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  • v.11(5); 2017 May

Critical Appraisal of Clinical Research

Azzam al-jundi.

1 Professor, Department of Orthodontics, King Saud bin Abdul Aziz University for Health Sciences-College of Dentistry, Riyadh, Kingdom of Saudi Arabia.

Salah Sakka

2 Associate Professor, Department of Oral and Maxillofacial Surgery, Al Farabi Dental College, Riyadh, KSA.

Evidence-based practice is the integration of individual clinical expertise with the best available external clinical evidence from systematic research and patient’s values and expectations into the decision making process for patient care. It is a fundamental skill to be able to identify and appraise the best available evidence in order to integrate it with your own clinical experience and patients values. The aim of this article is to provide a robust and simple process for assessing the credibility of articles and their value to your clinical practice.

Introduction

Decisions related to patient value and care is carefully made following an essential process of integration of the best existing evidence, clinical experience and patient preference. 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:

  • Combat information overload;
  • Identify papers that are clinically relevant;
  • Continuing Professional Development (CPD).

Carrying out Critical Appraisal:

Assessing the research methods used in the study is a prime step in its critical appraisal. This is done using checklists which are specific to the study design.

Standard Common Questions:

  • What is the research question?
  • What is the study type (design)?
  • Selection issues.
  • What are the outcome factors and how are they measured?
  • What are the study factors and how are they measured?
  • What important potential confounders are considered?
  • What is the statistical method used in the study?
  • Statistical results.
  • What conclusions did the authors reach about the research question?
  • Are ethical issues considered?

The Critical Appraisal starts by double checking the following main sections:

I. Overview of the paper:

  • The publishing journal and the year
  • The article title: Does it state key trial objectives?
  • The author (s) and their institution (s)

The presence of a peer review process in journal acceptance protocols also adds robustness to the assessment criteria for research papers and hence would indicate a reduced likelihood of publication of poor quality research. Other areas to consider may include authors’ declarations of interest and potential market bias. Attention should be paid to any declared funding or the issue of a research grant, in order to check for a conflict of interest [ 2 ].

II. ABSTRACT: Reading the abstract is a quick way of getting to know the article and its purpose, major procedures and methods, main findings, and conclusions.

  • Aim of the study: It should be well and clearly written.
  • Materials and Methods: The study design and type of groups, type of randomization process, sample size, gender, age, and procedure rendered to each group and measuring tool(s) should be evidently mentioned.
  • Results: The measured variables with their statistical analysis and significance.
  • Conclusion: It must clearly answer the question of interest.

III. Introduction/Background section:

An excellent introduction will thoroughly include references to earlier work related to the area under discussion and express the importance and limitations of what is previously acknowledged [ 2 ].

-Why this study is considered necessary? What is the purpose of this study? Was the purpose identified before the study or a chance result revealed as part of ‘data searching?’

-What has been already achieved and how does this study be at variance?

-Does the scientific approach outline the advantages along with possible drawbacks associated with the intervention or observations?

IV. Methods and Materials section : Full details on how the study was actually carried out should be mentioned. Precise information is given on the study design, the population, the sample size and the interventions presented. All measurements approaches should be clearly stated [ 3 ].

V. Results section : This section should clearly reveal what actually occur to the subjects. The results might contain raw data and explain the statistical analysis. These can be shown in related tables, diagrams and graphs.

VI. Discussion section : This section should include an absolute comparison of what is already identified in the topic of interest and the clinical relevance of what has been newly established. A discussion on a possible related limitations and necessitation for further studies should also be indicated.

Does it summarize the main findings of the study and relate them to any deficiencies in the study design or problems in the conduct of the study? (This is called intention to treat analysis).

  • Does it address any source of potential bias?
  • Are interpretations consistent with the results?
  • How are null findings interpreted?
  • Does it mention how do the findings of this study relate to previous work in the area?
  • Can they be generalized (external validity)?
  • Does it mention their clinical implications/applicability?
  • What are the results/outcomes/findings applicable to and will they affect a clinical practice?
  • Does the conclusion answer the study question?
  • -Is the conclusion convincing?
  • -Does the paper indicate ethics approval?
  • -Can you identify potential ethical issues?
  • -Do the results apply to the population in which you are interested?
  • -Will you use the results of the study?

Once you have answered the preliminary and key questions and identified the research method used, you can incorporate specific questions related to each method into your appraisal process or checklist.

1-What is the research question?

For a study to gain value, it should address a significant problem within the healthcare and provide new or meaningful results. Useful structure for assessing the problem addressed in the article is the Problem Intervention Comparison Outcome (PICO) method [ 3 ].

P = Patient or problem: Patient/Problem/Population:

It involves identifying if the research has a focused question. What is the chief complaint?

E.g.,: Disease status, previous ailments, current medications etc.,

I = Intervention: Appropriately and clearly stated management strategy e.g.,: new diagnostic test, treatment, adjunctive therapy etc.,

C= Comparison: A suitable control or alternative

E.g.,: specific and limited to one alternative choice.

O= Outcomes: The desired results or patient related consequences have to be identified. e.g.,: eliminating symptoms, improving function, esthetics etc.,

The clinical question determines which study designs are appropriate. There are five broad categories of clinical questions, as shown in [ Table/Fig-1 ].

[Table/Fig-1]:

Categories of clinical questions and the related study designs.

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 ].

  • Is the sample defined? Human, Animals (type); what population does it represent?
  • Does it mention eligibility criteria with reasons?
  • Does it mention where and how the sample were recruited, selected and assessed?
  • Does it mention where was the study carried out?
  • Is the sample size justified? Rightly calculated? Is it adequate to detect statistical and clinical significant results?
  • Does it mention a suitable study design/type?
  • Is the study type appropriate to the research question?
  • Is the study adequately controlled? Does it mention type of randomization process? Does it mention the presence of control group or explain lack of it?
  • Are the samples similar at baseline? Is sample attrition mentioned?
  • All studies report the number of participants/specimens at the start of a study, together with details of how many of them completed the study and reasons for incomplete follow up if there is any.
  • Does it mention who was blinded? Are the assessors and participants blind to the interventions received?
  • Is it mentioned how was the data analysed?
  • Are any measurements taken likely to be valid?

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.)

  • -Soundness, effectiveness of the measuring instrument;
  • -What does the test measure?
  • -Does it measure, what it is supposed to be measured?
  • -How well, how accurately does it measure?

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:

  • - How were subjects chosen or recruited? If not random, are they representative of the population?
  • - Types of Blinding (Masking) Single, Double, Triple?
  • - Is there a control group? How was it chosen?
  • - How are patients followed up? Who are the dropouts? Why and how many are there?
  • - Are the independent (predictor) and dependent (outcome) variables in the study clearly identified, defined, and measured?
  • - Is there a statement about sample size issues or statistical power (especially important in negative studies)?
  • - If a multicenter study, what quality assurance measures were employed to obtain consistency across sites?
  • - Are there selection biases?
  • • In a case-control study, if exercise habits to be compared:
  • - Are the controls appropriate?
  • - Were records of cases and controls reviewed blindly?
  • - How were possible selection biases controlled (Prevalence bias, Admission Rate bias, Volunteer bias, Recall bias, Lead Time bias, Detection bias, etc.,)?
  • • Cross Sectional Studies:
  • - Was the sample selected in an appropriate manner (random, convenience, etc.,)?
  • - Were efforts made to ensure a good response rate or to minimize the occurrence of missing data?
  • - Were reliability (reproducibility) and validity reported?
  • • In an intervention study, how were subjects recruited and assigned to groups?
  • • In a cohort study, how many reached final follow-up?
  • - Are the subject’s representatives of the population to which the findings are applied?
  • - Is there evidence of volunteer bias? Was there adequate follow-up time?
  • - What was the drop-out rate?
  • - Any shortcoming in the methodology can lead to results that do not reflect the truth. If clinical practice is changed on the basis of these results, patients could be harmed.

