。因此，存在结果测量可能被扭曲的风险，研究结果可能会被扭曲。使用结果评估员的盲法来最大限度地降低这种风险。检查文章中报告的有关结果评估员在治疗分配方面的盲法的详细信息。文章中是否有任何关于结果评估员的信息？那些评估治疗对结果影响的人是否不知道参与者被分配到比较组？

Were treatment groups treated identically other than the intervention of interest?
治疗组的治疗是否与感兴趣的干预措施相同？

In order to attribute the “effect” to the “cause” (the treatment or intervention of interest), assuming that there is no selection bias, there should be no other difference between the groups in terms of treatment or care received, other than the manipulated cause (the treatment or intervention controlled by the researchers). If there are other exposures or treatments occurring at the same time as the cause (the treatment or intervention of interest), then the effect may not be attributed to the examined cause (the investigated treatment), as it is plausible that the effect may be explained by other exposures or treatments occurring at the same time as the cause (the treatment of interest). Examine the reported exposures or interventions received by the compared groups. Are there other exposures or treatments occurring at the same time as the cause? Is it plausible that the effect may be explained by other exposures or treatments occurring at the same time as the cause? Is it clear that there is no other difference between the groups in terms of treatment or care received, other than the intervention of interest?
为了将“效果”归因于“原因”（感兴趣的治疗或干预），假设没有选择偏倚，除了操纵的原因（研究人员控制的治疗或干预）之外，两组在接受的治疗或护理方面不应有其他差异。如果与病因同时发生其他暴露或治疗（感兴趣的治疗或干预），则该效应可能不归因于所检查的原因（所研究的治疗），因为该效应可能由与病因同时发生的其他暴露或治疗（感兴趣的治疗）来解释是合理的。检查比较组报告的暴露或接受的干预措施。是否在病因的同时发生其他暴露或治疗？这种影响是否可能由与病因同时发生的其他暴露或治疗来解释？除了感兴趣的干预之外，两组之间在接受的治疗或护理方面没有其他区别，这是否很清楚？

8. Was follow-up complete and, if not, were differences between groups in terms of their follow-up adequately described and analyzed?
8. 随访是否完整，如果没有，是否充分描述和分析了各组之间在随访方面的差异？

For this question, follow-up refers to the time period from the moment of random allocation (random assignment or randomization) to compared groups to the end time of the trial. This critical appraisal question asks if there is complete knowledge (measurements, observations etc.) for the entire duration of the trial, as previously defined (that is, from the moment of random allocation to the end time of the trial), for all randomly allocated participants. If there is incomplete follow-up, that is incomplete knowledge about all randomly allocated participants, this is known in the methodological literature as the post-assignment attrition. As randomized controlled trials (RCTs) are not perfect, there is almost always post-assignment attrition, and the focus of this question is on the appropriate exploration of post-assignment attrition (description of loss to follow-up, description of the reasons for loss to follow-up, the estimation of the impact of loss to follow-up on the effects etc.). If there are differences with regards to the loss to follow-up between the compared groups in an RCT, these differences represent a threat to the internal validity of a randomized experimental study exploring causal effects, as these differences may provide a plausible alternative explanation for the observed effect even in the absence of the cause (the treatment or intervention of interest). When appraising an RCT, check if there were differences with regards to the loss to follow-up between the compared groups. If follow-up was incomplete (that is, there is incomplete information on all participants), examine the reported details about the strategies used in order to address incomplete follow-up, such as descriptions of loss to follow-up (absolute numbers, proportions, reasons for loss to follow-up) and impact analyses (the analyses of the impact of loss to follow-up on results). Was there a description of the incomplete follow-up (number of participants and the specific reasons for loss to follow-up)? It is important to note that with regards to loss to follow-up, it is not enough to know the number of participants and the proportions of participants with incomplete data. The reasons for loss to follow-up are essential in the analysis of risk of bias, even if the numbers and proportions of participants with incomplete data are similar or identical in compared groups or if the patterns of reasons for loss to follow-up are different (e.g. side effects caused by the intervention of interest, lost contact). These may impose a risk of bias if not appropriately explored and considered in the analysis. If there are differences between groups with regards to the loss to follow-up (numbers/proportions and reasons), was there an analysis of patterns of loss to follow-up? If there are differences between the groups with regards to the loss to follow-up, was there an analysis of the impact of the loss to follow-up on the results? [Note: Question 8 is NOT about intention-to-treat (ITT) analysis.]
对于这个问题，随访是指从随机分配（随机分配或随机化）到比较组到试验结束的时间段。这个关键的评估问题询问所有随机分配的参与者在试验的整个持续时间（即从随机分配的那一刻到试验结束时间）是否有完整的知识（测量、观察等）。如果随访不完整，即对所有随机分配的参与者的不完全了解，这在方法学文献中被称为分配后损耗。由于随机对照试验 （RCT） 并不完美，几乎总是存在分配后损耗，本问题的重点是对分配后损耗的适当探索（描述失访、描述失访原因、估计失访对效果的影响等）。如果随机对照试验中比较组之间的失访率存在差异，则这些差异对探索因果效应的随机实验研究的内部有效性构成威胁，因为即使没有原因（感兴趣的治疗或干预），这些差异也可能为观察到的效果提供合理的替代解释。在评估随机对照试验时，检查比较组之间在失访率方面是否存在差异。 如果随访不完整（即所有参与者的信息不完整），请检查报告的有关为解决不完整随访而使用的策略的详细信息，例如对失访的描述（绝对数字比例失访的原因）和影响分析（失访对结果的影响分析）。是否有关于不完全随访的描述（受试者人数和失访的具体原因）？需要注意的是，关于失访，仅仅知道受试者的人数和数据不完整的受试者比例是不够的。在分析偏倚风险时，失访的原因至关重要，即使数据不完整的受试者的数量和比例在比较组中相似或相同，或者失访的原因模式不同（例如，由感兴趣的干预引起的副作用，失去联系）。如果在分析中没有适当地探索和考虑这些因素，可能会带来偏倚的风险。如果各组之间在失访（数量/比例和原因）方面存在差异，是否对失访模式进行了分析？如果两组之间在失访方面存在差异，是否分析了失访对结果的影响？[注意：问题 8 与意向治疗 （ITT） 分析无关。]

