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1. Did the study address a clearly focused research question?
CONSIDER:

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

Is the research question ‘focused’ in terms of: PICO

Hint: This can usually be found with a quick read of abstract

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2. Was the assignment of participants to interventions randomised?
CONSIDER:

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?

Hint: information on addressing bias is usually found in the methods section or sometimes the abstract

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5. Were the study groups similar at the start of
the randomised controlled trial?
CONSIDER:
• 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?

Hint: baseline info usually found in table 1

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3. Were all participants who entered the study
accounted for at its conclusion?

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?

Hint: RCTs usually include a flowchart with follow up section - based on CONSORT statement

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4. Blinding

Were the participants ‘blind’ to intervention they were given?

Were the investigators ‘blind’ to the intervention they were giving to participants?

Were the people assessing/analysing outcome/s ‘blinded’?

Hint: information on addressing bias is usually found in the methods section or sometimes the abstract

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Full systematic review & meta-analysis paper

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Full systematic review & meta-analysis paper

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Systematic review and meta-analysis for critical appraisal workshop (1)

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Skim the abstract for some context

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Remember concepts such as…

• p-values

• Cohen’s d

• confidence intervals

• the pooled effect (red diamond)

Note: The intervention was manipulation of the patient-clinician relationship via e.g. "...better attention to non-verbal signals, not interrupting, sitting down, making appropriate eye contact".

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7. Were the effects of intervention reported comprehensively?

Which statistical tests were used?

Were p values reported?

Were confidence intervals (CIs) reported?

What outcomes were measured, and were they clearly specified?

Was there any missing or incomplete data?

Were potential sources of bias identified?