A. ARE THE TRIAL RESULTS VALID (Internal Validity)?

1. What question did the study ask?

• P: Study population
o Inclusion criteria
o Exclusion criteria

• I: Specific intervention given

• C: Comparison intervention

• O: Relevant outcomes considered

o Primary
o Secondary

2. Was the assignment of patients to treatments Yes No Unclear 

randomised?

• If so, how and by whom?

• Was there allocation concealment?

3. Were the groups similar at the start of the trial? Yes No Unclear 

• Demographics
How do you know?

• Baseline variables
How do you know?

PHTY211 Intervention Template_2022

 4. Aside from the allocated treatment, were the groups Yes No Unclear 
treated equally?

• Any other factors affecting results

5. Were all patients who entered the trial properly Yes No Unclear 
accounted for?

• Was there loss to follow up?

• Was this acceptable?

• Were patients analysed in the groups to which they were Yes No Unclear 
randomised (ITT)?

6. Were patients, health workers and study personnel Yes No Unclear 
‘blind’ to treatment? Yes No Unclear 
Yes No Unclear 

• Subjects:
• Therapist:
• Outcome assessors:

7. Based on the above criteria, how would you rate the

quality of this trial?

PHTY211 Intervention Template_2021

B. WHAT WERE THE RESULTS?

8. How large was the treatment effect?

• What outcomes were reported?

• How are the results presented?

• Is the minimal clinically worthwhile effect reported?

• If so, what is it?

• What was the difference between the 2 groups for

the primary outcome? If not provided can it be
calculated? If so then calculate the change.
• Show appropriate equation
• Plug in appropriate numbers
• Correct answer

9 How precise was the estimate of the treatment

effect?

• What are the confidence limits? If not provided can

they be calculated? If so then calculate the 95%
CI.
• Show appropriate equation
• Plug in appropriate numbers
• Correct answer

PHTY211 Intervention Template_2022

C. Will the results help me in caring for my patient? (External Validity)

10. Is my patient so different to those in the study that

the results cannot apply?

• Do you think that the patients covered by the

trial are similar enough to your population?
o Age
o Disability level
o Socioeconomic status
o Culture
o Setting
o Era

11. Is the treatment feasible in my setting?

• Were all clinically important outcomes

considered from the perspective of the following:
o Individual
o Policy makers & practitioners
o Family & carers
o Wider community

• Any side effects?

PHTY211 Intervention Template_2022

12. Will the potential benefits of treatment outweigh the
potential harms of treatment for my patient?

Consider the following:

• Time?
• Effort?
• Pain/discomfort/stress

• Do the results suggest practice/policy should

change?

PHTY211 Intervention Template_2022