Richard R Clayton

I would like to ask a domain question: what is a comprehensive behavioural smoking cessation programme? Those terms are used by the US Food and Drug Administration (FDA) for both Nicorette and for the patches. What are the minimal elements and criteria for designation as a comprehensive behavioural smoking cessation programme? Is it appropriate to treat nicotine withdrawal in the absence of a comprehensive behavioural smoking cessation programme?

The first place to look for an answer to these questions is the product patient instructions because that is where many patients get their information about smoking cessation. The instructions for Nicorette are quite clear: Nicorette is indicated as a temporary aid to the cigarette smoker seeking to give up his or her smoking habit while participating in a behavioral modification program under medical or dental supervision. The efficacy of Nicorette as an aid to smoking cessation was demonstrated in clinical studies, which showed that Nicorette gum in comparison to controlled chewing gums increased the likelihood of smoking cessation among participants in behavioral modification programs. As used in the context of this labeling, behavioral modification refers to supervised programs of education, counseling and psychologic support. The efficacy of Nicorette use without concomitant participation in a behavioral modification program has not been established.

The instructions for the patches are similar: Patch treatment is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. Patch treatment should be used as part of a comprehensive behavioral smoking cessation program. The success or failure of smoking cessation depends heavily on the quality, intensity and frequency of supportive care. Patients are more likely to quit smoking if they are seen frequently and participate in formal smoking cessation programs.

Given the emphasis put by the FDA on comprehensive behavioural smoking cessation programmes, I believe it is critical for the FDA to define exactly what these terms mean.

I would like to suggest that we don’t need all the different levels described by Dr Abrams. We ought instead to start with an assumption that most of the people we are seeing today are probably dependent on nicotine, most of them started using nicotine at an early age, and that an increasing proportion of those who are smokers are, in fact, dependent.

The literature is now robust and consistent in finding that active nicotine products are significantly more effective than placebo products in creating chemically verified success rates; that group support and behavioural modification are more effective that self-help or brief interventions; that nicotine replacement, reduction and withdrawal therapy, in combination with behavioural modification yields the highest success rates. Given the weight and consistency of the scientific evidence, we believe that a formal smoking cessation programme cannot be considered ‘truly comprehensive’ without nicotine replacement, reduction and withdrawal therapy. With this as an assumption, perhaps the nicotine products should not be seen as adjunct to comprehensive behavioural smoking cessation programmes, but rather as an integral part of the overall protocol of therapy of treating nicotine dependence for the majority of smokers.

We believe that the following assumptions are critical. First, smoking is a complex behaviour which is anchored in various environmental and other types of contexts. Second, it is virtually impossible to understand smoking without first understanding the re-inforcing properties of nicotine and the role of self-administration patterns as reinforcers. Third, nicotine dependence involves four elements, all of which have to be developed and treated and discussed in a comprehensive programme: the habit, the physical addiction, the social factors and the psychological factors.

A comprehensive behavioural smoking cessation programme should address the entire nexus of behaviour commonly associated with smoking, such as the effects of nicotine and smoking on the central, sympathetic and the parasympathetic nervous systems. For example, our patients get very upset when they get constipated and don’t expect it. A comprehensive programme would prepare smokers becoming non-smokers for this mundane but important consequence. Other effects of nicotine and smoking which ought to be covered are: effects on the cardiovascular and pulmonary systems; the relationship of nicotine and smoking to anxiety, depression and other psychosocial disabilities; the relationship of nicotine and smoking to the consumption of other drugs, particularly caffeine, alcohol, and medications; the relationship of nicotine and smoking to exercise, eating, weight management, and other stress-management behaviours and to the psychosocial and other strategies of relapse prevention. If you are going to claim a programme is comprehensive, we believe the programme should cover all of the things listed above and more. This, of course, has important implications for the length of a programme.

