Difference between revisions of "Appraisal sheets"

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<span style="display: block; text-align: center;"><span style="display: block; font-size: 26px; text-align: center;">[[home | HOME]] [[Index page | INDEX]] [[Search Database | SEARCH DATABASE]] [[What is a CAT? | WHAT IS A CAT?]] [[What can I do? | WHAT CAN YOU DO?]] [[Introduction | INTRODUCTION]] [[What is hyperbaric medicine? | HBO EXPLAINED]]</span>
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<span style="display: block; text-align: center;"><span style="display: block; font-size: 26px; text-align: center;">[[Home|HOME]] [[Index_page|INDEX]] [[Search_Database|SEARCH DATABASE]] [[What_is_a_CAT?|WHAT IS A CAT?]] [[What_can_I_do?|WHAT CAN YOU DO?]] [[Introduction|INTRODUCTION]] [[What_is_hyperbaric_medicine?|HBO EXPLAINED]]</span></span>  
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<span style="display: block; text-align: center;">[[File:Sumhorsa.gif|center|Sumhorsa.gif]] <span style="display: block; text-align: center;"></span><span style="display: block; text-align: center;"></span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 130%;">The tables below are standardised critical appraisal sheets I use to help write the CATs on this site. I find that the answers to each of these questions helps me to avoid missing a fatal flaw in the paper, and directly assists the correct information getting into the final CAT.</span></span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 130%;">The attached file is a standardised critical appraisal sheet I use to help write the CATs on this site. I find that the answers to each of these questions helps me to avoid missing a fatal flaw in the paper, and directly assists the correct information getting into the final CAT.</span>
 
  
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| <span style'''"display: block; text-align: center;">'''<span style'''"font-size: 21px;">HBO EVIDENCE</span>'''</span><br><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 21px;">CRITICAL APPRAISAL WORKSHEET</span>'''</span>
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| style="width: 896px;" | <span style="display: block; text-align: center;"><span>'''<span><span style="font-size:larger;">HBO EVIDENCE</span></span>'''</span><br/> <span style="font-size:larger;">'''CRITICAL APPRAISAL WORKSHEET'''</span></span>
 
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|< <span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 120%; text-align: center;">'''Important information that should be in the paper'''</span> ||< <span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 120%; text-align: center;">'''Potential related problems'''</span> ||< <span style="display: block; font-family: Arial,Helvetica,sans-serif; font-size: 120%; text-align: center;">'''Threats to the internal and external validity of the study[1]'''</span>
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{|
 
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|< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''1.1a''' What is the research question posed in the paper? </span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''1.1b''' Is it about the impact of a therapy, causality, evaluation of a diagnostic test or about the magnitude of a health problem?[2]</span> ||< <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''1.2''' Is this question relevant to the practice of diving or hyperbaric medicine?</span> ||<  
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| <span style="display: block; text-align: center;"><span style="font-size:medium;">'''Important information that should be in the paper'''</span></span>
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| <span style="display: block; text-align: center;"><span style="font-size:medium;">'''Potential related problems'''</span></span>
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| <br/> <span style="display: block; text-align: center;"><span style="display: block; font-family: Arial,Helvetica,sans-serif; font-size: 120%; text-align: center;"><span style="font-size:medium;">'''Threats to the internal and external validity of the study[1]'''</span></span></span>
 
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|< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''2.1''' What is the study type?[3]</span> ||< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''2.2''' Is the study type appropriate to the research question?</span> ||< <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''2.3''' If not, how useful are the results likely to be?</span>  
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| <span style="display: block; text-align: center;">'''1.1a''' What is the research question posed in the paper?<br/> '''1.1b''' Is it about the impact of a therapy, causality, evaluation of a diagnostic test or about the magnitude of a health problem?[2]</span>
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| <span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"><span style="font-size:small;">'''1.2'''</span> I<span style="font-size:small;">s this question relevant to the practice of diving or hyperbaric medicine?</span></span></span>
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|< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''3.1a''' Define the population in which the authors are interested. Are the study subjects representative of this population?</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''3.1b''' If assigned to groups, how was this accomplished?</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''3.1c''' How many reached final follow-up?</span> ||< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''3.2a''' Are there selection biases?[4]</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''3.2b''' Was allocation random? Was allocation made after a decision to enter the trial?</span> ||< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''3.3a''' Any threat to external validity? Any threat to internal validity?</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''3.3b''' Any threat to internal validity?</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%; text-align: justify;">'''3.3c''' Does this proportion threaten internal validity?</span>  
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| <span style="display: block; text-align: center;">'''2.1''' What is the study type?[3]</span>
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| <span style="display: block; text-align: center;">'''2.2''' Is the study type appropriate to the research question?</span>
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| <span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"><span style="font-size:small;">'''2.3''' If not, how useful are the results likely to be?</span></span></span>
 
