Newcastle-Ottawa scale for bias assessment for case-controlled studies |
|
|
Newcastle-Ottawa scale for bias assessment |
Cariou et al[9], 2008 |
Grmec et al[10], 2009 |
Selection |
3 |
2 |
Comparability |
2 |
2 |
Exposure |
3 |
3 |
Cochrane Risk of Bias tool for the Randomized controlled study (Cariou et al[11]) |
|
|
Entry |
Judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Quote: “Patients were randomly assigned in a 1:1 ratio to the intervention or the control group” |
Allocation concealment (selection bias) |
Low risk |
Quote: “Randomization was performed centrally with the use of a computer-generated assignment sequence Intervention assignments were made in permuted blocks of varying size and were stratified according to site” |
Blinding of participants and personnel (performance bias) |
High risk |
Comment: Probably done |
|
|
Quote: “Single-blinded”; “physicians performing neurological follow-up and final outcome measurement, as well as study administrators and statisticians, were unaware of the intervention assignments” |
|
|
Comment: Probably done. However, only single blinding performed |
Blinding of outcome assessment (detection bias) (patient-reported outcomes) |
Low risk |
Quote: “Single-blinded” |
|
|
Comment: Probably done |
Blinding of outcome assessment (detection bias) (mortality) |
Low risk |
Obtained from medical records; Quote “CPC was assessed by face-to-face contact with patients still hospitalized, and through phone interviews in discharged patients using a standardized protocol” |
|
|
Review authors do not believe this will introduce bias |
Incomplete outcome data addressed (attrition bias) (Longer-term outcomes, > 6 wk) |
Low risk |
60 d: 1/234 missing from intervention group (“lost to follow-up”); 0/242 missing from control group |
Selective reporting (reporting bias) |
Low risk |
A single scale to assess neurological outcomes was used and reported (CPC score) |