Tom Cooper and I suggest that any comprehensive behavioural smoking cessation programme will incorporate nicotine replacement, and reduction and withdrawal therapy as an option for the patient and, therefore must directly address how to use those items effectively. For example, Nicorette has a much higher success rate if the product is used appropriately, but how many of our programmes have dealt specifically with the importance of oral pH for the use of Nicorette? If oral pH information had been available to all patients who ever used Nicorette from the outset, the success rate reported in the literature would have been much higher.

A truly comprehensive programme must include: (1) face to face interaction with a therapist who is qualified to either write a prescription for nicotine products or is supervised by someone who is able to write a prescription for nicotine products; (2) systematic integration of use of the product with individualized behavioural supportive care; and (3) supportive care within the context of a group, because people do better when they teach each other and learn from each other.

In the clinical trials for both nicotine polacrilex and nicotine transdermal systems, there were significant differences in chemically verified success rates across study sites. We believe that this is an important piece of information from a scientific as well as a therapeutic perspective. The existing literature indicates that an important problem in the treatment of all substance abuse disorders is a lack of fidelity to a manual driven protocol. We believe that a manual driven protocol and therapy is or should be a requisite for designation as a truly comprehensive programme.

The bottom line is simply this: if the FDA has defined Nicorette and the nicotine patches as pharmacological adjuncts to a comprehensive behavioural smoking cessation programme, the FDA should be required to define and specify what constitutes a comprehensive behavioural smoking cessation programme.

Finally, I would like to introduce some new ideas for you to consider. First, it is time to consider treatment of nicotine dependence among adolescents, preferably within the school setting. If we provide treatment of nicotine dependence closer to the onset, particularly for a gateway drug like nicotine, a plausible hypothesis is for long-lasting impacts on the use of other drugs. Early treatment of nicotine dependence could create different demands for treatment of other co-morbid conditions formerly masked by nicotine self-administration. These are important research hypotheses which have scientific, therapeutic, and public policy implications. Second, our research group has just finished an analysis of data from the Drug Use Forecasting (DUF) system for 75 301 arrestees in 24 sites nation-wide from 1989 to 1991. We found that over 70% are current users of nicotine and feel that they are currently dependent on nicotine. A formal and comprehensive treatment of nicotine dependence within the correctional setting might have large and long-range beneficial effects, simply in terms of the periodicity of painting and repairing the facilities, not to mention the health effects, other effects, and health care costs for those patients. What are the possible long-term savings of providing comprehensive behavioural smoking cessation programmes in such settings for morbidity for this type of population? Third, we believe it is time to consider, design, and deliver formal and comprehensive smoking cessation programmes to housing projects and groups with low socioeconomic status. We believe that the pharmaceutical industry has a civic responsibility to approach those parts of the population where the morbidity costs are extremely high. Perhaps there are new and innovative programme delivery systems to achieve this goal. Formal and comprehensive treatment programmes in racial/ethnic minority areas using churches or other community-based systems as the channel for prevention and treatment should be possible. Nicotine replacement, reduction and withdrawal therapy does not have to be culturally sensitive. Dependence on nicotine is independent of race, creed, or colour. Finally, it is time to consider formal, comprehensive, nicotine treatment programmes in drug treatment settings because virtually all of the people in ‘drug’ treatment programmes are actually dependent on nicotine as well as other drugs. You ask them what they would like to give up last, and most of them mention nicotine. Perhaps we should have formal comprehensive treatment of nicotine at the front end of the treatment process, not at the back end. Perhaps treatment of alcohol and other drug dependence should be delivered simultaneously with treatment of nicotine dependence.

Carole Hudgings

It is my pleasure to be with you this morning. The Agency for Health Care Policy and Research (AHCPR) is pleased to be a co-sponsor of this conference. In the few minutes allotted, I will describe an important new activity at AHCPR related to smoking cessation.

