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  • Does use of ‘non-trial’ cessation support help explain the lack of effect from offering NRT to quitline callers in a RCT?

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Research letter
Does use of ‘non-trial’ cessation support help explain the lack of effect from offering NRT to quitline callers in a RCT?
  1. Graeme Docherty1,
  2. Sarah Lewis1,
  3. Andy McEwen2,
  4. Linda Bauld3,
  5. Tim Coleman4
  1. 1Department of Epidemiology and Public Health, UK Centre for Tobacco Control Studies, University of Nottingham, Nottingham, UK
  2. 2Department of Epidemiology and Public Health, Cancer Research UK Health Behaviour Research Centre, UK Centre for Tobacco Control Studies, University College London, London, UK
  3. 3UK Centre for Tobacco Control Studies, Institute of Social Marketing, University of Stirling, Stirling, UK
  4. 4Division of Primary Care, UK Centre for Tobacco Control Studies and NIHR School for Primary Care Research, University of Nottingham, Queen's Medical Centre, Nottingham, UK
  1. Correspondence to Graeme Docherty, Department of Epidemiology and Public Health, UK Centre for Tobacco Control Studies, University of Nottingham, C100, Clinical Sciences Building, City Hospital, Hucknall Road, Nottingham NG5 1PB, UK; graeme.docherty{at}nottingham.ac.uk

http://dx.doi.org/10.1136/tobaccocontrol-2013-051107

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    Introduction

    Quitlines help smokers to stop but few studies have explored how behavioural and medicinal interventions can be optimally delivered via this route.1 One of these was the PORTSSS trial, which found that offering free nicotine replacement therapy (NRT) vouchers did not increase cessation rates compared with no offer.2 It also found that a ‘proactive’, more intensive call regime from/to clients did not improve cessation rates over ‘usual care’. Was it possible that participants who did not receive a voucher for NRT sought out and used other forms of cessation support, which minimised any effect of receiving the NRT voucher? Use of ‘non-trial’ support varied across PORTSSS trial intervention groups and, in this analysis, we sought to determine whether or not use of this substantially affected trial findings.

    Methods

    Our secondary analysis included all 2591 randomised participants of the PORTSSS trial. PORTSSS was a randomised controlled trial (RCT) of an English, government-funded quitline, comparing two forms of behavioural support, with and without the offer of a free NRT voucher using a parallel-group, factorial 2×2 design. Non-trial support …

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    Footnotes

    • Contributors GD conducted the analysis and led writing of the manuscript. TC assisted with the study design and advised on the analysis. SL supervised the analysis. All authors were involved in the review of the manuscript prior to submission.

    • Funding The work was undertaken by the UK Centre for Tobacco Control Studies, a UKCRC Public Health Research Centre of Excellence. Funding from British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. The PORTSSS trial was funded by the Department of Health in England.

    • Competing interests TC has, within the last 5  years, spoken at two conferences which were organised and funded by Pierre Fabre Laboratories, a company which manufactures NRT products. He has also advised a public relations company on the (lack of) evidence for using Nicobloc as an aid for smoking cessation. AM receives a personal income from Cancer Research UK via University College London. He has received travel funding, honorariums and consultancy payments from manufacturers of smoking cessation products (Pfizer Ltd, Novartis UK and GSK Consumer Healthcare Ltd) and hospitality from North51 who provide online and database services. He also receives payment for providing training to smoking cessation specialists; receives royalties from books on smoking cessation and has a share in a patent of a nicotine delivery device. LB is vice-chair of the Cancer Research UK Tobacco Advisory Group and serves as Scientific Adviser to the Department of Health on tobacco control. GD and SL have no conflicts of interest to declare.

    • Patient consent Obtained.

    • Ethics approval The PORTSSS trial received a favourable opinion by Leicestershire, Northamptonshire and Rutland Research Ethics Committee (08/H0406/164).

    • Provenance and peer review Not commissioned; externally peer reviewed.