Example: randomized controlled trial - case-control study- cohort study.
2- What is the study type (design)?
The study design of the research is fundamental to the usefulness of the study.
In a clinical paper the methodology employed to generate the results is fully explained. In general, all questions about the related clinical query, the study design, the subjects and the correlated measures to reduce bias and confounding should be adequately and thoroughly explored and answered.
Participants/Sample Population:
Researchers identify the target population they are interested in. A sample population is therefore taken and results from this sample are then generalized to the target population.
The sample should be representative of the target population from which it came. Knowing the baseline characteristics of the sample population is important because this allows researchers to see how closely the subjects match their own patients [ 4 ].
Sample size calculation (Power calculation): A trial should be large enough to have a high chance of detecting a worthwhile effect if it exists. Statisticians can work out before the trial begins how large the sample size should be in order to have a good chance of detecting a true difference between the intervention and control groups [ 5 ].
Researchers use measuring techniques and instruments that have been shown to be valid and reliable.
Validity refers to the extent to which a test measures what it is supposed to measure.
(the extent to which the value obtained represents the object of interest.)
Reliability: In research, the term reliability means “repeatability” or “consistency”
Reliability refers to how consistent a test is on repeated measurements. It is important especially if assessments are made on different occasions and or by different examiners. Studies should state the method for assessing the reliability of any measurements taken and what the intra –examiner reliability was [ 6 ].
3-Selection issues:
The following questions should be raised:
Researchers employ a variety of techniques to make the methodology more robust, such as matching, restriction, randomization, and blinding [ 7 ].
Bias is the term used to describe an error at any stage of the study that was not due to chance. Bias leads to results in which there are a systematic deviation from the truth. As bias cannot be measured, researchers need to rely on good research design to minimize bias [ 8 ]. To minimize any bias within a study the sample population should be representative of the population. It is also imperative to consider the sample size in the study and identify if the study is adequately powered to produce statistically significant results, i.e., p-values quoted are <0.05 [ 9 ].
4-What are the outcome factors and how are they measured?
5-What are the study factors and how are they measured?
Data Analysis and Results:
- Were the tests appropriate for the data?
- Are confidence intervals or p-values given?
Confounding Factors:
A confounder has a triangular relationship with both the exposure and the outcome. However, it is not on the causal pathway. It makes it appear as if there is a direct relationship between the exposure and the outcome or it might even mask an association that would otherwise have been present [ 9 ].
6- What important potential confounders are considered?
7- What is the statistical method in the study?
Interpretation of p-value:
The p-value refers to the probability that any particular outcome would have arisen by chance. A p-value of less than 1 in 20 (p<0.05) is statistically significant.
Confidence interval:
Multiple repetition of the same trial would not yield the exact same results every time. However, on average the results would be within a certain range. A 95% confidence interval means that there is a 95% chance that the true size of effect will lie within this range.
8- Statistical results:
Are statistical tests performed and comparisons made (data searching)?
Correct statistical analysis of results is crucial to the reliability of the conclusions drawn from the research paper. Depending on the study design and sample selection method employed, observational or inferential statistical analysis may be carried out on the results of the study.
It is important to identify if this is appropriate for the study [ 9 ].
Clinical significance:
Statistical significance as shown by p-value is not the same as clinical significance. Statistical significance judges whether treatment effects are explicable as chance findings, whereas clinical significance assesses whether treatment effects are worthwhile in real life. Small improvements that are statistically significant might not result in any meaningful improvement clinically. The following questions should always be on mind:
9- What conclusions did the authors reach about the study question?
Conclusions should ensure that recommendations stated are suitable for the results attained within the capacity of the study. The authors should also concentrate on the limitations in the study and their effects on the outcomes and the proposed suggestions for future studies [ 10 ].
Do the citations follow one of the Council of Biological Editors’ (CBE) standard formats?
10- Are ethical issues considered?
If a study involves human subjects, human tissues, or animals, was approval from appropriate institutional or governmental entities obtained? [ 10 , 11 ].
Critical appraisal of RCTs: Factors to look for:
[ Table/Fig-2 ] summarizes the guidelines for Consolidated Standards of Reporting Trials CONSORT [ 12 ].
Summary of the CONSORT guidelines.
Title and abstract | Identification as a RCT in the title- Structured summary (trial design, methods, results, and conclusions) |
---|---|
Introduction | -Scientific background -Objectives |
Methods | -Description of trial design and important changes to methods -Eligibility criteria for participants -The interventions for each group -Completely defined and assessed primary and secondary outcome measures -How sample size was determined -Method used to generate the random allocation sequence -Mechanism used to implement the random allocation sequence -Blinding details -Statistical methods used |
Results | -Numbers of participants, losses and exclusions after randomization -Results for each group and the estimated effect size and its precision (such as 95% confidence interval) -Results of any other subgroup analyses performed |
Discussion | -Trial limitations -Generalisability |
Other information | - Registration number |
Critical appraisal of systematic reviews: provide an overview of all primary studies on a topic and try to obtain an overall picture of the results.
In a systematic review, all the primary studies identified are critically appraised and only the best ones are selected. A meta-analysis (i.e., a statistical analysis) of the results from selected studies may be included. Factors to look for:
[ Table/Fig-3 ] summarizes the guidelines for Preferred Reporting Items for Systematic reviews and Meta-Analyses PRISMA [ 13 ].
