关键质量评估技能项目(Critical appraisal skills programme, CASP)是英国牛津大学循证医学中心制定的质量评价项目，可用于评估随机对照试验、队列研究、病例对照研究、定性研究等多种设计类型的研究质量，每个清单包含约10-12个问题。本文着重介绍CASP病例对照研究质量评价清单。
关键词：Meta分析; 病例对照研究质量评价; 队列研究质量评价; 观察性研究质量评价; 关键质量评估技能项目; CASP
一、病例对照研究质量评价CASP清单使用方法
CASP清单在评估队列研究时需要考虑研究结果的有效性、研究结果的内容、结果是否适用三个方面的问题。CASP评价病例对照研究的清单共计11个条目，其中前2个条目是筛选问题，后9个条目是具体问题。1~6和9~11条均用“是”“否”“不知道”进行评价。
| 评价条目 Evaluation item | 评价标准 Evaluation criteria | Yes 是 | No 否 | Can’t Tell 不知道 |
| Section A：Are the results of the study valid? | ||||
| 译文：第一部分，研究结果是否可靠？ | ||||
| 1. Did the study address a clearly focused issue? | ①the population studied ②Whether the study tried to detect a beneficial or harmful effect ③the risk factors studied | |||
| 译文：1. 研究是否提出了清晰明确的研究问题？ | ①研究人群 ②研究是为了检测有益或有害的效应？ ③研究的危险因素 | |||
| 2. Did the authors use an appropriate method to answer their question? | ①Is a case control study an appropriate way of answering the question under the circumstances ②Did it address the study question | |||
| 译文：2. 回答研究问题的方法是否合适 | ①在该情况下，病例对照研究是否符合研究目的(病例对照研究尤其适合罕见病研究或研究有害效应) ②病例对照研究能否解决研究问题 | |||
| 3. Were the cases recruited in an acceptable way? | We are looking for selection bias which might compromise validity of the findings ①are the cases defined precisely ②were the cases representative of a defined population (geographically and/or temporally) ③was there an established reliable system for selecting all the cases ④are they incident or prevalent ⑤is there something special about the cases ⑥is the time frame of the study relevant to disease/exposure ⑦was there a sufficient number of cases selected ⑧was there a power calculation | |||
| 译文：3. 病例的选择方法是否合适 | 主要聚焦于可能影响研究结果有效性的选择偏倚： ①病例的定义是否准确 ②病例组的代表性(地区人口学代表性和时间代表性) ③有无建立系统可靠的方法来检测病例 ④是研究发病率还是患病率 ⑤病例组有无特殊特征 ⑥研究时间范围是否与疾病/暴露有关 ⑦样本量充足吗 ⑧计算把握度了吗 | |||
| 4. Were the controls selected in an acceptable way? | We are looking for selection bias which might compromise the generalisability of the findings ①were the controls representative of the defined population (geographically and/or temporally) ②was there something special about the controls ③was the non-response high, could non-respondents be different in any way ④are they matched, population based or randomly selected ⑤was there a sufficient number of controls selected | |||
| 译文：4. 对照的选择方法是否合适？ | 主要聚焦于可能影响结果普遍性的选择偏倚： ①对照组的代表性(地区人口学代表性和时间代表性) ②对照组有无特殊特征 ③无应答率高吗？不应答的人群是否具有不同特征 ④使用匹配选择、人群来源还是随机选择 ⑤样本量充足吗 | |||
| 5. Was the exposure accurately measured to minimise bias? | ①was the exposure clearly defined and accurately measured ②did the authors use subjective or objective measurements ③do the measures truly reflect what they are supposed to measure (have they been validated) ④were the measurement methods similar in the cases and controls ⑤did the study incorporate blinding where feasible ⑥is the temporal relation correct (does the exposure of interest precede the outcome) | |||
| 译文：5. 是否准确测量暴露因素以减少偏倚？ | 主要聚焦于测量偏倚、回忆偏倚或分类偏倚： ①暴露因素是否有明确的定义？测量方法是否准确？ ②研究者使用的是主观还是客观的测量方法 ③测量方法的真实性如何(是否被验证过？) ④病例组和对照组使用的测量方法是否相同 ⑤在适合使用盲法的地方是否使用了盲法 ⑥时间顺序正确吗(研究的暴露因素是否在结局前) | |||
