Items

Scores

Notes

A. Was an effective method of randomisation used?

Y = yes, e.g. use of random tables
? = no description of method
N = quasi‐randomised method only

To achieve 'Y', a random (unpredictable) assignment sequence is required.

B. Was the assigned treatment adequately concealed prior to allocation?

Y = method did not allow disclosure of assignment ? = small but possible chance of disclosure of assignment or unclear N = quasi‐randomised or open list/tables

For example, a method using centralised (e.g. allocation by a central office unaware of subject characteristics) or independently‐controlled randomisation.

Cochrane code (see Handbook): Clearly yes = A; Not sure = B; Clearly no = C.

C. Were the outcomes of participants who withdrew described and included in the analysis (intention to treat)?

Y = no dropouts or withdrawals well described and accounted for in analysis.
? = withdrawals described and analysis not possible
N = no mention, inadequate mention, or obvious differences and no adjustment

D. Were the outcome assessors blind to assignment status?

Y = effective action taken to blind outcome assessors
? = small or moderate chance of unblinding of outcome assessors
N = not possible, or not mentioned (unless double‐blind), or possible but not done

E. Were the treatment and control groups comparable at entry?

Y = good comparability of groups, or confounding adjusted for in analysis
? = confounding small; mentioned but not adjusted for
N = large potential for confounding, or not discussed

The principal confounders considered were sex, age, previous overuse lower‐limb injury and prior physical activity profile.

F. Were the participants blind to assignment status after allocation?

Y = effective action taken to blind participants
? = small or moderate chance of unblinding of participants
N = not possible, or not mentioned (unless double‐blind), or possible but not done

G. Were the treatment providers blind to assignment status?

Y = effective action taken to blind treatment providers
? = small or moderate chance of unblinding of treatment providers
N = not possible, or not mentioned (unless double‐blind), or possible but not done

H. Were care programmes, other than the trial options, identical?

Y = care programmes clearly identical
? = clear but trivial differences
N = not mentioned or clear and important differences in care

Examples of clinically important differences in other interventions (co‐interventions) are those which could act as active measures for prevention of hamstring injuries: training programmes, advice on activity and etc.

I. Were the inclusion and exclusion criteria clearly defined?

Y = clearly defined
? = inadequately defined
N = not defined

To achieve 'Y', the inclusion or exclusion of individuals with a) previous hamstring injuries and b) previous exposure to trial intervention needs to be confirmed.

J. Were the interventions clearly defined?

Y = clearly defined interventions are applied with a standardised protocol
? = clearly defined interventions are applied but the application protocol is not standardised
N = intervention and/or application protocol are poorly or not defined

K. Were the outcome measures used clearly defined? (by outcome)

Y = optimal
? = adequate
N = not defined, not adequate

To achieve 'Y', the method and strategy of data collection need to be clearly defined.

L. Were diagnostic tests used in outcome assessment clinically useful? (by outcome)

Y = clearly defined and best available tests are applied with a standardised protocol
? = clearly defined tests are applied but the application protocol is not standardised
N = tests and/or application protocol are poorly or not defined

M. Is the surveillance active, and of clinically appropriate duration?(by outcome)

Y = active surveillance and appropriate duration
? = active surveillance, but inadequate duration
N = surveillance not active or not defined

N. Was compliance of subjects disclosed?

Y = compliance greater than 90% in each group after randomisation
? = compliance with allocated procedure reported
N = compliance not mentioned

Measures of compliance are likely to vary and thus the way of estimating the 90% compliance will depend on the measures used in individual trials.