Scolaris Content Display Scolaris Content Display

Cochrane Database of Systematic Reviews Protocol - Intervention

Mobile phone‐based interventions for smoking cessation

This is not the most recent version

Collapse all Expand all

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To determine whether mobile phone‐based interventions are effective at helping smokers to quit.

Background

Most smokers start during their teens and more than 80% report having their first cigarette before their 18th birthday (Lamkin 1998). What starts as adolescent experimentation frequently leads to regular smoking; those adolescents who smoke four or more cigarettes have a high likelihood of becoming regular smokers (defined as at least one cigarette per day for 30 days) and research suggests that adolescents are also likely to understimate the addictive nature of tobacco (Lamkin 1998). However research indicates that many young smokers would like to cut down or quit smoking (Lamkin 1998). There is some evidence that smoking cessation programmes designed for adolescents are effective in the short term but not much is known about long term efficacy. Existing smoking cessation services such as advice from a health professional and nicotine replacment therapy are under‐utilised by young people (Rodgers 2005).

Mass media has a powerful role in influencing youth culture. Smoking behaviours, when realistically portrayed by role models or media 'stars' and associated with positive outcomes such as power, romance, social status and success, are likely to be imitated by young people. Being 'cool' is important to teenagers and if smoking is portrayed as a cool behaviour, adolescents are likely to imitate this behaviour (Watson 2003). Feeling awkward is not cool and mobile phones also provide a means for young adults to remain cool and have something to do with their hands in situations where they are alone. In this way they may be seen as an alternative to smoking.

Since the introduction of mobile phone networks in the 1980s, the use of mobile phones has grown exponentially. It is estimated that there will be 2.6 billion users of mobile phones around the globe by the end of 2006; based on a compounded annual growth rate of 8.7%, the total is expected to be 3.5 billion by the end of 2010 (Pyramid 2006). Mobile phones have been particularly embraced by young adults, with the large majority of young adults in economically developed countries owning a mobile phone (Rodgers 2005). More recently the rapid expansion in the use of text messaging saw this phenomenon exceed one trillion messages a year, and expected to be over 2.3 trillion by 2010 (Reuters 2006). The current increase in 2.5G and 3G phones and mobile phone content will increase delivery of picture, audio, and video messages to accompany this growth in text messaging.

Health services around the world have started to introduce the use of mobile phones to support patients. In particular mobile phones (voice and text messaging) have been used to improve medication adherence, send appointment reminders, improve monitoring and self‐management of chronic disorders (such as diabetes), report test results, provide support between appointments, and support treatment in difficult cases. Particular patient groups that have been targeted as appropriate include those with chronic disorders requiring ongoing self‐management, and mental health service users.

Smoking cessation programmes are also starting to use mobile phones, particularly as adjuncts to quitlines, internet and other programmes such as the NHS Stop Smoking Services 'Together' programme. Cessation interventions that are aimed at young adults appear ideally suited for delivery via mobile phones, as young people appreciate the anonymity and confidentiality allowable, and the ease of use anywhere at anytime. Other benefits of mobile phone‐based cessation interventions might include cost‐effective delivery, scalable to large populations independent of location, time‐sensitive messages with an 'always on' device, and provision of distraction/entertainment and increased social support.

It is likely that the use of mobile phones will continue to grow rapidly as they become even more ubiquitous and as technological advances increase their applications and functions. It is therefore important to determine whether mobile phones can be effective at helping smokers to quit.

Objectives

To determine whether mobile phone‐based interventions are effective at helping smokers to quit.

Methods

Criteria for considering studies for this review

Types of studies

Randomized or quasi‐randomized controlled trials.

Types of participants

All smokers who want to quit smoking. No age restrictions will apply.

