Carson 2014

Methods	Country: Australia Setting: Respiratory, cardiology, neurology, vascular and general medicine wards of 3 Adelaide (South Australia) hospitals Aim: To evaluate efficacy and safety of varenicline + quitline counselling vs quitline counselling alone in people admitted with smoking‐related acute illnesses Study Design: Phase II/III open‐label single‐blind RCT Dates conducted: August 2008 ‐ December 2011 Power calculation: 196 participants per arm, based on a 15% difference (45% vs 30%) at 52 wks, giving 80% power, 0.05 2‐sided significance Study name: Smoking Termination Opportunity for inPatients (STOP)
Participants	392 adult smokers, aged 18 ‐ 75, smoking 10 CPD+, willing to quit, admitted with acute smoking‐related illnesses; randomised to varenicline + counselling (196) or counselling alone (196) Mean age 53, 32% women, 96% white, mean CPD 25, mean FTND 5.6, mean baseline LoS 6.5 days Exclusion criteria: Standard pharmacotherapy criteria, acute or pre‐existing psychiatric illness, history of psychosis or suicidal ideation, use of varenicline in past 12m
Interventions	1. Varenicline 1.0 mg x 2/d for 12 wks, including wk 1 at titrated dose (described as standard MIMS dosing schedule), + counselling 2. Counselling only Both groups received Quit SA 5A behavioural counselling, i.e. maximum of 8 calls over 3m. Also booklet Quit because you can, + stickers and fridge magnets. Participants had to set a TQD within 1st 2 wks Contacts were attempted with all participants at days 3 and 5, wks 1, 2, 3, 4, 12 (EoT). Additional contacts at wks 26 and 52
Outcomes	Primary outcome: Self‐reported CAR (< 5 cigs in total) (2 wks ‐ 12m) Secondary outcomes: CAR at 4, 12 and 26 wks. 7‐day PPA each week for 1st 4 wks; craving; prevalence of I/P smoking; Reduced hospital bed utilisation; Reduction in healthcare costs CO validation ≤ 10 ppm used only in "a random sub‐set of subjects"
Treatment type	Medication: VARENICLINE
Notes	Partially funded by the Department of Respiratory Medicine, Queen Elizabeth Hospital, Adelaide, SA; information based on unpublished data supplied by authors, + published 2014 study report New for 2012 update (study ID was Smith 2012; changed for 2015 update)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"A pre‐defined, central, computer‐generated randomization sequence was used to assign subjects in a 1:1 ratio to either 12 weeks of treatment with varenicline plus Quitline‐counseling or 12 weeks of Quitline‐counseling alone."
Allocation concealment (selection bias)	Low risk	"using opaque, sealed envelopes with consecutive numbers"
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Open‐label design. Attempt at single‐blinding (statistical investigator). "Participants and investigators were not blinded to treatment assignment". "Randomization and allocation concealment were performed by respiratory staff independent of the study"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	"Missing data from questionnaire (e.g., a question missed when administering follow‐up) were randomly imputed via a computer programme" 84% varenicline completed the study at 52 wks, vs 82% in the placebo group
Selective reporting (reporting bias)	Unclear risk	None noted
Other bias	Unclear risk	None noted