| Items |
Scores |
Notes |
| D1. Was a method of randomisation performed? |
2 = yes, clearly described method of randomisation
1 = unclear whether treatment allocation was truly random
0 = no, prospective study or other design without (quasi‐)random assignment |
|
| M‐A. (D2) Was the assigned treatment adequately concealed prior to allocation? |
2 = 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 (Alderson 2004b): Clearly Yes = A; Not sure = B; Clearly No = C. |
| M‐B. (D9) Were the outcomes of patients who withdrew described and included in the analysis (intention to treat)? |
2 = withdrawals well described and accounted for in analysis
1 = withdrawals described and analysis not possible
0 = no mention, inadequate mention or obvious differences and no adjustment |
|
| M‐C. (D5) Were the outcome assessors blinded to treatment status? |
2 = effective action taken to blind assessors
1 = small or moderate chance of unblinding of assessors
0 = not mentioned or not possible |
|
| M‐D. (D3) Were the treatment and control group comparable at entry? |
2 = good comparability of groups, or confounding adjusted for in analysis
1 = confounding small; mentioned but not adjusted for
0 = large potential for confounding, or not discussed |
|
| M‐E. (D7) Were the patients blind to assignment status after allocation? |
2 = effective action taken to blind patients
1 = small or moderate chance of unblinding patients
0 = not possible, or not mentioned (unless double‐blind), or possible but not done |
|
| M‐F. (D6) Were the treatment providers blind to assignment status after allocation? |
2 = 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 |
|
| M‐G. Were care programmes, other than the trial options, identical? |
2 = care programmes clearly identical
1 = clear but trivial differences
0 = not mentioned or clear and important differences in care programmes |
|
| M‐H. (D4) Were the inclusion and exclusion criteria clearly defined? |
2 = clearly defined
1 = inadequately defined
0 = not defined |
|
| M‐I. Were the interventions clearly defined? |
2 = clearly defined interventions are applied with a standardised protocol
1 = clearly defined interventions are applied but the application protocol is not standardised
0 = intervention and/or application poorly or not defined |
|
| M‐J. Were the outcome measures used clearly defined? |
2 = clearly defined
1 = inadequately defined
0 = not defined |
|
| M‐K. Were diagnostic tests used in outcome assessment clinically useful? (by outcome) |
2 = optimal
1 = adequate
0 = not defined, not adequate |
|
| M‐L. Was the surveillance active and of clinically appropriate duration? |
2 = active surveillance and appropriate duration (> three weeks)
1 = active surveillance, but inadequate duration (< three weeks)
0 = surveillance not active or not defined. |
|
| D8. Were point estimates and measures of variability presented for the primary outcome measures? |
2 = point estimates and measures of variability presented
1 = point estimates, but no measures of variability presented
0 = only vague descriptions of outcome measures presented |
|
| T. Was the compliance rate in each group unlikely to cause bias? |
2 = compliance well described and accounted for in analysis
1 = compliance well described but differences between groups not accounted for in analysis
0 = compliance unclear |
|
| X. Was a predefined set of diagnostic criteria provided for the included patients? |
2 = clear description of diagnosis as well as diagnostic criteria were provided, or clear diagnostic exclusion criteria were provided
(e.g. 'chondromalacia patellae', defined by the presence of lesions in patellar cartilage determined at arthroscopy)
1 = only diagnosis without criteria was provided (e.g. 'chondromalacia patellae') and no clear diagnostic exclusion criteria were provided
0 = neither clear diagnosis nor criteria or symptoms were provided (e.g. 'anterior knee pain') |
|