Types of interventions

We will include studies which examine any type of mobile phone‐based intervention. This includes any intervention aimed at mobile phone users, based around delivery via mobile phone, and using any functions or applications that can be sent via a mobile phone.
We will exclude trials where mobile phones are used as as adjunct to a face‐to‐face or internet‐based programmes to remind participants of appointments etc, or where the effects of the various components of a multi‐faceted programme cannot be separated.

We will not include trials of telephone‐based counselling interventions that may be delivered via mobile phones but that can also be delivered using traditional telephone systems. These trials are covered in a separate Cochrane review (Stead 2006).

Types of outcome measures

The primary outcome of interest will be smoking cessation (sustained, prolonged or point prevalence abstinence) at least six months after the start of the intervention, and longer wherever the data are available. We will also assess the secondary outcome of abstinence at four weeks. We will use the strictest available definition of abstinence, preferring sustained or prolonged abstinence over point prevalence. We will prefer but will not require biochemically verified smoking status.

Search methods for identification of studies

We will search the specialized register of the Cochrane Tobacco Addiction Review group, using the terms 'mobile phone', 'cell phone', 'txt,' 'pxt,' 'sms', 'mms' in the title or abstract or as keywords.

We will also search MEDLINE, EMBASE, CINAHL, PsycINFO and the Cochrane Central Register of Controlled Trials (CENTRAL), using the MeSH term 'cellular phone/' and text terms 'mobile phone*', 'cell* adj phone*', 'txt', 'pxt', 'sms', 'mms', in combination with both MeSH (smoking/ smoking cessation/ tobacco use disorder/ )or free text terms for smoking (smok*, tobacco or cigar* or nicotine).

We will search the National Research Register and the ClinicalTrials register for ongoing or recently completed studies. We will search through the reference lists of identified studies and we will attempt to contact the authors of ongoing studies.

We will place no restrictions on language or publication date.

Data collection and analysis

Study selection
RW and HM will run a comprehensive search using the strategy outlined above. We will download citations into an Endnote library, with duplicate citations deleted. From the abstracts and the titles of the downloaded citations two authors (RW and HM) will identify potentially eligible studies and will obtain full text copies of these studies. The same authors will independently select studies to be included against the criteria listed above. We will resolve any disagreements by discussion, by contacting study authors, or by referring to RB who will act as arbiter if required. We will record reasons for exclusion of studies in the appropriate Table.

Methodological quality assessment and data extraction
From the included studies, we will extract information on the following quality criteria and methodological details, and will present them in the Characteristics of Included Studies Table. The articles will not be blinded for authors, institution and journal, because the review authors who will perform the quality assessment are familiar with the literature. If an article does not contain enough information on methodological criteria, i.e., if one or more criteria are scored 'unclear', we will contact the trial authors for additional information.

Trial characteristics

  • Method of randomization

  • Presence or absence of blinding to treatment allocation (non‐blinded/open label, single‐, double‐ or triple‐blind)

  • Quality of allocation concealment (adequate, unclear, inadequate, not used)

  • Number of participants randomized, excluded and lost to follow up

  • Definitions of smoker and smoking cessation

  • Whether an intention‐ to‐treat analysis was done (i.e. including in the analysis all participants in the groups to which they were originally randomized)

  • Whether a power calculation was done

  • Duration, timing and location of the study

Characteristics of the study participants

  • Definition of smoker and smoking status as used in the study

  • Demographic characteristics of smokers in the study

  • Other inclusion criteria

  • Exclusion criteria

Interventions used

  • Type and 'dose' of mobile phone intervention used

  • Type of control/placebo intervention used

  • Duration of intervention

  • Duration of follow up

Outcomes

  • Smoking cessation at six months (self‐reported abstinence and/or biochemically verified abstinence). This is the primary outcome, and will contribute to any meta‐analysis.

  • Smoking cessation at four weeks (self‐reported abstinence and/or biochemically verified abstinence)

  • Smoking cessation at longest follow up, if greater than six months

Data analysis
RW and HM will independently extract the data using a standardized form. We will regard those trial participants who drop out of the trial or are lost to follow up as continuing smokers. We will note any report of deaths or adverse events for each trial.