The mission of the AHCPR is to enhance the quality, appropriateness, and effectiveness of health care, as well as to enhance access to health care services. Much of the work of the Agency is to conduct or support others in pursuit of health services research.

One of the major initiatives within the Agency is the Medical Treatment Effectiveness Program. This initiative includes four major components: patient outcomes research; clinical practice guidelines; data bases for research; and dissemination of research and guideline information. Development of the clinical practice guidelines is one of the two missions of the AHCPR’s Office of the Forum for Quality and Effectiveness in Health Care.

The Institute of Medicine provided a definition of clinical practice guidelines as follows: ‘Practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for special clinical circumstances.’ Two important aspects of this definition are that guidelines be systematically developed statements, developed following review and analysis of relevant scientific evidence, and that the statements are designed to assist both practitioner and patient decision-making. The AHCPR currently has 20 clinical practice guidelines under development; four of these have been released to date (Acute pain management; Urinary incontinence in adults; Prediction and prevention of pressure ulcers in adults; and Cataract in adults).

Smoking prevention and cessation was announced as a topic of guideline development earlier this year. An important consideration for this guideline topic is the fact that we have active cross-agency involvement within the Department of Health and Human Services. The development of a smoking prevention and cessation guideline is co-sponsored by the Centers for Disease Control, and we will also have participation from other agencies, including the National Cancer Institute, National Heart, Lung, and Blood Institute, and National Institute on Drug Abuse.

AHCPR-sponsored guidelines are developed by multi-disciplinary panels composed of experts from the scientific and clinical practice communities, as well as consumers. A key task for the Forum is selection of the multi-disciplinary panel of experts and consumers that will develop the clinical practice guideline. Based on a national search initiated through an announcement in the Federal Register, more than 100 nominations, representing 18 different specialties or disciplines, have been received for the smoking prevention and cessation guideline panel.

When the guideline panel has been selected and appointed, one of its first major tasks will be to narrow and define the topic of smoking prevention and cessation for which a clinical practice guideline will be written. The next major task of the panel will be to review systematically all of the scientific literature that relates to the questions identified for this guideline topic. The AHCPR’s systematic methodology for development of a guideline results in an evidence-based guideline. The scientific literature is analysed to identify evidence of effectiveness of various treatment alternatives, and to review the specific benefits and harms associated with each intervention. Only in the absence of scientific evidence is expert opinion used as the basis for guideline recommendations. In addition, the process of guideline development is explicitly documented.

There are several opportunities for input to the guideline development process from the broader community of interested parties. One opportunity occurs at an open forum or public meeting, in which the panel receives testimony from any individual or group interested in development of the clinical practice guideline. This public meeting is announced in the Federal Register. The second opportunity occurs at the time of peer and pilot review, when the draft guideline is reviewed by scientists and practicing clinicians.

AHCPR-sponsored clinical practice guidelines are published in several versions for different types of audiences: A Technical Report; a Clinical Practice Guideline (desk reference for clinicians); a Quick Reference Guide for clinicians; and a Patient’s Guide (in English and Spanish). When the guideline is completed, the work of disseminating the guideline information and implementing its recommendations into clinical practice begins. We expect published clinical practice guidelines to influence decision-making of both practitioners and patients.

The AHCPR is pleased to be a co-sponsor of this conference, and looks forward to developing a clinical practice guideline on the important topic of smoking prevention and cessation.

Judith K Ockene

I would like to elaborate a bit on the physician’s role in this comprehensive plan, and indicate that this also can be extrapolated to dentists and other health care providers.

Seventy percent of smokers have contact with a physician each year. Of healthy smokers, 60% have contact with a physician each year. The physician therfore becomes an important individual in helping to triage smokers into a comprehensive plan.

There have been several teams of investigators that have looked at physician efficacy with regard to smoking intervention. A summary of these data clearly indicates that physicians are very efficacious when it comes to doing intervention and that there are certain smokers who will respond to these physicians. We at the University of Massachusetts Medical School were part of a team of investigators funded by the National Cancer Institute to look at the different interventions that physicians use.

