Table 2.
Publication | Armstrong (2005) [22] |
Schwartz (2009) [23] |
Hooker (2011) [24] |
Metcalfe (2017) [25] |
---|---|---|---|---|
Criterion | ||||
Adequate sequence generation | + | + | + | + |
Adequate allocation concealment | + | ? | ? | ? |
Blinding of participants and personnel | (−)b | (−)c | (−)c | – |
Blinding of outcome assessors | + | -a | -a | -a, d |
No incomplete outcome data | ? | ? | ? | ? |
No selective outcome reporting | + | + | + | + |
No other sources of bias | + | + | + | + |
RISK OF BIAS | Unclear | High | High | High |
+ Met criterion;? Unclear; − Unmet criterion; RCT: randomized controlled trial
aPatient-Reported Outcome Measures (PROMs) with unblinded patients
bpatients and outcome assessors blinded, staff not blinded
cpatients not blinded, blinding of staff not or not completely mentioned
dresearch assistant blinded but likely that blinding has been broken