Summary of PRISMA guidelines.
Title | Identification of the report as a systematic review, meta-analysis, or both. |
---|---|
Abstract | Structured Summary: background; objectives; eligibility criteria; results; limitations; conclusions; systematic review registration number. |
Introduction | -Description of the rationale for the review -Provision of a defined statement of questions being concentrated on with regard to participants, interventions, comparisons, outcomes, and study design (PICOS). |
Methods | -Specification of study eligibility criteria -Description of all information sources -Presentation of full electronic search strategy -State the process for selecting studies -Description of the method of data extraction from reports and methods used for assessing risk of bias of individual studies in addition to methods of handling data and combining results of studies. |
Results | Provision of full details of: -Study selection. -Study characteristics (e.g., study size, PICOS, follow-up period) -Risk of bias within studies. -Results of each meta-analysis done, including confidence intervals and measures of consistency. -Methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression). |
Discussion | -Summary of the main findings including the strength of evidence for each main outcome. -Discussion of limitations at study and outcome level. -Provision of a general concluded interpretation of the results in the context of other evidence. |
Funding | Source and role of funders. |
Critical appraisal is a fundamental skill in modern practice for assessing the value of clinical researches and providing an indication of their relevance to the profession. It is a skills-set developed throughout a professional career that facilitates this and, through integration with clinical experience and patient preference, permits the practice of evidence based medicine and dentistry. By following a systematic approach, such evidence can be considered and applied to clinical practice.
The tools listed below will help identify the many ways that error and bias can distort research results.
These tools generally have a core set of questions around 'risk of bias'. Some tools also include other questions to address precision and external validity i.e. generalisability.
The recommended Cochrane risk of bias tools define internal validity as "risk of bias" and consider that to be the key concept when assessing if a study is valid.
Among the collection is a set of checklists that SURE has developed, please note that these have not been externally validated.
The Cochrane Collaboration advocate against the use of scales yielding a summary score.
If you have any feedback and suggestions for improvement, please contact us:
We conduct systematic and literature reviews in the fields of health and social care, investigate methodological innovation and provide consultancy and training services.
Specialist Unit for Review Evidence, Cardiff University, 6th Floor, Neuadd Meirionnydd, Heath Park campus, Cardiff, CF14 4YS
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Critical appraisal skills are important for anyone wishing to make informed decisions or improve the quality of healthcare delivery. A good critical appraisal provides information regarding the believability and usefulness of a particular study. However, the appraisal process is often overlooked, and critically appraising quantitative research can be daunting for both researchers and clinicians. This chapter introduces the concept of critical appraisal and highlights its importance in evidence-based practice. Readers are then introduced to the most common quantitative study designs and key questions to ask when appraising each type of study. These studies include systematic reviews, experimental studies (randomized controlled trials and non-randomized controlled trials), and observational studies (cohort, case-control, and cross-sectional studies). This chapter also provides the tools most commonly used to appraise the methodological and reporting quality of quantitative studies. Overall, this chapter serves as a step-by-step guide to appraising quantitative research in healthcare settings.
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Cavaleri, R., Bhole, S., Arora, A. (2019). Critical Appraisal of Quantitative Research. In: Liamputtong, P. (eds) Handbook of Research Methods in Health Social Sciences. Springer, Singapore. https://doi.org/10.1007/978-981-10-5251-4_120
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This guide, aimed at health students, provides basic level support for appraising quantitative research papers. It's designed for students who have already attended lectures on critical appraisal. One framework for appraising quantitative research (based on reliability, internal and external validity) is provided and there is an opportunity to practise the technique on a sample article.
Please note this framework is for appraising one particular type of quantitative research a Randomised Controlled Trial (RCT) which is defined as
a trial in which participants are randomly assigned to one of two or more groups: the experimental group or groups receive the intervention or interventions being tested; the comparison group (control group) receive usual care or no treatment or a placebo. The groups are then followed up to see if there are any differences between the results. This helps in assessing the effectiveness of the intervention.(CASP, 2020)
To practise following this framework for critically appraising a quantitative article, please look at the following article:
Marrero, D.G. et al. (2016) 'Comparison of commercial and self-initiated weight loss programs in people with prediabetes: a randomized control trial', AJPH Research , 106(5), pp. 949-956.