We looked at three different interventions. One group (A) received personal advice. The next intervention was what we called a patient- centered counselling intervention (group B), where the physician helped the patient develop a plan for cessation. The third group (C) received also the counselling intervention plus an assessment of nicotine dependency, and then, for the patients who seemed to need it and desire it, prescription of nicotine replacement. At that time the only replacement that was available was nicotine-containing gum.

In the advice group A, 9% of patients reported cessation at 6 months. In the patient- centered counselling group B, 12% reported cessation while in group C, 17% were not smoking at 6 months.

It is useful to look at the amount of time the physicians reported spending with the smokers, which was relatively consistent with what the patient reported, although a little bit lower. In group A, the physician spent about 7 minutes with the patient providing personalised advice; in group B about 12 minutes was spent, and in group C, the physician spent about 14 minutes plus an assistant who spent about an additional 4 minutes to provide information about how to use nicotine-re- placement therapy.

Dr Abrams mentioned that there’s a grey area between what we can do minimally and what we can do in a moderate amount of time. I would say that between these two we can see a two-fold difference in cessation rates. In other words, if you go from the advice to the counselling plus condition, we have twice the amount of time spent and twice the amount of cessation.

At 12 months we see a maintenance rate, that is, the percentage of smokers who stopped smoking after their visit with their physicians and stayed off cigarettes, of 6%, 8%, and 10%. I would submit that counselling plus is an extremely important intervention and one that I think should be included in our practice guidelines. There are still some issues we need to consider, such as reimbursement. Should we be reimbursing for X minutes of time? Should we be saying that there is a level of intervention that must occur for every smoker? What should those guidelines be? I am pleased to hear that AHCPR will be working on those guidelines.

Also, we need to ask ourselves what training guidelines there should be for physicians and other health care providers. I would submit that we must have guidelines for training and that these guidelines should include at least 2 to 3 hours of counselling training for all physicians. The study that we did was with physicians in training for family practice and internal medicine. We conducted a later study, which we have just completed, and asked ourselves: Does the level of skill of the physician really matter? From preliminary analyses we find that cessation of patients was directly related to the skill of the physician. To me, this indicates that there must be some minimal level of skill training for physicians to be able to provide interventions.

The next question we must ask ourselves is which group of individuals will benefit from physician intervention. And I think, as Dr Abrams said earlier, that this is a grey area. There aren’t clear indications of which group will actually benefit. We know that less addicted individuals are more likely to benefit, and we saw that in our study. In each of the three conditions, the less addicted individuals were more likely to not be smoking than the more addicted individuals. But we also saw clearly that, in the group in which nicotine addiction was assessed and prescriptions given to the patients who were most addicted, that the more addicted smoker was more likely to be helped. So how do we triage patients? I think that Dr Abrams’ plan of triaging holds very well for the physician. The physician must be able to determine the level of readiness of the patient to make a change; whether or not that individual has stopped in the past-our data indicate that there’s a much greater likelihood that, with advice only, individuals who have already stopped previously are more likely to stop; whether or not the individual needs nicotine replacement or addiction therapy ; and whether or not he or she would want to enter a comprehensive programme; most patients are likely not to want such a referral. I submit that there is a large group of patients who will clearly benefit from an initial intervention with his/her physician or dentist.

In summary, my recommendations are that the individuals who have contact with the largest amount of smokers must be included in our comprehensive. These are individuals in the health care professions (physicians, dentists and other health care providers), who should have a minimal level of training to do intervention. We must not only develop guidelines for this training but also decide on what should be the minimal amount of contact that physicians should have with their patients over health-related issues such as smoking and how will that time be reimbursed in our health care system? These issues must be addressed if we are truly concerned about the health of all people in our country.