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|< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''4.1''' What is being studied (study factor)? How is it measured?[5]</span> ||< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''4.2''' Is there any likely measurement error (differential or non-differential)?[6]</span> ||< <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''4.3''' Is there any likely important cause of bias? (Beware differential error with Case-Control Studies).</span>  
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<span style="display: block; text-align: center;">'''3.1a''' Define the population in which the authors are interested. Are the study subjects representative of this population?</span>
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<span style="display: block; text-align: center;">'''3.1b''' If assigned to groups, how was this accomplished?</span>
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<br/> <span style="display: block; text-align: center;">'''3.1c''' How many reached final follow-up?</span>
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<span style="display: block; text-align: center;">'''3.2a''' Are there selection biases?[4]</span>
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<br/> <span style="display: block; text-align: center;">'''3.2b''' Was allocation random? Was allocation made after a decision to enter the trial?</span>
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<span style="display: block; text-align: center;">'''3.3a''' Any threat to external validity? Any threat to internal validity?</span>
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<br/> <span style="display: block; text-align: center;">'''3.3b''' Any threat to internal validity?</span>
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<br/> <span style="display: block; text-align: center;">'''3.3c''' Does this proportion threaten internal validity?</span>
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|< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''5.1''' What outcomes are being assessed (outcome factors)?</span> ||< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''5.2''' Any important outcomes missed? Any likely measurement error (differential or non-differential)? </span> ||< <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''5.3''' Do missed outcomes reduce the applicability of this study? Is there any likely source of bias?</span>  
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| <span style="display: block; text-align: center;">'''4.1''' What is being studied (study factor)? How is it measured?[5]</span>
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| <span style="display: block; text-align: center;">'''4.2''' Is there any likely measurement error (differential or non-differential)?[6]</span>
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| <span style="display: block; text-align: center;"><span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">'''4.3''' Is there any likely important cause of bias? (Beware differential error with Case-Control Studies).</span></span></span>
 
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|< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''6.1a''' What potential confounders are considered?</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''6.1b''' How were they dealt with?</span> ||< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''6.2a''' Any important confounders missing?</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''6.2b''' Were they dealt with adequately, or subject to measurement error?</span> ||< <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''6.3''' How likely is confounding to be a significant source of bias?</span>  
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| <span style="display: block; text-align: center;">'''5.1''' What outcomes are being assessed (outcome factors)?</span>
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| <span style="display: block; text-align: center;">'''5.2''' Any important outcomes missed? Any likely measurement error (differential or non-differential)?</span>
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| <span style="display: block; text-align: center;"><span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">'''5.3''' Do missed outcomes reduce the applicability of this study? Is there any likely source of bias?</span></span></span>
 
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|< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''7.1a''' Is a point estimate of effect given?[7]</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''7.1b''' Are confidence intervals given? If not in a study with statistically non-significant findings, is power given?</span> ||< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''7.2a''' Is it reasonable to accept these results are not due to chance?</span><br><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''7.2b''' Are the differences reported clinically significant? Was the sample size sufficient to detect a clinically significant difference?</span> ||< <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''7.3''' Is this study useful or inconclusive in answering the research question?</span>  
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<span style="display: block; text-align: center;">'''6.1a''' What potential confounders are considered?</span>
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<br/> <span style="display: block; text-align: center;">'''6.1b''' How were they dealt with?</span>
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<span style="display: block; text-align: center;">'''6.2a''' Any important confounders missing?</span>
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<br/> <span style="display: block; text-align: center;">'''6.2b''' Were they dealt with adequately, or subject to measurement error?</span>
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| <span style="display: block; text-align: center;"><span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">'''6.3''' How likely is confounding to be a significant source of bias?</span></span></span>
 
