BMJ 2001;322:1396-1400 [Abridged] ( 9 June )

Primary care

Cost effectiveness of computer tailored and non-tailored smoking cessation letters in general practice: randomised controlled trial

A Scott Lennox, clinical research fellow aLiesl M Osman, senior research fellow bEhud Reiter, lecturer cRoma Robertson, research assistant cJames Friend, professor of respiratory medicine bIan McCann, research assistant aDiane Skatun, research fellow dPeter T Donnan, medical statistician e

a Department of General Practice and Primary Care, University of Aberdeen, Aberdeen AB25 2AY, b Department of Medicine and Therapeutics, University of Aberdeen, c Department of Computing Science, University of Aberdeen, d Health Economics Research Unit, University of Aberdeen, e Medicines Monitoring Unit, Department of Clinical Pharmacology, University of Dundee, Dundee DD1 9SY

Correspondence to: A Scott Lennox s.lennox{at}abdn.ac.uk


    Abstract
Top
Abstract
Introduction
Methods
Results
Discussion
References

Objectives: To develop and evaluate, in a primary care setting, a computerised system for generating tailored letters about smoking cessation.
Design: Randomised controlled trial.
Setting: Six general practices in Aberdeen, Scotland.
Participants: 2553 smokers aged 17 to 65.
Interventions: All participants received a questionnaire asking about their smoking. Participants subsequently received either a computer tailored or a non-tailored, standard letter on smoking cessation, or no letter.
Main outcome measures: Prevalence of validated abstinence at six months; change in intention to stop smoking in the next six months.
Results: The validated cessation rate at six months was 3.5% (30/857) (95% confidence interval 2.3% to 4.7%) for the tailored letter group, 4.4% (37/846) (3.0% to 5.8%) for the non-tailored letter group, and 2.6% (22/850) (1.5% to 3.7%) for the control (no letter) group. After adjustment for significant covariates, the cessation rate was 66% greater (-4% to 186%; P=0.07) in the non-tailored letter group than that in the no letter group. Among participants who smoked <20 cigarettes per day, the cessation rate in the non-tailored letter group was 87% greater (0% to 246%; P=0.05) than that in the no letter group. Among heavy smokers who did not quit, a 76% higher rate of positive shift in "stage of change" (intention to quit within a particular period of time) was seen compared with those who received no letter (11% to 180%; P=0.02). The increase in cost for each additional quitter in the non-tailored letter group compared with the no letter group was £89.
Conclusions: In a large general practice, a brief non-tailored letter effectively increased cessation rates among smokers. A tailored letter was not effective in increasing cessation rates but promoted shift in movement towards cessation ("stage of change") in heavy smokers. As a pragmatic tool to encourage cessation of smoking, a mass mailing of non-tailored letters from general practices is more cost effective than computer tailored letters or no letters.


What is already known on this topic
Brief opportunistic advice on stopping smoking that is given face to face by health professionals increases rates of cessation by 2-3%

Intensive, expert-led interventions increase cessation rates by up to 20% or more but are expensive and reach only a small proportion of smokers

Written advice tailored to an individual's "stage of change" (intention to stop in a particular period of time) has been claimed to be as effective as intensive interventions, but previous studies of tailored written advice did not biochemically validate cessation

What this paper adds
A simple standard letter sent to patients of general practices that gave brief advice on stopping smoking increased the biochemically validated rate of cessation by 2%

A letter tailored to the individual's "stage of change" was not more effective than the non-tailored standard letter

Although the increase in cessation resulting from the non-tailored standard letter was small, this intervention was highly cost effective



    Introduction
Top
Abstract
Introduction
Methods
Results
Discussion
References

Cigarette smoking continues to be a major preventable source of illness and premature death in Scotland. Intensive, expert-led interventions have relatively high success rates but reach only a small proportion of smokers. The real potential for reducing the national prevalence of smoking lies in the widespread implementation of brief interventions. 1 2

Two studies in North America investigated computer generated personalised letters as a method of encouraging smoking cessation. 3 4 The numbers of participants, however, were small, and in neither study were smokers' claims to have stopped smoking validated biochemically. We believed that a larger study, with biochemical validation, was needed on a population with a wider socioeconomic range.


    Methods
Top
Abstract
Introduction
Methods
Results
Discussion
References

Our randomised controlled trial compared the effect on smoking cessation of a computer tailored letter, a non-tailored letter, and no letter. Ethical approval was obtained from the Grampian joint ethical committee.