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?

  • -Are all relevant outcomes assessed?
  • -Is measurement error an important source of bias?

5-What are the study factors and how are they measured?

  • -Are all the relevant study factors included in the study?
  • -Have the factors been measured using appropriate tools?

Data Analysis and Results:

- Were the tests appropriate for the data?

- Are confidence intervals or p-values given?

  • How strong is the association between intervention and outcome?
  • How precise is the estimate of the risk?
  • Does it clearly mention the main finding(s) and does the data support them?
  • Does it mention the clinical significance of the result?
  • Is adverse event or lack of it mentioned?
  • Are all relevant outcomes assessed?
  • Was the sample size adequate to detect a clinically/socially significant result?
  • Are the results presented in a way to help in health policy decisions?
  • Is there measurement error?
  • Is measurement error an important source of bias?

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?

  • -Are potential confounders examined and controlled for?
  • -Is confounding an important source of bias?

7- What is the statistical method in the study?

  • -Are the statistical methods described appropriate to compare participants for primary and secondary outcomes?
  • -Are statistical methods specified insufficient detail (If I had access to the raw data, could I reproduce the analysis)?
  • -Were the tests appropriate for the data?
  • -Are confidence intervals or p-values given?
  • -Are results presented as absolute risk reduction as well as relative risk reduction?

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.

  • When p-value is less than significance level, which is usually 0.05, we often reject the null hypothesis and the result is considered to be statistically significant. Conversely, when p-value is greater than 0.05, we conclude that the result is not statistically significant and the null hypothesis is accepted.

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:

  • -Do statistical tests answer the research question?

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 ].

  • -Was the sample size adequate to detect a clinically/socially significant result?
  • -Are the results presented in a way to help in health policy decisions?

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:

  • -If the results are statistically significant, do they also have clinical significance?
  • -If the results are not statistically significant, was the sample size sufficiently large to detect a meaningful difference or effect?

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 ].

  • -Are the questions posed in the study adequately addressed?
  • -Are the conclusions justified by the data?
  • -Do the authors extrapolate beyond the data?
  • -Are shortcomings of the study addressed and constructive suggestions given for future research?
  • -Bibliography/References:

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:

  • Allocation (randomization, stratification, confounders).
  • Follow up of participants (intention to treat).
  • Data collection (bias).
  • Sample size (power calculation).
  • Presentation of results (clear, precise).
  • Applicability to local population.

[ Table/Fig-2 ] summarizes the guidelines for Consolidated Standards of Reporting Trials CONSORT [ 12 ].

[Table/Fig-2]:

Summary of the CONSORT guidelines.

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:

  • Literature search (did it include published and unpublished materials as well as non-English language studies? Was personal contact with experts sought?).
  • Quality-control of studies included (type of study; scoring system used to rate studies; analysis performed by at least two experts).
  • Homogeneity of studies.

[ Table/Fig-3 ] summarizes the guidelines for Preferred Reporting Items for Systematic reviews and Meta-Analyses PRISMA [ 13 ].

[Table/Fig-3]:

Summary of PRISMA guidelines.

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.

Financial or other Competing Interests

Systematic Reviews and Meta-Analyses: Critical Appraisal

  • Get Started
  • Exploratory Search
  • Where to Search
  • How to Search
  • Grey Literature
  • What about errata and retractions?
  • Eligibility Screening

Critical Appraisal

  • Data Extraction
  • Synthesis & Discussion
  • Assess Certainty
  • Share & Archive

All relevant studies must undergo a critical appraisal to evaluate the risk of bias , or internal and external validity, of all relevant references.

This step often occurs simultaneously with the Data Extraction  phase. It is a vital stage of the systematic review process to uphold the cornerstone of reducing bias .

Risk of Bias Tools

  • Presenting Results

Critical Appraisal 

Critical appraisal is also referred to as quality assessment , risk of bias assessment , and similar variations. Sometimes the critical appraisal phase is confused with the assessment of certainty of evidence  - although related, these are independent  stages of the systematic review process.

According to the Center for Evidence-Based Medicine (CEBM): 

"Critical appraisal is the process of carefully and systematically assessing the outcome of scientific research (evidence) to judge its trustworthiness, value and relevance in a particular context. Critical appraisal looks at the way a study is conducted and examines factors such as internal validity , generalizability and relevance."

Systematic reviews require a formal, systematic, uniform appraisal of the quality - or  risk of bias  - of all   relevant  studies. In a critical appraisal, you are examining the methods   not  the results .

Process Details

Use risk of bias tools  f or this stage - these tools are often formatted as checklists. You can find more about risk of bias tools in the next tab! If a refresher of some common biases, definitions, and examples is helpful, check out the Catalogue of Bias  from the University of Oxford and CEBM.

Just like the other stages of a systematic review,  2 reviewers  should assess risk of bias in each reference . As such, your team should calculate and report interrater reliability , deciding ahead of time how to resolve conflicts. Oftentimes the critical appraisal occurs at the same time as data extraction .

In addition to the formal risk of bias assessment, your team should also consider meta-biases like publication bias, selective reporting, etc. Search for errata and retractions related to included research, and consider other limitations of and concerns about the included studies and how this may impact the reliability of your review.

Note: Subjectivity of Critical Appraisal 

The critical appraisal is inherently subjective , from the selection of the RoB tool(s) to the final assessment of each study. Therefore, it is important to consider how tools compare, and how this process may impact the results of your review. Check out these studies evaluating Risk of Bias Tools:

Page MJ, McKenzie JE, Higgins JPT  Tools for assessing risk of reporting biases in studies and syntheses of studies: a systematic review   BMJ Open 2018;8:e019703. doi:  10.1136/bmjopen-2017-019703

Losilla, J.-M., Oliveras, I., Marin-Garcia, J. A., & Vives, J. (2018).  Three risk of bias tools lead to opposite conclusions in observational research synthesis.   Journal of Clinical Epidemiology ,  101 , 61–72.  https://doi.org/10.1016/j.jclinepi.2018.05.021

Margulis, A. V., Pladevall, M., Riera-Guardia, N., Varas-Lorenzo, C., Hazell, L., Berkman, N., Viswanathan, M., & Perez-Gutthann, S. (2014).  Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: The Newcastle-Ottawa Scale and the RTI item bank .  Clinical Epidemiology , 359.  https://doi.org/10.2147/CLEP.S66677

Select Risk of Bias Tool(s)

When you think of a critical appraisal in a systematic review and/or meta-analysis, think of assessing the  risk of bias  of included studies. The potential biases to consider will vary by study design. Therefore, risk of bias tool(s) should be selected based on the designs of included studies.  If you include more than one study design , you'll include more than one risk of bias tool.  Whenever possible, select tools developed for a discipline relevant to your topic.

