The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. Journal of Epidemiology and Community Health, 52 6 , — This checklist offers a comprehensive critical appraisal tool for public health practitioners, policy-makers and decision-makers. The tool is a step-by-step, easy-to-use assessment suitable for all quantitative study methodologies. Each section includes instructions and a scoring system for individual sections and a final overall score.
However, the general structure of the tool and the assessments seems useful to follow when creating risk of bias assessments for NRS. For experimental and controlled studies, and for prospective cohort studies see Box This is the minimum assessment review authors should carry out and more details will usually be required. An additional component is to assess the risk of bias due to confounding.
In , the Good Research for Comparative Effectiveness GRACE Initiative was established and developed principles to help healthcare providers, researchers, journal readers, and editors evaluate inherent quality for observational research studies of comparative effectiveness [ 41 ].
DTA has several unique features in terms of its design which differ from standard intervention and observational evaluations. In , Penny et al. Other relevant tools reviewed by Whiting et al. Health economic evaluation research comparatively analyses alternative interventions with regard to their resource uses, costs and health effects [ 57 ].
Nowadays, health economic study is increasingly popular. Of course, its methodological quality also needs to be assessed before its initiation. However, we regard the Consolidated Health Economic Evaluation Reporting Standards CHEERS statement [ 61 ] as a reporting tool rather than a methodological quality assessment tool, so we do not recommend it to assess the methodological quality of health economic evaluation.
In healthcare, qualitative research aims to understand and interpret individual experiences, behaviours, interactions, and social contexts, so as to explain interested phenomena, such as the attitudes, beliefs, and perspectives of patients and clinicians; the interpersonal nature of caregiver and patient relationships; illness experience; and the impact of human sufferings [ 62 ]. Compared with quantitative studies, assessment tools for qualitative studies are fewer. Clinical prediction study includes predictor finding prognostic factor studies, prediction model studies development, validation, and extending or updating , and prediction model impact studies [ 66 ].
For prediction model impact studies, if it uses a randomized comparative design, tools for RCT can be used, especially the RoB 2. Nowadays, only the JBI has a critical appraisal checklist for the assessment of text and expert opinion papers Table S 3 K. Measurements can be subjective or objective, and either unidimensional e. Systematic review and meta-analysis are popular methods to keep up with current medical literature [ 4 — 6 ]. Their ultimate purposes and values lie in promoting healthcare [ 6 , 77 , 78 ].
Meta-analysis is a statistical process of combining results from several studies, commonly a part of a systematic review [ 11 ]. Of course, critical appraisal would be necessary before using systematic review and meta-analysis.
In , Sacks et al. However, this original AMSTAR instrument did not include an assessment on the risk of bias for non-randomised studies, and the expert group thought revisions should address all aspects of the conduct of a systematic review.
Hence, the new instrument for randomised or non-randomised studies on healthcare interventions - AMSTAR 2 was released in [ 83 ], and Table S 4 A presents its major items. Among those tools, the AMSTAR 2 is suitable for assessing systematic review and meta-analysis based on randomised or non-randomised interventional studies, the DSU NMA methodology checklist for network meta-analysis, while the ROBIS for meta-analysis based on interventional, diagnostic test accuracy, clinical prediction, and prognostic studies.
Clinical practice guideline CPG is integrated well into the thinking of practicing clinicians and professional clinical organizations [ 85 — 87 ]; and also make scientific evidence incorporated into clinical practice [ 88 ]. However, not all CPGs are evidence-based [ 89 , 90 ] and their qualities are uneven [ 91 — 93 ]. Until now there were more than 20 appraisal tools have been developed [ 94 ]. Among them, the Appraisal of Guidelines for Research and Evaluation AGREE instrument has the greatest potential in serving as a basis to develop an appraisal tool for clinical pathways [ 94 ].
Hence, critical appraisal of evidence before using is a key point in this process [ , ]. In , Mulrow CD [ ] pointed out that medical reviews needed routinely use scientific methods to identify, assess, and synthesize information. Hence, perform methodological quality assessment is necessary before using the study.
This phenomenon indicates more universal education of clinical epidemiology is needed for medical students and professionals. The methodological quality tool development should according to the characteristics of different study types. Compared with our previous systematic review [ 11 ], we found some tools are recommended and remain used, some are used without recommendation, and some are eliminated [ 10 , 29 , 30 , 36 , 53 , 94 , — ].
These tools produce a significant impetus for clinical practice [ , ]. In addition, compared with our previous systematic review [ 11 ], this review stated more tools, especially those developed after , and the latest revisions. Of course, we also adjusted the method of study type classification.
Firstly, in , the NICE provided 7 methodology checklists but only retains and updated the checklist for economic evaluation now. Besides, the Cochrane RoB 2. Secondly, we also introduced tools for network meta-analysis, outcome measurement instruments, text and expert opinion papers, prediction studies, qualitative study, health economic evaluation, and CER. Thirdly, we classified interventional studies into randomized and non-randomized sub-types, and then further classified non-randomized studies into with and without controlled group.