9. Were participants analyzed in the groups to which they were randomized?
9. 参与者是否在他们被随机分配的组中进行了分析？

This question is about the intention-to-treat (ITT) analysis. There are different statistical analysis strategies available for the analysis of data from RCTs, such as ITT (known also as intent to treat), per-protocol analysis, and as-treated analysis. In the ITT analysis, the participants are analyzed in the groups to which they were randomized, regardless of whether they actually participated or not in those groups for the entire duration of the trial, received the experimental intervention or control intervention as planned, or whether they were compliant or not with the planned experimental intervention or control intervention. The ITT analysis compares the outcomes for participants from the initial groups created by the initial random allocation of participants to those groups. Check if ITT was reported, and check the details of the ITT. Were participants analyzed in the groups to which they were initially randomized, regardless of whether they actually participated in those groups, and regardless of whether they actually received the planned interventions? [Note: The ITT analysis is a type of statistical analysis recommended in the Consolidated Standards of Reporting Trials (CONSORT) statement on best practices in trials reporting. It is considered a marker of good methodological quality of the analysis of results of a randomized trial. The ITT is estimating the effect of offering the intervention, that is, the effect of instructing the participants to use or take the intervention; it is not estimating the effect of actually receiving the intervention of interest.]
这个问题是关于意向治疗 （ITT） 分析的。有不同的统计分析策略可用于分析来自随机对照试验的数据，例如ITT（也称为意向治疗）、按方案分析和治疗后分析。在ITT分析中，参与者在他们被随机分配的组中进行分析，无论他们是否在整个试验期间实际参与这些组，是否按计划接受实验干预或对照干预，或者他们是否符合计划的实验干预或对照干预。ITT 分析比较了由初始随机分配参与者到这些组创建的初始组的参与者的结果。检查是否报告了 ITT，并检查 ITT 的详细信息。参与者是否在他们最初被随机分配的组中进行了分析，无论他们是否真的参加了这些组，也不管他们是否真的接受了计划的干预？[注：ITT分析是试验报告综合标准（CONSORT）关于试验报告最佳实践的声明中推荐的一种统计分析。它被认为是随机试验结果分析方法学质量良好的标志。ITT 正在估计提供干预的效果，即指导参与者使用或采取干预的效果;它没有估计实际接受感兴趣的干预的效果。

10. Were outcomes measured in the same way for treatment groups?
10. 治疗组的结局测量方式是否相同？

If the outcome (effect) is not measured in the same way in the compared groups, there is a threat to the internal validity of a study exploring a causal relationship as the differences in outcome measurements may be confused with an effect of the treatment (cause). Check if the outcomes were measured in the same way. Same instrument or scale used? Same measurement timing? Same measurement procedures and instructions?
如果结果（效果）在比较组中以相同的方式测量，则探索因果关系的研究的内部有效性受到威胁，因为结果测量的差异可能会与治疗的效果（原因）混淆。检查结果是否以相同的方式测量。使用相同的仪器或秤？相同的测量时间？相同的测量程序和说明？

11. Were outcomes measured in a reliable way?
11. 结果的衡量是否可靠？

Unreliability of outcome measurements is one threat that weakens the validity of inferences about the statistical relationship between the cause and the effect estimated in a study exploring causal effects. Unreliability of outcome measurements is one of the different plausible explanations for errors of statistical inference with regards to the existence and the magnitude of the effect determined by the treatment (cause). Check the details about the reliability of measurement such as the number of raters, training of raters, the intra-rater reliability, and the inter-raters reliability within the study (not as reported in external sources). This question is about the reliability of the measurement performed in the study, it is not about the validity of the measurement instruments/scales used in the study. [Note: Two other important threats that weaken the validity of inferences about the statistical relationship between the cause and the effect are low statistical power and the violation of the assumptions of statistical tests. These other two threats are explored within Question 12.]
结果测量的不可靠性是一种威胁，它削弱了在探索因果关系的研究中估计的原因和结果之间统计关系的推论的有效性。结果测量的不可靠性是统计推断误差的不同合理解释之一，即治疗（原因）确定的影响的存在和程度。检查有关测量可靠性的详细信息，例如评估者的数量、评估者的培训、评估者内部的信度和研究中的评估者间信度（与外部来源不同）。这个问题是关于研究中进行的测量的可靠性，而不是关于研究中使用的测量仪器/秤的有效性。[注：削弱关于原因和结果之间统计关系的推论有效性的另外两个重要威胁是低统计功效和违反统计检验的假设。问题 12 探讨了其他两个威胁。

12. Was appropriate statistical analysis used?
12. 是否使用了适当的统计分析？

Inappropriate statistical analysis may cause errors of statistical inference with regards to the existence and the magnitude of the effect determined by the treatment (cause). Low statistical power and the violation of the assumptions of statistical tests are two important threats that weaken the validity of inferences about the statistical relationship between the cause and the effect. Check whether the assumptions of statistical tests were respected; if appropriate statistical power analysis was performed; if appropriate effect sizes were used; if appropriate statistical procedures or methods were used given the number and type of dependent and independent variables, the number of study groups, the nature of the relationship between the groups (independent or dependent groups), and the objectives of statistical analysis (association between variables, prediction, survival analysis etc).
不适当的统计分析可能会导致关于治疗（原因）确定的影响的存在和程度的统计推断错误。低统计功效和违反统计检验假设是两个重要的威胁，它们削弱了关于原因和结果之间统计关系的推论的有效性。检查是否遵守了统计检验的假设;是否进行了适当的统计功效分析;是否使用适当的效应量;如果考虑到因变量和自变量的数量和类型、研究组的数量、组（独立组或因缘组）之间关系的性质以及统计分析的目标（变量之间的关联预测、生存分析等），是否使用适当的统计程序或方法。