Carole Tracy Orleans

I’m batting clean-up here, so I want to try to briefly integrate the comments of my copanellists. At the risk of oversimplifying, I’d like to submit: (1) that I think that we already know many of the essential features of a stepped-care model, and (2) without elaborating, that the particular model that I’m going to present has a strong science base. It is nowhere near as comprehensive as the more detailed stepped-care model which David Abrams has outlined, but I think it is a useful starting point.

Essential criteria for stepped care

Any useful treatment model must apply to all smokers, not just those ready to stop smoking. It must recognise quitting as a dynamic multi-stage process, not the result of a one-shot intervention. It must incorporate initial and repeated bio-behavioural assessment of the smoker, and provide for triage into increasingly more appropriate treatments over repeated quit attempts. It must apply to a variety of settings and providers. As David Abrams noted, using such a stepped care model offers the potential to be far more cost-effective than the way we now treat nicotine addiction. Moreover, with a restructured health care system, we may have an unique opportunity to do something we haven’t been able to do yet. The expected shift towards health plans and managed care organisations that provide care through integrated networks of services and providers, combined with an unprecedented capability to select and deliver interventions with patient-treatment matching (aided by sophisticated information systems, expert systems, computer-based personalised programmes) will enable us to provide smokers and smokeless tobacco users with better matched and more effective treatments.

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Figure

Outline of a stepped-care model

As the figure shows, we have to start by creating a facilitative environment for treating tobacco addiction. Most of our medical settings and hospitals are now smokefree. Excise taxes are going to be another force working on the smoker, along with expanded clean indoor air restrictions. But we must also remove the barriers. A large part of the reason that American smokers are not using effective treatments is that the financial barriers are formidable. Smoking cessation and nicotine addiction treatments are currently not reimbursed. This is an issue that this conference must address.

Next, any useful stepped-care model requires an initial assessment to steer patient- treatment matching. We now have many good assessment tools to help the provider understand the extent of the addiction and begin to sort out how to make good triage decisions. But we don’t have a marker for smoking. In clinical trials with physicians, I’ve found better compliance following a stepped-care model once patients are identified as smokers.¹ We need to make smoking a vital sign, as Michael Fiore has recommended.² Along these lines, there’s some very exciting work going on to develop low-cost cotinine dipsticks ($1.00) to aid in identifying smokers. These could be integrated easily into primary care settings so that we would do a better job of detecting smokers and providing clinic-based surveillance of tobacco use and addiction. There is also exciting work underway using portable nicotine dosimeters to monitor individual and household exposures to environmental tobacco smoke.³ Cotinine dipsticks and nicotine dosimeters are powerful tools, not only as potential biomarkers, but also as tools for motivating smoking behaviour change.

Motivating a quit attempt among identified smokers and spit tobacco users is very important, not only by pointing out the personal risk of tobacco use and benefits of quitting, but also by helping smokers or spit tobacco users to understand intrinsic motives to quitting. I increasingly see people coming into treatment because of external pressures, but we know that quitters do best when they’re motivated intrinsically⁴ To make extrinsically motivated smokers more intrinsically motivated to quit, we can use a new intervention called ‘motivational interviewing,’ originally developed by Bill Miller and his colleagues at the University of New Mexico for problem drinkers.⁵ We can readily incorporate motivational interviewing and biomarker feedback into treatments for precontemplators who are not ready for action or cessation treatments (see figure 1).