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|< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''8.1''' What are the authors’ conclusions?</span> ||< <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''8.2''' Have the authors correctly interpreted the results?</span> ||< <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''8.3''' Have the authors considered study limitations in their conclusions?</span>  
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|  
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<span style="display: block; text-align: center;">'''7.1a''' Is a point estimate of effect given?[7]</span>
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<br/> <span style="display: block; text-align: center;">'''7.1b''' Are confidence intervals given? If not in a study with statistically non-significant findings, is power given?</span>
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<span style="display: block; text-align: center;">'''7.2a''' Is it reasonable to accept these results are not due to chance?</span>
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<br/> <span style="display: block; text-align: center;">'''7.2b''' Are the differences reported clinically significant? Was the sample size sufficient to detect a clinically significant difference?</span>
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| <span style="display: block; text-align: center;"><span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">'''7.3''' Is this study useful or inconclusive in answering the research question?</span></span></span>
 
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| <span style="display: block; text-align: center;">'''8.1''' What are the authors’ conclusions?</span>
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| <span style="display: block; text-align: center;">'''8.2''' Have the authors correctly interpreted the results?</span>
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| <span style="display: block; text-align: center;"><span style="font-size:small;"><span style="font-family: Arial, Helvetica, sans-serif;">'''8.3''' Have the authors considered study limitations in their conclusions?</span></span></span>
 
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| <span style'''"display: block; text-align: center;">'''<span style'''"font-size: 21px;">CRITICAL APPRAISAL WORKSHEET</span>'''</span><br><span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 21px;">for Meta-analysis and systematic reviews</span>'''</span><span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 18px;">[8] </span></span>
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| style="width: 908px;" | <span style="display: block; text-align: center;"><span style="font-size:larger;">'''CRITICAL APPRAISAL WORKSHEET'''<br/> '''for Meta-analysis and systematic reviews'''[8] </span></span>
 
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 21px;">Important information that should be in the paper</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-size: 21px;">Potential related problems</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style="font-size: 21px;">Threats to the internal and external validity of the study</span>'''</span></span>
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<span style="display: block; text-align: center;"></span>  
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| '''<span style'''"font-size: 16px;">1.1a</span>'''<span style'''"font-size: 16px;"> Does the review address a focused clinical question?</span><br>**<span style'''"font-size: 16px;">1.1b</span>'''<span style'''"font-size: 16px;"> Is it about the impact of a therapy, causality, evaluation of a diagnostic test or about the magnitude of a health problem?</span> || '''<span style'''"font-size: 16px;">1.2</span>'''<span style'''"font-size: 16px;"> Does this question address the clinical problem?</span> || 
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| <span style="display: block; text-align: center;">'''<span style="font-size:medium;">Important information that should be in the paper</span>'''</span>
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| '''<span style="font-size:medium;"><span style="display: block; text-align: center;">Potential related problems</span></span>'''
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| <span style="display: block; text-align: center;">'''<span style="font-size:medium;">Threats to the internal and external validity of the study</span>'''</span>
 