13. Was the trial design appropriate for the topic, and any deviations from the standard RCT design accounted for in the conduct and analysis?
13.试验设计是否适合该主题，以及在进行和分析中是否考虑了与标准RCT设计的任何偏差？

Certain RCT designs, such as the crossover RCT, should only be conducted when appropriate. Alternative designs may also present additional risks of bias if not accounted for in the design and analysis. Crossover trials should only be conducted in people with a chronic, stable condition, where the intervention produces a short term effect (i.e. relief in symptoms). Crossover trials should ensure there is an appropriate period of washout between treatments.
某些随机对照试验设计，如交叉随机对照试验，应仅在适当的时候进行。如果在设计和分析中不考虑替代设计，也可能带来额外的偏倚风险。交叉试验应仅在慢性、病情稳定的人群中进行，在这些患者中，干预会产生短期效果（即症状缓解）。交叉试验应确保治疗之间有适当的清除期。

Cluster RCTs randomize groups of individuals, forming “clusters.” When we are assessing outcomes on an individual level in cluster trials, there are unit-of-analysis issues, as individuals within a cluster are correlated. This should be taken into account by the study authors when conducting analysis, and ideally authors will report the intra-cluster correlation coefficient.
整群随机对照试验随机化个体群体，形成“集群”。当我们在整群试验中评估个体水平的结果时，存在分析单元问题，因为聚类中的个体是相关的。研究作者在进行分析时应考虑到这一点，理想情况下，作者将报告簇内相关系数。

Stepped-wedge RCTs may be appropriate when it is expected the intervention will do more good than harm or due to logistical, practical, or financial considerations in the rollout of a new treatment/intervention. Data analysis in these trials should be conducted appropriately, taking into account the effects of time.
当预计干预措施利大于弊时，或由于后勤、实践或财务方面的考虑，在推出新的治疗/干预措施时，阶梯式楔形随机对照试验可能是合适的。这些试验中的数据分析应适当进行，同时考虑到时间的影响。

Activity 3:

Critical Appraisal of Observational Studies
观察性研究的批判性评估

This activity requires you to work in pairs. One member of the pair will focus on the study by Izurieta, et al. (2015) while the other member of the pair will focus on the study by Fritsch, et al. (2005) provided on page 34 and page 56 of this workbook. Complete an appraisal for your designated paper using the checklist provided.
此活动要求您两人一组工作。两人中的一名成员将专注于Izurietaet al.（2015）的研究，而另一名成员将专注于Fritschet al.（2005）的研究，该研究在本工作手册的第34页和第56页中提供。使用提供的清单完成对指定论文的评估。

Once complete, comment on the methodological quality of your designated paper:
完成后，对指定论文的方法学质量发表评论：

JBI Critical Appraisal Checklist for Cohort Studies
JBI 队列研究的批判性评估清单

Reviewer      Date
审稿人日期      

Author  Izurieta, et al. (2015)  Year  Record Number
作者 Izurieta， et al. （2015） 年份记录编号  

Overall appraisal:  Include ☐  Exclude ☐  Seek further info ☐
总体评价： 包括 ☐ 排除 ☐ 寻求更多信息 ☐

Comments (Including reason for exclusion)
评论（包括排除原因）

Explanation of Cohort Studies Critical Appraisal Tool
队列研究批判性评估工具的解释

Answers: Yes, No, Unclear, or Not/Applicable
答案：是、否、不清楚或不适用

Were the two groups similar and recruited from the same population?
这两个群体是否相似并且从同一人群中招募？

Check the paper carefully for descriptions of participants to determine if patients within and across groups have similar characteristics in relation to exposure (e.g. risk factor under investigation). The two groups selected for comparison should be as similar as possible in all characteristics except for their exposure status, relevant to the study in question. The authors should provide clear inclusion and exclusion criteria that they developed prior to recruitment of the study participants.
仔细检查论文中对参与者的描述，以确定组内和组间的患者是否具有与暴露相关的相似特征（例如正在调查的危险因素）。选择进行比较的两组在所有特征上应尽可能相似，除了与相关研究相关的暴露状态。作者应提供他们在招募研究参与者之前制定的明确纳入和排除标准。

Were the exposures measured similarly to assign people to both exposed and unexposed groups?
暴露的测量是否类似，将人们分配到暴露组和未暴露组？

A high quality study at the level of cohort design should describe how the exposures were measured. The exposure measures should be clearly defined and described in detail. This will enable reviewers to assess whether or not the participants received the exposure of interest.
队列设计层面的高质量研究应描述如何测量暴露。应明确界定和详细描述暴露措施。这将使审稿人能够评估参与者是否接受了感兴趣的曝光。

Was the exposure measured in a valid and reliable way?
暴露量是否以有效和可靠的方式测量？

The study should clearly describe the method of measurement of exposure. Assessing validity requires that a gold standard is available to which the measure can be compared. The validity of exposure measurement usually relates to whether a current measure is appropriate or whether a measure of past exposure is needed.
该研究应清楚地描述暴露的测量方法。评估有效性需要有一个可以比较该措施的黄金标准。暴露测量的有效性通常与当前测量是否合适或是否需要测量过去的暴露有关。

Reliability refers to the processes included in an epidemiological study to check repeatability of measurements of the exposures. These usually include intra-observer reliability and inter-observer reliability.
可靠性是指流行病学研究中包含的过程，以检查暴露测量的可重复性。这些通常包括观察者内部信度和观察者间信度。

