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. Author manuscript; available in PMC: 2014 May 15.
Published in final edited form as: Cochrane Database Syst Rev. 2013 Oct 23;10:CD001055. doi: 10.1002/14651858.CD001055.pub4
Methods Cluster-randomised trial to evaluate dissemination of a behavioUrally-based program to support women to stop smoking in pregnancy
Study conducted in Queensland (Australia). Data collection dates not stated
Participants Inclusion criteria: Public hospitals which provided antenatal and delivery care for 10 or more patients a year, had less than 50% Aboriginal and Torres Strait Islander population, and did not currently provide any antenatal smoking cessation care
Exclusion criteria: Not further specified.
Recruitment: Hospitals were matched on number of births, location of population centre (rural/metropolitan), and whether they had a specific antenatal clinic 80 (92% public hospitals) hospitals eligible. 10 omitted as they stopped providing antenatal care. 70 hospitals (35 pairs) included
Baseline characteristics: Characteristics of individuals not reported.
No outcomes included in study so not coded.
Interventions Control: Received ‘awareness’ phase of intervention based in Rogers’ Diffusion of Innovation theory. Flyers were distributed to all hospitals
Intervention: Control +‘Persuasion’ phase, which included an educational workshop and presentation. ‘Implementation phase’ where each hospital conducted the recommended program
Main intervention strategy: Intensive dissemination vs less intensive intervention. No outcomes to include in analysis
Intensity: NA
Outcomes Self-reported implementation of program at each hospital. Success was defined as the routine offer of an evidence-based smoking cessation program to at least 80% of the pregnant clients who smoke
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Report states hospitals were randomised into intervention and control groups, within matched pairs
Allocation concealment (selection bias) Unclear risk Not reported.
Incomplete outcome data (attrition bias)
All outcomes
High risk Complete follow-up could not be obtained primarily due to the inability to contact either the medical superintendent or the director of nursing after a minimum of 3 attempts
High attrition (37% hospitals), though those not responding were included in analysis as ‘not implemented’
Selective reporting (reporting bias) Unclear risk Smoking cessation rates not reported, but not included as an aim of this dissemination study
Other bias Low risk No other bias detected.
Biochemical validation of smoking abstinence (detection bias) Unclear risk Smoking status not assessed in this dissemination study.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk Unclear whether control hospitals were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk Not stated.
Incomplete implementation High risk 37% reported as ‘not implemented’.
Equal baseline characteristics in study arms Low risk Matching of the hospitals was successful as there were no differences in number of births, rurality, and whether they had a specialised antenatal service at baseline
Contamination of control group Low risk Cluster design likely to minimise risk of contamination.