Risk of bias tools  are simply checklists used to consider bias specific to a study design, and sometimes discipline. 

  • Cochrane Risk of Bias Tool  | randomized trials, health
  • Collaboration for Environmental Evidence (CEE) Critical Appraisal Tool, Prototype  | environmental management focused
  • Crowe Critical Appraisal Tool  | mixed methods
  • Meta-QAT  | public health focused
  • Meta-QAT Grey Literature Companion | grey literature
  • Mixed Method Appraisal Tool (MMAT) | mixed method ( more detail )
  • Newcastle-Ottawa Scale | non-randomized studies
  • RTI Item Bank  | observational studies
  • SYRCLE's Risk of Bias Tool | animal studies
  • Quality Checklist for Blogs | blogs
  • Quality Checklist for Podcasts | podcasts

Risk of Bias Toolsets

Risk of bias tool sets  are a series of tools developed by the same group or organization, where each tool addresses a specific study design. The organization is usually discipline specific. Note that many also include a systematic review and/or meta-analysis quality assessment tool, but that these tools will not be useful during this stage as existing reviews will not be folded into your synthesis.

Critical Appraisal Skills Programme (CASP) Checklists include tools for:

  • Randomized Controlled Trials 
  • Qualitative Studies
  • Cohort Study
  • Diagnostic Study
  • Case Control Study
  • Economic Evaluation
  • Clinical Prediction Rule 

National Institutes of Health (NIH) Study Quality Assessment Tools include tools for:

  • Controlled intervention studies
  • Observational cohort and cross-sectional studies
  • Case-control studies
  • Before-after (pre-post) studies without control
  • Case series studies

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) includes tools for:

  • Case-control
  • Cross-sectional
  • Conference abstracts

Joanna Briggs Institute (JBI) Manual for Evidence Synthesis includes the following tools found in respective relevant chapters:

  • Qualitative research (appendix 2.1)
  • Randomized controlled trials (appendix 3.1)
  • Quasi-experimental studies (non-randomized experimental studies; appendix 3.3)
  • Text and opinion (appendix 4.1)  with explanation (Appendix 4.2)
  • Prevalence studies (appendix 5.1)
  • Cohort studies (appendix 7.1)
  • Case-control studies (appendix 7.2)
  • Case series (appendix 7.3)
  • Case reports (appendix 7.4)
  • Cross sectional studies (appendix 7.5)
  • Diagnostic test accuracy (appendix 9.1)

Latitudes Network 

  • Systematic Reviews ( ROBIS )
  • Randomized Controlled Trials ( RoB 2 ) 
  • Cohort studies - interventions ( ROBINS-I )
  • Cohort studies - exposure ( ROBINS-E ) 
  • Diagnostic accuracy studies ( QUADAS-2 ; QUADAS-C ) 
  • Prognostic accuracy studies ( QUAPAS ) 
  • Prediction models ( PROBAST ) 
  • Reliability studies ( COSMIN )

Risk of Bias Tool Repositories

Risk of bias tool repositories  are curated lists of existing tools - kind of like what we've presented above. Although we update this guide with new tools as we find them, these repositories may contain additional resources:

  • Quality Assessment and Risk of Bias Tool Repository , from Duke University's Medical Center Library & Archives
  • Interactive Tableau Dataset of 68 Risk of Bias Tools , from the National Toxicology Program

Presenting Critical Appraisal Results

Risk of bias within each reference should be presented in a table like the one seen below. Studies are presented along the y-axis and biases considered (what is addressed by the tool) along the x-axis, such that each row belongs to a study , and each column belongs to a bias (or domain/category of biases).

Example - Graphic representation of risk of bias within each study

It is also best practice to present the bias across the included set of literature  (seen below). Each bias or bias category  is represented as a row and each row is associated with a bar showing the  percentage of the total included literature  that was rated as low risk, some risk, high risk, or unable to determine the risk. 

Example - Graphic representation of risk of bias across each study

The images above can be created using the ROBVIS package of metaverse for evidence synthesis in R. You can create your own graphics without using this software.

Methodological Guidance

  • Health Sciences
  • Animal, Food Sciences
  • Social Sciences
  • Environmental Sciences

Cochrane Handbook  -  Part 2: Core Methods

Chapter 7 : Considering bias and conflicts of interest among the included studies

  • 7.2 Empirical evidence of bias
  • 7.3 General procedures for risk-of-bias assessment
  • 7.4 Presentation of assessment of risk of bias
  • 7.5 Summary assessments of risk of bias 
  • 7.6 Incorporating assessment of risk of bias into analyses 
  • 7.7 Considering risk of bias due to missing results
  • 7.8 Considering source of funding and conflict of interest of authors of included studies 

Chapter 8: Assessing risk of bias in randomized trial

  • 8.2 Overview of RoB 2
  • 8.3 Bias arising from the randomization process
  • 8.4 Bias due to deviations from intended interventions
  • 8.5 Bias due to missing outcome data 
  • 8.6 Bias in measurement of the outcome
  • 8.7 Bias in selection of the reported result
  • 8.8 Differences from the previous version of the tool

Chapter 25:  Risk of bias in non-randomized studies

SYREAF Resources

Step 3: identifying eligible papers.

Conducting systematic reviews of intervention questions II: Relevance screening, data extraction, assessing risk of bias , presenting the results and interpreting the findings.  Sargeant JM, O’Connor AM. Zoonoses Public Health. 2014 Jun;61 Suppl 1:39-51. doi: 10.1111/zph.12124. PMID: 24905995

Campbell -  MECCIR

C51. Assessing risk of bias / study quality ( protocol & review / final manuscript )

C52. Assessing risk of bias / study quality in duplicate  ( protocol & review / final manuscript )

C53. Supporting judgements of risk of bias / study quality ( review / final manuscript )

C54. Providing sources of information for risk of bias / study quality assessments ( review / final manuscript )

C55. Differentiating between performance bias and detection bias  ( protocol & review / final manuscript )

C56. If applicable, assessing risk of bias due to lack of blinding for different outcomes ( review / final manuscript )

C57. If applicable, assessing completeness of data for different outcomes ( review / final manuscript )

C58. If applicable, summarizing risk of bias when using the Cochrane Risk of Bias tool ( review / final manuscript )

C59. Addressing risk of bias / study quality in the synthesis  ( review / final manuscript )

C60. Incorporating assessments of risk of bias  ( review / final manuscript )

CEE  -  Guidelines and Standards for Evidence synthesis in Environmental Management

Section 7.  critical appraisal of study validity.

CEE Standards for conduct and reporting

7.1.2   Internal validity

7.1.3  External validity 

Reporting in Protocol and Final Manuscript

  • Final Manuscript

In the Protocol |  PRISMA-P

Risk of bias individual studies (item 14).

...planned approach to assessing risk of bias should include the constructs being assessed and a definition for each, reviewer judgment options (high, low, unclear), the number of assessors ...training, piloting, previous risk of bias assessment experience...method(s) of assessment (independent or in duplicate)...

Protocol for reporting results

" ...summarise risk of bias assessments across studies or outcomes ..."

Protocol for reporting  impact on synthesis

"...describe how risk of bias assessments will be incorporated into data synthesis (that is, subgroup or sensitivity analyses) and their potential influence on findings of the review (Item 15c) in the protocol..."

In the Final Manuscript |  PRISMA

For the critical appraisal stage, PRISMA requires specific items to be addressed in both the methods and results section.

