Aveyard 2007.
Methods | Randomised controlled clinical trial of behavioural support for smoking cessation (the “Patch in Practice Study”) Study period: July 2002 to March 2005 |
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Participants | N = 925 Recruited from 26 general practice clinics in Buckinghamshire and Oxfordshire, UK Inclusion criteria: current smokers, age ≥ 18, smoked ≥ 10 cigarettes/d Exclusion criteria: contraindications to nicotine replacement therapy (NRT) |
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Interventions | Basic support (N = 469) Weekly support (N = 456) Participants were randomised to behavioural support provided by practice nurse before quitting, telephoned around quit day, and seen 1 and 4 weeks after the initial appointment (basic support) vs basic support plus weekly support ‐ additional telephone call at 10 days and 3 weeks after the initial appointment, and an additional visit at 2 weeks to motivate adherence to nicotine replacement and to renew quit attempts. 15 mg/16 h nicotine patches were given to all participants. |
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Outcomes |
Primary outcomes: confirmed sustained abstinence at 1, 4, 12, and 26 weeks from quit day. Sustained abstinence was defined as self‐reported total abstinence after a 14‐day grace period from quit date confirmed by expired air carbon monoxide (CO) < 10 ppm. Secondary outcomes: not indicated |
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Funding source | “This study was funded by a programme grant from Cancer Research UK (trial registration ISRCTN 05689186). United Pharmaceuticals supplied the nicotine patches for the study free to be given without charge to the participants.” | |
Declaration of interest | “PA has received free nicotine replacement products from Novartis and nortriptyline from King Pharmaceuticals for distribution to trial participants; personal income for advice to Xenova, a biotechnology company investigating a nicotine vaccine; small gifts and had numerous meals paid for by drug companies, including those producing medications for smoking cessation; and travel grants to attend conferences from the Society for Research in Nicotine and Tobacco. KB, CS, and AA have received small gifts and had meals paid for by drug companies, including those manufacturing medications for smoking cessation. M Munafó has received fees for invited lectures from the National Health Service, GlaxoSmithKline, Novartis, the Moffitt Cancer Research Center, and the Karolinska Institutet; benefits in kind (hospitality, etc.) from various pharmaceutical companies; research and travel support from the European Research Advisory Board, GlaxoSmithKline, Pfizer Consumer Healthcare and Novartis; and he has acted as a consultant to the European Commission, The American Institutes for Research, the National Audit Office, and G‐Nostics Ltd. EJ has received consultancy income from the European Network for Smoking Prevention. M Murphy has received consultancy income from the European Network for Smoking Prevention and has provided scientific consultancy services through the University of Oxford ISIS Innovation to the National Audit Office and G‐Nostics Ltd. The Childhood Cancer Research Group and the Cancer Research UK General Practice Research Group have received unrestricted educational grants, research project grants, and consultancy fees from Ciba Geigy/Novartis, GlaxoSmithKline, Pharmacia/Pfizer, Ares‐Serono, Sanofi‐Synthelabo, Third Wave Technologies, Astra Zeneca, and G‐Nostics.” | |
Notes | This paper did not report analyses of pharmacogenetics. However, DNA was collected from all trial participants and analyses of pharmacogenetics were reported in subsequent papers (David 2008; David 2011; Munafò 2008;Munafò 2009; Munafò 2011; Munafò 2012;Spruell 2012; Uhl 2010). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number sequence generation specified |
Allocation concealment (selection bias) | Low risk | Random number sequence sealed in numbered envelopes. Nurses opened sealed envelopes in sequence following eligibility and consent determination. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and nurses were necessarily not blinded to allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Research staff was blinded to allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up was balanced and transparently reported. |
Selective reporting (reporting bias) | Low risk | Primary outcomes were reported. |
Other bias | Low risk | DNA samples were collected on all participants at the time of study entry. |