Were confounding factors identified?
是否确定了混杂因素？

Confounding occurs where the estimated intervention exposure effect is biased by the presence of some difference between the comparison groups (apart from the exposure investigated/of interest). Typical confounders include baseline characteristics, prognostic factors, or concomitant exposures (e.g. smoking). A confounder is a difference between the comparison groups and it influences the direction of the study results. A high quality study at the level of cohort design will identify the potential confounders and measure them (where possible). This is difficult for studies where behavioral, attitudinal, or lifestyle factors may impact on the results.
当估计的干预暴露效果因对照组之间存在某些差异而存在偏差时，就会发生混杂（除了调查/感兴趣的暴露）。典型的混杂因素包括基线特征、预后因素或伴随暴露（例如吸烟）。混杂因素是对照组之间的差异，它会影响研究结果的方向。队列设计层面的高质量研究将识别潜在的混杂因素并对其进行测量（在可能的情况下）。对于行为、态度或生活方式因素可能影响结果的研究来说，这是困难的。

Were strategies to deal with confounding factors stated?
是否说明了处理混杂因素的策略？

Strategies to deal with effects of confounding factors may be dealt with within the study design or in data analysis. By matching or stratifying sampling of participants, effects of confounding factors can be adjusted for. When dealing with adjustment in data analysis, assess the statistics used in the study. Most will be some form of multivariate regression analysis to account for the confounding factors measured. Look out for a description of statistical methods as regression methods such as logistic regression are usually employed to deal with confounding factors/variables of interest.
处理混杂因素影响的策略可以在研究设计或数据分析中处理。通过对参与者进行匹配或分层抽样，可以调整混杂因素的影响。在处理数据分析中的调整时，请评估研究中使用的统计数据。大多数将是某种形式的多变量回归分析，以解释所测量的混杂因素。注意统计方法的描述，因为回归方法（如逻辑回归）通常用于处理感兴趣的混杂因素/变量。

Were the groups/participants free of the outcome at the start of the study (or at the moment of exposure)?
在研究开始时（或暴露时），各组/参与者是否没有结果？

The participants should be free of the outcomes of interest at the start of the study. Refer to the methods section in the paper for this information, which is usually found in descriptions of participant/sample recruitment, definitions of variables, and/or inclusion/exclusion criteria.
参与者在研究开始时应该没有感兴趣的结果。有关此信息，请参阅论文中的方法部分，该信息通常位于参与者/样本招募的描述、变量定义和/或纳入/排除标准中。

Were the outcomes measured in a valid and reliable way?
结果是否以有效和可靠的方式衡量？

Read the methods section of the paper. If, for example, lung cancer is assessed based on existing definitions or diagnostic criteria, then the answer to this question is likely to be “yes.” If lung cancer is assessed using observer reported, or self-reported scales, the risk of over- or underreporting is increased, and objectivity is compromised. Importantly, determine if the measurement tools used were validated instruments as this has a significant impact on outcome assessment validity.
阅读论文的方法部分。例如，如果根据现有定义或诊断标准评估肺癌，那么这个问题的答案很可能是“是”。如果使用观察者报告或自我报告的量表评估肺癌，则会增加过度报告或报告不足的风险，并且客观性会受到损害。重要的是，确定所使用的测量工具是否是经过验证的工具，因为这对结果评估的有效性有重大影响。

Having established the objectivity of the outcome measurement (e.g. lung cancer) instrument, it’s important to establish how the measurement was conducted. Were those involved in collecting data trained or educated in the use of the instrument/s (e.g. radiographers)? If there was more than one data collector, were they similar in terms of level of education, clinical or research experience, or level of responsibility in the piece of research being appraised?
在确定了结果测量（例如肺癌）工具的客观性后，重要的是要确定测量是如何进行的。参与收集数据的人员（例如放射技师）是否接受过使用仪器的培训或教育？如果有多个数据收集者，它们在教育水平、临床或研究经验或被评估研究的责任水平方面是否相似？

Was the follow-up time reported and sufficient to be long enough for outcomes to occur?
是否报告了随访时间，并且足够长以产生结果？

The appropriate length of time for follow-up will vary with the nature and characteristics of the population of interest and/or the intervention, disease, or exposure. To estimate an appropriate duration of follow-up, refer to multiple papers and take note of the range for duration of follow-up. The opinions of experts in clinical practice or clinical research may also assist in determining an appropriate duration of follow-up; for example, a longer timeframe may be needed to examine the association between occupational exposure to asbestos and the risk of lung cancer. It is important, particularly in cohort studies, that follow-up is long enough to enable the outcomes. However, it should be remembered that the research question and outcomes being examined will most likely dictate the follow-up time.
适当的随访时间长短将根据感兴趣人群的性质和特征和/或干预措施、疾病或暴露情况而有所不同。要估计适当的随访时间，请参阅多篇论文并注意随访时间的范围。临床实践或临床研究中专家的意见也可能有助于确定适当的随访时间，例如，可能需要更长的时间框架来检查职业接触石棉与肺癌风险之间的关联。重要的是，特别是在队列研究中，随访时间要足够长，才能获得结果。但是，应该记住，正在检查的研究问题和结果很可能会决定随访时间。

Was follow-up complete, and if not, were the reasons to loss to follow-up described and explored?
随访是否完成，如果没有，是否描述和探讨了失访的原因？

It is important in a cohort study that a greater percentage of people are followed up. As a general guideline, at least 80% of patients should be followed up. Generally a dropout rate of 5% or less is considered insignificant. A rate of 20% or greater is considered to significantly impact on the validity of the study. However, in observational studies conducted over a lengthy period of time, a higher dropout rate is to be expected. A decision on whether to include or exclude a study because of a high dropout rate is a matter of judgment based on the reasons why people dropped out, and whether dropout rates were comparable in the exposed and unexposed groups.
在队列研究中，对更大比例的人进行随访是很重要的。作为一般指南，至少 80% 的患者应接受随访。一般来说，5%或更低的辍学率被认为是微不足道的。20% 或更高的比率被认为对研究的有效性有重大影响。然而，在长期进行的观察性研究中，预计辍学率会更高。由于高辍学率而决定是否纳入或排除一项研究，是基于人们辍学的原因以及暴露组和未暴露组的辍学率是否具有可比性来判断的问题。