Study Risk of Bias Assessment (Item 11; report in methods )

Essential items.

  • Specify the tool(s) (and version) used to assess risk of bias in the included studies.
  • Specify the methodological domains/components/items of the risk of bias tool(s) used.
  • Report whether an overall risk of bias judgment that summarised across domains/components/items was made, and if so, what rules were used to reach an overall judgment.
  • If any adaptations to an existing tool to assess risk of bias in studies were made (such as omitting or modifying items), specify the adaptations.
  • If a new risk of bias tool was developed for use in the review, describe the content of the tool and make it publicly accessible.
  • Report how many reviewers assessed risk of bias in each study, whether multiple reviewers worked independently (such as assessments performed by one reviewer and checked by another), and any processes used to resolve disagreements between assessors.
  • Report any processes used to obtain or confirm relevant information from study investigators.
  • If an automation tool was used to assess risk of bias in studies, report how the automation tool was used (such as machine learning models to extract sentences from articles relevant to risk of bias88), how the tool was trained , and details on the tool’s performance and internal validation

Risk of Bias in Studies (Item 18; report in results )

  • Present tables or figures indicating for each study the risk of bias in each domain /component/item assessed and overall study-level risk of bias.
  • Present justification for each risk of bias judgment—for example, in the form of relevant quotations from reports of included studies.

Additional Items

If assessments of risk of bias were done for specific outcomes or results in each study , consider displaying risk of bias judgments on a forest plot, next to the study results, so that the limitations of studies contributing to a particular meta-analysis are evident (see Sterne et al86 for an example forest plot).

Decorative - a recording on this topic is available!

We host a workshop each fall on critical appraisal, check out our latest recording !

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  • Last Updated: Feb 2, 2024 6:24 PM
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  • Published: 31 January 2022

The fundamentals of critically appraising an article

  • Sneha Chotaliya 1  

BDJ Student volume  29 ,  pages 12–13 ( 2022 ) Cite this article

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Sneha Chotaliya

We are often surrounded by an abundance of research and articles, but the quality and validity can vary massively. Not everything will be of a good quality - or even valid. An important part of reading a paper is first assessing the paper. This is a key skill for all healthcare professionals as anything we read can impact or influence our practice. It is also important to stay up to date with the latest research and findings.

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Chambers R, 'Clinical Effectiveness Made Easy', Oxford: Radcliffe Medical Press , 1998

Loney P L, Chambers L W, Bennett K J, Roberts J G and Stratford P W. Critical appraisal of the health research literature: prevalence or incidence of a health problem. Chronic Dis Can 1998; 19 : 170-176.

Brice R. CASP CHECKLISTS - CASP - Critical Appraisal Skills Programme . 2021. Available at: https://casp-uk.net/casp-tools-checklists/ (Accessed 22 July 2021).

White S, Halter M, Hassenkamp A and Mein G. 2021. Critical Appraisal Techniques for Healthcare Literature . St George's, University of London.

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Chotaliya, S. The fundamentals of critically appraising an article. BDJ Student 29 , 12–13 (2022). https://doi.org/10.1038/s41406-021-0275-6

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critical appraisal presentation

“The purpose of critical appraisal is to determine the scientific merit of a research report and its applicability to clinical decision making.” 1 Conducting a critical appraisal of a study is imperative to any well executed evidence review, but the process can be time consuming and difficult. 2 The critical appraisal process requires “a methodological approach coupled with the right tools and skills to match these methods is essential for finding meaningful results.” 3 In short, it is a method of differentiating good research from bad research.

Critical Appraisal by Study Design (featured tools)

