items

scores

notes

(1) Was the assigned treatment adequately concealed prior to allocation?

3 = method did not allow disclosure of assignment.
1 = small but possible chance of disclosure of assignment or unclear.
0 = quasi‐randomised or open list/tables.

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

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

3 = withdrawals well described and accounted for in analysis.
1 = withdrawals described and analysis not possible, or probably no withdrawals.
0 = no mention, inadequate mention, or obvious differences and no adjustment.

(3) Were the outcome assessors blinded to treatment status?

3 = effective action taken to blind assessors.
1 = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted.
0 = not mentioned or not possible.

(4) Were important baseline characteristics reported and comparable?

3 = good comparability of groups, or confounding adjusted for in analysis.
1 = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data.
0 = large potential for confounding, or not discussed.

The principal confounders considered were age, gender, type of fracture, type of treatment, existing co‐morbidities (arthritis), prior functional and mental status, and complications.

(5) Were the participants blind to assignment status after allocation?

3 = effective action taken to blind participants.
1 = small or moderate chance of unblinding of participants.
0 = not possible, or not mentioned (unless double‐blind), or possible but not done.

(6) Were the treatment providers blind to assignment status?

3 = effective action taken to blind treatment providers.
1 = small or moderate chance of unblinding of treatment providers.
0 = not possible, or not mentioned (unless double‐blind), or possible but not done.

(7) Were care programmes, other than the trial options, identical?

3 = care programmes clearly identical.
1 = clear but trivial differences, or some evidence of comparability.
0 = not mentioned or clear and important differences in care programmes.

Examples of clinically important differences in other interventions were: differences in treatment intervention (e.g. surgery, plaster cast; duration of immobilisation), differences in call back times for assessment, clinician experience and speciality.

(8) Were the inclusion and exclusion criteria for entry clearly defined?

3 = clearly defined (including type of treatment).
1 = inadequately defined.
0 = not defined.

(9) Were the interventions clearly defined (including who provided the care)?

3 = clearly defined interventions are applied with a standardised protocol and care providers identified.
1 = clearly defined interventions are applied but the application protocol is not standardised or care providers identified.
0 = intervention and/or application protocol are poorly or not defined.

(10) Were the outcome measures used clearly defined?

3 = clearly defined.
1 = inadequately defined.
0 = not defined.

(11) Were the outcome measures clinically useful ‐ with adequate accuracy, precision and considerations of observer variation ‐ including active follow‐up?

3 = optimal.
1 = adequate.
0 = not defined, not adequate.

(12) Was the timing (e.g. duration of surveillance) clinically appropriate?

3 = optimal. (> 1 year)
1 = adequate. (6 months ‐ 1 year)
0 = not defined, not adequate. (< 6 months)