Interventions
At the start of the study we sent all participants a questionnaire asking about their current smoking behaviour, attitudes to smoking, perception of barriers to quitting, and intention to quit in the next six months or in one month. After we received their questionnaire, we sent each participant a computer tailored letter, a non-tailored letter, or just a letter thanking them for participating in the study ("no letter").

Tailored letter---We developed a computerised system for generating tailored letters. The system determined the text to be included in each participant's letter, based on the answers given in the questionnaire. The phrases and decision rules were devised by experts on smoking cessation and on patient information, in collaboration with the developers of the software. The experts were informed by their clinical experience and their knowledge of various models of behaviour change,5 in particular the "stage of change" model of smoking cessation.6 How the letters were tailored is given in more detail on the BMJ 's website.

Non-tailored letter---This was essentially a default tailored letter produced by scanning a blank questionnaire. To this extent, both interventions were expert interventions, based on a considerable input of time, knowledge, and experience.

No letter---We sent control participants a letter thanking them for their participation and informing them that they would receive material at the end of the study (either a tailored or a non-tailored letter, should either have been shown to be effective).

Recruitment
We recruited participants from smokers aged 17 to 65 years registered at six general practices in Aberdeen. From the computerised records of the practices we identified 7427 patients, who were sent a consent form and a questionnaire to collect information to form the basis of the tailoring. We sent two reminders at intervals of three weeks.

Assignment and mailing of the letters
After the questionnaires and consent forms were returned, we randomised the participants individually to the groups using computer generated random numbers. We mailed materials appropriate to each group immediately after randomisation.

Follow up
Follow up at six months was by postal questionnaire, with two reminders at intervals of three weeks. We attempted telephone follow up of non-respondents.

Outcome measures
The main outcome measure was point abstinence at six months. We validated self reports of smoking cessation by salivary cotinine assay.7 Participants lost to follow up and those whose report of cessation could not be confirmed biochemically were classed as continuing smokers.

We also measured movement in "stage of change" with respect to smoking, analysed as either a positive shift or null shift (no change or negative shift). Participants' initial stage of change was obtained from the postal questionnaire and classified as "pre-contemplator" (no intention to quit in the next six months), "contemplator" (intending to quit in the next six months), or "preparer" (intending to quit in the next month). The main economic outcome measure was cost effectiveness, expressed as the cost for each additional non-smoker at six months.

We estimated the abstinence rate at six months in the control group at 8%, based on reported rates of 7-11% in randomised controlled trials.8-10 Even a modest increase in the cessation rate would be clinically worthwhile. We therefore chose an increase from 8% to 13%. To detect this difference with a power of 80% at the 95% significance level required 590 participants in each group.

Methods of analysis
We used chi 2 tests to analyse categorical variables. Differences between groups were assessed by using analysis of variance. We used multiple logistic regression to assess relations between outcomes and group membership.11 Analyses were adjusted for age, sex, level of social deprivation, heaviness of smoking, time to first cigarette of the day, and initial stage of change.


    Results
Top
Abstract
Introduction
Methods
Results
Discussion
References

Response rates and overall cessation rates
Of the 6155 valid mailings, 2612 responses were valid (42.4%). A total of 2553 participants did not withdraw, and the follow up rate was 78.1% (1995/2553). A total of 154 (6.0%) participants claimed to have stopped smoking after the intervention. Salivary samples for biochemical validation were obtained from 99 participants. Eighty nine participants were validated as having stopped smoking, giving an overall validated cessation rate of 3.5% (89/2553).


                              
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Table 1. Results of logistic modelling of validated smoking cessation (n=2553)


                              
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Table 2. Results of logistic modelling of rates of validated smoking cessation according to heaviness of smoking and initial stage of change

Characteristics of respondents
The groups were similar in age, sex, level of social deprivation, and initial stage of change. The percentage of heavy smokers was higher in the tailored letter group than in the non-tailored letter group.

Outcomes
Sex, age, and heaviness of smoking were not associated with cessation, but there was a significant inverse association with level of social deprivation. Participants whose initial stage of change was contemplator or preparer were more likely to have stopped than pre-contemplators, as were participants who had their first cigarette later in the day (table 1). Validated cessation rates were 3.5% (30/857; 95% confidence interval 2.3% to 4.7%) in the tailored letter group, 4.4% (37/846; 3.0% to 5.8%) in the non-tailored letter group, and 2.6% (22/850; 1.5% to 3.7%) in the control group. After adjusting for confounding variables, we found that participants receiving a non-tailored letter were 66% more likely to have quit than those receiving no letter. After adjustment for confounding variables, participants who received either a tailored or non-tailored letter were 53% more likely to have quit than those receiving no letter.