  • Non-RCTs or Observational Studies
  • Diagnostic Accuracy
  • Animal Studies
  • Qualitative Research
  • Tool Repository
  • AMSTAR 2 The original AMSTAR was developed to assess the risk of bias in systematic reviews that included only randomized controlled trials. AMSTAR 2 was published in 2017 and allows researchers to “identify high quality systematic reviews, including those based on non-randomised studies of healthcare interventions.” 4 more... less... AMSTAR 2 (A MeaSurement Tool to Assess systematic Reviews)
  • ROBIS ROBIS is a tool designed specifically to assess the risk of bias in systematic reviews. “The tool is completed in three phases: (1) assess relevance(optional), (2) identify concerns with the review process, and (3) judge risk of bias in the review. Signaling questions are included to help assess specific concerns about potential biases with the review.” 5 more... less... ROBIS (Risk of Bias in Systematic Reviews)
  • BMJ Framework for Assessing Systematic Reviews This framework provides a checklist that is used to evaluate the quality of a systematic review.
  • CASP Checklist for Systematic Reviews This CASP checklist is not a scoring system, but rather a method of appraising systematic reviews by considering: 1. Are the results of the study valid? 2. What are the results? 3. Will the results help locally? more... less... CASP (Critical Appraisal Skills Programme)
  • CEBM Systematic Reviews Critical Appraisal Sheet The CEBM’s critical appraisal sheets are designed to help you appraise the reliability, importance, and applicability of clinical evidence. more... less... CEBM (Centre for Evidence-Based Medicine)
  • JBI Critical Appraisal Tools, Checklist for Systematic Reviews JBI Critical Appraisal Tools help you assess the methodological quality of a study and to determine the extent to which study has addressed the possibility of bias in its design, conduct and analysis.
  • NHLBI Study Quality Assessment of Systematic Reviews and Meta-Analyses The NHLBI’s quality assessment tools were designed to assist reviewers in focusing on concepts that are key for critical appraisal of the internal validity of a study. more... less... NHLBI (National Heart, Lung, and Blood Institute)
  • RoB 2 RoB 2 “provides a framework for assessing the risk of bias in a single estimate of an intervention effect reported from a randomized trial,” rather than the entire trial. 6 more... less... RoB 2 (revised tool to assess Risk of Bias in randomized trials)
  • CASP Randomised Controlled Trials Checklist This CASP checklist considers various aspects of an RCT that require critical appraisal: 1. Is the basic study design valid for a randomized controlled trial? 2. Was the study methodologically sound? 3. What are the results? 4. Will the results help locally? more... less... CASP (Critical Appraisal Skills Programme)
  • CONSORT Statement The CONSORT checklist includes 25 items to determine the quality of randomized controlled trials. “Critical appraisal of the quality of clinical trials is possible only if the design, conduct, and analysis of RCTs are thoroughly and accurately described in the report.” 7 more... less... CONSORT (Consolidated Standards of Reporting Trials)
  • NHLBI Study Quality Assessment of Controlled Intervention Studies The NHLBI’s quality assessment tools were designed to assist reviewers in focusing on concepts that are key for critical appraisal of the internal validity of a study. more... less... NHLBI (National Heart, Lung, and Blood Institute)
  • JBI Critical Appraisal Tools Checklist for Randomized Controlled Trials JBI Critical Appraisal Tools help you assess the methodological quality of a study and to determine the extent to which study has addressed the possibility of bias in its design, conduct and analysis.
  • ROBINS-I ROBINS-I is a “tool for evaluating risk of bias in estimates of the comparative effectiveness… of interventions from studies that did not use randomization to allocate units… to comparison groups.” 8 more... less... ROBINS-I (Risk Of Bias in Non-randomized Studies – of Interventions)
  • NOS This tool is used primarily to evaluate and appraise case-control or cohort studies. more... less... NOS (Newcastle-Ottawa Scale)
  • AXIS Cross-sectional studies are frequently used as an evidence base for diagnostic testing, risk factors for disease, and prevalence studies. “The AXIS tool focuses mainly on the presented [study] methods and results.” 9 more... less... AXIS (Appraisal tool for Cross-Sectional Studies)
  • NHLBI Study Quality Assessment Tools for Non-Randomized Studies The NHLBI’s quality assessment tools were designed to assist reviewers in focusing on concepts that are key for critical appraisal of the internal validity of a study. • Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies • Quality Assessment of Case-Control Studies • Quality Assessment Tool for Before-After (Pre-Post) Studies With No Control Group • Quality Assessment Tool for Case Series Studies more... less... NHLBI (National Heart, Lung, and Blood Institute)
  • Case Series Studies Quality Appraisal Checklist Developed by the Institute of Health Economics (Canada), the checklist is comprised of 20 questions to assess “the robustness of the evidence of uncontrolled, [case series] studies.” 10
  • Methodological Quality and Synthesis of Case Series and Case Reports In this paper, Dr. Murad and colleagues “present a framework for appraisal, synthesis and application of evidence derived from case reports and case series.” 11
  • MINORS The MINORS instrument contains 12 items and was developed for evaluating the quality of observational or non-randomized studies. 12 This tool may be of particular interest to researchers who would like to critically appraise surgical studies. more... less... MINORS (Methodological Index for Non-Randomized Studies)
  • JBI Critical Appraisal Tools for Non-Randomized Trials JBI Critical Appraisal Tools help you assess the methodological quality of a study and to determine the extent to which study has addressed the possibility of bias in its design, conduct and analysis. • Checklist for Analytical Cross Sectional Studies • Checklist for Case Control Studies • Checklist for Case Reports • Checklist for Case Series • Checklist for Cohort Studies
  • QUADAS-2 The QUADAS-2 tool “is designed to assess the quality of primary diagnostic accuracy studies… [it] consists of 4 key domains that discuss patient selection, index test, reference standard, and flow of patients through the study and timing of the index tests and reference standard.” 13 more... less... QUADAS-2 (a revised tool for the Quality Assessment of Diagnostic Accuracy Studies)
  • JBI Critical Appraisal Tools Checklist for Diagnostic Test Accuracy Studies JBI Critical Appraisal Tools help you assess the methodological quality of a study and to determine the extent to which study has addressed the possibility of bias in its design, conduct and analysis.
  • STARD 2015 The authors of the standards note that “[e]ssential elements of [diagnostic accuracy] study methods are often poorly described and sometimes completely omitted, making both critical appraisal and replication difficult, if not impossible.”10 The Standards for the Reporting of Diagnostic Accuracy Studies was developed “to help… improve completeness and transparency in reporting of diagnostic accuracy studies.” 14 more... less... STARD 2015 (Standards for the Reporting of Diagnostic Accuracy Studies)
  • CASP Diagnostic Study Checklist This CASP checklist considers various aspects of diagnostic test studies including: 1. Are the results of the study valid? 2. What were the results? 3. Will the results help locally? more... less... CASP (Critical Appraisal Skills Programme)
  • CEBM Diagnostic Critical Appraisal Sheet The CEBM’s critical appraisal sheets are designed to help you appraise the reliability, importance, and applicability of clinical evidence. more... less... CEBM (Centre for Evidence-Based Medicine)
  • SYRCLE’s RoB “[I]mplementation of [SYRCLE’s RoB tool] will facilitate and improve critical appraisal of evidence from animal studies. This may… enhance the efficiency of translating animal research into clinical practice and increase awareness of the necessity of improving the methodological quality of animal studies.” 15 more... less... SYRCLE’s RoB (SYstematic Review Center for Laboratory animal Experimentation’s Risk of Bias)
  • ARRIVE 2.0 “The [ARRIVE 2.0] guidelines are a checklist of information to include in a manuscript to ensure that publications [on in vivo animal studies] contain enough information to add to the knowledge base.” 16 more... less... ARRIVE 2.0 (Animal Research: Reporting of In Vivo Experiments)
  • Critical Appraisal of Studies Using Laboratory Animal Models This article provides “an approach to critically appraising papers based on the results of laboratory animal experiments,” and discusses various “bias domains” in the literature that critical appraisal can identify. 17
  • CEBM Critical Appraisal of Qualitative Studies Sheet The CEBM’s critical appraisal sheets are designed to help you appraise the reliability, importance and applicability of clinical evidence. more... less... CEBM (Centre for Evidence-Based Medicine)
  • CASP Qualitative Studies Checklist This CASP checklist considers various aspects of qualitative research studies including: 1. Are the results of the study valid? 2. What were the results? 3. Will the results help locally? more... less... CASP (Critical Appraisal Skills Programme)
  • Quality Assessment and Risk of Bias Tool Repository Created by librarians at Duke University, this extensive listing contains over 100 commonly used risk of bias tools that may be sorted by study type.
  • Latitudes Network A library of risk of bias tools for use in evidence syntheses that provides selection help and training videos.

References & Recommended Reading

1.     Kolaski, K., Logan, L. R., & Ioannidis, J. P. (2024). Guidance to best tools and practices for systematic reviews .  British Journal of Pharmacology ,  181 (1), 180-210

2.    Portney LG.  Foundations of clinical research : applications to evidence-based practice.  Fourth edition. ed. Philadelphia: F A Davis; 2020.

3.     Fowkes FG, Fulton PM.  Critical appraisal of published research: introductory guidelines.   BMJ (Clinical research ed).  1991;302(6785):1136-1140.

4.     Singh S.  Critical appraisal skills programme.   Journal of Pharmacology and Pharmacotherapeutics.  2013;4(1):76-77.

5.     Shea BJ, Reeves BC, Wells G, et al.  AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both.   BMJ (Clinical research ed).  2017;358:j4008.

6.     Whiting P, Savovic J, Higgins JPT, et al.  ROBIS: A new tool to assess risk of bias in systematic reviews was developed.   Journal of clinical epidemiology.  2016;69:225-234.

7.     Sterne JAC, Savovic J, Page MJ, et al.  RoB 2: a revised tool for assessing risk of bias in randomised trials.  BMJ (Clinical research ed).  2019;366:l4898.

8.     Moher D, Hopewell S, Schulz KF, et al.  CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials.  Journal of clinical epidemiology.  2010;63(8):e1-37.

9.     Sterne JA, Hernan MA, Reeves BC, et al.  ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions.  BMJ (Clinical research ed).  2016;355:i4919.

10.     Downes MJ, Brennan ML, Williams HC, Dean RS.  Development of a critical appraisal tool to assess the quality of cross-sectional studies (AXIS).   BMJ open.  2016;6(12):e011458.

11.   Guo B, Moga C, Harstall C, Schopflocher D.  A principal component analysis is conducted for a case series quality appraisal checklist.   Journal of clinical epidemiology.  2016;69:199-207.e192.

12.   Murad MH, Sultan S, Haffar S, Bazerbachi F.  Methodological quality and synthesis of case series and case reports.  BMJ evidence-based medicine.  2018;23(2):60-63.

13.   Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J.  Methodological index for non-randomized studies (MINORS): development and validation of a new instrument.   ANZ journal of surgery.  2003;73(9):712-716.

