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Critical appraisal of randomized controlled trial

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Presentation on theme: "Critical appraisal of randomized controlled trial"— Presentation transcript:

1 Critical appraisal of randomized controlled trial
ارائه : دکتر ترانه موحد

2 What is Critical Appraisal?
= QUALITY ASSESSMENT

3 What is quality? quality is a complex concept or ‘construct’.
can be acknowledged without difficulty, but it is not easy to define or measure. Quality means different things to different people

4 1-The external validity =
Applicability= Generalisability the preciscion and extent to which it is possible to generalise the results of the trial to other settings

5 population, intervention, outcome
Is related to the definition of well-formulate questions : population, intervention, outcome It determine by inclusion and exclusion criteria

6 2-The internal validity :
the degree to which the trial design, conduct, analysis, and presentation have minimized or avoided systematic biases.

7 Sources of bias in trials of healthcare interventions
selection bias performance bias attrition bias detection bias

8 Sara Mortaz Hejri

9 Randomization = allocation concealment

10 Even when the allocation codes are kept in sealed opaque envelopes, investigators, for instance, can look through the envelopes using powerful lights or even open the envelope using steam and reseal it without others noticing.

11 allocation concealment is rarely reported and perhaps rarely implemented in RCTs.
A recent study showed that allocation concealment was reported in less than 10% of articles describing RCTs published in prominent journals in five different languages

12 Simple randomisation

13 Block randomisation GP Practice 1 GP Practice 2

14 Stratified randomisation

15 inadequate : - the use of case record numbers, -dates of birth or day of the week,

16 Even when the trials are described as double-blind, mostly do not provide adequate information on how blinding was achieved or statements on the perceived success (or failure) of double-blinding efforts

17 3-The appropriateness of data analysis and presentation.

18 4-The ethical implications of the intervention they evaluate

19 intention to treat analysis:
all the study participants are included in the analyses as part of the groups to which they were randomised regardless of whether they completed the study or not.

20 Bias in non rct randomisation is the only means of allocation that controls for unknown and unmeasured confounders as well as those that are known and measured It is possible to control for confounders that are known and measured in observational studies, such as case-control and cohort studies by matching.

21 TOOLS: Checklist : the components are evaluated separately and do not have numerical scores attached to them Scale: each item is scored numerically and an overall quality score is generated.

22 JADAD easy and quick to use (it takes less than five minutes to score a trial report) provides consistent measurements has construct validity

23 Sara Mortaz Hejri

24 It has been shown that studies that obtain 2 or less points are likely to produce treatment effects which are 35% larger than those produced by trials with 3 or more points.


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