How to use this practical example
Marrero, d.g. et al (2016) 'comparison of commercial and self-initiated weight loss programs in people with prediabetes: a randomized control trial', ajph research , 106(5), pp. 949-956., step 1. take a quick look at the article, step 2. click on the internal validity tab above - there are questions to help you appraise the article, read the questions and look for the answers in the article. , step 3. click on each question and our answers will appear., step 4. repeat with the other aspects of external validity and reliability. , questioning the internal validity:, randomisation : how were participants allocated to each group did a randomisation process taken place, comparability of groups: how similar were the groups eg age, sex, ethnicity – is this made clear, blinding (none, single, double or triple): who was not aware of which group a patient was in (eg nobody, only patient, patient and clinician, patient, clinician and researcher) was it feasible for more blinding to have taken place , equal treatment of groups: were both groups treated in the same way , attrition : what percentage of participants dropped out did this adversely affect one group has this been evaluated, overall internal validity: does the research measure what it is supposed to be measuring, questioning the external validity:, attrition: was everyone accounted for at the end of the study was any attempt made to contact drop-outs, sampling approach: how was the sample selected was it based on probability or non-probability what was the approach (eg simple random, convenience) was this an appropriate approach, sample size (power calculation): how many participants was a sample size calculation performed did the study pass, exclusion/ inclusion criteria: were the criteria set out clearly were they based on recognised diagnostic criteria, what is the overall external validity can the results be applied to the wider population, questioning the reliability (measurement tool) internal validity:, internal consistency reliability (cronbach’s alpha). has a cronbach’s alpha score of 0.7 or above been included, test re-test reliability correlation. was the test repeated more than once were the same results received has a correlation coefficient been reported is it above 0.7 , validity of measurement tool. is it an established tool if not what has been done to check if it is reliable pilot study expert panel literature review criterion validity (test against other tools): has a criterion validity comparison been carried out was the score above 0.7, what is the overall reliability how consistent are the measurements , overall validity and reliability:, overall how valid and reliable is the paper.
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Consumers of research (researchers, administrators, educators and clinicians) frequently use standard critical appraisal tools to evaluate the quality of published research reports. However, there is no consensus regarding the most appropriate critical appraisal tool for allied health research. We summarized the content, intent, construction and psychometric properties of published, currently available critical appraisal tools to identify common elements and their relevance to allied health research.
A systematic review was undertaken of 121 published critical appraisal tools sourced from 108 papers located on electronic databases and the Internet. The tools were classified according to the study design for which they were intended. Their items were then classified into one of 12 criteria based on their intent. Commonly occurring items were identified. The empirical basis for construction of the tool, the method by which overall quality of the study was established, the psychometric properties of the critical appraisal tools and whether guidelines were provided for their use were also recorded.
Eighty-seven percent of critical appraisal tools were specific to a research design, with most tools having been developed for experimental studies. There was considerable variability in items contained in the critical appraisal tools. Twelve percent of available tools were developed using specified empirical research. Forty-nine percent of the critical appraisal tools summarized the quality appraisal into a numeric summary score. Few critical appraisal tools had documented evidence of validity of their items, or reliability of use. Guidelines regarding administration of the tools were provided in 43% of cases.
There was considerable variability in intent, components, construction and psychometric properties of published critical appraisal tools for research reports. There is no "gold standard' critical appraisal tool for any study design, nor is there any widely accepted generic tool that can be applied equally well across study types. No tool was specific to allied health research requirements. Thus interpretation of critical appraisal of research reports currently needs to be considered in light of the properties and intent of the critical appraisal tool chosen for the task.
Peer Review reports
Consumers of research (clinicians, researchers, educators, administrators) frequently use standard critical appraisal tools to evaluate the quality and utility of published research reports [ 1 ]. Critical appraisal tools provide analytical evaluations of the quality of the study, in particular the methods applied to minimise biases in a research project [ 2 ]. As these factors potentially influence study results, and the way that the study findings are interpreted, this information is vital for consumers of research to ascertain whether the results of the study can be believed, and transferred appropriately into other environments, such as policy, further research studies, education or clinical practice. Hence, choosing an appropriate critical appraisal tool is an important component of evidence-based practice.
Although the importance of critical appraisal tools has been acknowledged [ 1 , 3 – 5 ] there appears to be no consensus regarding the 'gold standard' tool for any medical evidence. In addition, it seems that consumers of research are faced with a large number of critical appraisal tools from which to choose. This is evidenced by the recent report by the Agency for Health Research Quality in which 93 critical appraisal tools for quantitative studies were identified [ 6 ]. Such choice may pose problems for research consumers, as dissimilar findings may well be the result when different critical appraisal tools are used to evaluate the same research report [ 6 ].
Critical appraisal tools can be broadly classified into those that are research design-specific and those that are generic. Design-specific tools contain items that address methodological issues that are unique to the research design [ 5 , 7 ]. This precludes comparison however of the quality of different study designs [ 8 ]. To attempt to overcome this limitation, generic critical appraisal tools have been developed, in an attempt to enhance the ability of research consumers to synthesise evidence from a range of quantitative and or qualitative study designs (for instance [ 9 ]). There is no evidence that generic critical appraisal tools and design-specific tools provide a comparative evaluation of research designs.
Moreover, there appears to be little consensus regarding the most appropriate items that should be contained within any critical appraisal tool. This paper is concerned primarily with critical appraisal tools that address the unique properties of allied health care and research [ 10 ]. This approach was taken because of the unique nature of allied health contacts with patients, and because evidence-based practice is an emerging area in allied health [ 10 ]. The availability of so many critical appraisal tools (for instance [ 6 ]) may well prove daunting for allied health practitioners who are learning to critically appraise research in their area of interest. For the purposes of this evaluation, allied health is defined as encompassing "...all occasions of service to non admitted patients where services are provided at units/clinics providing treatment/counseling to patients. These include units primarily concerned with physiotherapy, speech therapy, family panning, dietary advice, optometry occupational therapy..." [ 11 ].