14.   Whiting PF, Rutjes AWS, Westwood ME, et al.  QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies.   Annals of internal medicine.  2011;155(8):529-536.

15.   Bossuyt PM, Reitsma JB, Bruns DE, et al.  STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies.   BMJ (Clinical research ed).  2015;351:h5527.

16.   Hooijmans CR, Rovers MM, de Vries RBM, Leenaars M, Ritskes-Hoitinga M, Langendam MW.  SYRCLE's risk of bias tool for animal studies.   BMC medical research methodology.  2014;14:43.

17.   Percie du Sert N, Ahluwalia A, Alam S, et al.  Reporting animal research: Explanation and elaboration for the ARRIVE guidelines 2.0.  PLoS biology.  2020;18(7):e3000411.

18.   O'Connor AM, Sargeant JM.  Critical appraisal of studies using laboratory animal models.   ILAR journal.  2014;55(3):405-417.

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Nuffield Department of Primary Care Health Sciences, University of Oxford

Critical Appraisal tools

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:

  • Does this study address a  clearly focused question ?
  • Did the study use valid methods to address this question?
  • Are the valid results of this study important?
  • Are these valid, important results applicable to my patient or population?

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

  • Systematic Reviews  Critical Appraisal Sheet
  • Diagnostics  Critical Appraisal Sheet
  • Prognosis  Critical Appraisal Sheet
  • Randomised Controlled Trials  (RCT) Critical Appraisal Sheet
  • Critical Appraisal of Qualitative Studies  Sheet
  • IPD Review  Sheet

Chinese - translated by Chung-Han Yang and Shih-Chieh Shao

  • Systematic Reviews  Critical Appraisal Sheet
  • Diagnostic Study  Critical Appraisal Sheet
  • Prognostic Critical Appraisal Sheet
  • RCT  Critical Appraisal Sheet
  • IPD reviews Critical Appraisal Sheet
  • Qualitative Studies Critical Appraisal Sheet 

German - translated by Johannes Pohl and Martin Sadilek

  • Systematic Review  Critical Appraisal Sheet
  • Diagnosis Critical Appraisal Sheet
  • Prognosis Critical Appraisal Sheet
  • Therapy / RCT Critical Appraisal Sheet

Lithuanian - translated by Tumas Beinortas

  • Systematic review appraisal Lithuanian (PDF)
  • Diagnostic accuracy appraisal Lithuanian  (PDF)
  • Prognostic study appraisal Lithuanian  (PDF)
  • RCT appraisal sheets Lithuanian  (PDF)

Portugese - translated by Enderson Miranda, Rachel Riera and Luis Eduardo Fontes

  • Portuguese – Systematic Review Study Appraisal Worksheet
  • Portuguese – Diagnostic Study Appraisal Worksheet
  • Portuguese – Prognostic Study Appraisal Worksheet
  • Portuguese – RCT Study Appraisal Worksheet
  • Portuguese – Systematic Review Evaluation of Individual Participant Data Worksheet
  • Portuguese – Qualitative Studies Evaluation Worksheet

Spanish - translated by Ana Cristina Castro

  • Systematic Review  (PDF)
  • Diagnosis  (PDF)
  • Prognosis  Spanish Translation (PDF)
  • Therapy / RCT  Spanish Translation (PDF)

Persian - translated by Ahmad Sofi Mahmudi

  • Prognosis  (PDF)
  • PICO  Critical Appraisal Sheet (PDF)
  • PICO Critical Appraisal Sheet (MS-Word)
  • Educational Prescription  Critical Appraisal Sheet (PDF)

Explanations & Examples

  • Pre-test probability
  • SpPin and SnNout
  • Likelihood Ratios

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Best Practice for Literature Searching

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  • 1. Managing references
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  • 3. Where to search
  • 4. Search strategy
  • 5. Screening results
  • 6. Paper acquisition
  • 7. Critical appraisal
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What is critical appraisal?

We critically appraise information constantly, formally or informally, to determine if something is going to be valuable for our purpose and whether we trust the content it provides.

In the context of a literature search, critical appraisal is the process of systematically evaluating and assessing the research you have found in order to determine its quality and validity. It is essential to evidence-based practice.

More formally, critical appraisal is a systematic evaluation of research papers in order to answer the following questions:

  • Does this study address a clearly focused question?
  • Did the study use valid methods to address this question?
  • Are there factors, based on the study type, that might have confounded its results?
  • Are the valid results of this study important?
  • What are the confines of what can be concluded from the study?
  • Are these valid, important, though possibly limited, results applicable to my own research?

What is quality and how do you assess it?

In research we commissioned in 2018, researchers told us that they define ‘high quality evidence’ by factors such as:

  • Publication in a journal they consider reputable or with a high Impact Factor.
  • The peer review process, coordinated by publishers and carried out by other researchers.
  • Research institutions and authors who undertake quality research, and with whom they are familiar.

In other words, researchers use their own experience and expertise to assess quality.

However, students and early career researchers are unlikely to have built up that level of experience, and no matter how experienced a researcher is, there are certain times (for instance, when conducting a systematic review) when they will need to take a very close look at the validity of research articles.

There are checklists available to help with critical appraisal.  The checklists outline the key questions to ask for a specific study design.  Examples can be found in the  Critical Appraisal  section of this guide, and the Further Resources section.  

You may also find it beneficial to discuss issues such as quality and reputation with:

  • Your principal investigator (PI)
  • Your supervisor or other senior colleagues
  • Journal clubs. These are sometimes held by faculty or within organisations to encourage researchers to work together to discover and critically appraise information.
  • Topic-specific working groups

The more you practice critical appraisal, the quicker and more confident you will become at it.

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  • Finding and using knowledge
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Critical appraisal

Quality assurance using critical appraisal enables the identification of research articles which are sufficiently well-designed to inform practice. The technique consists of the identification of studies which cross a quality threshold followed by the extraction of their most important points. This page includes a critical appraisal skills programme CASP checklist, CASP elearning modules, and practical exercises.

Critical appraisal enables the identification of research articles which are sufficiently well-designed to inform practice. The technique consists of the identification of studies which cross a quality threshold followed by the extraction of their most important points.

The process involves :

  • systematically evaluating scientific literature ;
  • identifying original research or meta-analyses which are methodically sound ;
  • selecting the items from the previous step which have a useful application in your daily work.

The application of the critical appraisal process results in the removal of barriers between research and practice and thus, supports the development of evidence based practice.

Retrieved research articles need to be assessed before a decision is made about their re-use. The three key principles in critically appraising research articles are :

  • Validity applies both to the design and the methods of research. Validity in data collection means that findings truly represent the phenomenon the researcher claims to measure.
  • Reliability is the measure of how consistently a research study or instrument accomplishes its intended purpose. It is synonymous with the consistency of a test, survey, observation, or other measuring device.
  • Relevance concerns whether a piece of research responds to some genuine need. In other words, are the results of academic interest only or is there a practical application for the findings?

Refine Condense the knowledge into concise and relevant ‘nuggets’ that represent the key insights, lessons learned and practices of the knowledge sources. If multiple sources of knowledge are harvested, identify common and opposing knowledge and highlight these.

