Methodology Checklist 2: Randomised Controlled Trials: Pages)

Methodology Checklist 2: Randomised Controlled
Trials
Study identification (Include author, title, year of publication, journal title,
pages)
Guideline topic:
Key Question No:
Before completing this checklist, consider:
Is the paper a randomized controlled trial or a controlled

clinical trial? If in doubt, check the study design algorithm available
from SIGN and make sure you have the correct checklist. If it is a
controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant,
and the study cannot be rated higher than 1+
Is the paper relevant to key question? Analyse using PICO (Patient
or Population Intervention Comparison Outcome). IF NO REJECT (give
reason below). IF YES complete the checklist.
Reason for rejection: Reason for rejection: 1. Paper not relevant to key
question 2. Other reason (please specify):
Checklist completed by:

Section 1: Internal validity
In a well conducted RCT study
In this study this criterion

is:
1.1 The study addresses an

Well covered
appropriate and clearly focused Adequately
question.
addressed
Poorly addressed
Not
addressed
Not
reported
Not
applicable
1.2 The assignment of subjects to

treatment groups is
randomised
Well covered
Adequately
addressed
Poorly addressed
Not
addressed
Not
reported
Not
applicable
1.3 An adequate concealment method

is used
Well covered
Adequately
addressed
Poorly addressed
Not
addressed
Not
reported
Not
applicable
1.4 Subjects and investigators are

kept blind about treatment
allocation
Well covered
Adequately
addressed
Poorly addressed
Not
addressed
Not
reported
Not
applicable
Well covered
Adequately
addressed
Poorly addressed
Not
addressed
Not
reported
Not
applicable
Well covered
Adequately
addressed
Poorly addressed
Not
addressed
Not
reported
Not
applicable
1.5 The treatment and control groups

are similar at the start of the
trial
1.6 The only difference between

groups is the treatment under
investigation
1.7 All relevant outcomes are

measured in a standard, valid
and reliable way
Well covered
Adequately
addressed
Poorly addressed
Not
addressed
Not
reported
Not
applicable
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 groups to which they were
randomly allocated (often
referred to as intention to treat
analysis)
Well covered
Adequately
addressed
Poorly addressed
Not
addressed
Not
reported
Not
applicable
1.1 Where the study is carried out at

0
more than one site, results are
comparable for all sites
Well covered
Adequately
addressed
Poorly addressed
Not
addressed
Not
reported
Not
applicable
Section 2:
OVERALL ASSESSMENT OF THE STUDY
How well was the study done to minimise

2.1
bias? Code ++, +, or -
2.2 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?
2.3 Are the results of this study directly

applicable to the patient group
targeted by this guideline?
2.4 Notes. Summarise the authors conclusions. Add any comments on

your own assessment of the study, and the extent to which it
answers your question.
The following section is provided for non-SIGN users of this

checklist and is being developed to conform to the standards
set by the Guidelines International Network Evidence Tables
Working Group.
Members of SIGN guideline groups do not need to complete
this section.
Section 3: description OF THE STUDY

PLEASE PRINT CLEARLY
3.1
Do we know who the study was funded

by?
Academic Institution
Healthcare
Industry
Government
NGO Public
funds Other
3.2
How many centres are patients recruited

from?
3.3
From which countries are patients

Scotland UK
selected? (Select all those involved. Note
USA Canada
additional countries after Other)
Australia New
Zealand France
Germany
Italy
Netherlands
Scandinavia
Spain
Other:
3.4
What is the social setting (ie type of

environment in which they live) of
patients in the study?
3.5
What criteria are used to decide who
Urban Rural
Mixed
should be INCLUDED in the study?
3.6
What criteria are used to decide who

should be EXCLUDED from the study?
3.7
What intervention or risk factor is

investigated in the study? (Include
dosage where appropriate)
3.8
What comparisons are made in the study

(ie what alternative treatments are used
to compare the intervention with).
Include dosage where appropriate.
3.9
What methods were used to randomize

patients, blind patients or investigators,
and to conceal the randomization
process from investigators?
3.1 How long did the active phase of the

0 study last?
3.1 How long were patients followed-up for,

1 during and after the study?
3.1 List the key characteristics of the patient

2 population. Note if there are any
significant differences between different
arms of the trial.
3.1 Record the basic data for each arm of the study. If there are more
3 than four arms, note data for subsequent arms at the bottom of the
page.
Arm 1:
Arm 2:
Arm 3:
Arm 4:
Treatmen
Treatmen
Treatmen
Treatment
t:
t:
t:
:
Sample
Sample
Sample
Sample
size:
No.
analysed
With
outcome:
Without
outcome:
size:
No.
analysed
With
outcome:
Without
outcome
>
Primary
outcome?
size:
No.
analysed
With
outcome:
Without
outcome
>
Primary
outcome?
size:
No.
analysed
With
outcome:
Without
outcome
Primary
outcome?
3.1 Record the basic data for each IMPORTANT outcome in the study. If
4
there are more than four, not data for additional outcomes at the
bottom of the page.
Outcome 1: Outcome 2: Outcome 3: Outcome 4:

Value:
Value:
Value:
Value:
Measure:
Measure:
Measure:
Measure:
P value
P value
P value
P value
Upper CI
Upper CI
Upper CI
Upper CI
Lower CI
Lower CI
Lower CI
Lower CI
Primary
Primary
Primary
Primary
outcome
outcome?
outcome?
outcome?
?
3.1 Notes. Summarise the authors conclusions. Add any comments on

5
your own assessment of the study, and the extent to which it
answers your question. {Much of this is likely to be contributed
by GDG members).

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Methodology Checklist 2: Randomised Controlled

Key Question No:

Before completing this checklist, consider:

Is the paper a randomized controlled trial or a controlled

Checklist completed by:

In this study this criterion

1.1 The study addresses an

1.2 The assignment of subjects to

1.3 An adequate concealment method

1.4 Subjects and investigators are

1.5 The treatment and control groups

1.6 The only difference between

1.7 All relevant outcomes are

1.8 What percentage of the

1.9 All the subjects are analysed in

1.1 Where the study is carried out at

OVERALL ASSESSMENT OF THE STUDY

How well was the study done to minimise

2.2 Taking into account clinical

2.3 Are the results of this study directly

2.4 Notes. Summarise the authors conclusions. Add any comments on

The following section is provided for non-SIGN users of this

Section 3: description OF THE STUDY

Do we know who the study was funded

How many centres are patients recruited

From which countries are patients

What is the social setting (ie type of

What criteria are used to decide who

should be INCLUDED in the study?

What criteria are used to decide who

What intervention or risk factor is

What comparisons are made in the study

What methods were used to randomize

3.1 How long did the active phase of the

3.1 How long were patients followed-up for,

3.1 List the key characteristics of the patient

Outcome 1: Outcome 2: Outcome 3: Outcome 4:

3.1 Notes. Summarise the authors conclusions. Add any comments on

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