2016年10月Sterne等在BMJ杂志上发表了关于非随机干预性研究(Non-randomized studies of the effects of interventions, NRSI)的更普适的偏倚风险评估工具ROBINS-I (Risk of bias in non-randomized studies-of intervention)，适用干预效果评价的多种非随机研究类型，主要包括观察性研究(队列研究、病例对照研究)和类实验等，是一个领域评估式工具。该工具的发布对于NRSI领域的质量评价具有里程碑式的意义。本文重点介绍ROBINS-I的使用方法，评估清单详细内容详见非随机对照研究质量评价——非随机干预性研究偏倚风险评估工具ROBINS-I (Risk of Bias in Non-randomized Studies-of Intervention) (二)和非随机对照研究质量评价——非随机干预性研究偏倚风险评估工具ROBINS-I (Risk of Bias in Non-randomized Studies-of Intervention) (三)。
关键词：非随机对照研究质量评价; 非随机干预性研究偏倚风险评估; NRSI; ROBINS-I
| Table1 | Bias domains included in ROBIN-I | |
| 表1 | ROBINS-I中的偏倚域 | |
| Domain (域) | Explanation (解释) |
| Pre-intervention | Risk of bias assessment is mainly distinct from assessments of randomised trials |
| 译文：干预前 | 译文：偏倚风险评估主要不同于随机试验的评估 |
| Bias due to confounding | Baseline confounding occurs when one or more prognostic variables (factors that predict the outcome of interest) also predicts the intervention received at baselineROBINS-I can also address time-varying confounding, which occurs when individuals switch between the interventions being compared and when post-baseline prognostic factors affect the intervention received after baseline |
| 译文：混杂偏倚 | 译文：当一个或多个预后变量(预测关注结局的因素)也能预测基线时接受的干预时，就会发生基线混杂ROBINS-I还可以处理时间依赖性混杂问题。如果参与者可以在干预组之间进行切换，那么干预和结果之间的关联可能会因为混杂而产生偏倚。当预后因素影响干预之间的切换时，就会发生这种情况时间依赖性混杂是指，该因素是研究结局的时间依赖性危险因素，同时该因素对后期的治疗或暴露有预测作用。如，在比较两种降糖药物与心血管疾病(CVD)风险关联的研究中，降糖药的使用会降低患者的糖化血红蛋白(HbA1c)水平，而HbA1c反映了血糖控制情况，又会影响降糖药种类和剂量的选择，同时HbA1c也被认为与CVD发生风险相关，因而HbA1c在特定时间成为治疗和结局之间关联的中介和混杂因素 |
| Bias in selection of participants into the study | When exclusion of some eligible participants, or the initial follow-up time of some participants, or some outcome events is related to both intervention and outcome, there will be an association between interventions and outcome even if the effects of the interventions are identicalThis form of selection bias is distinct from confounding—A specific example is bias due to the inclusion of prevalent users, rather than new users, of an intervention |
| 译文：研究对象选择的偏倚 | 译文：当排除部分符合条件的参与者，或部分参与者的初始随访时间；或某些研究对象的选择与干预和结局同时相关时，即使干预的效果相同，也会存在选择偏倚这种形式的选择偏倚不同于混杂——如，由于干预中包含了现患病例而不是新发病例而产生的偏倚 |
| At intervention | Risk of bias assessment is mainly distinct from assessments of randomised trials |
| 译文：干预中 | 译文：偏倚风险评估主要不同于随机试验的评估 |
| Bias in classification of interventions | Bias introduced by either differential or non-differential misclassification of intervention statusNon-differential misclassification is unrelated to the outcome and will usually bias the estimated effect of intervention towards the null Differential misclassification occurs when misclassification of intervention status is related to the outcome or the risk of the outcome, and is likely to lead to bias |
| 干预分类的偏倚 | 干预状态的差异或非差异错分导致的偏倚非差异性错分与结局无关，通常会使干预的估计效果偏向零当干预状态的错分与结局或结局的风险相关时，就会发生差异错分，并可能导致偏倚 |
| Post-intervention | Risk of bias assessment has substantial overlap with assessments of randomised trials |
| 译文：干预后 | 译文：偏倚风险评估与随机试验的评估有很大的重叠 |
| Bias due to deviations from intended interventions | Bias that arises when there are systematic differences between experimental intervention and comparator groups in the care provided, which represent a deviation from the intended intervention (s) Assessment of bias in this domain will depend on the type of effect of interest (either the effect of assignment to intervention or the effect of starting and adhering to intervention) |
| 译文：偏离既定干预措施的偏倚 | 译文：当实验组和对照组之间提供的干预措施存系统性差异时而导致的偏倚，这表明偏离了既定的干预这一领域的偏倚评估取决于感兴趣的效应类型(干预的分配效应或干预的依从效应) |
| Bias due to missing data | Bias that arises when later follow-up is missing for individuals initially included and followed (such as differential loss to follow-up that is affected by prognostic factors); bias due to exclusion of individuals with missing information about intervention status or other variables such as confounders |
