Evidence map›Paper›PMID 22647290›Full record

Trial reportTrials2012

Self-help materials for the prevention of smoking relapse: study protocol for a randomized controlled trial.

Fujian Song, Richard Holland, Garry R Barton, Max Bachmann, Annie Blyth, Viv Maskrey, Paul Aveyard, Stephen Sutton, Jo Leonardi-Bee, Thomas H Brandon

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02693561 (Effectiveness of Deep Breathing, a Self-Help Book and Additive Effects of The Two Interventions in Cigarette Consumption, Anxiety and Depression and Motivation to Stop Smoking in Students of the Anhembi Morumbi University), which is not on this map. Cited by 5 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02693561 naunknown statusnot on this mapstarted 2015, after this paper: background citation

Effectiveness of Deep Breathing, a Self-Help Book and Additive Effects of The Two Interventions in Cigarette Consumption, Anxiety and Depression and Motivation to Stop Smoking in Students of the Anhembi Morumbi University

TypeinterventionalSponsorAnhembi Morumbi UniversityRan2015 to 2016Enrolled85ConditionsSmoking CessationArmsDeep Breathing Exercises, Self-Help Book
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Relapse prevention interventions for smoking cessation.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Relapse prevention interventions for smoking cessation.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Print-based self-help interventions for smoking cessation.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Trial
  5. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Fujian SongNorwich Medical School, Faculty of Medicine and Health Science, University of East Anglia, Norwich NR4 7TJ, UK. Fujian.song@uea.ac.uk
Richard Holland
Garry R Barton
Max Bachmann
Annie Blyth
Viv Maskrey
Paul Aveyard
Stephen Sutton
Jo Leonardi-Bee
Thomas H Brandon

Funding

British Heart FoundationCancer Research UKDepartment of Health 09/91/36Medical Research Council
6 · The paper itself

Abstract

backgroundMost people who stop smoking successfully for a few weeks will return to smoking again in the medium term. There are few effective interventions to prevent this relapse and none used routinely in clinical practice. A previous exploratory meta-analysis suggested that self-help booklets may be effective but requires confirmation. This trial aims to evaluate the effectiveness and cost-effectiveness of a set of self-help educational materials to prevent smoking relapse in the National Health Service (NHS) Stop Smoking Service. METHODS/

designThis is an open, randomized controlled trial. The target population is carbon monoxide (CO) verified quitters at four weeks in the NHS stop smoking clinic (total sample size N = 1,400). The experimental intervention tested is a set of eight revised Forever Free booklets, including an introduction booklet and more extensive information on all important issues for relapse prevention. The control intervention is a leaflet that has no evidence to suggest it is effective but is currently given to some patients using NHS stop smoking services. Two follow-up telephone interviews will be conducted at three and 12 months after the quit date. The primary outcome will be prolonged abstinence from months four to 12 with no more than five lapses, confirmed by a CO test at the 12-month assessment. The secondary outcomes will be seven-day self-report point prevalence abstinence at three months and seven-day biochemically confirmed point prevalence abstinence at 12 months. To assess cost-effectiveness, costs will be estimated from a health service perspective and the EQ-5D will be used to estimate the QALY (Quality Adjusted Life Year) gain associated with each intervention. The comparison of smoking abstinence rates (and any other binary outcomes) between the two trial arms will be carried out using odds ratio as the outcome statistic and other related statistical tests. Exploratory subgroup analyses, including logistic regression analyses with interaction terms, will be conducted to investigate possible effect-modifying variables. DISCUSSION: The possible effect of self-help educational materials for the prevention of smoking relapse has important public health implications.

trial registrationCurrent Controlled Trials ISRCTN36980856.

Indexed as

Health Knowledge, Attitudes, PracticePamphletsPatient Education as TopicResearch DesignSmoking PreventionAdaptation, PsychologicalBreath TestsCost-Benefit AnalysisEnglandHealth Care CostsHumansLogistic ModelsOdds RatioSecondary PreventionSmokingSmoking Cessation

Identifiers

PMID22647290
PMCPMC3480895

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.