Reporting of efforts to follow up participants that dropped out may be regarded as an indicator of a well-conducted study. Look for a clear and justifiable description of why people were left out, excluded, dropped out etc. If there is no clear description or a statement in this regards, this will be a “No.”
报告对退出的受试者进行随访的努力可被视为一项进行良好的研究的指标。寻找一个清晰和合理的描述，说明为什么人们被排除在外、被排除在外、辍学等。如果在这方面没有明确的描述或声明，这将是“否”。

10. Were strategies to address incomplete follow-up utilized?
10. 是否采用了解决不完整随访的策略？

Some people may withdraw due to change in employment or some may die; however, it is important that their outcomes are assessed. Selection bias may occur as a result of incomplete follow-up. Therefore, participants with unequal follow-up periods must be taken into account in the analysis, which should be adjusted to allow for differences in length of follow-up periods. This is usually done by calculating rates that use person-years at risk (i.e. considering time in the denominator).
有些人可能会因为工作变动而退出，有些人可能会死亡;然而，重要的是评估他们的结果。随访不完全可能导致选择偏倚。因此，在分析中必须考虑随访期不平等的参与者，并应对其进行调整以允许随访期长度的差异。这通常是通过计算使用处于危险中的人年（即在分母中考虑时间）的比率来完成的。

11. Was appropriate statistical analysis used?
11. 是否使用了适当的统计分析？

As with any consideration of statistical analysis, consideration should be given to whether there was a more appropriate alternate statistical method that could have been used. The methods section of cohort studies should be detailed enough for reviewers to identify which analytical techniques were used (in particular, regression or stratification) and how specific confounders were measured.
与任何统计分析的考虑一样，应考虑是否有更合适的替代统计方法可以使用。队列研究的方法部分应足够详细，以便评价员确定使用了哪些分析技术（特别是回归或分层）以及如何测量特定的混杂因素。

For studies utilizing regression analysis, it is useful to determine if the study identified which variables were included and how they related to the outcome. If stratification was the analytical approach used, were the strata of analysis defined by the specified variables? Additionally, it is also important to assess the appropriateness of the analytical strategy in terms of the assumptions associated with the approach, as differing methods of analysis are based on differing assumptions about the data and how it will respond.
对于使用回归分析的研究，确定研究是否确定了哪些变量被纳入以及它们与结局的关系是有用的。如果使用分层分析方法，那么分析层是否由指定的变量定义？此外，根据与方法相关的假设来评估分析策略的适当性也很重要，因为不同的分析方法基于对数据及其响应方式的不同假设。

Fritsch, et al. (2005)

Fritsch, et al. (2005)

Fritsch, et al. (2005)

JBI Critical Appraisal Checklist for Case Control Studies
JBI病例对照研究的批判性评估清单

Reviewer      Date
审稿人日期     

Author  Fritsch, et al. (2005)   Year  Record Number
作者 Fritsch， et al. （2005） 年份记录编号 

Overall appraisal:  Include ☐  Exclude ☐  Seek further info ☐
总体评价： 包括 ☐ 排除 ☐ 寻求更多信息 ☐

Comments (Including reason for exclusion)
评论（包括排除原因）

Explanation of Case Control Studies Critical Appraisal Tool
病例对照研究批判性评估工具的解释

Answers: Yes, No, Unclear, or Not Applicable
答案：是、否、不清楚或不适用

Were the groups comparable other than presence of disease in cases or absence of disease in controls?
除了病例中存在疾病或对照组中没有疾病之外，这些组是否具有可比性？

The control group should be representative of the source population that produced the cases. This is usually done by individual matching, wherein controls are selected for each case on the basis of similarity with respect to certain characteristics other than the exposure of interest. Frequency or group matching is an alternative method. Selection bias may result if the groups are not comparable.
对照组应具有产生病例的源人群的代表性。这通常是通过单独匹配来完成的，其中根据与感兴趣暴露以外的某些特征的相似性为每种情况选择对照。频率或组匹配是一种替代方法。如果各组不具有可比性，则可能导致选择偏差。

Were cases and controls matched appropriately?
病例和对照是否适当匹配？

As in item 1, the study should include clear definitions of the source population. Sources from which cases and controls were recruited should be carefully looked at. For example, cancer registries may be used to recruit participants in a study examining risk factors for lung cancer, which typify population-based case control studies. Study participants may be selected from the target population, the source population, or from a pool of eligible participants (such as in hospital-based case control studies).
与第1项一样，研究应包括对源人群的明确定义。应仔细研究招募病例和对照的来源。例如，癌症登记处可用于招募研究肺癌危险因素的研究参与者，这是基于人群的病例对照研究的典型代表。研究参与者可以从目标人群、源人群或符合条件的参与者中（例如在基于医院的病例对照研究中）中选择。

Were the same criteria used for identification of cases and controls?
是否使用相同的标准来识别病例和对照？

It is useful to determine if patients were included in the study based on either a specified diagnosis or definition. This is more likely to decrease the risk of bias. Characteristics are another useful approach to matching groups, and studies that did not use specified diagnostic methods or definitions should provide evidence on matching by key characteristics. A case should be defined clearly. It is also important that controls must fulfil all the eligibility criteria defined for the cases except for those relating to diagnosis of the disease.
根据特定的诊断或定义确定患者是否被纳入研究是有用的。这更有可能降低偏倚的风险。特征是匹配组的另一种有用方法，未使用特定诊断方法或定义的研究应提供按关键特征匹配的证据。案例应明确定义。同样重要的是，控制必须满足为病例定义的所有资格标准，但与疾病诊断相关的标准除外。

