Was the study designed to assess the outcomes of an intervention?

Is the research question ‘formulated’ in terms of:

•     Population studied

•     Intervention given

•     Comparator chosen

•     Outcomes measured?

• How was randomisation carried out? Was the method appropriate?

• Was randomisation sufficient to eliminate systematic bias?

• Was the allocation sequence concealed from investigators and participants?

• Were losses to follow-up and exclusions after randomisation accounted for?

• Were participants analysed in the study groups to which they were randomised (intention-to-treat analysis)?

• Was the study stopped early? If so, what was the reason?

·   Were the baseline characteristics of each study group (e.g. age, sex, socio-economic group) clearly set out?

Were there any differences between the study groups that could affect the outcome/s?

·     Was there a clearly defined study protocol?

·     If any additional interventions were given (e.g. tests or treatments), were they similar between the study groups?

Were the follow-up intervals the same for each study group?

•  Was a power calculation undertaken?

•  What outcomes were measured, and were they clearly specified?

•  How were the results expressed? For binary outcomes, were relative and absolute effects reported?

•  Were the results reported for each outcome in each study group at each follow-up interval?

•  Was there any missing or incomplete data?

•  Was there differential drop-out between the study groups that could affect the results?

•  Were potential sources of bias identified?

•   Which statistical tests were used?

•   Were p values reported?

Were confidence intervals (CIs) reported?

·        What was the size of the intervention or treatment effect?

·        Were harms or unintended effects reported for each study group?

Was a cost-effectiveness analysis undertaken? (Cost-effectiveness analysis allows a comparison to be made between different interventions used in the care of the same condition or problem.)

•   Are the study participants similar to the people in your care?

•   Would any differences between your population and the study participants alter the outcomes reported in the study?

•   Are the outcomes important to your population?

•  Are there any outcomes you would have wanted information on that have not been studied or reported?

Are there any limitations of the study that would affect your decision?

·  What resources are needed to introduce this intervention taking into account time, finances, and skills development or training needs?

·  Are you able to disinvest resources in one or more existing interventions in order to be able to re-invest in the new intervention?