As the diagram shows, we can think about at least two levels of treatment: minimal treatment and intensive treatment. Minimal treatment generally consists of provider advice to quit, brief counselling from a health care provider, and a self-help guide. We have better self-help materials than we ever have had in the US, and they’re increasingly tailored and targeted to special populations and special concerns. And we have better self-help adjuncts to add to the mix. Numerous studies, like the one Judy Ockene just presented, have shown that the best minimal contact treatments involve multiple contacts, multiple providers, and a mix of interventions (face-to-face, print, pharmacological).⁶ But even if you offer only provider advice and a good self-help guide, you will get impressive results. We now have proven protocols for adjunctive treatments involving telephone counselling and personalised computer-generated mailings. Plus we have proven pharmacological adjuncts in the form of nicotine-replacement therapy. We get the same quit rates as are obtained with intensive treatments when minimal treatments are enhanced with provider advice and these adjuncts.⁷

The intensive treatments shown here include multi-session consultations and clinics, and extend all the way up to the kind of inpatient treatment programme which Richard Hurt and his colleagues have launched at the Mayo Clinic. As figure 1 shows, and as we have discussed today, pharmacological adjuncts should always be used with a minimal or intensive treatment, never on their own. Finally, follow-up has to be part of this model, not only for people we’re treating, but also for the so-called ‘precontemplators’ who receive only a motivational treatment. Follow-up makes this a cyclical stepped care model- allowing for re-cycling by those who don’t quit or who relapse.

Minimal contact models for physicians and allied practitioners

The National Cancer Institute, as many of you know, has promulgated a simple four-step model: ask, advise, assist, arrange. Ask your patients if they smoke, advise them to quit, assist them to quit using self-referral methods and pharmacologic aids, and always arrange follow-up.⁸ The same model now has been promulgated for a number of health care providers who must also play an active role in treating tobacco addiction:

Nurses Nurses are the largest single health professional group. They often have far more contact with patients than physicians and are important physician extenders in the stepped care model. There are two excellent guides, one from the NHLBI⁹ and one from the Minnesota Coalition for a Smoke-free Society,¹⁰ outlining a four-step model for nurses.

Physician assistants There are 20 000 practicing physician assistants in the US, most of them are in primary care, and 80% are in states that allow them to prescribe. This is a provider group we’ve overlooked.

Respiratory therapists There are over 100000 respiratory therapists in the 5700 hospitals across the country, and Louise Nett has done excellent work to develop a hospital-based intervention model that uses the respiratory therapist as the chief intervenor.¹¹ We don’t have data yet, but intervention research is currently underway. We’re only just now discovering the hospital as a place where we can intervene strategically with captive populations of smokers. Smokers use more inpatient services. Of some 25 million adult short-term hospitalisations every year, a minimum of 7 million are likely to be smokers. The new JCAHO regulations banning hospital smoking give us opportunities to intervene with smokers who are temporarily abstaining but may not have made the decision to quit smoking.

Certified Addiction Counsellors (CACs) CACs can play a major role by treating the chemically dependent smoker. John Slade has done pioneering work to develop training and certification programmes for CACs so that they can work in their own settings with smokers.

Dentists A number of controlled intervention studies have shown powerful effect with minimal contact interventions using dentists and hygienists, not only for smoking, but also for spit tobacco addiction.

Pharmacists Pharmacists are going to play an increasingly important role in the delivery of nicotine addiction treatment and support services with the rise in the use of pharmacologic quitting aids. In addition, the 1990 OBRA (Omnibus Budget Reconciliation Act) regulations require that pharmacists become more involved in medication counselling. Numerous patient, pharmacist, and physician surveys indicate that this is a promising direction. To me, it is exciting that there are computers in 90% of the 56 000 pharmacies in the US, and that we could harness prescription medication databases to designate and deliver personalised interventions aimed at smokers using nicotine-replacement products.

The need to provide adjunctive treatment with nicotine-replacement therapy

The need to assist smokers using nicotine- replacement products is dramatically underscored by the results of a study we just completed at Fox Chase. We followed 1070 older smokers, aged 65 to 74, who filled transdermal nicotine prescriptions in the first three months of 1992 through Pennsylvania’s statewide prescription plan for the elderly.¹² Thirty-four percent of these smokers reported a past history of coronary heart disease. We asked them in a 6-month follow-up call what kind of advice and assistance they got from pharmacists and physicians along with their transdermal nicotine prescription, and this is what we found: only 54% got any initial advice from the physician or pharmacist. Most of the advice was patch use advice, given in 46% of cases; 37% of these patients said they got the starter kits that were supplied with their product; 28% got a generic guide only. But only 4% used or read any of the materials they got. Out of a total of 871 patients, only 21% were given specific advice on how to stop smoking while 18% got some other kind of advice or aids; 4% reported referral to a comprehensive behavioural treatment programme, and 1% got a help line referral. We also asked if these quitters got any treatment or advice or support about transdermal patch use later on; 63% said yes.

