Russell 2021.
| Study characteristics | ||
| Methods | Design: RCT Setting: London, UK |
|
| Participants | 426, 53% M NRT = 141; Myblu plus NSPs group = 145; Myblu plus FBNPs group = 140 Inclusion criteria: Established daily cigarette smokers aged 18 years and older were recruited in London, UK |
|
| Interventions | EC type: pod 3 arms: NRT; mybluTM containing nicotine salt e‐liquid pods (NSPs); myblu plus freebase nicotine e‐liquid pods (FBNPs). NRT: Over‐the‐counter nicotine replacement therapies (NRTs). Free for 3 months Myblu plus NSPs group: A closed system pod e‐vapour product (mybluTM) containing nicotine salt e‐liquid pods (NSPs). Free for 3 months Myblu plus FBNPs group: A closed system pod e‐vapour product (mybluTM) containing freebase nicotine e‐liquid pods (FBNPs). Free for 3 months Participants of both myblu arms were given a primary device, a backup device, and reimbursement for retail purchases of up to 12 e‐liquid pods (6 packs of x2 pods) per month for 3 months. Participants were encouraged to use their assigned e‐vapour product and to choose and change flavours and nicotine concentrations of their assigned e‐liquid pods as they wished |
|
| Outcomes | Online surveys administered at study enrolment and then at 1, 2, 3 and 6‐months post‐enrolment assessed self‐reported past 30‐day consumption of conventional cigarettes and use of NRTs and assigned e‐vapour products Self‐reported 6‐month past 30‐day cigarette abstinence rate Reduction in smoking |
|
| Study funding | E‐cigarette/Alternative nicotine products Industry | |
| Author declarations | NS | |
| Notes | New for Sept 2021 update Conference abstract |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Unclear if participants were blinded (conference abstract only) but all participants received active interventions so performance bias judged unlikely |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐report only but all participants received active interventions so differential misreport judged unlikely |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The 6‐month retention rate was 85.8% in the NRT group, 85.5% in the myblu plus NSPs group, and 73.6% in the myblu plus FBNPs group |
| Selective reporting (reporting bias) | Unclear risk | No protocol or clinical trial record available to determine whether all prespecified outcomes are reported |