The unique nature of allied health practice needs to be considered in allied health research. Allied health research thus differs from most medical research, with respect to:
• the paradigm underpinning comprehensive and clinically-reasoned descriptions of diagnosis (including validity and reliability). An example of this is in research into low back pain, where instead of diagnosis being made on location and chronicity of pain (as is common) [ 12 ], it would be made on the spinal structure and the nature of the dysfunction underpinning the symptoms, which is arrived at by a staged and replicable clinical reasoning process [ 10 , 13 ].
• the frequent use of multiple interventions within the one contact with the patient (an occasion of service), each of which requires appropriate description in terms of relationship to the diagnosis, nature, intensity, frequency, type of instruction provided to the patient, and the order in which the interventions were applied [ 13 ]
• the timeframe and frequency of contact with the patient (as many allied health disciplines treat patients in episodes of care that contain multiple occasions of service, and which can span many weeks, or even years in the case of chronic problems [ 14 ])
• measures of outcome, including appropriate methods and timeframes of measuring change in impairment, function, disability and handicap that address the needs of different stakeholders (patients, therapists, funders etc) [ 10 , 12 , 13 ].
In supplementary data [see additional file 1 ].
Two independent researchers (PK, NMW) participated in all aspects of this review, and they compared and discussed their findings with respect to inclusion of critical appraisal tools, their intent, components, data extraction and item classification, construction and psychometric properties. Disagreements were resolved by discussion with a third member of the team (KG).
Data extraction consisted of a four-staged process. First, identical replica critical appraisal tools were identified and removed prior to analysis. The remaining critical appraisal tools were then classified according to the study design for which they were intended to be used [ 1 , 2 ]. The scientific manner in which the tools had been constructed was classified as whether an empirical research approach has been used, and if so, which type of research had been undertaken. Finally, the items contained in each critical appraisal tool were extracted and classified into one of eleven groups, which were based on the criteria described by Clarke and Oxman [ 4 ] as:
• Study aims and justification
• Methodology used , which encompassed method of identification of relevant studies and adherence to study protocol;
• Sample selection , which ranged from inclusion and exclusion criteria, to homogeneity of groups;
• Method of randomization and allocation blinding;
• Attrition : response and drop out rates;
• Blinding of the clinician, assessor, patient and statistician as well as the method of blinding;
• Outcome measure characteristics;
• Intervention or exposure details;
• Method of data analyses ;
• Potential sources of bias ; and
• Issues of external validity , which ranged from application of evidence to other settings to the relationship between benefits, cost and harm.
An additional group, " miscellaneous ", was used to describe items that could not be classified into any of the groups listed above.
Data was synthesized using MS Excel spread sheets as well as narrative format by describing the number of critical appraisal tools per study design and the type of items they contained. Descriptions were made of the method by which the overall quality of the study was determined, evidence regarding the psychometric properties of the tools (validity and reliability) and whether guidelines were provided for use of the critical appraisal tool.
One hundred and ninety-three research reports that potentially provided a description of a critical appraisal tool (or process) were identified from the search strategy. Fifty-six of these papers were unavailable for review due to outdated Internet links, or inability to source the relevant journal through Australian university and Government library databases. Of the 127 papers retrieved, 19 were excluded from this review, as they did not provide a description of the critical appraisal tool used, or were published in languages other than English. As a result, 108 papers were reviewed, which yielded 121 different critical appraisal tools [ 1 – 5 , 7 , 9 , 15 – 102 , 116 ].
We identified 14 instruments (12% all tools) which were reported as having been constructed using a specified empirical approach [ 20 , 29 , 30 , 32 , 35 , 40 , 49 , 51 , 70 – 72 , 79 , 103 , 116 ]. The empirical research reflected descriptive and/or qualitative approaches, these being critical review of existing tools [ 40 , 72 ], Delphi techniques to identify then refine data items [ 32 , 51 , 71 ], questionnaires and other forms of written surveys to identify and refine data items [ 70 , 79 , 103 ], facilitated structured consensus meetings [ 20 , 29 , 30 , 35 , 40 , 49 , 70 , 72 , 79 , 116 ], and pilot validation testing [ 20 , 40 , 72 , 103 , 116 ]. In all the studies which reported developing critical appraisal tools using a consensus approach, a range of stakeholder input was sought, reflecting researchers and clinicians in a range of health disciplines, students, educators and consumers. There were a further 31 papers which cited other studies as the source of the tool used in the review, but which provided no information on why individual items had been chosen, or whether (or how) they had been modified. Moreover, for 21 of these tools, the cited sources of the critical appraisal tool did not report the empirical basis on which the tool had been constructed.
Seventy-eight percent (N = 94) of the critical appraisal tools were developed for use on primary research [ 1 – 5 , 7 , 9 , 18 , 19 , 25 – 27 , 34 , 37 – 41 ], while the remainder (N = 26) were for secondary research (systematic reviews and meta-analyses) [ 2 – 5 , 15 – 36 , 116 ]. Eighty-seven percent (N = 104) of all critical appraisal tools were design-specific [ 2 – 5 , 7 , 9 , 15 – 90 ], with over one third (N = 45) developed for experimental studies (randomized controlled trials, clinical trials) [ 2 – 4 , 25 – 27 , 34 , 37 – 73 ]. Sixteen critical appraisal tools were generic. Of these, six were developed for use on both experimental and observational studies [ 9 , 91 – 95 ], whereas 11 were purported to be useful for any qualitative and quantitative research design [ 1 , 18 , 41 , 96 – 102 , 116 ] (see Figure 1 , Table 1 ).