Moreover, we also classified cross-sectional study into analytic and purely descriptive sub-types, and case-series into interventional and observational sub-types.
These processing courses were more objective and comprehensive. However, further efforts remain necessary to develop appraisal tools. For some study types, only one assessment tool is suitable, such as CER, outcome measurement instruments, text and expert opinion papers, case report, and CPG. Besides, there is no proper assessment tool for many study types, such as overview, genetic association study, and cell study. Moreover, existing tools have not been fully accepted.
In the future, how to develop well accepted tools remains a significant and important work [ 11 ]. Our review can help the professionals of systematic review, meta-analysis, guidelines, and evidence users to choose the best tool when producing or using evidence. Moreover, methodologists can obtain the research topics for developing new tools. Therefore, users must receive formal training relevant epidemiological knowledge is necessary , and hold rigorous academic attitude, and at least two independent reviewers should be involved in evaluation and cross-checking to avoid performance bias [ ].
The authors thank all the authors and technicians for their hard field work for development methodological quality assessment tools. All authors read and approved the final manuscript.
This work was supported in part by the Entrusted Project of National commission on health and health of China No. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The authors declare that there are no conflicts of interest in this study.
The data and materials used during the current review are all available in this review. Lin-Lu Ma, Email: moc. Yun-Yun Wang, Email: moc. Zhi-Hua Yang, Email: moc. Di Huang, Email: moc.
Hong Weng, Email: moc. Xian-Tao Zeng, Email: moc. Supplementary information accompanies this paper at National Center for Biotechnology Information , U. Journal List Mil Med Res v. Mil Med Res. Published online Feb Author information Article notes Copyright and License information Disclaimer. Corresponding author. Received Jan 17; Accepted Feb This article has been cited by other articles in PMC. Major components of the tools for assessing intervention studies.
Additional file 2: Table S2. Major components of the tools for assessing observational studies and diagnostic study. Additional file 3: Table S3. Major components of the tools for assessing other primary medical studies. Additional file 4: Table S4. Major components of the tools for assessing secondary medical studies. Abstract Methodological quality risk of bias assessment is an important step before study initiation usage. Keywords: Methodological quality, Risk of bias, Quality assessment, Critical appraisal, Methodology checklist, Appraisal tool, Observational study, Qualitative study, Interventional study, Outcome measurement instrument.
Table 1 The basic characteristics of the included methodological quality risk of bias assessment tools. Open in a separate window. Animal study Before starting clinical trials, the safety and effectiveness of new drugs are usually tested in animal models [ 28 ], so animal study is considered as preclinical research, possessing important significance [ 29 , 30 ].
Non-randomised studies In clinical research, RCT is not always feasible [ 35 ]; therefore, non-randomized design remains considerable. Tools for observational studies and diagnostic study Observational studies include cohort study, case-control study, cross-sectional study, case series, case reports, and comparative effectiveness research [ 41 ], and can be divided into analytical and descriptive studies [ 42 ].
Cohort study Cohort study includes prospective cohort study, retrospective cohort study, and ambidirectional cohort study [ 43 ]. Validation process includes piloting the tool on a small sample of published studies, focusing on the assessment of the consistency and reliability of the tool. It is also piloted in a number of diagnostic reviews. Regression analyses are used to investigate associations between study characteristics and estimates of diagnostic accuracy in primary studies.
It is made up of four domains namely and applied in 4 phases. Consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results, and discussion sections of articles.
Eighteen items are common to cohort studies, case—control studies, and cross-sectional studies, and 4 are specific to each of the 3 study designs. Von Elm, E. The strengthening the reporting of observational studies in epidemiology STROBE statement: guidelines for reporting observational studies. Lancet , — Contains 6 domains with scores of "low", "high" or "unclear". A new form of literature review has emerged, Mixed Studies Review. These Assesses Qualitative 6 items , Quantitative experimental 3 items , Quantitative observational 3 items and Mixed Methods 3 items.
A scoring system for appraising mixed methods research, and concomitantly appraising qualitative, quantitative and mixed methods primary studies in Mixed Studies Reviews. IInternational Journal of Nursing Studies. Consists of 14 questions and can be used either as a checklist or a total score. It provides clinicians with a quick way of appraising the quality of a clinical guideline. Consists of 23 items. It assesses the quality of the guidelines, provides a methodological strategy for the development of guidelines; and aims to inform what information and how information ought to be reported in guidelines.
Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care. Face, construct and criterion validity were measured. Attitudes about the instrument and user guide were collected by questionnaire. Methods for the economic evaluation of health care programmes. Oxford : Oxford University Press, How to use an article about a diagnostic test. How to use an overview. Therapy CA Worksheet.
Therapy Critical Appraisal Worksheet is a methodological checklist which provides key criteria relevant to therapy studies.
Evidence based medicine. How to practice and teach it. Fourth Edition. Churchill Livingstone: Edinburgh, Diagnostic CA Worksheet. Diagnostic Critical Appraisal Worksheet is a methodological checklist which provides key criteria relevant to diagnostic studies. Harm CA Worksheet.
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