Research

 

Prev SAQs: consider adding

·        Objectives of an ethics review

·        Pros and cons of multi-centre trials

·        What is the value of case reports

 

NHMRC levels of evidence:

I

Systematic review

II

Proper RCT

III-1

Pseudo RCT

III-2

Comparative study with concurrent control

-Cohort study

-Case-control study

III-3

Comparative study without concurrent control

IV

Case series

V

Case report

 

NHMRC grades of recommendation:

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

 

Trial phases:

Phase

Numbers

Purpose

0

10-20

Kinetics

1

20-100

Safety + dose finding

2

100-300

Safety + efficacy

3

1k-2k

Safety + efficacy

4

Many

Safety + efficacy

 

Meta-analysis:

Definitions

·      Systematic review: combined analysis of multiple studies

·      Meta-analysis: combined quantitative analysis of multiple studies

Stages

·      Define inclusion and exclusion criteria

·      Search for trials

·      Assess heterogeneity

·      Perform meta-analysis

·      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

·      Get an answer

Cons

·      Combining apples and oranges

Interpretation

·      Negative result -> probably accept

·      Positive result -> probably do a large RCT to confirm

 

Critical appraisal of a paper:

https://www.anzca.edu.au/getattachment/a19babcd-6c16-4be1-acb1-e986e1609447/SRA-critical-appraisal-of-a-paper-guidelines

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?

 

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