CASP critical appraisal checklists Collection of critical appraisal tools designed by the Critical Appraisal Skills Programme (CASP) to be used when reading research. Includes checklists for: Systematic Reviews, Randomised Controlled Trials, Cohort Studies, Case Control Studies, Economic Evaluations, Diagnostic Studies, Qualitative studies and Clinical Prediction Rule

Open University PROMPT checklist PROMPT: Presentation, Relevance, Objectivity, Method, Provenance, Timeliness provideS a structured approach to critical evaluation of information

Understanding health research This tool will guide you through a series of questions to help you to review and interpret a published health research paper

RGU Critical Appraisal guide Guides you through questions to consider with links to more help

CEBM: Which study design? Short article from the Centre for Evidence-Based Medicine (CEBM) to help you identify what type of study a paper is

NHS GGC Library Network: Critical Appraisal Tools pathway Collection of links to checklists and other useful tools to help with critical appraisal

Full fact Independant fact checker website, evaluating we claims made by politicians, public institutions and journalists, as well as viral content online

NHS Inform Reliable health information for patients and service users

  • Evidence Based Medicine toolkit  (BMJ Best Practice)
  • Critical appraisal guide  (NHS Northumbria Library)
  • Quiz: An introduction to critical appraisal (Cochrane Common Mental Disorders Group)
  • Students 4 Best Evidence  (S4BE)

eLearning modules

  • eLearning: Introduction to conducting systematic reviews  (Cochrane)
  • eLearning: Evidence Essentials online modules aimed at the public on how to read and understand RCTs and systematic reviews (Cochrane)
  • eLearning: Understanding Evidence (NCCMT)

Video collections

  • NCCMT: Understanding research evidence
  • Barts Health NHS Trust: Bite size critical appraisal videos
  • UCL: Using the CASP checklist for appraisal of qualitative research

Help with statistics

  • CASP Glossary
  • S4BE: Critical Thinking
  • S4BE: How to read a forest plot
  • How to read a paper the basics of evidence-based medicine : Trisha Greenhalgh (sign in with NHSScotland OpenAthens to read)
  • Evidence based medicine journal  (sign in with NHSScotland OpenAthens to read)
  • A nurses’ guide to the hierarchy of research designs and evidence  (Rebecca Ingham-Broomfield)

Choosing a topic

Ideally your audience will choose an article of interest to them. Below are some sources which can provide ideas

  • Officially “retired” but articles can still be found on the Wayback Machine internet archive e.g.
  • Cancer treatment response may be affected by gut bacteria
  • Marriage may help lower dementia risk
  • Focused on heart health research that has appeared in media
  • Students for best evidence: Health in the media

Reusable materials

  • Reusable critical appraisal presentation and terminology list ( Link )
  • Accessing and appraising evidence slides template ( Download , 20 MB)
  • Critical appraisal practical exercises ( Download , 32 KB)

critical appraisal

Critical Appraisal

Jan 02, 2020

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Critical Appraisal. Acknowledgement. Acknowledgment to Dr Sharmini Selvarajah and Dr Ho Tze Ming for preparation of the core contents of this presentation. Critical Appraisal. What it is?

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Acknowledgement Acknowledgment to Dr Sharmini Selvarajah and Dr Ho Tze Ming for preparation of the core contents of this presentation.

Critical Appraisal • What it is? Systematically assessing literature to assess its (trustworthiness), relevance, validity and applicability to specific situations. • What it isn’t? • Assessment of results only • Based only on statistical analyses

Why is it necessary? • It is an essential skill for clinicians to find and use research evidence reliably and efficiently for purpose of evidence-based medical practices and research Reference: http://www.medicine.ox.ac.uk/bandolier/painres/download/whatis/what_is_critical_appraisal.pdf

Why is it necessary? • “we need reliable information about what might harm or help us when we make healthcare decisions. Research involves gathering data, then collating and analyzing it to produce meaningful information. However, not all research is good quality and many studies are biased and their results untrue. This can lead us to draw false conclusions.” Reference: http://www.medicine.ox.ac.uk/bandolier/painres/download/whatis/what_is_critical_appraisal.pdf

Why is it necessary? • Studies which don't report their methods fully overstate the benefits of treatments by around 25% • Khan et al. Arch Intern med, 1996; Maher et al, Lancet 1998. • Studies funded by a pharmaceutical company were found to be 4 times as likely to give results that were favourable to the company than independent studies • Lexchin et al, BMJ, 2003 Source: Sarah Lawson, November 2010. Critical appraisal of quantitative research

Why is it necessary? • “If healthcare professionals and patients are going to make the best decisions they need to be able to: • Decide which studies are relevant; • Decide whether studies have been undertaken in a way that makes their findings reliable; • Make sense of the results; and • Know what these results mean in the context of the decision they are making.” Reference: http://www.medicine.ox.ac.uk/bandolier/painres/download/whatis/what_is_critical_appraisal.pdf

What you need in order to do critical appraisals • Know the subject and current information • Knowledge on study designs • Different study designs are used for different research questions • Different study designs have different sources of biases • Knowledge on statistics • There are different methods of presenting the same data

What you need in order to do critical appraisals of literature • Generally literature in peer-reviewed journals have been appraised by peers. • Have a clear intention or purpose, such as the title or objectives of planned study • Use available appraisal tools as a start; tools only help to organize the appraisal process but final decision is still with the investigator

How to appraise? • Based on types of studies: ie: systematic review, RCT • Is the study valid?[validity] • Study question relevant, ie: equipoise? Study design and methodology appropriate? bias? Is statistical analyses correct? Data justify conclusions? • What are the results?[ reliability] • Does the result show a statistically better outcome • Are the results useful? [applicability] • Valid to your study population? generalizable to local setting?

How to appraise? PICO tool: Population, Intervention, Comparison, Outcome Clinical problem Define the question Search Evaluate Decide Appraise Critical appraisal

TEN QUESTIONS TO ASK WHEN CRITICALLY APPRAISING A RESEARCH ARTICLE • Is the study question relevant? • Does the study add anything new? • What type of research question is being asked? • Was the study design appropriate for the research question? • Did the study methods address the most important potential sources of bias? • Was the study performed according to the original protocol? • Does the study test a stated hypothesis? • Were the statistical analyses performed correctly? • Do the data justify the conclusions? • Are there any conflicts of interest? Ref: JM Young & MJ Solomon, Nature Clinical Practice Gastroenterology & Hepatology (2009) 6, 82-91

Starting critical appraisals • Use available tools as a start • E.g. • Centre for Evidence-Based-Medicine critical appraisal tools • http://www.cebm.net/critical-appraisal/ • http://www.sign.ac.uk/methodology/checklists.html • http://www.casp-uk.net/#!casp-tools-checklists/c18f8

Thank you Any Questions?

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MoSCoW Prioritization

What is moscow prioritization.

MoSCoW prioritization, also known as the MoSCoW method or MoSCoW analysis, is a popular prioritization technique for managing requirements. 

  The acronym MoSCoW represents four categories of initiatives: must-have, should-have, could-have, and won’t-have, or will not have right now. Some companies also use the “W” in MoSCoW to mean “wish.”

What is the History of the MoSCoW Method?

Software development expert Dai Clegg created the MoSCoW method while working at Oracle. He designed the framework to help his team prioritize tasks during development work on product releases.

You can find a detailed account of using MoSCoW prioritization in the Dynamic System Development Method (DSDM) handbook . But because MoSCoW can prioritize tasks within any time-boxed project, teams have adapted the method for a broad range of uses.