| 译文：缺失数据的偏倚 | 译文：入组时或在后续随访过程中缺失的研究对象产生的偏倚(如由于预后导致的差异性失访)；由于排除了缺失干预状态或其他变量(如混杂因素)的个体而产生的偏倚 |
| Bias in measurement of outcomes | Bias introduced by either differential or non-differential errors in measurement of outcome data. Such bias can arise when outcome assessors are aware of intervention status, if different methods are used to assess outcomes in different intervention groups, or if measurement errors are related to intervention status or effects |
| 译文：结局测量的偏倚 | 译文：结局数据测量过程中由于差异性或非差异性误差导致的偏倚。当结局评价者知道干预状态时，如果使用不同的方法评估不同组的结局，或者如果测量误差与干预状态或结局有关时，就会出现这种偏倚 |
| Bias in selection of the reported result | Selective reporting of results in a way that depends on the findings and prevents the estimate from being included in a meta-analysis (or other synthesis) |
| 译文：结果选择性报告的偏倚 | 译文：结果的选择性报告取决于结果是如何产生的，应防止选择性报告结果被纳入荟萃分析(或其他综述)中 |
每个待评价的模块(域)下设置多个问题条目，需要评价者做出判断，最终根据5个模块的评价结果对整体偏倚风险进行评估。各个条目的回答选项有：是(Yes，Y)，可能是(Probably yes，PY)，可能否(Probably no，PN)，否(No，N)，未知(No information，NI)。如果条目需要根据前一个条目的结果作答，则备选答案中新增“不适用”(Not applicable，NA)选项。
整体偏倚评估：完成各个条目的回答与评价后，评价者需要根据回答的情况对相应领域的偏倚风险按照事先制定的标准给出“低、中、高、极高或不清楚”(low，moderate，serious，critical，or no information)的风险评估。最后根据所在单个领域的评估结果对“整体评估”这一综合领域做出评价。
整体偏倚评估原则为：所有7个评价领域为低风险则整体为“低”(Low risk of bias)，所有7个评价领域为低或中风险则整体为“中”(Moderate risk of bias)，至少一个评价领域为高风险但无任何评价领域为极高风险，则整体为“高”(High risk of bias)，若至少一个评价领域为极高风险，则整体为“极高”(Critical risk of bias)，若缺乏关键评价领域的相关信息，则整体偏倚风险为“未获得评估信息(未知)”(No information，NI)。
| Table 2 | Interpretation of domain-level and overall risk of bias judgements in ROBINS-I* | |||
| 表2 | ROBINS-I中域级和总体偏倚判断风险的解释 | |||
| Judgement判断类型 | Within each domain在每个域内 | Across domains跨领域 | Criterion标准 |
| Low risk of bias | The study is comparable to a well performed randomised trial with regard to this domain | The study is comparable to a well performed randomised trial | The study is judged to be at low risk of bias for all domains |
| 风险低 | 在该方面(领域)，该研究可与一项表现良好的随机试验相媲美 | 该项研究与一项表现良好的随机试验相当 | 该研究被认为在所有领域的偏倚风险均较低 |
| Moderate risk of bias | The study is sound for a non-randomised study with regard to this domain but cannot be considered comparable to a well performed randomised trial | The study provides sound evidence for a nonrandomised study but cannot be considered comparable to a well performed randomised trial | The study is judged to be at low or moderate risk of bias for all domains |
| 中风险 | 对于该领域的非随机研究而言，该研究是合理的，但不能与表现良好的随机试验相提并论 | 该研究为非随机研究提供了可靠的证据，但不能与一项表现良好的随机试验相提并论 | 该研究在所有领域均被判定为低或中等风险 |
| Serious risk of bias | The study has some important problems in this domain | The study has some important problems | The study is judged to be at serious risk of bias in at least one domain, but not at critical risk of bias in any domain |
| 高风险 | 该研究在这一领域还存在比较大的问题 | 该研究还存在比较大的问题 | 该研究被认为至少在一个领域存在严重偏倚风险，但不是在所有领域都存在严重偏倚风险 |
| Critical risk of bias | The study is too problematic in this domain to provide any useful evidence on the effects of intervention | The study is too problematic to provide any useful evidence and should not be included in any synthesis | The study is judged to be at critical risk of bias in at least one domain |
| 极高风险 | 该研究在这一领域存在问题太多，无法就干预的效果提供任何有用的证据 | 该研究问题太多，无法提供任何有用的证据，不应该被纳入任何综述性研究 | 该研究被认为至少在一个领域存在严重的偏倚风险 |
| No information | No information on which to base a judgement about risk of bias for this domain | No information on which to base a judgement about risk of bias | There is no clear indication that the study is at serious or critical risk of bias and there is a lack of information in one or more key domains of bias (a judgement is required for this) |
| 未知 | 没有信息可用来判断该领域的偏倚风险 | 没有信息可以用来判断偏倚风险 | 没有明确的证据表明该研究存在严重或极严重的偏倚风险，并且在一个或多个关键领域缺少信息(对此需要判断) |
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