The QUADAS-2, QUIPS, and PROBAST tools are not specific for prognostic accuracy studies and the use of these tools to assess the risk of bias in prognostic accuracy studies is prone to bias. Therefore, QUAPAS, a risk of bias assessment tool for prognostic accuracy studies, has recently been developed. The tool combines QUADAS-2, QUIPS, and PROBAST, and consists of 5 domains, 18 signaling questions, 5 risk of bias questions, and 4 applicability questions. This paper will introduce the content and usage of QUAPAS to provide inspiration and references for domestic researchers.
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.
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.
ObjectiveTo systematically interpret the updated risk of bias in non-randomized studies of interventions version 2 (ROBINS-I V2) in 2024, summarizing its key improvements, operational procedures, and clinical application value. MethodsThrough literature review and case studies, the improvements of ROBINS-I V2 were compared with the 2016 version, including the expansion of bias domains, refinement of signaling questions, and optimization of decision flowcharts. A retrospective study in stomatology was used to demonstrate the practical application of the tool. ResultsThe ROBINS-I V2 tool has restructured the hierarchy and refined the definitions of bias domains, optimized the evaluation processes across seven risk-of-bias dimensions, and minimized subjective judgment errors through standardized decision flowcharts. ConclusionROBINS-I V2 significantly improves the rigor of bias assessment in non-randomized intervention studies through its scientific design and standardized workflow. It is recommended for evidence quality grading and decision-making support in clinical research.
Selective non-reporting and publication bias of study results threaten the validity of systematic reviews and meta-analyses, thus affect clinical decision making. There are no rigorous methods to evaluate the risk of bias in network meta-analyses currently. This paper introduces the main contents of ROB-MEN (risk of bias due to missing evidence in network meta-analysis), including tables of the tool, operation process and signal questions. The pairwise comparisons table and the ROB-MEN table are the tool’s core. The ROB-MEN tool can be applied to very large and complex networks including lots of interventions to avoid time-consuming and labor-intensive process, and it has the advantages of clear logic, complete details and good applicability. It is the first tool used to evaluate the risk of bias due to missing evidence in network meta-analysis and is useful to researchers, thus being worth popularizing and applying.
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.
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.
ObjectivesTo comprehensively evaluate the methodological quality and applicability of the results of systematic reviews on acupuncture treatment for primary depression.MethodsWeb of Science, EMbase, PubMed, The Cochrane Library, CNKI, CBM, WanFang Data and VIP databases were electronically searched to collect systematic reviews/meta-analyses on acupuncture treatment for primary depression from inception to December 5th, 2018. Two researchers independently screened and extracted data by using tools of AMSTAR 2 to evaluate the methodological quality, using ROBIS to assess risk of bias, and using CASP-S.R to evaluate the applicability of the results.ResultsA total of 18 systematic reviews/meta-analyses were included, and all focused on acupuncture intervention, including 2 primary outcome indicators. According to AMSTAR 2 evaluation results, there were 4 high quality studies, 12 medium quality studies and 2 low quality studies; ROBIS results found 10 high bias risk studies, 7 low bias risk studies and 1 unclear; CASP-S.R showed only 4 design studies applicable to local individuals, and there were no studies on the relationship between design benefits, hazards and costs.ConclusionsThe quality of systematic reviews/meta-analyses for acupuncture treatment of primary depression is moderate, however with a certain bias. Most studies may not directly benefit local individuals. All studies have no relationship with cost hazards. It is expected for further reviewers to strictly follow systematic evaluation method to improve research quality and reduce bias, while the applicability of the systematic review to individuals from different regions should be considered as well as the relationship between the benefit and cost hazard. In addition, more valid RCTs are required to provide higher quality evidence and explore correlated and comprehensive mechanism.
The risk of bias assessment tool 2.0 (RoB 2.0) for analyzing cluster randomized trials and crossover trials (revised version 2021) has been updated. The current paper briefly delineates the history of the RoB 2.0 tool and includes an explanation and interpretation of the updated contents and software operation process for use with cluster randomized trials and crossover trials. Compared with the previous versions, the updated RoB 2.0 tool (revised version 2021) has the advantage of precise language and is easily understood. Thus, the updated RoB 2.0 tool merits popularization and further general application.
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.