Tobacco Use and Cessation

THE EMPIRICAL BASIS FOR THE GUIDELINE

One of the first tasks the Guideline panel faced was developing a set of a priori criteria to define the evidence that would form the basis of subsequent meta-analyses. A survey of bibliographies and computer databases revealed over 3,000 articles published from 1975 to 1994 related in some way to smoking cessation. Evidence to be included had to report the results of a randomized, controlled trial of a tobacco-use cessation intervention; provide results on follow up at least 5 months after the quit date; be published in a peer-reviewed journal; be published in English; and fall within the 1975 to 1994 (inclusive) review period. Only about 10% (slightly over 300) of the articles reviewed met the inclusion criteria set by the panel.

For the articles that were selected, three independent reviewers read the article and coded it on dimensions such as frequency and duration of treatment, treatment outcome, control and intervention conditions, sample sizes, and so forth. Once independent coding was complete, the reviewers met to adjudicate any discrepancies in their coding; if this was not possible, the discrepancy was resolved by a senior project staff member. One of the most important measures produced by this coding was the effect of treatment, which was represented as a modified intent-to-treat analysis. Here, all persons randomized to a given treatment were used in the denominator, but only those persons confirmed as abstinent were represented in the numerator. Given that in virtually all studies some persons are lost to follow up, this represented a conservative assumption that any person for whom no information was available was classified as smoking. Studies that used biochemical confirmation of self-reported abstinence from smoking were coded; it is interesting to note that meta-analyses using only biochemically confirmed outcomes did not differ significantly from those studies lacking such confirmation. ^[5]

Treatment effects and other codes formed the basis for a dataset used in developing meta-analyses, which produced logistic regression coefficients that were converted to odds ratios (ORs). Significant meta-analytic results (i.e., significant ORs) formed the basis for the Guideline recommendations. Once the Guideline panel created a preliminary draft, copies were sent to 155 external peer reviewers for evaluation on the grounds of validity, reliability, clarity, clinical applicability, and utility. Following incorporation of the peer review feedback, the final version of the Guideline was release in April, 1996. It comprised six major recommendations:

1. Effective smoking cessation treatments are available, and every patient who smokes should be offered one or more of these treatments.
2. It is essential that clinicians determine and document the tobacco-use status of every patient treated in a health care setting.
3. Brief cessation treatments are effective, and at least a minimal intervention should be provided to every patient who uses tobacco.
4. A dose-response relation exists between the intensity and duration of a treatment and its effectiveness. In general, the more intense the treatment, the more effective it is in producing long-term abstinence from tobacco.
5. Three treatment elements, in particular, are effective, and one or more of these elements should be included in smoking cessation treatment

Nicotine replacement therapy (nicotine patches or gum)



Social support (clinician-provided encouragement and assistance)



Skills training and problem solving (techniques on achieving and maintaining abstinence)



6. Effective reduction of tobacco use requires that health care systems make institutional changes that result in systematic identification of, and intervention with, all tobacco users at every visit. ^[5]

ASKING ABOUT TOBACCO USE

The first task in any effective smoking cessation intervention is to determine the target audience. Until recently, health care organizations have been less than successful in consistently assessing and documenting the tobacco use status of patients. A meta-analysis of nine studies on the effect of clinic-wide smoking status screening systems indicated that in clinics where a screening system was in place (compared with clinics where no screening system was in place), the OR for clinician intervention increased threefold (OR = 3.1, 95% CI = 2.2-4.2). ^[5] This dramatic increase in intervention typically occurs without any special emphasis of the clinicians' behavior, rather, it appears that having information on tobacco use status available in a consistent and uniform manner is an adequate prompt. ^[6] In addition to the dramatic increase in rates of clinician intervention, there was a suggestion (not statistically significant) that use of a screening system also increased cessation rates. ^[5]

One simple and cost-effective way to document tobacco use status is to include it as one of the vital signs. The clinic staff member responsible for measuring blood pressure, pulse, and so forth during clinic visits also asks the patient whether she or he is a current, former, or never user of tobacco. This information can be captured on preprinted progress note paper, a computer record, or by a vital sign stamp. Other suggested methods involve stickers or other chart reminders. ^[1] It is important that the assessment be done for every patient and at every visit. Because assessment of the traditional vital signs is a routine part of medical practice, this screening process takes virtually no time, and very little in the way of resources (one-time development of a new progress note page or stamp).

