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

Guideline topic:

Key Question No:

Checklist completed by:

In a well conducted RCT study...

In this study this criterion is:

1.1

The study addresses an appropriate and clearly focused question.

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

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

1.5

The treatment and control groups are similar at the start of the trial

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

1.6

The only difference between groups is the treatment under investigation

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

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

1.10

Where the study is carried out at more than one site, results are comparable for all sites

Well covered

Adequately addressed

Poorly addressed

Not addressed

Not reported

Not applicable

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?

3.1

How many patients are included in this study?

Please indicate number in each arm of the study, at the time the study began.

3.2

What are the main characteristics of the patient population?

3.3

What intervention (treatment, procedure) is being investigated in this study?

List all interventions covered by the study.

3.4

What comparisons are made in the study?

Are comparisons made between treatments, or between treatment and placebo / no treatment?

3.5

How long are patients followed-up in the study?

Length of time patients are followed from beginning participation in the study. Note specified end points used to decide end of follow-up (e.g. death, complete cure). Note if follow-up period is shorter than originally planned.

3.6

What outcome measure(s) are used in the study?

List all outcomes that are used to assess effectiveness of the interventions used.

3.7

What size of effect is identified in the study?

List all measures of effect in the units used in the study – e.g. absolute or relative risk, NNT, etc. Include p values and any confidence intervals that are provided.

3.8

How was this study funded?

List all sources of funding quoted in the article, whether Government, voluntary sector, or industry.

3.9

Does this study help to answer your key question?

Summarise the main conclusions of the study and indicate how it relates to the key question.