Table 2.
Summary of quality assessment of included randomised controlled trials
Study | Was assignment of treatment really random? | Was allocation concealed and concealment method described? | Were groups similar at baseline? | Were eligibility criteria specified? | Who was blinded to treatment allocation? | Was intention to treat analysis used and were drop outs accounted for? |
---|---|---|---|---|---|---|
Batraw1 | Yes; computer generated list | Yes; sealed envelopes | Yes* | Yes | Participants, therapists, and outcome assessors | Yes, yes |
Bolligerw2 | Yes; computer generated list | Yes; sealed envelopes | Yes* | Yes | Participants, therapists, and outcome assessors | Yes, yes |
Hausteinw3 | Yes; computer generated list | Yes; sealed envelopes | Yes | Yes | Participants, therapists, and outcome assessors | Yes, yes |
Rennardw4 | Likely, but method not described | Likely, but method not reported | Yes | Yes | Participants, therapists, and outcome assessors | Yes, yes |
Wennikew5 | Yes (stratified by Fagerström score); computer generated list | Yes; sealed code list | Yes* | Yes | Participants, therapists, and outcome assessors | Yes, yes |
Wood-Bakerw6 | Yes (stratified by Fagerström score); computer generated list | Yes; sealed envelopes | Yes | Yes | Participants, therapists, and outcome assessors | Yes, yes |
Etterw7 | Yes; computer generated list | Unclear | Yes | Yes | Participants and outcome assessors | Most outcomes†, yes |
When extensive unpublished study reports were available, they were used for quality analysis.
*Except for small imbalance in sex distribution.
†Not intention to treat for product usage and for completeness of blinding of participants (determined at six months).