Among participants who smoked <20 cigarettes a day, those who received a non-tailored letter were 87% more likely to have quit than those who received no letter (table 2). Among participants who smoked >= 20 cigarettes a day and among pre-contemplators there were no differences between either the tailored letter group or the non-tailored letter group and the no letter group. On the other hand, contemplators or preparers who received the non-tailored letter had a higher cessation rate than those who received no letter.

Among participants who did not stop smoking, heavy smokers who received the tailored letter were 76% more likely (11% to 180%) to have made a positive shift in stage of change compared with those who received no letter.

Economic evaluation

Cost effectiveness of the non-tailored letter intervention
Thirty seven of the 846 participants who received a non-tailored letter stopped smoking, compared with 22 of the 850 participants who received no letter. Costs based on the actual number of participants recruited indicate that these 15 additional quitters were gained at a total cost of £464.

Although the analysis was based on only the 846 smokers who responded to the initial contact, cost effectiveness analysis should also consider the potential benefits of the intervention to people who did not respond to the experimental intervention, because in real life the non-tailored letter would be distributed to everyone in the target population. The worst case scenario assumes that only the 846 participants were smokers, giving a cost effectiveness ratio of £89 per additional quitter. The best case scenario assumes that all mistargeted participants (that is, those responding to the initial contact as non-smokers or those who received wrongly addressed letters) had declared themselves, leaving the remaining 1219 participants as smokers. Assuming they behave in a similar manner to the 846 who received the non-tailored letter, this gives a cost effectiveness ratio of £37 per quitter. Using a discount rate of 5% gives a cost per life year gained of between £50 and £122.12


    Discussion
Top
Abstract
Introduction
Methods
Results
Discussion
References

The cessation rate of 4.4% is low compared with rates of 19% and 25% in two previous studies of computer generated letters and 21% in a mass media intervention by the Health Education Board for Scotland. 3 4 13 However, our study had methodological strengths: it was carried out on a randomly chosen population who had not actively volunteered to take part in the intervention and had no special motivation to quit; it used an intention to treat analysis, with all participants lost to follow up being classed as continuing smokers; claims of participants to have stopped smoking were biochemically validated; and the tailored and non-tailored letters were created from the same text base.

In contrast, the high rates of cessation in the other studies were based on self reported cessation, and subjects who dropped out were omitted from the calculations of rates of continuing smoking. In some studies the form of the materials used for the control group was very different from that in the tailored intervention. None of these studies used biochemical validation of non-smoking. Contrary to the argument that biochemical validation is unnecessary in brief intervention studies,14 our findings indicate that not validating cessation results in an overestimate of cessation. Furthermore, one study based its success rate on a subgroup of light smokers who had intended to quit smoking.3 If we had used these methods, our rate of cessation would have been 20% or more.

Raw et al summarised evidence on the validated effect of different types of cessation intervention.15 The most effective is nicotine replacement therapy, which increases the rate of cessation by 8% at six months. Brief advice from a doctor increases abstinence at six months by 2-3%. Two validated studies by the British Thoracic Society found that up to three personalised but non-tailored letters, from doctors to outpatients in chest clinics, increased cessation by 2-3%.16 The present study has found that even one short non-tailored letter from a patient's general practice is as effective as these last two brief interventions.

Can we conclude that tailored letters are not effective?
Our hypothesis that tailored letters would be more effective than non-tailored letters was not supported by the findings. However, we might consider that our non-tailored letter was in fact tailored---or at least personalised---to some extent. Although the non-tailored letter was not tailored to individuals, it was more personal than a general leaflet giving advice on smoking cessation: it was in a letter format, with the crest of the local university and the logo of the patient's general practice, and was ostensibly from "the practice." This degree of personalisation may account for some of its effect.16

The tailored letter was effective in increasing heavy smokers' readiness to stop smoking, whereas the non-tailored letter was ineffective. Although this finding was from a subanalysis done after the main analysis, it was significant at the level of P=0.02. The finding needs to be confirmed by further investigation but is reported here because it is potentially important for this group of smokers, which is held to be little affected by brief interventions.

The greater effectiveness of the non-tailored letter among smokers intending to quit in the next six months may be due to the fact that all participants in the non-tailored letter group received specific advice on how to prepare for and cope with difficulties during an attempt to quit, whereas many smokers in the tailored letter group did not receive this behavioural information. Instead they received more cognitive input aimed at boosting motivation and confidence in achieving goals. Although both cognitive and behavioural input is appropriate for such smokers,6 letters may be better suited to conveying behavioural than cognitive interventions.

