关键词:Meta分析; 队列研究质量评价; 病例对照研究质量评价; 观察性研究质量评价; 关键质量评估技能项目; CASP
一、队列研究质量评价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评价队列研究的清单共计12个条目,其中前2个条目是筛选问题,后10个是具体问题。1~7和10~12条均用“是”“否”“不知道”进行评价。
二、队列研究质量评价CASP清单
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? | ① the population studied ② the risk factors studied ③ is it clear whether the study tried to detect a beneficial or harmful effect ④ the outcomes considered | |||
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研究的危险因素 ③可能的有益或有害的效应 ④结局指标 | |||
2. Was the cohort recruited in an acceptable way? | Look for selection bias which might compromise the generalisability of the findings: ①was the cohort representative of a defined population ②was there something special about the cohort ③was everybody included who should have been | |||
译文:2. 研究对象的选择是否合适? | 主要聚焦于可能影响结果普遍性的选择偏倚: ①是否可以代表欲研究的人群 ②样本人群有什么特别的特征吗 ④是否纳入了所有应纳入的研究对象 | |||
3. Was the exposure accurately measured to minimise bias? | Look for measurement or classification bias: ①did they use subjective or objective measurements ②do the measurements truly reflect what you want them to (have they been validated) ③were all the subjects classified into exposure groups using the same procedure | |||
译文:3. 是否准确地测量了暴露因素以减少偏倚? | 主要聚焦于测量或分类偏倚: ①使用的是主观还是客观的测量方法 ②测量结果的真实性如何(是否被验证过?) ③测量方式是一样的吗 | |||
4. Was the outcome accurately measured to minimise bias? | Look for measurement or classification bias: ①did they use subjective or objective measurements ②do the measurements truly reflect what you want them to (have they been validated) ③has a reliable system been established for detecting all the cases (for measuring disease occurrence) ④were the measurement methods similar in the different groups ⑤were the subjects and/or the outcome assessor blinded to exposure (does this matter) | |||
译文:4. 是否准确测量了结局以减少偏倚? | 主要聚焦于测量或分类偏倚: ①使用的是主观还是客观的测量方法 ②测量结果的真实性如何(是否被验证过?) ③有无建立可靠的系统方法来检测所有的病例(测量疾病的发生) ④不同组的诊断方式是否相似 ⑤是否对研究对象及结果评价者采取盲法(这点很重要) | |||
5A. Have the authors identified all important confounding factors? | list the ones you think might be important, and ones the author missed | |||
译文:5A. 作者是否考虑到所有重要的混杂因素? | 译文:列出作者忽略但您考虑到的因素 | |||
5B. Have they taken account of the confounding factors in the design and/or analysis? | look for restriction in design, and techniques e.g. modelling, stratified-, regression-, or sensitivity analysis to correct, control or adjust for confounding factors | |||
译文:5B. 在设计和/或分析过程中是否考虑了控制混杂因素? | 译文: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 | |||
6A. Was the follow up of subjects complete enough? | ①the good or bad effects should have had long enough to reveal themselves ②the persons that are lost to follow-up may have different outcomes than those available for assessment ③in an open or dynamic cohort, was there anything special about the outcome of the people leaving, or the exposure of the people entering the cohort | |||
译文:6A. 对研究对象的随访是否完整? | 译文: ①应有足够的随访时间以观察到所有有利或不利的效应 ②失访人群是否可能具有不同的结局 ③在开放或动态队列中,对于失访和加入队列的研究对象有无特殊性 | |||
6B. Was the follow up of subjects long enough? | ||||
译文:6B. 随访时间是否足够长? | ||||
Section B:What are the results? | ||||
译文:第二部分,研究结果是什么? | ||||
7. What are the results of this study? | ①what are the bottom line results ②have they reported the rate or the proportion between the exposed/unexposed, the ratio/rate difference ③how strong is the association between exposure and outcome (RR) ④what is the absolute risk reduction (ARR) | |||
译文:7. 研究结果是什么? | ①基线的结果 ②是否报道了暴露组和非暴露组的发生率或比例以及率差或比值差 ③暴露因素与结局的关联强度如何(RR值为多少) ④绝对危险度降低值(ARR值)是多少 | |||
8. How precise are the results? | look for the range of the confidence intervals, if given | |||
译文:8. 研究结果的精确度如何? | 置信区间是多少 | |||
9. Do you believe the results? | ①big effect is hard to ignore ②can it be due to bias, chance or confounding ③are the design and methods of this study sufficiently flawed to make the results unreliable ④Bradford Hills criteria (e.g. time sequence, dose-response gradient, biological plausibility, consistency) | |||
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? | ①a cohort study was the appropriate method to answer this question ②the subjects covered in this study could be sufficiently different from your population to cause concern ③your local setting is likely to differ much from that of the study ④you can quantify the local benefits and harms | |||
译文:10. 研究结果能否用于目标人群? | ①队列研究是回答这个问题的合适方法 ②纳入研究的人群是否与你要用于的人群相似 ③研究环境是否和你要用于的环境相似 ④能否量化对要用于人群的有益和有害影响 | |||
11. Do the results of this study fit with other available evidence? | ||||
译文:11. 研究结果与其他证据是否吻合? | ||||
12. What are the implications of this study for practice? | ①one observational study rarely provides sufficiently robust evidence to recommend changes to clinical practice or within health policy decision making ②for certain questions, observational studies provide the only evidence ③recommendations from observational studies are always stronger when supported by other evidence | |||
译文:12. 这项研究对实践有什么意义? | ①一项观察性研究很少能提供足够有力的证据来改变临床实践或健康政策决策 ②对于有些问题,只能通过观察性研究提供证据 ③当获得其他方面证据的支持时,观察性研究可以提供强有力的建议 |
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队列研究质量评价清单更多内容详见网站https://casp-uk.net/casp-tools-checklists/cohort-study-checklist/
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