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| '''<span style'''"font-size: 16px;">2.1 </span>'''<span style'''"font-size: 16px;">Were the criteria used to select studies for inclusion appropriate?</span> || '''<span style'''"font-size: 16px;">2.2 </span>'''<span style'''"font-size: 16px;">Are the study types appropriate to the research question?</span> || '''<span style'''"font-size: 16px;">2.3 </span>'''<span style'''"font-size: 16px;">If not, how useful are the results likely to be?</span>  
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<span style="display: block; text-align: center;"><span style="font-size:small;">'''1.1a''' Does the review address a focused clinical question?</span></span>
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<br/> <span style="display: block; text-align: center;"><span style="font-size:small;">'''1.1b''' Is it about the impact of a therapy, causality, evaluation of a diagnostic test or about the magnitude of a health problem?</span></span>
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| <span style="font-size:small;"><span style="display: block; text-align: center;">'''1.2''' Does this question address the clinical problem?</span></span>
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| '''<span style'''"font-size: 16px;">3.1a </span>'''<span style'''"font-size: 16px;">Is it likely that important and relevant studies were missed?</span><br>**<span style'''"font-size: 16px;">3.1b </span>'''<span style'''"font-size: 16px;">Was the validity of the included studies appraised?</span> || '''<span style'''"font-size: 16px;">3.2a </span>'''<span style'''"font-size: 16px;">Could this alter the overall result?</span> || '''<span style'''"font-size: 16px;">3.3a </span>'''<span style'''"font-size: 16px;">Could this reduce the validity of the review conclusions?</span><br>**<span style'''"font-size: 16px;">3.3b </span>'''<span style'''"font-size: 16px;">Any threat to internal validity?</span>  
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| <span style="font-size:small;"><span style="display: block; text-align: center;">2.1 Were the criteria used to select studies for inclusion appropriate?</span></span>
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| <span style="font-size:small;"><span style="display: block; text-align: center;">2.2 Are the study types appropriate to the research question?</span></span>
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| <span style="font-size:small;"><span style="display: block; text-align: center;">2.3 If not, how useful are the results likely to be?</span></span>
 
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| '''<span style'''"font-size: 16px;">4.1 </span>'''<span style'''"font-size: 16px;">Are all clinically important outcomes considered?</span> ||  || '''<span style'''"font-size: 16px;">4.3 </span>'''<span style'''"font-size: 16px;">Do any missed outcomes seriously affect the usefulness of this review?</span>  
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<span style="font-size:small;"><span style="display: block; text-align: center;">3.1a Is it likely that important and relevant studies were missed?</span></span>
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<br/> <span style="font-size:small;"><span style="display: block; text-align: center;">3.1b Was the validity of the included studies appraised?</span></span>
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| <span style="font-size:small;"><span style="display: block; text-align: center;">3.2a Could this alter the overall result?</span></span>
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<span style="font-size:small;"><span style="display: block; text-align: center;">3.3a Could this reduce the validity of the review conclusions?</span></span>
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<br/> <span style="font-size:small;"><span style="display: block; text-align: center;">3.3b Any threat to internal validity?</span></span>
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| '''<span style'''"font-size: 16px;">5.1a </span>'''<span style'''"font-size: 16px;">What are the overall results of the review?</span><br>**<span style'''"font-size: 16px;">5.1b </span>'''<span style'''"font-size: 16px;">How precise are the results?</span> || '''<span style'''"font-size: 16px;">5.1a </span>'''<span style'''"font-size: 16px;">Are the results statistically significant?</span><br>**<span style'''"font-size: 16px;">5.2b</span>'''<span style'''"font-size: 16px;"> Are the results clinically significant?</span> || 
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| <span style="font-size:small;"><span style="display: block; text-align: center;">4.1 Are all clinically important outcomes considered?</span></span>
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| <span style="font-size:small;"><span style="display: block; text-align: center;">4.3 Do any missed outcomes seriously affect the usefulness of this review?</span></span>
 