Number of critical appraisal tools per study design [1,2]
One thousand, four hundred and seventy five items were extracted from these critical appraisal tools. After grouping like items together, 173 different item types were identified, with the most frequently reported items being focused towards assessing the external validity of the study (N = 35) and method of data analyses (N = 28) (Table 2 ). The most frequently reported items across all critical appraisal tools were:
Eligibility criteria (inclusion/exclusion criteria) (N = 63)
Appropriate statistical analyses (N = 47)
Random allocation of subjects (N = 43)
Consideration of outcome measures used (N = 43)
Sample size justification/power calculations (N = 39)
Study design reported (N = 36)
Assessor blinding (N = 36)
Systematic reviews.
Eighty-seven different items were extracted from the 26 critical appraisal tools, which were designed to evaluate the quality of systematic reviews. These critical appraisal tools frequently contained items regarding data analyses and issues of external validity (Tables 2 and 3 ).
Items assessing data analyses were focused to the methods used to summarize the results, assessment of sensitivity of results and whether heterogeneity was considered, whereas the nature of reporting of the main results, interpretation of them and their generalizability were frequently used to assess the external validity of the study findings. Moreover, systematic review critical appraisal tools tended to contain items such as identification of relevant studies, search strategy used, number of studies included and protocol adherence, that would not be relevant for other study designs. Blinding and randomisation procedures were rarely included in these critical appraisal tools.
One hundred and twenty thirteen different items were extracted from the 45 experimental critical appraisal tools. These items most frequently assessed aspects of data analyses and blinding (Tables 1 and 2 ). Data analyses items were focused on whether appropriate statistical analysis was performed, whether a sample size justification or power calculation was provided and whether side effects of the intervention were recorded and analysed. Blinding was focused on whether the participant, clinician and assessor were blinded to the intervention.
Forty-seven different items were extracted from the seven diagnostic critical appraisal tools. These items frequently addressed issues involving data analyses, external validity of results and sample selection that were specific to diagnostic studies (whether the diagnostic criteria were defined, definition of the "gold" standard, the calculation of sensitivity and specificity) (Tables 1 and 2 ).
Seventy-four different items were extracted from the 19 critical appraisal tools for observational studies. These items primarily focused on aspects of data analyses (see Tables 1 and 2 , such as whether confounders were considered in the analysis, whether a sample size justification or power calculation was provided and whether appropriate statistical analyses were preformed.
Thirty-six different items were extracted from the seven qualitative study critical appraisal tools. The majority of these items assessed issues regarding external validity, methods of data analyses and the aims and justification of the study (Tables 1 and 2 ). Specifically, items were focused to whether the study question was clearly stated, whether data analyses were clearly described and appropriate, and application of the study findings to the clinical setting. Qualitative critical appraisal tools did not contain items regarding sample selection, randomization, blinding, intervention or bias, perhaps because these issues are not relevant to the qualitative paradigm.
Experimental and observational studies.
Forty-two different items were extracted from the six critical appraisal tools that could be used to evaluate experimental and observational studies. These tools most frequently contained items that addressed aspects of sample selection (such as inclusion/exclusion criteria of participants, homogeneity of participants at baseline) and data analyses (such as whether appropriate statistical analyses were performed, whether a justification of the sample size or power calculation were provided).
Seventy-eight different items were contained in the ten critical appraisal tools that could be used for all study designs (quantitative and qualitative). The majority of these items focused on whether appropriate data analyses were undertaken (such as whether confounders were considered in the analysis, whether a sample size justification or power calculation was provided and whether appropriate statistical analyses were preformed) and external validity issues (generalization of results to the population, value of the research findings) (see Tables 1 and 2 ).
We found no critical appraisal instrument specific to allied health research, despite finding at least seven critical appraisal instruments associated with allied health topics (mostly physiotherapy management of orthopedic conditions) [ 37 , 39 , 52 , 58 , 59 , 65 ]. One critical appraisal development group proposed two instruments [ 9 ], specific to quantitative and qualitative research respectively. The core elements of allied health research quality (specific diagnosis criteria, intervention descriptions, nature of patient contact and appropriate outcome measures) were not addressed in any one tool sourced for this evaluation. We identified 152 different ways of considering quality reporting of outcome measures in the 121 critical appraisal tools, and 81 ways of considering description of interventions. Very few tools which were not specifically targeted to diagnostic studies (less than 10% of the remaining tools) addressed diagnostic criteria. The critical appraisal instrument that seemed most related to allied health research quality [ 39 ] sought comprehensive evaluation of elements of intervention and outcome, however this instrument was relevant only to physiotherapeutic orthopedic experimental research.
Forty-nine percent (N = 58) of critical appraisal tools summarised the results of the quality appraisal into a single numeric summary score [ 5 , 7 , 15 – 25 , 37 – 59 , 74 – 77 , 80 – 83 , 87 , 91 – 93 , 96 , 97 ] (Figure 2 ). This was achieved by one of two methods:
Number of critical appraisal tools with, and without, summary quality scores
An equal weighting system, where one point was allocated to each item fulfilled; or
A weighted system, where fulfilled items were allocated various points depending on their perceived importance.
