There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.
Abstract
Smoking cessation treatment is now integrated into many health-care systems and a
major research effort is under way to improve current success rates. Until now results
from randomized clinical trials have been reported in many different ways, leading
to problems of interpretation. We propose six standard criteria comprising the 'Russell
Standard' (RS). These criteria are applicable to trials of cessation aids where participants
have a defined target quit date and there is face-to-face contact with researchers
or clinic staff, as follows. (1) Follow-up for 6 months (RS6) or 12 months (RS12)
from the target quit date or the end of a predefined 'grace period'; (2) self-report
of smoking abstinence over the whole follow-up period allowing up to five cigarettes
in total; (3) biochemical verification of abstinence at least at the 6-month or 12-month
follow-up point; (4) use of an 'intention-to-treat' approach in which data from all
randomized smokers are included in the analysis unless they have died or moved to
an untraceable address (participants who are included in the analysis are counted
as smokers if their smoking status at the final follow-up cannot be determined); (5)
following-up 'protocol violators' and using their true smoking status in the analysis;
and (6) collecting follow-up data blind to smokers' allocation to trial group. We
believe that these criteria provide the best compromise between practicability and
surrogacy for long-term cessation and will enable meaningful comparison between studies.
There may be good reasons why other outcome criteria would also be reported, and studies
that involve interventions with special groups or where there is no designated target
quit date or face to face contact would need to adapt these criteria accordingly.