I 
Systematic review 
II 
Proper RCT 
III1 
Pseudo RCT 
III2 
Comparative study with concurrent control Cohort study Casecontrol study 
III3 
Comparative study without concurrent control 
IV 
Case series 
V 
Case report 
A 
Excellent 
· Many good trials · Guides practice 
B 
Good 
· Couple of good trials · Guides practice in most situations 
C 
Satisfactory 
· Couple of ok trials · Careful with application 
D 
Poor 
· Low quality trials · Beware application 
Phase 
Numbers 
Purpose 
0 
1020 
Kinetics 
1 
20100 
Safety + dose finding 
2 
100300 
Safety + efficacy 
3 
1k2k 
Safety + efficacy 
4 
Many 
Safety + efficacy 
Type 
Explanation 
Mitigation 
Hawthorne effect 
Being studied = feel good 
Control group 
Sampling bias 
Study participants are not reflective of the population 
Appropriate inclusion and exclusion criteria 
Selection 
Intervention and control groups are not the same 
Randomisation 
Performance 
Unequal care between groups 
Identical care except for intervention vs control 
Attrition 
Unequal withdrawal between groups 
Impossible to overcome 
Reporting 
Some findings reported, others not 

Response 
Questions encourage a certain type of answer 
Control group 
Recall 
Patient reports symptoms differently depending upon allocation 
Patient blinding 
Detection 
Intervention and control group assessed differently 
Assessor blinding Predefined criteria 
Observer 
Data collector able to be subjective about the outcome 
Assessor blinding Hard outcomes 
Publication 
Negative results don’t get published 
Clinical trial registries 
Definitions 
· Narrative review: pick and choose according to your world view · Systematic review: combined systematic analysis of multiple studies · Metaanalysis: combined quantitative analysis of multiple studies 
Stages 
· Define inclusion and exclusion criteria · Search for trials · Assess heterogeneity · Perform metaanalysis · Assess whether result makes sense 
Forest plot 
= what’s the outcome? · X axis: odds ratio · Y axis: individual studies · Dot size: weight · Line width: confidence intervals · Diamond centre: point estimate · Diamond width: confidence interval 
Funnel plot 
= is there publication bias? · Large studies should cluster around the true effect · Publication bias is suspected if results cluster on one side of the plot 
Pros 
· Statistical power · Generalisability 
Cons 
· Whether to combine apples and oranges · How to combine apples and oranges 
Interpretation 
· Negative result > probably accept · Positive result > probably do a large RCT to confirm 
Indications 
· Long latency · Rare outcome · Unethical intervention · Unethical to wait 
Process 
e.g. casecase control study · Generate hypothesis: exposure > outcome · Find patients with exposure · Find patients with no exposure · Match them in as many ways as possible · Calculate odds ratio 
ANZCA version:
Introduction 
· Appropriate question · Appropriate study design · Appropriate endpoint 
Research methods 
· Measurement techniques · Who, where, when, how many, how long for · Control group, randomization, blinding · Inclusion and exclusion criteria 
Result 
· Answers the question? · Statistically significant? · Presented clearly? · Missing data and why? 
Discussion & conclusion 
· Logical? · Biased? 
Summary 
· Quality? · Relevance? · Changes my practice? 
Simple version:
Intro 
Why did they bother? · Original? · Incremental? · Significant? 
Method 
Did they do it properly? · Right subjects? · Right intervention? · Right outcome of interest? 
Result 
What did they find? · What is the result? · Is it statistically significant? · Is it clinically significant? · If positive, why? (positive IRL, or confounder?) · If negative, why? (negative IRL, or underpowered?) · If fancy statistics, why? · If missing patients, why? 
Implication 
What does this mean? · Does this change what I think? (balance of evidence) · Does this change what I should do? (patient population) · Does this change what I could do? (feasibility) 
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