However, there was no justification provided for any of the scoring systems used. In the remaining critical appraisal tools (N = 62), a single numerical summary score was not provided [ 1 – 4 , 9 , 25 – 36 , 60 – 73 , 78 , 79 , 84 – 90 , 94 , 95 , 98 – 102 ]. This left the research consumer to summarize the results of the appraisal in a narrative manner, without the assistance of a standard approach.
Few critical appraisal tools had documented evidence of their validity and reliability. Face validity was established in nine critical appraisal tools, seven of which were developed for use on experimental studies [ 38 , 40 , 45 , 49 , 51 , 63 , 70 ] and two for systematic reviews [ 32 , 103 ]. Intra-rater reliability was established for only one critical appraisal tool as part of its empirical development process [ 40 ], whereas inter-rater reliability was reported for two systematic review tools [ 20 , 36 ] (for one of these as part of the developmental process [ 20 ]) and seven experimental critical appraisal tools [ 38 , 40 , 45 , 51 , 55 , 56 , 63 ] (for two of these as part of the developmental process [ 40 , 51 ]).
Forty-three percent (N = 52) of critical appraisal tools had guidelines that informed the user of the interpretation of each item contained within them (Table 2 ). These guidelines were most frequently in the form of a handbook or published paper (N = 31) [ 2 , 4 , 9 , 15 , 20 , 25 , 28 , 29 , 31 , 36 , 37 , 41 , 50 , 64 – 67 , 69 , 80 , 84 – 87 , 89 , 90 , 95 , 100 , 116 ], whereas in 14 critical appraisal tools explanations accompanied each item [ 16 , 26 , 27 , 40 , 49 , 51 , 57 , 59 , 79 , 83 , 91 , 102 ].
Our search strategy identified a large number of published critical appraisal tools that are currently available to critically appraise research reports. There was a distinct lack of information on tool development processes in most cases. Many of the tools were reported to be modifications of other published tools, or reflected specialty concerns in specific clinical or research areas, without attempts to justify inclusion criteria. Less than 10 of these tools were relevant to evaluation of the quality of allied health research, and none of these were based on an empirical research approach. We are concerned that although our search was systematic and extensive [ 104 , 105 ], our broad key words and our lack of ready access to 29% of potentially useful papers (N = 56) potentially constrained us from identifying all published critical appraisal tools. However, consumers of research seeking critical appraisal instruments are not likely to seek instruments from outdated Internet links and unobtainable journals, thus we believe that we identified the most readily available instruments. Thus, despite the limitations on sourcing all possible tools, we believe that this paper presents a useful synthesis of the readily available critical appraisal tools.
The majority of the critical appraisal tools were developed for a specific research design (87%), with most designed for use on experimental studies (38% of all critical appraisal tools sourced). This finding is not surprising as, according to the medical model, experimental studies sit at or near the top of the hierarchy of evidence [ 2 , 8 ]. In recent years, allied health researchers have strived to apply the medical model of research to their own discipline by conducting experimental research, often by using the randomized controlled trial design [ 106 ]. This trend may be the reason for the development of experimental critical appraisal tools reported in allied health-specific research topics [ 37 , 39 , 52 , 58 , 59 , 65 ].
We also found a considerable number of critical appraisal tools for systematic reviews (N = 26), which reflects the trend to synthesize research evidence to make it relevant for clinicians [ 105 , 107 ]. Systematic review critical appraisal tools contained unique items (such as identification of relevant studies, search strategy used, number of studies included, protocol adherence) compared with tools used for primary studies, a reflection of the secondary nature of data synthesis and analysis.
In contrast, we identified very few qualitative study critical appraisal tools, despite the presence of many journal-specific guidelines that outline important methodological aspects required in a manuscript submitted for publication [ 108 – 110 ]. This finding may reflect the more traditional, quantitative focus of allied health research [ 111 ]. Alternatively, qualitative researchers may view the robustness of their research findings in different terms compared with quantitative researchers [ 112 , 113 ]. Hence the use of critical appraisal tools may be less appropriate for the qualitative paradigm. This requires further consideration.
Of the small number of generic critical appraisal tools, we found few that could be usefully applied (to any health research, and specifically to the allied health literature), because of the generalist nature of their items, variable interpretation (and applicability) of items across research designs, and/or lack of summary scores. Whilst these types of tools potentially facilitate the synthesis of evidence across allied health research designs for clinicians, their lack of specificity in asking the 'hard' questions about research quality related to research design also potentially precludes their adoption for allied health evidence-based practice. At present, the gold standard study design when synthesizing evidence is the randomized controlled trial [ 4 ], which underpins our finding that experimental critical appraisal tools predominated in the allied health literature [ 37 , 39 , 52 , 58 , 59 , 65 ]. However, as more systematic literature reviews are undertaken on allied health topics, it may become more accepted that evidence in the form of other research design types requires acknowledgement, evaluation and synthesis. This may result in the development of more appropriate and clinically useful allied health critical appraisal tools.
A major finding of our study was the volume and variation in available critical appraisal tools. We found no gold standard critical appraisal tool for any type of study design. Therefore, consumers of research are faced with frustrating decisions when attempting to select the most appropriate tool for their needs. Variable quality evaluations may be produced when different critical appraisal tools are used on the same literature [ 6 ]. Thus, interpretation of critical analysis must be carefully considered in light of the critical appraisal tool used.