Would better help from pharmacists, physicians, and self-help programmes make a difference? Our results suggest they could make a major difference. We looked at those who got no advice or consultation at all, those who got advice either at the time of prescription or at any time following, and those who got advice at both points. We found that the more contact with the physician or pharmacist, the higher the quit rates, and the less smoking while on the patch (p < 0.05). We found that not only did those patients receiving more advice have a higher quit rate, but those who got more advice and assistance were more likely to use the behavioural coping strategies that we’ve been hearing about, were more likely, for instance, to set a quit date or to get more exercise. They were more likely to refill their prescriptions, they used patches longer, and if they didn’t quit, they were more likely to say they would try again, and try the patch again. Moreover, they were significantly less likely to smoke while using the patch. Smoking on the patch was a major predictor of poor outcome in this study. In fact, 47% of these older patients smoked on the patch, 19% smoked every day, 5% said they smoked a pack or more a day.

So I think we have compelling evidence from many sources that care providers of all disciplines need to be involved in a comprehensive stepped-care model, many of the essential elements of which are already known, and that this will lead ultimately to more effective, cost-effective, and equitable care for nicotine addiction.

Questions and answers

MASUD ANSARI: You mentioned in the stage of relapse and recycling that 60 to 80% of those who stop smoking relapse. My question is, considering that the literature says that if a person stays away from cigarettes from three to five days, he’s considered a non-smoker, are the 60 to 80% influenced more by biological or environmental factors?

DAVID B ABRAMS: The bottom line is that usually the relapse rates are based on a 24- or 48-hour quit attempt, so anybody who relapses after 24 hours is considered a relapser. The data do show that over 30% of the relapses occur within the first seven days, and I think it’s probably true that these are the more dependent smokers suffering from withdrawal. And in the stepped-care model that I suggested, that would be one of the step-up criteria. If they had a difficulty quitting, you would ask that question the next time around, and if the answer was yes, step them up to a higher level of care.

In terms of relapse prevention, we do get very good results with the highest levels of care. With the best behaviour modification programme, 40% are still abstinent at one- year follow-up, and if you add nicotine replacement to that, some of the better studies show 60% long-term maintenance, even with fairly dependent smokers.

In terms of environmental factors I think that’s true. Cues and temptations to smoke do precipitate relapse, and so does stress, negative emotions and so forth, and there’s a lot of environmental management at that level that might help reduce the relapse rate, whether it’s a smoking ban in the workplace or rearranging the work environment to reduce the stress level.

MATTHEW BARS: We at Medical Smoking Centers are using pulmonary function studies, and I was wondering if that’s the type of biofeedback that you’re talking about?

CAROLE TRACY ORLEANS: I think that all kinds of biological assessment can be used in two ways, both as markers of severity of nicotine addiction or nicotine addiction-caused disease, and also to motivate smokers. There’s a wonderful study by Risser and Belcher where nurses armed with pulmonary function test results, CO feedback and equipment, trained briefly to amplify people’s pulmonary symptoms to them, tripled quit rates, and this was in a very brief intervention. We’re now doing some work at Fox Chase Cancer Center to look at feedback of heightened genetic susceptibility to lung cancer, to throw those kinds of data into the mix, to get the message to the smoker you are at risk and there are benefits for you in quitting.