Was exposure measured in a standard, valid, and reliable way?
是否以标准、有效和可靠的方式测量暴露？

The study should clearly describe the method of measurement of exposure. Assessing validity requires that a gold standard is available to which the measure can be compared. The validity of exposure measurement usually relates to whether a current measure is appropriate or whether a measure of past exposure is needed.
该研究应清楚地描述暴露的测量方法。评估有效性需要有一个可以比较该措施的黄金标准。暴露测量的有效性通常与当前测量是否合适或是否需要测量过去的暴露有关。

Case control studies may investigate many different “exposures” that may or may not be associated with the condition. In these cases, reviewers should use the main exposure of interest for their review to answer this question when using this tool at the study level.
病例对照研究可能会调查许多不同的“暴露”，这些“暴露”可能与该病症相关，也可能与该病无关。在这些情况下，评价员在研究层面使用此工具时，应使用其评价感兴趣的主要暴露来回答这个问题。

Reliability refers to the processes included in an epidemiological study to check repeatability of measurements of the exposures. These usually include intra-observer reliability and inter-observer reliability.
可靠性是指流行病学研究中包含的过程，以检查暴露测量的可重复性。这些通常包括观察者内部信度和观察者间信度。

Was exposure measured in the same way for cases and controls?
病例和对照组的暴露测量方式是否相同？

As in item 4, the study should clearly describe the method of measurement of exposure. The exposure measures should be clearly defined and described in detail. Assessment of exposure or risk factors should have been carried out according to same procedures or protocols for both cases and controls.
与第 4 项一样，研究应清楚地描述暴露的测量方法。应明确界定和详细描述暴露措施。对病例和对照组的暴露或危险因素的评估应按照相同的程序或方案进行。

Were confounding factors identified?
是否确定了混杂因素？

Confounding has occurred where the estimated intervention exposure effect is biased by the presence of some difference between the comparison groups (apart from the exposure investigated/of interest). Typical confounders include baseline characteristics, prognostic factors, or concomitant exposures (e.g. smoking). A confounder is a difference between the comparison groups and it influences the direction of the study results. A high quality study at the level of case control design will identify the potential confounders and measure them (where possible). This is difficult for studies where behavioral, attitudinal, or lifestyle factors may impact on the results.
当估计的干预暴露效果因对照组之间存在一些差异而存在偏差时，就会发生混杂（除了调查/感兴趣的暴露）。典型的混杂因素包括基线特征、预后因素或伴随暴露（例如吸烟）。混杂因素是对照组之间的差异，它会影响研究结果的方向。病例对照设计层面的高质量研究将识别潜在的混杂因素并对其进行测量（在可能的情况下）。对于行为、态度或生活方式因素可能影响结果的研究来说，这是困难的。

Were strategies to deal with confounding factors stated?
是否说明了处理混杂因素的策略？

Strategies to deal with effects of confounding factors may be dealt within the study design or in data analysis. By matching or stratifying sampling of participants, effects of confounding factors can be adjusted for. When dealing with adjustment in data analysis, assess the statistics used in the study. Most will be some form of multivariate regression analysis to account for the confounding factors measured. Look out for a description of statistical methods as regression methods such as logistic regression are usually employed to deal with confounding factors/variables of interest.
处理混杂因素影响的策略可以在研究设计或数据分析中处理。通过对参与者进行匹配或分层抽样，可以调整混杂因素的影响。在处理数据分析中的调整时，请评估研究中使用的统计数据。大多数将是某种形式的多变量回归分析，以解释所测量的混杂因素。注意统计方法的描述，因为回归方法（如逻辑回归）通常用于处理感兴趣的混杂因素/变量。

Were outcomes assessed in a standard, valid, and reliable way for cases and controls?
是否以标准、有效和可靠的方式对病例和对照组评估结局？

Read the methods section of the paper. If, for example, lung cancer is assessed based on existing definitions or diagnostic criteria, then the answer to this question is likely to be “yes.” If lung cancer is assessed using observer-reported or self-reported scales, the risk of over- or underreporting is increased, and objectivity is compromised. Importantly, determine if the measurement tools used were validated instruments, as this has a significant impact on outcome assessment validity.
阅读论文的方法部分。例如，如果根据现有定义或诊断标准评估肺癌，那么这个问题的答案很可能是“是”。如果使用观察者报告或自我报告的量表评估肺癌，则会增加多报或少报的风险，并且客观性会受到影响。重要的是，确定所使用的测量工具是否是经过验证的工具，因为这对结果评估的有效性有重大影响。

Having established the objectivity of the outcome measurement (e.g. lung cancer) instrument, it’s important to establish how the measurement was conducted. Were those involved in collecting data trained or educated in the use of the instrument/s (e.g. radiographers)? If there was more than one data collector, were they similar in terms of level of education, clinical or research experience, or level of responsibility in the piece of research being appraised?
在确定了结果测量（例如肺癌）工具的客观性后，重要的是要确定测量是如何进行的。参与收集数据的人员（例如放射技师）是否接受过使用仪器的培训或教育？如果有多个数据收集者，它们在教育水平、临床或研究经验或被评估研究的责任水平方面是否相似？

Was the exposure period of interest long enough to be meaningful?
感兴趣的暴露期是否足够长而有意义？

It is particularly important in a case control study that the exposure time was sufficient enough to show an association between the exposure and the outcome. It may be that the exposure period may be too short or too long to influence the outcome.
在病例对照研究中，暴露时间足以显示暴露与结果之间的关联尤为重要。可能是暴露期太短或太长而无法影响结果。