The variability in the content of critical appraisal tools could be accounted for by the lack of any empirical basis of tool construction, established validity of item construction, and the lack of a gold standard against which to compare new critical tools. As such, consumers of research cannot be certain that the content of published critical appraisal tools reflect the most important aspects of the quality of studies that they assess [ 114 ]. Moreover, there was little evidence of intra- or inter-rater reliability of the critical appraisal tools. Coupled with the lack of protocols for use, this may mean that critical appraisers could interpret instrument items in different ways over repeated occasions of use. This may produce variable results [123].
Based on the findings of this evaluation, we recommend that consumers of research should carefully select critical appraisal tools for their needs. The selected tools should have published evidence of the empirical basis for their construction, validity of items and reliability of interpretation, as well as guidelines for use, so that the tools can be applied and interpreted in a standardized manner. Our findings highlight the need for consensus to be reached regarding the important and core items for critical appraisal tools that will produce a more standardized environment for critical appraisal of research evidence. As a consequence, allied health research will specifically benefit from having critical appraisal tools that reflect best practice research approaches which embed specific research requirements of allied health disciplines.
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Centre for Allied Health Evidence: A Collaborating Centre of the Joanna Briggs Institute, City East Campus, University of South Australia, North Terrace, Adelaide, 5000, Australia
Persis Katrak, Nicola Massy-Westropp, VS Saravana Kumar & Karen A Grimmer
School of Physiotherapy, The University of Melbourne, Melbourne, 3010, Australia
Andrea E Bialocerkowski
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PK Sourced critical appraisal tools
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KAG Study conception and design
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Katrak, P., Bialocerkowski, A.E., Massy-Westropp, N. et al. A systematic review of the content of critical appraisal tools. BMC Med Res Methodol 4 , 22 (2004). https://doi.org/10.1186/1471-2288-4-22
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DOI : https://doi.org/10.1186/1471-2288-4-22
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CASP has produced simple critical appraisal checklists for the key study designs. These are not meant to replace considered thought and judgement when reading a paper but are for use as a guide and aide memoire. All CASP checklists cover three main areas: validity , results and clinical relevance.
Critical Appraisal is the process of carefully and systematically examining research to judge its trustworthiness, and its value and relevance in a particular context. It is an essential skill for evidence-based medicine because it allows people to find and use research evidence reliably and efficiently.
Learn more about what critical appraisal is, why we need it and more
A complete list (published & unpublished) of articles and research papers about CASP and other critical appraisal tools and approaches, covering from 1993-2012.
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Critical appraisal is the process of carefully and systematically examining research to judge its trustworthiness, and its value/relevance in a particular context by providing a framework to evaluate the research. During the critical appraisal process, researchers can:
Burls, A. (2009). What is critical appraisal? In What Is This Series: Evidence-based medicine. Available online at What is Critical Appraisal?
Critical appraisal is included in the process of writing high quality reviews, like systematic and integrative reviews and for evaluating evidence from RCTs and other study designs. For more information on systematic reviews, check out our Systematic Review guide.
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Critical appraisal worksheets to help you appraise the reliability, importance and applicability of clinical evidence.
Critical appraisal is the systematic evaluation of clinical research papers in order to establish:
If the answer to any of these questions is “no”, you can save yourself the trouble of reading the rest of it.
This section contains useful tools and downloads for the critical appraisal of different types of medical evidence. Example appraisal sheets are provided together with several helpful examples.
Critical Appraisal Worksheets
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JBI offers a suite of critical appraisal instruments that are freely available to systematic reviewers and researchers investigating the methodological limitations of primary research studies. The JBI instruments are designed to be study-specific and are presented as questions in a checklist. The JBI instruments have existed in a checklist-style format for approximately 20 years; however, as the field of research synthesis expands, many of the tools offered by JBI have become outdated. The JBI critical appraisal tools for quantitative studies (eg, randomized controlled trials, quasi-experimental studies) must be updated to reflect the current methodologies in this field. Cognizant of this and the recent developments in risk-of-bias science, the JBI Effectiveness Methodology Group was tasked with updating the current quantitative critical appraisal instruments. This paper details the methods and rationale that the JBI Effectiveness Methodology Group followed when updating the JBI critical appraisal instruments for quantitative study designs. We detail the key changes made to the tools and highlight how these changes reflect current methodological developments in this field.
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Use this guide to find information resources about critical appraisal including checklists, books and journal articles.
Shea BJ and others (2017) AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions or both, British Medical Journal, 358.
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JBI's Evidence Synthesis Critical Appraisal Tools Assist in Assessing the Trustworthiness, ... "Revising the JBI quantitative critical appraisal tools to improve their applicability: An overview of methods and the development process" ... Munn Z, Porritt K. Qualitative research synthesis: methodological guidance for systematic reviewers ...
Schondelmeyer A. C., Bettencourt A. P., Xiao R., Beidas R. S., Wolk C. B., Landrigan C. P., Brady P. W., Brent C. R., Parthasarathy P., Kern-Goldberger A. S., Sergay ...
Critical appraisal is the assessment of research studies' worth to clinical practice. Critical appraisal—the heart of evidence-based practice—involves four phases: rapid critical appraisal, evaluation, synthesis, and recommendation. This article reviews each phase and provides examples, tips, and caveats to help evidence appraisers ...
