This checklist can be downloaded as an Adobe Acrobat PDF file, for ease of printing.

Tick [ ] those that apply

- Is the study observational? [ ]

(see A-1.1 and A-1.2) - If Yes
- Is the study experimental? [ ]

(see A-1.1, A-1.2) - If Yes
- Is the study a type of trial e.g. a clinical trial? [
]

(see A-1.7, A-1.8) - If Yes
- Is the study a controlled trial (i.e. is there a
control group)? [ ]

(see A-1.8 and B-3) - Is it a randomised trial
(i.e. are study subjects randomly allocated to groups)? [
]

(see A-1.8 and B-5) - If Yes to randomised trial
- Is it important to have similar numbers in each
randomisation group? (you may need to use blocks) [
]

(see B-5.6) - Are any known factors strongly prognostic? [
]

(you may need to randomise in strata)

(see B-5.7) - If Yes to strongly prognostic factors
- Is the proposed sample size small? [ ]

(see B-5.8)

- Is the proposed sample size small? [ ]
- Are groups of individuals to be randomised together
to the same treatment? [ ]

(see B-5.9) - Is this a cross over trial? [ ]

(see B-5.10b) - Is the assessor blind? [ ]

(see A-1.8 and B-4) - Are the study subjects blind? [ ]

(see A-1.8 and B-4)

- Is it important to have similar numbers in each
randomisation group? (you may need to use blocks) [
]

- Is the study a controlled trial (i.e. is there a
control group)? [ ]

- Is the study a type of trial e.g. a clinical trial? [
]
- Is the study prospective? [ ]

(see A-2) - If Yes
- Have you specified the length of follow up? [ ]

(see A-2)

- Have you specified the length of follow up? [ ]

- Have you described where they come from? [ ]
- Have you explained why they are an appropriate group? [ ]
- Have you described how the study subjects will be selected? [ ]
- Have you specified inclusion / exclusion criteria? [ ]
- Have you specified your proposed sample size taking into account refusals/drop-outs? [ ]

- Have you described all outcome and explanatory variables in
terms of data type and scale of measurement? [ ]

(see A-4.1 and A-4.2) - Have you described how the data will be collected? [ ]

(see A-4.3) - If using a questionnaire or a non-standard measurement, have
you provided information on its reliability and validity? [
]

(see A-4.4, A-4.4a, A-4.4b, A-4.4c)

- Have you provided a sample size calculation? [ ]

(see D-1) - Have you defined the outcome variable(s) used in the sample
size calculation? [ ]

(see D-5) - Have you defined the effect size which would be of clinical
importance? [ ]

(see D-4.5) - Have you described the power and significance level of the sample
size calculation? [ ]

(see D-4.3 and D-4.4) - Has your sample size made allowance for expected response rates
and other sample attrition? [ ]

(see D-6) - Is your sample size consistent with the study aims? [ ]

(see D-7) - Is your sample size consistent with the proposed analysis of the
study? [ ]

(see D-7) - Is your description of the sample size calculation adequate? [
]

(See examples in D-8)

- Have you described the proposed statistical methods using
appropriate terminology? [ ]

(see E-1.1, E-1.2) - Are the proposed methods appropriate for the types of data generated
by your study? [ ]

(see E-2, E-2.1, E-11) - Will the assumptions made by the proposed methods hold? [
]

(see E-4, E-4.1) - Do the proposed methods take account of the structure of the data
set (structure such as hierarchy, clustering, matching, paired
data)? [ ]

(see E-3, E-6, E-6.2, E-10) - Have important confounding factors been listed and methods of
adjusting for them presented? [ ]

(see E-5) - Will the proposed methods take account of multiple testing
where appropriate? [ ]

(see E-7.1, E-7.2, E-7.3, E-7.4, E-7.4a, E-7.4b, E-7.4c, E-7.4d, E-7.4e, E-7.4f) - Have biases due to measurement error been considered e.g.
regression towards the mean? [ ]

(see E-8) - Have details on the calculation of confidence intervals been
provided? [ ]

(see E-12)

- Have you specified that your analysis will be by intention to
treat? [ ]

(see E-9)

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Last updated: 10 September, 2009.