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| '''<span style'''"font-size: 16px;">6.1 </span>'''<span style'''"font-size: 16px;">Can the results be applied to my patients?</span> || '''<span style'''"font-size: 16px;">6.2 </span>'''<span style'''"font-size: 16px;">Are the benefits worth the harms and costs?</span> || 
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<span style="font-size:small;"><span style="display: block; text-align: center;">5.1a What are the overall results of the review?</span></span>
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<br/> <span style="font-size:small;"><span style="display: block; text-align: center;">5.1b How precise are the results?</span></span>
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<span style="font-size:small;"><span style="display: block; text-align: center;">5.1a Are the results statistically significant?</span></span>
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<br/> <span style="font-size:small;"><span style="display: block; text-align: center;">5.2b Are the results clinically significant?</span></span>
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| <span style="font-size:small;"><span style="display: block; text-align: center;">6.1 Can the results be applied to my patients?</span></span>
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| <span style="font-size:small;"><span style="display: block; text-align: center;">6.2 Are the benefits worth the harms and costs?</span></span>
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**<span style="font-family: Arial,Helvetica,sans-serif; font-size: 140%;">NOTES TO ACCOMPANY THE WORKSHEET</span>'''
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<p style="text-align: center;">'''<span style="font-size:medium;"><span style="font-family: Arial, Helvetica, sans-serif; text-align: center;">NOTES TO ACCOMPANY THE WORKSHEET</span></span>'''</p> <span style="display: block; text-align: center;"></span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. Internal validity - how well is the study done within itself, are the methods used reliable and trustworthy so that we can believe the results? External validity - how applicable are these results (whether or not you believe them) to the kinds of situation or patients you would like to apply them to? For example, a diving equipment trial that enrolled Navy SEALS might not be directly applicable to a recreational diver).</span>
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<br/> <span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. Internal validity - how well is the study done within itself, are the methods used reliable and trustworthy so that we can believe the results? External validity - how applicable are these results (whether or not you believe them) to the kinds of situation or patients you would like to apply them to? For example, a diving equipment trial that enrolled Navy SEALS might not be directly applicable to a recreational diver).</span></span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">2. These are the four main 'types' of question posed in papers. For the purposes of this wiki, nearly all papers are about the impact of a therapy or intervention of some sort (eg, a new breathing apparatus for diving).</span>
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<span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">2. These are the four main 'types' of question posed in papers. For the purposes of this wiki, nearly all papers are about the impact of a therapy or intervention of some sort (eg, a new breathing apparatus for diving).</span></span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">3. If not a randomsied trial of some type, then it is not relevant for this wiki.</span>
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<span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">3. If not a randomsied trial of some type, then it is not relevant for this wiki.</span></span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">4. Selection bias is not usually a problem with RCTs, but look for reassurances that any of the subjects could have gone into any of the arms of the study.</span>
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<span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">4. Selection bias is not usually a problem with RCTs, but look for reassurances that any of the subjects could have gone into any of the arms of the study.</span></span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">5. The study factor is simply the new drug or equipment or whatever is being assessed. For example, the Clarke study assesses HBOT for the treatment of radiation proctitis - so HBOT is the study factor.</span>
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<span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">5. The study factor is simply the new drug or equipment or whatever is being assessed. For example, the Clarke study assesses HBOT for the treatment of radiation proctitis - so HBOT is the study factor.</span></span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">6. Are you happy that they really gave whatever drug or treatment they said they did? Not usually a problem for us in this field.</span>
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<span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">6. Are you happy that they really gave whatever drug or treatment they said they did? Not usually a problem for us in this field.</span></span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">7. The point estimate of effect is the measured difference between groups in the main outcome. For example, the difference in the proportion of ulcers healed in a study of chronic wounds.</span>
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<span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">7. The point estimate of effect is the measured difference between groups in the main outcome. For example, the difference in the proportion of ulcers healed in a study of chronic wounds.</span></span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">8. This sheet is for meta-analyses rather than individual studies.</span>
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<span style="display: block; text-align: center;"><span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">8. This sheet is for meta-analyses rather than individual studies.</span></span>
  
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Revision as of 21:30, 13 March 2019

HOME INDEX SEARCH DATABASE WHAT IS A CAT? WHAT CAN YOU DO? INTRODUCTION HBO EXPLAINED  

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The tables below are standardised critical appraisal sheets I use to help write the CATs on this site. I find that the answers to each of these questions helps me to avoid missing a fatal flaw in the paper, and directly assists the correct information getting into the final CAT.

 

HBO EVIDENCE
CRITICAL APPRAISAL WORKSHEET

 

 

Important information that should be in the paper Potential related problems
Threats to the internal and external validity of the study[1]
1.1a What is the research question posed in the paper?
1.1b Is it about the impact of a therapy, causality, evaluation of a diagnostic test or about the magnitude of a health problem?[2]
1.2 Is this question relevant to the practice of diving or hyperbaric medicine?  
2.1 What is the study type?[3] 2.2 Is the study type appropriate to the research question? 2.3 If not, how useful are the results likely to be?