Abstract. Healthcare professionals are often expected to critically appraise research evidence in order to make recommendations for practice and policy development. Here we describe the Critical Appraisal Toolkit (CAT) currently used by the Public Health Agency of Canada. The CAT consists of: algorithms to identify the type of study design ...
Methods and guidance to produce a reliable evidence synthesis. Several international consortiums of EBM experts and national health care organizations currently provide detailed guidance (Table (Table1). 1).They draw criteria from the reporting and methodological standards of currently recommended appraisal tools, and regularly review and update their methods to reflect new information and ...
For example, in quantitative research a critical appraisal checklist assists a reviewer in assessing each study according to the same (pre-determined) criteria; that is, checklists help standardize the process, if not the outcome (they are navigational tools, not anchors, Booth, Citation 2007). Also, if the checklist has been through a rigorous ...
There are hundreds of critical appraisal checklists and tools you can choose from, which can be very overwhelming. There are so many because there are many kinds of research, knowledge can be communicated in a wide range of ways, and whether something is appropriate to meet your information needs depends on your specific context.
Critical appraisal is the course of action for watchfully and systematically examining research to assess its reliability, value and relevance in order to direct professionals in their vital clinical decision making [1]. Critical appraisal is essential to: Continuing Professional Development (CPD).
JBI Critical Appraisal Tools All systematic reviews incorporate a process of critique or appraisal of the research evidence. The purpose of this appraisal is to assess the methodological quality of a study and to determine the extent to which a study has addressed the possibility of bias in its design, conduct and analysis. All papers
This contains five items from the JBI-Qualitative Assessment and Review Instrument critical appraisal tool to assess dependability and then assess three levels of credibility; these are shown in Table 6.5. These are aspects of studies that are equivalent to reliability and internal validity in quantitative research, respectively.
Feedback or suggestions. If you have any feedback and suggestions for improvement, please contact us: Specialist Unit for Review Evidence. [email protected]. +44 (0)29 2068 7913. Tools to help identify the many ways that errors and bias can affect research results.
Abstract. Critical appraisal skills are important for anyone wishing to make informed decisions or improve the quality of healthcare delivery. A good critical appraisal provides information regarding the believability and usefulness of a particular study. However, the appraisal process is often overlooked, and critically appraising quantitative ...
This guide, aimed at health students, provides basic level support for appraising quantitative research papers. It's designed for students who have already attended lectures on critical appraisal. One framework for appraising quantitative research (based on reliability, internal and external validity) is provided and there is an opportunity to ...
quality. 1 Introduction. Critical appraisal describes the process of analyzing a study in a rigorous and. methodical way. Often, this process involves working through a series of questions. to ...
Consumers of research (researchers, administrators, educators and clinicians) frequently use standard critical appraisal tools to evaluate the quality of published research reports. However, there is no consensus regarding the most appropriate critical appraisal tool for allied health research. We summarized the content, intent, construction and psychometric properties of published, currently ...
Critical Appraisal is the process of carefully and systematically examining research to judge its trustworthiness, and its value and relevance in a particular context. It is an essential skill for evidence-based medicine because it allows people to find and use research evidence reliably and efficiently. Learn more about what critical appraisal ...
Critical Appraisal of Studies. Critical appraisal is the process of carefully and systematically examining research to judge its trustworthiness, and its value/relevance in a particular context by providing a framework to evaluate the research. During the critical appraisal process, researchers can: Decide whether studies have been undertaken ...
This section contains useful tools and downloads for the critical appraisal of different types of medical evidence. Example appraisal sheets are provided together with several helpful examples. Critical Appraisal Worksheets. English. Systematic Reviews Critical Appraisal Sheet; Diagnostics Critical Appraisal Sheet; Prognosis Critical Appraisal ...
Our aim is to discuss the suitability and usability of the Critical Appraisal Skills Programme (CASP) qualitative checklist tool for quality appraisal in qualitative evidence synthesis in order to support and improve future appraisal exercises framed by the tool. 30 The CASP tool is the most commonly used checklist/criteria-based tool for ...
Revising the JBI quantitative critical appraisal tools to improve their applicability: an overview of methods and the development process. The revised JBI critical appraisal tool for the assessment of risk of bias for randomized controlled trials. For almost 25 years, JBI's critical appraisal tools have assisted systematic reviewers assess ...
The JBI instruments have existed in a checklist-style format for approximately 20 years; however, as the field of research synthesis expands, many of the tools offered by JBI have become outdated. The JBI critical appraisal tools for quantitative studies (eg, randomized controlled trials, quasi-experimental studies) must be updated to reflect ...
Cathala X and Moorley C (2018) How to appraise quantitative research, Evidence-Based Nursing, 21(4), pp. 99-101. ... An outline of AMSTAR 2 and its use for as a critical appraisal tool for systematic reviews. View article (open access) Smith J and Noble H (2014) Bias in research, Evidence-Based Nursing, 17 (4), pp. 100-101. ...
Research Guides; Health Science Libraries; ... Data Extraction Tools; Meta-Analysis Tools; Critical Appraisal Checklists; Grading the Strength of Evidence Tools; Risk of Bias Tools ... Tools for Evidence Synthesis. On this page you will find tools for the different steps of the evidence synthesis process. If you are looking for even more tools ...