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
Poorly addressed
1.2 The assignment of subjects to treatment Well covered Not addressed
groups is randomised Adequately Not reported
addressed Not applicable
Poorly addressed
1.3 An adequate method is used Well covered Not addressed
Adequately Not reported
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
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
Poorly addressed
1.6 The only difference between groups is Well covered Not addressed
the treatment under investigation Adequately Not reported
addressed Not applicable
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
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 (often referred to as intention to addressed Not applicable
treat analysis) Poorly addressed
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
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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