Measurement properties studies of patient-reported outcome measures (PROMs) aims to validate the measurement properties of PROMs. In the process of designing and statistical analysis of these measurement properties studies, bias will occur if there are any defects, which will affect the quality of PROMs. Therefore, the COSMIN (consensus-based standards for the selection of health measurement instruments) team has developed the COSMIN risk of bias (COSMIN-RoB) checklist to evaluate risk of bias of studies on measurement properties of PROMs. The checklist can be used to develop systematic reviews of PROMs measurement properties, and for PROMs developers, it can also be used to guide the research design in the measurement tool development process for reducing bias. At present, similar assessment tools are lacking in China. Therefore, this article aims to introduce the primary contents of COSMIN-RoB checklist and to interpret how to evaluate risk of bias of the internal structure studies of PROMs with examples.
The current issue of air pollution has pushed the development of the corresponding observational air pollution studies. The World Health Organization has developed a new risk of bias (RoB) assessment instrument and a related guideline for assessing the risk of potential bias in observational air pollution studies. This study introduced the background, methods, uses, advantages and disadvantages, precautions, and usage scenarios of the RoB instrument. It is expected to provide researchers with corresponding quality evaluation tools when writing related systematic review and meta-analysis, which will also help provide reporting standards for observational air pollution studies, thereby improving the quality of studies.
Evidence synthesis is the process of systematically gathering, analyzing, and integrating available research evidence. The quality of evidence synthesis depends on the quality of the original studies included. Validity assessment, also known as risk of bias assessment, is an essential method for assessing the quality of these original studies. Currently, there are numerous validity assessment tools available, but some of them lack a rigorous development process and evaluation. The application of inappropriate validity assessment tools to assessing the quality of the original studies during the evidence synthesis process may compromise the accuracy of study conclusions and mislead the clinical practice. To address this dilemma, the LATITUDES Network, a one-stop resource website for validity assessment tools, was established in September 2023, led by academics at the University of Bristol, U.K. This Network is dedicated to collecting, sorting and promoting validity assessment tools to improve the accuracy of original study validity assessments and increase the robustness and reliability of the results of evidence synthesis. This study introduces the background of the establishment of the LATITUDES Network, the included validity assessment tools, and the training resources for the use of validity assessment tools, in order to provide a reference for domestic scholars to learn more about the LATITUDES Network, to better use the appropriate validity assessment tools to conduct study quality assessments, and to provide references for the development of validity assessment tools.
High-quality randomized controlled trials are the best source of evidence to explain the relationship between health interventions and outcomes. However, in cases where they are insufficient, indirect, or inappropriate, researchers may need to include non-randomized studies of interventions to strengthen the evidence body and improve the certainty (quality) of evidence. The latest research from the GRADE working group provides a way for researchers to integrate randomized and non-randomized evidence. The present paper introduced the relevant methods to provide guidance for systematic reviewers, health technology assessors, and guideline developers.
The COSMIN-RoB checklist includes three sections with a total of 10 boxes, which is used to evaluate risk of bias of studies on content validity, internal structure, and other measurement properties. COSMIN classifies reliability, measurement error, criteria validity, hypothesis testing for construct validity, and responsiveness as other measurement properties, which primarily focus on the quality of the (sub)scale as a whole, rather than on the item level. Among the five measurement properties, reliability, measurement error and criteria validity are the most widely used in the studies. Therefore, this paper aims to interpret COSMIN-RoB checklist with examples to guide researchers to evaluate the risk of bias of the studies on reliability, measurement error and criteria validity of PROMs.
This paper introduces the main contents of ROB-ME (Risk Of Bias due to Missing Evidence), including backgrounds, scope of the tool, signal questions and the operation process. The ROB-ME tool has the advantages of clear logic, complete details, simple operation and good applicability. The ROB-ME tool offers considerable advantages for assessing the risk of non-reporting biases and will be useful to researchers, thus being worth popularizing and applying.
Nonrandomized studies are an important method for evaluating the effects of exposures (including environmental, occupational, and behavioral exposures) on human health. Risk of bias in nonrandomized studies of exposures (ROBINS-E) is used to evaluate the risk of bias in natural or occupational exposure observational studies. This paper introduces the main contents of ROBINS-E 2022, including backgrounds, seven domains, signal questions and the operation process.
GRADE（Grades of Recommendation, Assessment, Development，and Evaluation）方法为卫生保健中的证据质量评价与推荐强度评级提供指导。对那些为系统评价、卫生技术评估及临床实践指南总结证据的人而言，GRADE具有重要意义。GRADE提供了一个系统而透明的框架用以明确问题，确定所关注的结局，总结针对某问题的证据，以及从证据到形成推荐或作出决策。GRADE方法的广泛传播与应用，获全球50余个组织认可，这些组织大多有很强的影响力（http://www.gradeworkinggroup.org/），足以证明该工作的重要性。本文介绍临床流行病学杂志将刊出的20篇系列文章，为如何使用GRADE方法提供指导。
The COSMIN community updated the COSMIN-RoB checklist on reliability and measurement error in 2021. The updated checklist can be applied to the assessment of all types of outcome measurement studies, including clinician-reported outcome measures (ClinPOMs), performance-basd outcome measurement instruments (PerFOMs), and laboratory values. In order to help readers better understand and apply the updated COSMIN-RoB checklist and provide methodological references for conducting systematic reviews of ClinPOMs, PerFOMs and laboratory values, this paper aimed to interpret the updated COSMIN-RoB checklist on reliability and measurement error studies.
ObjectiveTo evaluate whether and to what extent the new risk of bias (ROB) tool has been used in Cochrane systematic reviews (CSRs) on acupuncture. MethodsWe searched the Cochrane Database of Systematic Review (CDSR) in issue 12, 2011. Two reviewers independently selected CSRs which primarily focused on acupuncture and moxibustion. Then the data involving in essential information, the information about ROB (sequence generation, allocation concealment, blindness, incomplete outcome data, selective reporting and other potential sources of bias) and GRADE were extracted and statistically analyzed. ResultsIn total, 41CSRs were identified, of which 19 CSRs were updated reviews. Thirty-three were published between 2009 and 2011. 60.98% reviews used the Cochrane Handbook as their ROB assessment tool. Most CSRs gave information about sequence generation, allocation concealment, blindness, and incomplete outcome data, however, half of them (54.55%, 8/69) showed selective reporting or other potential sources of bias. Conclusion"Risk of bias" tools have been used in most CSRs on acupuncture since 2009. However, the lack of evaluation items still remains.