Was appropriate statistical analysis used?
是否使用了适当的统计分析？

As with any consideration of statistical analysis, consideration should be given to whether there was a more appropriate alternate statistical method that could have been used. The methods section should be detailed enough for reviewers to identify which analytical techniques were used (in particular, regression or stratification) and how specific confounders were measured.
与任何统计分析的考虑一样，应考虑是否有更合适的替代统计方法可以使用。方法部分应足够详细，以便评价者确定使用了哪些分析技术（特别是回归或分层）以及如何测量特定的混杂因素。

For studies utilizing regression analysis, it is useful to determine if the study identified which variables were included and how they related to the outcome. If stratification was the analytical approach used, were the strata of analysis defined by the specified variables? Additionally, it is also important to assess the appropriateness of the analytical strategy in terms of the assumptions associated with the approach as differing methods of analysis are based on differing assumptions about the data and how it will respond.
对于使用回归分析的研究，确定研究是否确定了哪些变量被纳入以及它们与结局的关系是有用的。如果使用分层分析方法，那么分析层是否由指定的变量定义？此外，根据与方法相关的假设来评估分析策略的适当性也很重要，因为不同的分析方法基于对数据及其响应方式的不同假设。

Activity 4:

Extracting Outcome Data
提取结果数据

Complete phase 1 data extraction using the two experimental studies you appraised earlier in Activity 2. One member of the pair will extract data from one study and the other member will extract data from the other study. Work within the same SUMARI project that you worked in for Activity 2.
使用您在活动 2 中之前评估的两项实验研究完成第 1 阶段的数据提取。该组合的一名成员将从一项研究中提取数据，另一名成员将从另一项研究中提取数据。在您为活动 2 工作的同一个 SUMARI 项目中工作。

Login to JBI SUMARI.

Select [Extraction] from the top menu bar for the project “The effectiveness of combination Nicotine Replacement Therapy versus single Nicotine Replacement Therapy on smoking cessation (Participant Name).”
从项目“联合尼古丁替代疗法与单一尼古丁替代疗法对戒烟的有效性（参与者姓名）”的顶部菜单栏中选择[提取]。

Select [Start] for the paper you will be extracting (Caldwell, et al. [2016] or Croghan, et al. [2003]).
选择[开始]作为要提取的论文（Caldwell等人[2016]或Croghanet al.[2003]）。

Fill in the appropriate details under the following headings:
在以下标题下填写适当的详细信息：

− Country

− Setting/context

− Participant characteristics
− 参与者特征

− Group description and sample (To add another group select [Add group])
− 组描述和示例（要添加其他组，请选择 [添加组]）

− Outcomes measured
− 衡量的结果

− Description of main results
− 主要结果说明

Select [Save].

Select [Back].

Activity 5:

Interpreting Forest Plots
解释森林地块

Study the forest plots below in pairs.
两人一组研究下面的森林地块。

Discuss the following questions with your partner:
与您的伴侣讨论以下问题：

What does this forest plot show? Is endocrine therapy more effective than chemotherapy for the outcome tumor response rate? Were the results significant? Is there heterogeneity present? Is this an appropriate meta-analysis to have conducted? Why or why not?
这个森林图显示了什么？内分泌治疗是否比化疗对结果肿瘤反应率更有效？结果是否显著？是否存在异质性？这是一项适当的荟萃分析吗？为什么或者为什么不？

Discuss the following questions with your partner:
与您的伴侣讨论以下问题：

What does this forest plot show? Is Heparin more effective in reducing the incidence of DVT than a placebo? Were the results statistically significant? Is there heterogeneity present?
这个森林图显示了什么？肝素在降低深静脉血栓形成率方面是否比安慰剂更有效？结果是否具有统计学意义？是否存在异质性？

Discuss the following questions with your partner:
与您的伴侣讨论以下问题：

What does this forest plot show? Is music more effective than control for reducing anxiety? Were the results statistically significant? Is there heterogeneity present?
这个森林图显示了什么？在减少焦虑方面，音乐比控制更有效吗？结果是否具有统计学意义？是否存在异质性？

Activity 6:

Extraction and Synthesis
提取与合成

Working in your pair, use the two experimental studies from Activity 2 and extract the data relevant to the outcome “Biochemically confirmed abstinence at 6 months” for both papers in JBI SUMARI. Undertake a meta-analysis for the following outcome: “Biochemically confirmed abstinence at 6 months.” Please work in the same project as Activities 2 and 4.
在您的配对中，使用活动 2 中的两项实验研究，并提取与 JBI SUMARI 中两篇论文的结果“6 个月时生化确认禁欲”相关的数据。对以下结果进行荟萃分析“6 个月时生化确认禁欲”。请与活动 2 和 4 在同一项目中工作。

Login to JBI SUMARI

Select [Synthesis] from the top menu bar for the project, “The effectiveness of combination Nicotine Replacement Therapy versus single Nicotine Replacement Therapy on smoking cessation (Your Name)”
从项目的顶部菜单栏中选择[综合]“联合尼古丁替代疗法与单一尼古丁替代疗法对戒烟的有效性（你的名字）”

Select [Comparative Meta-analysis].
选择[比较荟萃分析]。

You will first need to enter a comparison. Select [Create] to do this. The comparison here is “Combination NRT versus Single NRT.” Select the tick to confirm the comparison.
您首先需要输入比较。选择[创建]执行此操作。此处的比较是“组合 NRT 与单个 NRT”选择勾号以确认比较。

Once you have entered the comparison, you need to create an outcome. Select [Open] and then [Create]. Type in “Biochemically confirmed abstinence at 6 months,” select the tick to confirm and then select dichotomous.
进入比较后，您需要创建一个结果。选择[打开]，然后选择[创建]。输入“6 个月时生化确认的禁欲”，选择要确认的勾号，然后选择二分法。

Select [Plot].