If data allow, we will conduct a meta‐analysis of the included studies, using the Mantel‐Haenszel Odds Ratio, fixed‐effect method, provided that there is no evidence of substantial statistical heterogeneity as assessed by the I2 statistic (Higgins 2003), which describes the percentage of total variation between studies that is due to heterogeneity rather than chance. Values over 50% suggest moderate heterogeneity, and values over 75% substantial heterogeneity.

If meta‐analysis is not appropriate, we will present summary and descriptive statistics.

We include in this protocol the Tobacco Addiction Group glossary of tobacco‐specific terms (Table 1).

Open in table viewer
Table 1. Glossary of terms

Term

Definition

Abstinence

A period of being quit, i.e. stopping the use of cigarettes or other tobacco products, May be defined in various ways; see also:
point prevalence abstinence; prolonged abstinence; continuous/sustained abstinence

Biochemical verification

Also called 'biochemical validation' or 'biochemical confirmation':
A procedure for checking a tobacco user's report that he or she has not smoked or used tobacco. It can be measured by testing levels of nicotine or cotinine or other chemicals in blood, urine, or saliva, or by measuring levels of carbon monoxide in exhaled breath or in blood.

Bupropion

A pharmaceutical drug originally developed as an antidepressant, but now also licensed for smoking cessation; trade names Zyban, Wellbutrin (when prescribed as an antidepressant)

Carbon monoxide (CO)

A colourless, odourless highly poisonous gas found in tobacco smoke and in the lungs of people who have recently smoked, or (in smaller amounts) in people who have been exposed to tobacco smoke. May be used for biochemical verification of abstinence.

Cessation

Also called 'quitting'
The goal of treatment to help people achieve abstinence from smoking or other tobacco use, also used to describe the process of changing the behaviour

Continuous abstinence

Also called 'sustained abstinence'
A measure of cessation often used in clinical trials involving avoidance of all tobacco use since the quit day until the time the assessment is made. The definition occasionally allows for lapses. This is the most rigorous measure of abstinence

'Cold Turkey'

Quitting abruptly, and/or quitting without behavioural or pharmaceutical support.

Craving

A very intense urge or desire [to smoke].
See: Shiffman et al 'Recommendations for the assessment of tobacco craving and withdrawal in smoking cessation trials'
Nicotine & Tobacco Research 2004: 6(4): 599‐614

Dopamine

A neurotransmitter in the brain which regulates mood, attention, pleasure, reward, motivation and movement

Efficacy

Also called 'treatment effect' or 'effect size':
The difference in outcome between the experimental and control groups

Harm reduction

Strategies to reduce harm caused by continued tobacco/nicotine use, such as reducing the number of cigarettes smoked, or switching to different brands or products, e.g. potentially reduced exposure products (PREPs), smokeless tobacco.

Lapse/slip

Terms sometimes used for a return to tobacco use after a period of abstinence. A lapse or slip might be defined as a puff or two on a cigarette. This may proceed to relapse, or abstinence may be regained. Some definitions of continuous, sustained or prolonged abstinence require complete abstinence, but some allow for a limited number or duration of slips. People who lapse are very likely to relapse, but some treatments may have their effect by helping people recover from a lapse.

nAChR

[neural nicotinic acetylcholine receptors]: Areas in the brain which are thought to respond to nicotine, forming the basis of nicotine addiction by stimulating the overflow of dopamine

Nicotine

An alkaloid derived from tobacco, responsible for the psychoactive and addictive effects of smoking.

Nicotine Replacement Therapy (NRT)

A smoking cessation treatment in which nicotine from tobacco is replaced for a limited period by pharmaceutical nicotine. This reduces the craving and withdrawal experienced during the initial period of abstinence while users are learning to be tobacco‐free The nicotine dose can be taken through the skin, using patches, by inhaling a spray, or by mouth using gum or lozenges.