DAVID B ABRAMS: I think the whole thing is immediate personalised relevant feedback. Taking a sample from the individual, and feeding it back to them is very powerful in moving people through the stage of change.

STANLEY G KARSON: We saw the numbers showing that the groups that are still smoking are the economically disadvantaged with less access to care, many of whom are minorities. My question, then, is how do we reach these populations, and how much are our energies and resources currently focused on reaching them?

CAROLE TRACY ORLEANS: There’s been an enormous amount of work done now at reaching special populations – the Latino population, the African-American population, Asian-American population. We’ve got some wonderful work going on in California under Proposition 99 right now with Native American smokers. And I’d have to echo some of Glen Bennett’s comments, that when we can provide access and tailor our treatments, not only so that they’re culturally sensitive, but so they take into account the differences in smoking patterns between these groups, we get the same return for our investment using the same kinds of stepped care models. I think Dick Windsor’s work with pregnancy was the first work in the country to show that when we could provide care to women in prenatal care, regardless of minority status or income, there were no racial differences or even income differences in outcome, so this chiefly has been a matter of access.

SAUL SHIFFMAN: I find myself in the unusual position of wanting to make a pitch for minimal interventions. At these meetings I’m usually an advocate of intensive interventions, but I’m concerned about the position that we’ve heard discussed that access to certain kinds of care, such as nicotine replacement, should be restricted to the context of very intensive interventions, and I think that would be unfortunate. I think the last thing we need is additional barriers to care, and contrary to what’s been said, the evidence is very clear that nicotine replacement has an effect, even in the context of minimal intervention. That’s not to say that we don’t get the maximal results from a programme that combines nicotine replacement with maximal behavioural treatment, but we do need to attend to a trade-off between maximal results for those treated and the biggest impact in the population. There’s no question that there’s a large segment of the smoking population that, even granted access, won’t avail themselves of these programmes, and we must not ignore that issue.

CAROLE TRACY ORLEANS: I feel I need to respond to that because I was not personally advocating an intensive intervention, although I think Dr Clayton was. But if you looked at the quit rates in our study, you could see that among those people who got minimal self-help kind of assistance and at least two contacts with a provider or a pharmacist or a physician, a quitter using transdermal nicotine had a 39% self-reported 6-month quit rate, and this is already quite excellent. The other thing is, as Judy Ockene has documented, you cannot assign smokers to maximal intervention. They don’t come, even if it’s free, even if it’s on Wednesday night and they said that’s when they wanted to be there; still only 1-5% will avail themselves.

EDWARD ANSELM: Clearly we talk about a community environment in which our smokers live and are exposed to four billion dollars worth of tobacco advertising. We talk about designing some sort of facilitative or supportive environment to help them quit smoking. I’m curious if any of the speakers are aware of any outcome data related to brands, and whether or not there’s any point in including brand identification in any smoking cessation programme.

CAROLE TRACY ORLEANS: Brand identification data has been collected by many people who use nicotine fading as a pre-quitting strategy (going from higher to lower dose nicotine cigarettes) and this can be very easily done using the UPC codes on cigarette packs.

DEBORAH J OSSIP-KLEIN: I wanted to briefly pick up on something that Dave Abrams had also touched on, and that is, just as we know that there are things that do work, we have a growing body of evidence of things that we know do not work, and some have been mentioned. This is exemplified by Ellen Gritz’s paper showing that sending out self-help materials to general smoking populations really doesn’t help. We also have some data on interventions that actually have iatrogenic effects, providing action-based strategies too soon, to smokers who are not ready for action- based strategies. We’ve recently completed a study in which we clearly demonstrated that we were remarkably and significantly effective in suppressing abstinence rates in post-myocardial infarction and peripheral vascular surgery patients if we intervened too soon or gave the action-oriented strategies too soon to this population. So I think concurrently with developing some standards and models of what are the effective interventions, we may be doing a service to the field to also identify what does not work or what has a harmful effect.