Once in the plotting stage, you will need to put in the parameters for your meta-analysis. You can try some different options here. Using the drop down menus, select “inverse variance” as the statistical method, use a “fixed” model with the “odds ratio” as the effect measure, with “95%” confidence interval.
进入绘图阶段后，您需要输入荟萃分析的参数。您可以在此处尝试一些不同的选项。使用下拉菜单，选择“逆方差”作为统计方法，使用“固定”模型，以“比值比”作为效果度量，置信区间为“95%”。

Select the “Line of No Effect Labels” as [Inverse] in the drop down menu.
在下拉菜单中选择“无效果标签行”作为[反转]。

In the data table, select your study (using the drop down menu) and enter the events and the total sample from both the experimental and control arms.
在数据表中，选择您的研究（使用下拉菜单），然后输入实验组和对照组的事件和总样本。

Select [Add] and then complete this information for the other study.
选择[添加]，然后为其他研究填写此信息。

Once you have done this for both the study by Caldwell, et al. (2016) and Croghan, et al. (2003), select [Generate]. This will produce your forest plot.
Now take some time to review the different parameters and view the output.
完成 Caldwell， et al. （2016） 和 Croghan， et al. （2003） 的研究后，选择 [生成]。这将产生您的林地。现在花一些时间查看不同的参数并查看输出。

What does this forest plot show? Is combination NRT more effective than single NRT at improving smoking abstinence? Were the results statistically significant? Is there heterogeneity present?
这个森林图显示了什么？在提高戒烟率方面，联合NRT是否比单一NRT更有效？结果是否具有统计学意义？是否存在异质性？

Knowledge Assessment
知识评估

1. External validity refers to:
1.外部有效性是指：

☐How “good” or “true” the results of a study are based on the limitation of potential bias in the study design and methods.
☐研究结果的“好”或“真实”程度取决于研究设计和方法中潜在偏倚的局限性。

☐The generalizability of the findings to the “real world” population of interest not under strict “experimental” control.
☐研究结果对不受严格“实验”控制的“真实世界”感兴趣的人群的可推广性。

☐How credible the results of a randomized controlled trial are.
☐随机对照试验结果的可信度。

2. Detection bias is:
2.检测偏差为：

☐Present when there are more than five time points at which outcomes are measured.
☐当有五个以上的时间点测量结果时出现。

☐Present when different assessors collect outcome data.
☐当不同的评估者收集结果数据时出现。

☐Present when there are systematic differences in how the data are collected between groups.
☐当组间数据收集方式存在系统差异时，会出现。

☐All of the above.
☐以上所有。

3. Whilst undertaking critical appraisal, to determine that there has been an attempt on the part of the researchers to limit attrition bias, you may look to see that:
3. 在进行批判性评估时，为了确定研究人员是否试图限制损耗偏差，您可以查看以下情况：

☐A per protocol analysis has been performed.
☐已根据协议执行分析。

☐The study is less than eight weeks’ duration to limit losses to follow-up.
☐该研究的持续时间少于八周，以限制随访的损失。

☐An available case analysis has been performed.
☐已执行可用案例分析。

☐An intention-to-treat analysis has been performed.
☐已进行意向性治疗分析。

4. A quasi-randomized controlled trial is named as such because:
4. 半随机对照试验之所以如此命名，是因为：

☐Opaque sealed envelopes weren't used for allocation of subjects to groups.
☐不透明的密封信封不用于将受试者分配到小组。

☐A systematic but non-random method was used to allocate subjects to treatment groups.
☐使用系统但非随机的方法将受试者分配到治疗组。

☐Participants were not blinded to their treatment allocation.
☐参与者对他们的治疗分配不知情。

5. Confounding occurs:
5. 发生混杂：

☐When the effects of two or more processes are not separated, so the apparent effect is not the true effect.
☐当两个或两个以上过程的效果没有分开时，表观效果就不是真正的效果。

☐When investigators mix up the data collection by accident.
☐当调查人员意外混淆数据收集时。

☐When there is systematic deviation of the results or inferences from the truth.
☐当结果或推论与事实有系统性偏差时。

☐Most commonly in randomized controlled trials.
☐最常见于随机对照试验。

6. Which of the following is an absolute rather than relative measure of difference?
6.以下哪项是绝对的，而不是相对的差异衡量标准？

☐Relative risk

☐Odds ratio

☐Risk difference
☐风险差异

☐Hazard ratio
☐风险比

7. When dealing with meta-analysis of continuous data, an effect measure you may calculate is the:
7. 在处理连续数据的荟萃分析时，您可以计算的效果度量是：

☐Odds ratio

☐Relative risk

☐Standardized mean difference
☐标准化均数差

8. Meta-analysis should only be undertaken:
8. 荟萃分析只应在下列情况下进行：

☐On randomized controlled trials.
☐关于随机对照试验。

☐Normally, only in the presence of clinical and methodological homogeneity.
☐通常，仅在存在临床和方法学同质性的情况下。

☐Where the studies to be included have similar sized populations.
☐其中纳入的研究具有相似规模的人群。

9. A sensitivity analysis may be performed during a systematic review to:
9. 在系统评价期间可以进行敏感性分析，以：

☐See how sensitive the data is to the normal distribution.
☐查看数据对正态分布的敏感程度。

☐To test the assumptions or decisions made by the reviewers.
☐测试审稿人做出的假设或决定。

☐Increase external validity of the findings of the review.
☐提高评价结果的外部有效性。

10. To minimize error during the data extraction process, reviewers can:
10. 为了尽量减少数据提取过程中的错误，审阅者可以：

☐Use a specialized data extraction form.
☐使用专门的数据提取表单。

☐Pilot test the data extraction form prior to use for the review.
☐在用于审查之前，先对数据提取表进行试点测试。

☐Train and assess all people involved in the data extraction process.
☐培训和评估参与数据提取过程的所有人。

☐Have blind extraction of the data from each study by two people.
☐由两个人从每项研究中盲目提取数据。

☐All of the above.
☐以上所有。

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