Outcome

Often used to describe the result being measured in trials that is of relevance to the review. For example smoking cessation is the outcome used in reviews of ways to help smokers quit. The exact outcome in terms of the definition of abstinence and the length of time that has elapsed since the quit attempt was made may vary from trial to trial.

Pharmacotherapy

A treatment using pharmaceutical drugs, e.g. NRT, bupropion

Point prevalence abstinence (PPA)

A measure of cessation based on behaviour at a particular point in time, or during a relatively brief specified period, e.g. 24 hours, 7 days. It may include a mixture of recent and long‐term quitters. cf. prolonged abstinence, continuous abstinence

Prolonged abstinence

A measure of cessation which typically allows a 'grace period' following the quit date (usually of about two weeks), to allow for slips/lapses during the first few days when the effect of treatment may still be emerging.
See: Hughes et al 'Measures of abstinence in clinical trials: issues and recommendations'; Nicotine & Tobacco Research, 2003: 5 (1); 13‐25

Relapse

A return to regular smoking after a period of abstinence

Secondhand smoke

Also called passive smoking or environmental tobacco smoke [ETS]
A mixture of smoke exhaled by smokers and smoke released from smouldering cigarettes, cigars, pipes, bidis, etc. The smoke mixture contains gases and particulates, including nicotine, carcinogens and toxins.

Self‐efficacy

The belief that one will be able to change one's behaviour, e.g. to quit smoking

SPC [Summary of Product Characteristics]

Advice from the manufacturers of a drug, agreed with the relevant licensing authority, to enable health professionals to prescribe and use the treatment safely and effectively.

Tapering

A gradual decrease in dose at the end of treatment, as an alternative to abruptly stopping treatment

Titration

A technique of dosing at low levels at the beginning of treatment, and gradually increasing to full dose over a few days, to allow the body to get used to the drug. It is designed to limit side effects.

Withdrawal

A variety of behavioural, affective, cognitive and physiological symptoms, usually transient, which occur after use of an addictive drug is reduced or stopped.
See: Shiffman et al 'Recommendations for the assessment of tobacco craving and withdrawal in smoking cessation trials'
Nicotine & Tobacco Research 2004: 6(4): 599‐614

Table 1. Glossary of terms

Term

Definition

Abstinence

A period of being quit, i.e. stopping the use of cigarettes or other tobacco products, May be defined in various ways; see also:
point prevalence abstinence; prolonged abstinence; continuous/sustained abstinence

Biochemical verification

Also called 'biochemical validation' or 'biochemical confirmation':
A procedure for checking a tobacco user's report that he or she has not smoked or used tobacco. It can be measured by testing levels of nicotine or cotinine or other chemicals in blood, urine, or saliva, or by measuring levels of carbon monoxide in exhaled breath or in blood.

Bupropion

A pharmaceutical drug originally developed as an antidepressant, but now also licensed for smoking cessation; trade names Zyban, Wellbutrin (when prescribed as an antidepressant)

Carbon monoxide (CO)

A colourless, odourless highly poisonous gas found in tobacco smoke and in the lungs of people who have recently smoked, or (in smaller amounts) in people who have been exposed to tobacco smoke. May be used for biochemical verification of abstinence.

Cessation

Also called 'quitting'
The goal of treatment to help people achieve abstinence from smoking or other tobacco use, also used to describe the process of changing the behaviour

Continuous abstinence

Also called 'sustained abstinence'
A measure of cessation often used in clinical trials involving avoidance of all tobacco use since the quit day until the time the assessment is made. The definition occasionally allows for lapses. This is the most rigorous measure of abstinence

'Cold Turkey'

Quitting abruptly, and/or quitting without behavioural or pharmaceutical support.