| 6A. Aside from the experimental intervention, were the groups treated equally? | List the ones you think might be important, that the author may have missed ①genetic ②environmental ③socio-economic | |||
| 译文：6A. 除了实验干预外，各组是否得到平等对待(考虑了哪些混杂因素)？ | 列出作者忽略但您考虑到的因素，如： ①基因的 ②环境的 ③社会经济的 | |||
| 6B. Have the authors taken account of the potential confounding factors in the design and/or in their analysis? | restriction in design, and techniques e.g. modelling, stratified-, regression-, or sensitivity analysis to correct, control or adjust for confounding factors | |||
| 译文：6B. 在设计和/或分析过程中，是否考虑了控制潜在混杂因素？ | 在设计阶段限制人群选择；在分析阶段采用模型拟合、分层分析、回归分析或敏感性分析来纠正、控制、调整混杂因素 | |||
| Section B：What are the results？ | ||||
| 译文：第二部分，研究结果是什么？ | ||||
| 7. How large was the treatment effect? | ①what are the bottom line results ②is the analysis appropriate to the design ③how strong is the association between exposure and outcome (look at the odds ratio) ④are the results adjusted for confounding, and might confounding still explain the association ⑤has adjustment made a big difference to the OR | |||
| 译文：7. 治疗效果有多大？ | ①基线的结果 ②分析方法合适吗 ③暴露因素与结局的关联强度如何(OR值为多少) ④调整混杂因素后，疗效是否仍然存在 ⑤调整混杂因素是否对OR值有很大的影响 | |||
| 8. How precise was the estimate of the treatment effect? | ①size of the p-value ②size of the confidence intervals ③have the authors considered all the important variables ④how was the effect of subjects refusing to participate evaluated | |||
| 译文：8. 治疗效果的评估是否精准？ | ①P值是多少 ②置信区间是多少 ③研究者是否考虑了所有重要的变量 ④如何评估研究对象拒绝参与带来的影响 | |||
| 9. Do you believe the results? | ①big effect is hard to ignore ②Can it be due to chance, bias, or confounding ③are the design and methods of this study sufficiently flawed to make the results unreliable ④consider Bradford Hills criteria (e.g. time sequence, does-response gradient, strength, biological plausibility) | |||
| 译文：9. 结果是否可信？ | ①无法忽略的大效应量 ②有无偏倚、偶然性或混杂因素的影响 ③研究的设计和方法是否有缺陷导致结果不可靠 ④是否满足Bradford Hills因果推断标准(时间先后顺序、剂量-反应关系、生物学合理性、多个研究结果的一致性) | |||
| Section C：Will the results help locally? | ||||
| 译文：第三部分，研究结果适用吗？ | ||||
| 10. Can the results be applied to the local population? | ①the subjects covered in the study could be sufficiently different from your population to cause concern ②your local setting is likely to differ much from that of the study ③can you quantify the local benefits and harms | |||
| 译文：10. 研究结果能否适用于目标人群？ | ①纳入研究的人群是否与你要用于的人群相似 ②研究环境是否和你要用于的环境相似 ③能否量化对要用于的人群的有益和有害效应 | |||
| 11. Do the results of this study fit with other available evidence? | all the available evidence from RCT’s Systematic Reviews, Cohort Studies, and Case Control Studies as well, for consistency | |||
| 译文：11. 研究结果与其他证据是否吻合？ | 译文：考虑所有可得到的，来自随机对照试验、系统评价、队列研究及病例对照研究的一致性较好的证据 | |||
二、病例对照研究质量评价CASP清单
注：本文内容是参考相关文献后对关键质量评估技能项目(Critical appraisal skills programme, CASP)的概述，仅代表本网站观点。关于CASP病例对照研究质量评价清单更多内容详见网站https://casp-uk.net/casp-tools-checklists/case-control-study-checklist/。
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