CONTROLLED

TRIALS
Before completing this checklist, consider:
 Is the paper a randomised 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:
1. Paper not relevant to key question

2. Other reason (please specify):

 SECTION 1: INTERNAL
In a well conducted RCT study…
VALIDITY
Does this study
do it?
1.1 The study addresses an Yes
appropriate and clearly focused No
question Can’t say
SECTION 1: INTERNAL VALIDITY

• If elements of the research question are

Yes present in the text. {Note that this does

not have to be exactly in the PICO format,
but all the elements must be present}.

No
• If there is no clear question in the text. This
would normally result in rejection of the
paper.
In a wellSECTION 1: INTERNAL
conducted RCT study… VALIDITY
Does this study do
it?
1.2 The assignment of subjects to Yes
treatment groups is randomised. No
Can’t say
 • If a good randomisation method is used such as
computer generated off-site allocation. If a poor
Yes randomisation method is used such as a coin-flip
then mark as ‘yes’, but mention in notes that the
randomisation method was poor.

• If alternate allocation used or deterministic

No methods such as day of the week, birth date, day
of arrival at the clinic etc.

• If randomisation is mentioned but method not

Can’t say specified. This must be mentioned in the notes
field and will downgrade the study
In a wellSECTION
conducted RCT study…
1: INTERNAL Does this study do
VALIDITY
it?
1.3 An adequate concealment method Yes
is used. No
Can’t say
 • If centralised allocation, computerised allocation
systems, sequential use of numbered/coded
Yes identical containers or sequential, numbered,
sealed, opaque envelopes

• If method of concealment used is regarded as

poor, or relatively easy to subvert (such as
investigators being able to access the sequence
No or use of non-identical containers or unsealed
envelopes). Mark as ‘no’ if no concealment
method is reported.

• If concealment is mentioned but not described.

Can’t say This must be mentioned in the notes field and
will downgrade the study.
In a wellSECTION
conducted RCT 1: INTERNAL
study… VALIDITY
Does this study
do it?
1.4 The design keeps subjects and Yes
investigators ‘blind’ about No
treatment allocation. Can’t say
Yes • It is important to assess who was actually
blinded not what the authors call it.

No • If the study could have been blinded, but

was not.

Can’t • If the presence of blinding is not clear.

The notes field should record the type of

say blinding used and any issues that this

could have had on the results.
 SECTION 1: INTERNAL
In a well conducted RCT study…
VALIDITY
Does this study do
it?

1.5 The treatment and control groups Yes

are similar at the start of the trial. No
Can’t say
 Yes • If the patient groups look
reasonably similar.

• If the patient groups have important

No differences in factors that may
influence the outcomes.

Can’t say • If the patient groups have not been

adequately described
 SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study
do it?

1.6 The only difference between Yes

groups is the treatment under No
investigation. Can’t say
 • If there appears to be no important
Yes differences between treatment groups
other than the treatment being studied

• If there appears to be an important

No difference between the two groups.

Can’t say • If there is no description of groups

 SECTION
In a well 1: INTERNAL
conducted RCT study… VALIDITY
Does this study
do it?
1.7 All relevant outcomes are Yes
measured in a standard, valid and No
reliable way. Can’t say
Yes • If there are clearly described
outcome measures.

• If measures are entirely subjective

No and based on human judgement
with no validation.

Can’t • If measures are unclear

say
In a well conducted RCT study…
Does this study do it?
SECTION 1: INTERNAL VALIDITY
1.8 What percentage of the individuals or clusters
recruited into each treatment arm of the study
dropped out before the study was completed?
The number of patients that
drop out of a study should
give concern if the number
is very high. Conventionally,
a 20% drop out rate is
regarded as acceptable, but
this may vary. Some regard
should be paid to why
patients dropped out, as
well as how many. It should
be noted that the drop out
rate may be expected to be
higher in studies conducted
over a long period of time. A
higher drop out rate will
normally lead to
downgrading, rather than
rejection of a study.
In a wellSECTION
conducted RCT study…
1: INTERNAL Does this study do
VALIDITY
it?
1.9 All the subjects are analysed in the Yes
groups to which they were No
randomly allocated (often referred Can’t say
to as intention to treat analysis). Not applicable
 • If the method used to deal with missing patient data
Yes
is explained.

• Analysis of participants according to the actual

interventions received, irrespective of their
randomised allocation; analysis based only on
participants who completed the trial and complied
No
with (or received some of) their allocated
intervention (per-protocol analysis); analysis based
only on participants for whom outcome data were
obtained (available case analysis).

• If there is insufficient information to make an

Can’t say
assessment

• If the trial’s objective is purely explanatory (to

determine efficacy rather than effectiveness, that is
the extent to which a treatment achieves its
Not applicable
intended effect under ideal circumstances) and
adequate justification is given for using an ‘as
treated’ or ‘per protocol’ analysis.
In a wellSECTION
conducted RCT study…
1: INTERNAL Does this study do
VALIDITY
it?
1.10 Where the study is carried out at Yes
more than one site, results are No
comparable for all sites. Can’t say
 • If there is no marked difference in the site data
Yes reported or if there is no difference in the centres that
can be determined

• If there is one or more sites that have markedly worse

No or better data than the others. Or if the sites have
different characteristics such as community treatment
against hospital inpatient treatment.

Can’t say • If no site specific data is given Not applicable - if there is

only one site.
2.1 SECTION 2: study
How well was the OVERALL ASSESSMENT
done to minimise OF
High quality (++)
bias? Code
THE as follows:
STUDY Acceptable (+)
Low quality (-)
Unacceptable – reject 0

2.2 Taking into account clinical considerations, This requires clinical

your evaluation of the methodology used, input and must be
and the statistical power of the study, are addressed by the
you certain that the overall effect is due to clinicians on the group.
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 and mention any areas of uncertainty raised above.
THANKYOU