Craving

A very intense urge or desire [to smoke].
See: Shiffman et al 'Recommendations for the assessment of tobacco craving and withdrawal in smoking cessation trials'
Nicotine & Tobacco Research 2004: 6(4): 599‐614

Dopamine

A neurotransmitter in the brain which regulates mood, attention, pleasure, reward, motivation and movement

Efficacy

Also called 'treatment effect' or 'effect size':
The difference in outcome between the experimental and control groups

Harm reduction

Strategies to reduce harm caused by continued tobacco/nicotine use, such as reducing the number of cigarettes smoked, or switching to different brands or products, e.g. potentially reduced exposure products (PREPs), smokeless tobacco.

Lapse/slip

Terms sometimes used for a return to tobacco use after a period of abstinence. A lapse or slip might be defined as a puff or two on a cigarette. This may proceed to relapse, or abstinence may be regained. Some definitions of continuous, sustained or prolonged abstinence require complete abstinence, but some allow for a limited number or duration of slips. People who lapse are very likely to relapse, but some treatments may have their effect by helping people recover from a lapse.

nAChR

[neural nicotinic acetylcholine receptors]: Areas in the brain which are thought to respond to nicotine, forming the basis of nicotine addiction by stimulating the overflow of dopamine

Nicotine

An alkaloid derived from tobacco, responsible for the psychoactive and addictive effects of smoking.

Nicotine Replacement Therapy (NRT)

A smoking cessation treatment in which nicotine from tobacco is replaced for a limited period by pharmaceutical nicotine. This reduces the craving and withdrawal experienced during the initial period of abstinence while users are learning to be tobacco‐free The nicotine dose can be taken through the skin, using patches, by inhaling a spray, or by mouth using gum or lozenges.

Outcome

Often used to describe the result being measured in trials that is of relevance to the review. For example smoking cessation is the outcome used in reviews of ways to help smokers quit. The exact outcome in terms of the definition of abstinence and the length of time that has elapsed since the quit attempt was made may vary from trial to trial.

Pharmacotherapy

A treatment using pharmaceutical drugs, e.g. NRT, bupropion

Point prevalence abstinence (PPA)

A measure of cessation based on behaviour at a particular point in time, or during a relatively brief specified period, e.g. 24 hours, 7 days. It may include a mixture of recent and long‐term quitters. cf. prolonged abstinence, continuous abstinence

Prolonged abstinence

A measure of cessation which typically allows a 'grace period' following the quit date (usually of about two weeks), to allow for slips/lapses during the first few days when the effect of treatment may still be emerging.
See: Hughes et al 'Measures of abstinence in clinical trials: issues and recommendations'; Nicotine & Tobacco Research, 2003: 5 (1); 13‐25

Relapse

A return to regular smoking after a period of abstinence

Secondhand smoke

Also called passive smoking or environmental tobacco smoke [ETS]
A mixture of smoke exhaled by smokers and smoke released from smouldering cigarettes, cigars, pipes, bidis, etc. The smoke mixture contains gases and particulates, including nicotine, carcinogens and toxins.

Self‐efficacy

The belief that one will be able to change one's behaviour, e.g. to quit smoking

SPC [Summary of Product Characteristics]

Advice from the manufacturers of a drug, agreed with the relevant licensing authority, to enable health professionals to prescribe and use the treatment safely and effectively.

Tapering

A gradual decrease in dose at the end of treatment, as an alternative to abruptly stopping treatment

Titration

A technique of dosing at low levels at the beginning of treatment, and gradually increasing to full dose over a few days, to allow the body to get used to the drug. It is designed to limit side effects.

Withdrawal

A variety of behavioural, affective, cognitive and physiological symptoms, usually transient, which occur after use of an addictive drug is reduced or stopped.
See: Shiffman et al 'Recommendations for the assessment of tobacco craving and withdrawal in smoking cessation trials'
Nicotine & Tobacco Research 2004: 6(4): 599‐614

Figures and Tables -
Table 1. Glossary of terms