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Critical Appraisal For Therapy Study To Determine The Result Of Internal Validity Uitm University Assignment

1291 words - 6 pages

Critical Appraisal for Therapy Articles
THERAPY STUDY: Are the results of the trial valid? (Internal Validity)
What question did the study ask?
Patients –
Intervention -
Comparison -
Outcome(s) –
1a. R- Was the assignment of patients to treatments randomised?
What is best?
Where do I find the information?
Centralised computer randomisation is ideal and often used in multi-centred trials. Smaller trials may use an independent person (e.g, the hospital pharmacy) to “police” the randomization.
The Methods should tell you how patients were allocated to groups and whether or not randomisation was concealed.
This paper: Yes No Unclear
1b. R- Were the groups similar at the start of the trial?
What is best?
Where do I find the information?
If the randomisation process worked (that is, achieved comparable groups) the groups should be similar. The more similar the groups the better it is.
There should be some indication of whether differences between groups are statistically significant (ie. p values).
The Results should have a table of "Baseline Characteristics" comparing the randomized groups on a number of variables that could affect the outcome (ie. age, risk factors etc). If not, there may be a description of group similarity in the first paragraphs of the Results section.
This paper: Yes No Unclear
2a. A – Aside from the allocated treatment, were groups treated equally?
What is best?
Where do I find the information?
Apart from the intervention the patients in the different groups should be treated the same, eg., additional treatments or tests.
Look in the Methods section for the follow-up schedule, and permitted additional treatments, etc and in Results for actual use.
This paper: Yes No Unclear
2b. A – Were all patients who entered the trial accounted for? – and were they analysed in the groups to which they were randomised?
What is best?
Where do I find the information?
Losses to follow-up should be minimal – preferably less than 20%. However, if few patients have the outcome of interest, then even small losses to follow-up can bias the results. Patients should also be analysed in the groups to which they were randomised – ‘intention-to-treat analysis’.
The Results section should say how many patients were andomised (eg., Baseline Characteristics table) and how many patients were actually included in the analysis. You will need to read the results section to clarify the number and reason for losses to follow-up.
This paper: Yes No Unclear
3. M - Were measures objective or were the patients and clinicians kept “blind” to which treatment was being received?
What is best?
Where do I find the information?
It is ideal if the study is ‘double-blinded’ – that is, both patients and investigators are unaware of treatment allocation. If the outcome is objective (eg., death) then blinding is less critical. If the outcome is subjective (eg., symptoms or function) then blinding of...

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