3.1a Define the population in which the authors are interested. Are the study subjects representative of this population?

3.1b If assigned to groups, how was this accomplished?


3.1c How many reached final follow-up?

3.2a Are there selection biases?[4]


3.2b Was allocation random? Was allocation made after a decision to enter the trial?

3.3a Any threat to external validity? Any threat to internal validity?


3.3b Any threat to internal validity?


3.3c Does this proportion threaten internal validity?

4.1 What is being studied (study factor)? How is it measured?[5] 4.2 Is there any likely measurement error (differential or non-differential)?[6] 4.3 Is there any likely important cause of bias? (Beware differential error with Case-Control Studies).
5.1 What outcomes are being assessed (outcome factors)? 5.2 Any important outcomes missed? Any likely measurement error (differential or non-differential)? 5.3 Do missed outcomes reduce the applicability of this study? Is there any likely source of bias?

6.1a What potential confounders are considered?


6.1b How were they dealt with?

6.2a Any important confounders missing?


6.2b Were they dealt with adequately, or subject to measurement error?

6.3 How likely is confounding to be a significant source of bias?

7.1a Is a point estimate of effect given?[7]


7.1b Are confidence intervals given? If not in a study with statistically non-significant findings, is power given?

7.2a Is it reasonable to accept these results are not due to chance?


7.2b Are the differences reported clinically significant? Was the sample size sufficient to detect a clinically significant difference?

7.3 Is this study useful or inconclusive in answering the research question?
8.1 What are the authors’ conclusions? 8.2 Have the authors correctly interpreted the results? 8.3 Have the authors considered study limitations in their conclusions?

 

 

CRITICAL APPRAISAL WORKSHEET
for Meta-analysis and systematic reviews[8]

 

Important information that should be in the paper Potential related problems Threats to the internal and external validity of the study

1.1a Does the review address a focused clinical question?


1.1b Is it about the impact of a therapy, causality, evaluation of a diagnostic test or about the magnitude of a health problem?

1.2 Does this question address the clinical problem?  
2.1 Were the criteria used to select studies for inclusion appropriate? 2.2 Are the study types appropriate to the research question? 2.3 If not, how useful are the results likely to be?

3.1a Is it likely that important and relevant studies were missed?


3.1b Was the validity of the included studies appraised?

3.2a Could this alter the overall result?

3.3a Could this reduce the validity of the review conclusions?


3.3b Any threat to internal validity?

4.1 Are all clinically important outcomes considered?   4.3 Do any missed outcomes seriously affect the usefulness of this review?

5.1a What are the overall results of the review?


5.1b How precise are the results?

5.1a Are the results statistically significant?


5.2b Are the results clinically significant?

 
6.1 Can the results be applied to my patients? 6.2 Are the benefits worth the harms and costs?  

 

NOTES TO ACCOMPANY THE WORKSHEET


1. Internal validity - how well is the study done within itself, are the methods used reliable and trustworthy so that we can believe the results? External validity - how applicable are these results (whether or not you believe them) to the kinds of situation or patients you would like to apply them to? For example, a diving equipment trial that enrolled Navy SEALS might not be directly applicable to a recreational diver).

2. These are the four main 'types' of question posed in papers. For the purposes of this wiki, nearly all papers are about the impact of a therapy or intervention of some sort (eg, a new breathing apparatus for diving).

3. If not a randomsied trial of some type, then it is not relevant for this wiki.

4. Selection bias is not usually a problem with RCTs, but look for reassurances that any of the subjects could have gone into any of the arms of the study.

5. The study factor is simply the new drug or equipment or whatever is being assessed. For example, the Clarke study assesses HBOT for the treatment of radiation proctitis - so HBOT is the study factor.

6. Are you happy that they really gave whatever drug or treatment they said they did? Not usually a problem for us in this field.

7. The point estimate of effect is the measured difference between groups in the main outcome. For example, the difference in the proportion of ulcers healed in a study of chronic wounds.

8. This sheet is for meta-analyses rather than individual studies.

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