The evidence from other studies of tailored interventions is equivocal. A recent review drew overly positive conclusions: a critical reading of the source material shows that, of eight methodologically sound studies, three showed no effect of tailoring.17 One of these three was the only trial to compare a one-off tailored letter with both a non-tailored letter and a control. Even in these five, as pointed out above, the lack of validation of self reported cessation brings into question the reliability of their results. However, it would be premature to conclude that tailoring is ineffective.

Cost effectiveness of the non-tailored letter
The cost per quitter of the non-tailored letter is estimated at between £37 and £89, which compares very favourably with other cessation interventions. 13 18-20 The cost effectiveness ratio of the Health Education Board for Scotland's mass media intervention was between £168 and £369, corresponding to a cost per discounted life year saved of between £304 and £656 (1993 prices).13 However, as pointed out above, this intervention used self reported quitting. If the true rate of quitting were lower, the corresponding cost effectiveness would also have been lower.

The present intervention is highly cost effective because of the low cost of its delivery. Using existing data held in general practices means that the delivery of the information does not require the target groups to be persuaded to receive the intervention.

The potential for implementation of the non-tailored letter intervention
Intervention by primary care professionals in the form of brief opportunistic advice increases smoking cessation by about 2-3% over control intervention, 15 21 but its implementation is limited by various constraints on health professionals.22 In contrast, the 2% increase in cessation found in the present study could be widely and easily realised by using the computerised data now usually held by general practices. Indeed, the quantity and quality of data on smoking held in general practices are set to improve as computers become more user friendly. Soon most practices will be capable of implementing this type of intervention, which would be well suited to implementation at the level of primary care groups or local healthcare cooperatives, and which could be part of a national strategy on smoking cessation. Coordinators from the smoking cessation services that have recently been set up in all health authorities and boards could play a central role.

Other potential settings include smoking helplines and workplaces. The only conditions necessary for implementation are a political will, a database of current smokers, and an administrative structure capable of producing and sending the letters.

    Acknowledgments

We thank Martin Pucci and Margaret Taylor for their contribution to the expert group; Steven Porter, Duncan MacIver, and Yvonne McKay for their programming expertise; Annette Hermse, the validation nurse; and the general practitioners and practice managers of participating practices for their cooperation.

Contributors: ASL contributed to the design of the study and to the expert group, led the evaluation, and prepared the manuscript for publication. LMO contributed to the design of the study and to the expert group, carried out some of the analysis, and helped prepare the manuscript for publication. ER contributed to the design of the study, led the development of the computer tailoring system, and helped prepare the manuscript for publication. RR coordinated the development of the computer tailoring system and helped prepare the manuscript for publication. JF contributed to the design of the study and to the expert group. IM was responsible for designing the questionnaire, data collection, and data entry. DS contributed to the design of, carried out, and reported the economic evaluation. PTD advised on statistical aspects of the study design and carried out most of the analysis. ASL, LMO, and ER are the guarantors for the paper.

    Footnotes

Funding: The Chief Scientist Office, Scottish Executive Health Department, with additional funding from the Engineering and Physical Sciences Research Council. The Health Economics Research Unit is funded by the Chief Scientist Office. The views expressed in this paper are those of the authors and not those of the funding bodies.

Competing interests: None declared.

The full version of this paper appears on the BMJ's website


    References
Top
Abstract
Introduction
Methods
Results
Discussion
References

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(Accepted 8 March 2001)


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Rapid Responses:

Read all Rapid Responses

Putting evidence into practice
Ruth Livingstone
bmj.com, 10 Jun 2001 [Full text]
Non-tailored smoking cessation letter is available to download
Scott Lennox
bmj.com, 12 Jun 2001 [Full text]
Is simple written advice on stopping smoking really so effective and cheap?
Robert Bunney
bmj.com, 25 Jun 2001 [Full text]
Yes, it really is
Scott Lennox
bmj.com, 6 Jul 2001 [Full text]
Comments on Lennox et al.
Victor J Strecher, et al.
bmj.com, 9 Aug 2001 [Full text]
Presentation of results is inappropriate
Guido Wendland
bmj.com, 14 Aug 2001 [Full text]
Reply to Strecher et al.
Scott Lennox, et al.
bmj.com, 31 Aug 2001 [Full text]
General Comment on Tailoring
Ehud Reiter
bmj.com, 31 Aug 2001 [Full text]
Re: Presentation of results is inappropriate
Scott Lennox, et al.
bmj.com, 7 Sep 2001 [Full text]
New correspondence email
Ehud R Reiter
bmj.com, 15 Oct 2002 [Full text]



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