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METHODOLOGY CHECKLIST 2: RANDOMISED CONTROLLED TRIALS

Study identification (Include author, title, year of publication, journal title, pages)

Section 1: Internal validity


In a well conducted RCT study... In this study this criterion is:
1.1 The study addresses an appropriate and Well covered Not addressed
clearly focused question. Adequately Not reported
addressed Not applicable
Write the reason of your answer: Poorly addressed

1.2 The assignment of subjects to treatment Well covered Not addressed


groups is randomised Adequately Not reported
addressed Not applicable
Write the reason of your answer: Poorly addressed

1.3 An adequate method is used Well covered Not addressed


Adequately Not reported
Write the reason of your answer: addressed Not applicable
Poorly addressed

1.4 Subjects and investigators are kept Well covered Not addressed
blind about treatment allocation Adequately Not reported
addressed Not applicable
Poorly addressed
Write the reason of your answer:

1.5 The treatment and control groups are Well covered Not addressed
similar at the start of the trial Adequately Not reported
addressed Not applicable
Write the reason of your answer: Poorly addressed

1.6 The only difference between groups is Well covered Not addressed
the treatment under investigation Adequately Not reported
addressed Not applicable
Write the reason of your answer: Poorly addressed

1.7 All relevant outcomes are measured in a Well covered Not addressed
standard, valid and reliable way Adequately Not reported
addressed Not applicable
Write the reason of your answer: Poorly addressed
1.8 What percentage of the individuals or
clusters recruited into each treatment arm .. %
of the study dropped out before the study
was completed?

1.9 All the subjects are analysed in the Well covered Not addressed
groups to which they were randomly Adequately Not reported
allocated addressed Not applicable
Poorly addressed
Write the reason of your answer:

1.10 Where the study is carried out at more Well covered Not addressed
than one site, results are comparable for Adequately Not reported
all sites addressed Not applicable
Poorly addressed
Write the reason of your answer:

Section 2: Overall assessment of the study


2.1 How well was the study done to
minimise bias?
Code ++, +, or -
2.2 If coded as +, or - what is the likely
direction in which bias might affect the
study results?
2.3 Taking into account clinical
considerations, your evaluation of the
methodology used, and the statistical
power of the study, are you certain that
the overall effect is due to the study
intervention?

2.4 Are the results of this study directly


applicable to the patient group targeted
by this guideline?

Section 3: Description of the study (the following information is required to complete


evidence tables facilitating cross-study comparisons
3.1 Do we know who the study was funded [ ] Academic Institution
by? [ ] Healthcare Industry
[ ] Government [ ] NGO [ ] Public funds
[ ] Other
3.2 How many centres are patients recruited
from?
3.3 What is the social setting (ie type of [ ] Urban [ ] Rural [ ] Mixed
environment in which they live) of
patients in the study?
3.4 What criteria are used to decide who
should be INCLUDED in the study?

3.5 What criteria are used to decide who


should be EXCLUDED from the study?

3.6 What intervention is investigated in the


study? (Include dosage where
appropriate)

3.7 What comparisons are made in the study?


(ie what alternative treatments are used to
compare the intervention with?). Include
dosage where appropriate.

3.8 What methods were used to randomise


patients, blind patients or investigators,
and to conceal the randomisation process
from investigators?

3.9 How long were patients followed-up for,


during and after the study?

3.10 List the key characteristics of the patient


population. Note if there are any
significant differences between different
arms of the trial.

3.11 Conclusion:

Guidelines Network
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