How Does MoSCoW Prioritization Work?

Before running a MoSCoW analysis, a few things need to happen. First, key stakeholders and the product team need to get aligned on objectives and prioritization factors. Then, all participants must agree on which initiatives to prioritize.

At this point, your team should also discuss how they will settle any disagreements in prioritization. If you can establish how to resolve disputes before they come up, you can help prevent those disagreements from holding up progress.

Finally, you’ll also want to reach a consensus on what percentage of resources you’d like to allocate to each category.

With the groundwork complete, you may begin determining which category is most appropriate for each initiative. But, first, let’s further break down each category in the MoSCoW method.

Start prioritizing your roadmap

Moscow prioritization categories.

Moscow

1. Must-have initiatives

As the name suggests, this category consists of initiatives that are “musts” for your team. They represent non-negotiable needs for the project, product, or release in question. For example, if you’re releasing a healthcare application, a must-have initiative may be security functionalities that help maintain compliance.

The “must-have” category requires the team to complete a mandatory task. If you’re unsure about whether something belongs in this category, ask yourself the following.

moscow-initiatives

If the product won’t work without an initiative, or the release becomes useless without it, the initiative is most likely a “must-have.”

2. Should-have initiatives

Should-have initiatives are just a step below must-haves. They are essential to the product, project, or release, but they are not vital. If left out, the product or project still functions. However, the initiatives may add significant value.

“Should-have” initiatives are different from “must-have” initiatives in that they can get scheduled for a future release without impacting the current one. For example, performance improvements, minor bug fixes, or new functionality may be “should-have” initiatives. Without them, the product still works.

3. Could-have initiatives

Another way of describing “could-have” initiatives is nice-to-haves. “Could-have” initiatives are not necessary to the core function of the product. However, compared with “should-have” initiatives, they have a much smaller impact on the outcome if left out.

So, initiatives placed in the “could-have” category are often the first to be deprioritized if a project in the “should-have” or “must-have” category ends up larger than expected.

4. Will not have (this time)

One benefit of the MoSCoW method is that it places several initiatives in the “will-not-have” category. The category can manage expectations about what the team will not include in a specific release (or another timeframe you’re prioritizing).

Placing initiatives in the “will-not-have” category is one way to help prevent scope creep . If initiatives are in this category, the team knows they are not a priority for this specific time frame. 

Some initiatives in the “will-not-have” group will be prioritized in the future, while others are not likely to happen. Some teams decide to differentiate between those by creating a subcategory within this group.

How Can Development Teams Use MoSCoW?

  Although Dai Clegg developed the approach to help prioritize tasks around his team’s limited time, the MoSCoW method also works when a development team faces limitations other than time. For example: 

Prioritize based on budgetary constraints.

What if a development team’s limiting factor is not a deadline but a tight budget imposed by the company? Working with the product managers, the team can use MoSCoW first to decide on the initiatives that represent must-haves and the should-haves. Then, using the development department’s budget as the guide, the team can figure out which items they can complete. 

Prioritize based on the team’s skillsets.

A cross-functional product team might also find itself constrained by the experience and expertise of its developers. If the product roadmap calls for functionality the team does not have the skills to build, this limiting factor will play into scoring those items in their MoSCoW analysis.

Prioritize based on competing needs at the company.

Cross-functional teams can also find themselves constrained by other company priorities. The team wants to make progress on a new product release, but the executive staff has created tight deadlines for further releases in the same timeframe. In this case, the team can use MoSCoW to determine which aspects of their desired release represent must-haves and temporarily backlog everything else.

What Are the Drawbacks of MoSCoW Prioritization?

  Although many product and development teams have prioritized MoSCoW, the approach has potential pitfalls. Here are a few examples.

1. An inconsistent scoring process can lead to tasks placed in the wrong categories.

  One common criticism against MoSCoW is that it does not include an objective methodology for ranking initiatives against each other. Your team will need to bring this methodology to your analysis. The MoSCoW approach works only to ensure that your team applies a consistent scoring system for all initiatives.

Pro tip: One proven method is weighted scoring, where your team measures each initiative on your backlog against a standard set of cost and benefit criteria. You can use the weighted scoring approach in ProductPlan’s roadmap app .

2. Not including all relevant stakeholders can lead to items placed in the wrong categories.

To know which of your team’s initiatives represent must-haves for your product and which are merely should-haves, you will need as much context as possible.

For example, you might need someone from your sales team to let you know how important (or unimportant) prospective buyers view a proposed new feature.

One pitfall of the MoSCoW method is that you could make poor decisions about where to slot each initiative unless your team receives input from all relevant stakeholders. 

3. Team bias for (or against) initiatives can undermine MoSCoW’s effectiveness.

Because MoSCoW does not include an objective scoring method, your team members can fall victim to their own opinions about certain initiatives. 

One risk of using MoSCoW prioritization is that a team can mistakenly think MoSCoW itself represents an objective way of measuring the items on their list. They discuss an initiative, agree that it is a “should have,” and move on to the next.

But your team will also need an objective and consistent framework for ranking all initiatives. That is the only way to minimize your team’s biases in favor of items or against them.

When Do You Use the MoSCoW Method for Prioritization?

MoSCoW prioritization is effective for teams that want to include representatives from the whole organization in their process. You can capture a broader perspective by involving participants from various functional departments.

Another reason you may want to use MoSCoW prioritization is it allows your team to determine how much effort goes into each category. Therefore, you can ensure you’re delivering a good variety of initiatives in each release.

What Are Best Practices for Using MoSCoW Prioritization?

If you’re considering giving MoSCoW prioritization a try, here are a few steps to keep in mind. Incorporating these into your process will help your team gain more value from the MoSCoW method.

1. Choose an objective ranking or scoring system.

Remember, MoSCoW helps your team group items into the appropriate buckets—from must-have items down to your longer-term wish list. But MoSCoW itself doesn’t help you determine which item belongs in which category.

You will need a separate ranking methodology. You can choose from many, such as:

  • Weighted scoring
  • Value vs. complexity
  • Buy-a-feature
  • Opportunity scoring

For help finding the best scoring methodology for your team, check out ProductPlan’s article: 7 strategies to choose the best features for your product .

2. Seek input from all key stakeholders.

To make sure you’re placing each initiative into the right bucket—must-have, should-have, could-have, or won’t-have—your team needs context. 

At the beginning of your MoSCoW method, your team should consider which stakeholders can provide valuable context and insights. Sales? Customer success? The executive staff? Product managers in another area of your business? Include them in your initiative scoring process if you think they can help you see opportunities or threats your team might miss. 

3. Share your MoSCoW process across your organization.

MoSCoW gives your team a tangible way to show your organization prioritizing initiatives for your products or projects. 

The method can help you build company-wide consensus for your work, or at least help you show stakeholders why you made the decisions you did.

Communicating your team’s prioritization strategy also helps you set expectations across the business. When they see your methodology for choosing one initiative over another, stakeholders in other departments will understand that your team has thought through and weighed all decisions you’ve made. 

If any stakeholders have an issue with one of your decisions, they will understand that they can’t simply complain—they’ll need to present you with evidence to alter your course of action.  

Related Terms

2×2 prioritization matrix / Eisenhower matrix / DACI decision-making framework / ICE scoring model / RICE scoring model

Prioritizing your roadmap using our guide

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