ADVICE TO QUIT SMOKING

Once current smokers are identified by the screening process, the next step is to provide a clear, strong, personalized message advising smoking cessation. Each of the three components is important in making brief advice as effective as possible. A clear message conveys the goal of becoming tobacco-free; thinking about quitting sometime, or a reduction in smoking rate, are only intermediate steps along the way. Clinicians should make their case as strongly as possible. It is not an exaggeration to say that for patients who smoke, eliminating tobacco is the single most important step they can take to improve their health. ^[17] Probably the most important component of brief advice is to personalize the message. It is difficult to imagine at the end of the 20th century that many people could be unaware of the health effects of tobacco use. For many people, though, the health risks are abstract knowledge that are not considered to apply to them. Patients report that advice from a clinician is an important factor in helping them decide to make a stop-smoking attempt. Part of that influence comes from personal knowledge of the individual's health history and familial risk factors. Insofar as possible, tie the presenting complaint to the health effects of smoking (e.g., chronic bronchitis, cardiovascular disease, management of asthma, diabetes). Some patients may be fatalistic about their own health, but given information on the effects of environmental tobacco smoke, will be willing to quit to protect the health of nonsmoking partners, children, grandchildren, or even the family pet.

Even a very brief message that is clear, strong, and personalized can have a positive effect. Seven studies involving brief physician advice of less than 3 minutes provided data for a meta-analysis. Cessation rates in the reference group, who received no advice, were 7.9%. Among those receiving less than 3 minutes of physician advice, cessation rates were 10.2%, a statistically significant increase. ^[5] While this increment is not dramatic in and of itself, it results from a very minimal intervention. The cumulative effect of providing at least brief advice to all patients who smoke, across the health care system, would results in thousands of additional smoking cessation successes each year.

ASSISTING WITH THE SMOKING CESSATION ATTEMPT

Providing brief advice encouraging smoking cessation should be considered a minimum standard of care provided to all patients identified as smokers. Not all patients respond to the advice by agreeing to make a quit attempt. Where there is no current motivation, it is sufficient to note that the physician is available to assist in the future with a quit attempt, and should check to see if the patient is ready at a future encounter. National data suggest that 70% of persons who smoke would like to quit, so chances are good that your brief advice may inspire a quit attempt. ^[3] In that case, there are several additional steps physicians can take to assist patients in quitting successfully.

THE HUMAN TOUCH

Behavioral aspects of assisting smoking cessation attempts may be classified into three general formats: self-help, individual counseling, or group counseling. Based on national surveys of smoking cessation behavior, the first of these appears to be most appealing to persons who smoke. The vast majority of quit attempts in a given year are undertaken "cold turkey", that is, without pharmacologic or behavioral assistance. ^[7] On the positive side, this requires little in the way of treatment resources, such as clinic visits, medication costs or copayments, or other professional fees, for the person attempting to quit. Evidence suggests that only about 5% of those attempting to quit this way are successful nonsmokers 1 year later. ^[7] Because many smokers may be inclined to select less intensive treatments, the Guideline examined the efficacy of various types of self-help materials, including those that could be used by potential quitters who preferred not to seek additional treatment, or did not have access to other smoking cessation treatments.

A meta-analysis of 25 studies examining various forms of treatments compared 23 study arms, where no intervention was given (reference group, with a 7.6% cessation rate and an arbitrary OR of 1.0), to eight study arms using self-help interventions. The self-help OR was 1.2 (9.3% cessation rate), but the 95% confidence interval estimate was 0.97 to 1.6. ^[5] Because the interval includes 1.0 (the reference OR), self-help interventions cannot be assumed to be significantly different, in a statistical sense, from no intervention. A further meta-analysis of 12 studies examined various types of self-help materials used alone, including telephone helplines; video or audiotapes; lists of community programs; and pamphlets, booklets, and manuals. Of these, only telephone helplines showed evidence of being effective on their own (OR = 1.4, CI = 1.1-1.8). ^[5] Because this OR was based on only three study arms, the Guideline gave only modest endorsement to the efficacy of such telephone support, pending a larger number of empirical findings of efficacy. In clinical practice, self-help materials may be combined to increase their effectiveness, as in the case where a patient is given a pamphlet, an audiotape, and perhaps a list of treatment programs in the community. ^[5]

While self-help materials appear to have little or no significant effect on smoking cessation rates by themselves, they should not be considered to be without value. These materials can be very helpful in conveying information to patients in an efficient manner, leaving the clinician more time to focus on critical issues. As an example, a clinician might spend 10 minutes of an office visit describing the nature and timecourse of nicotine withdrawal symptoms, leaving little or no time to discuss coping with urges to smoke, or the proper use of smoking cessation pharmacotherapy. The same clinician could provide the patient with a pamphlet that covers nicotine withdrawal, and spend the time saved delivering more effective interventions. As part of the Guideline process, a Consumer Version ( You Can Quit Smoking) was developed in both English and Spanish, and is available from the Government Printing Office. ^*

The same meta-analysis that compared all self-help interventions to the no-intervention reference group also examined the effectiveness of individual and group counseling. Both types of counseling were equally effective and more than doubled long term cessation rates, relative to no intervention. The contrast with self-help alone interventions is striking. Interpersonal contact appears to be a critical component of successful smoking cessation efforts. Whether it is done one-on-one or in a group depends largely on individual preferences and the availability of local resources.

A series of follow up meta-analyses examined components of the intensity of treatment, for example, intensity of person-to-person counseling, number of treatment sessions, and duration of therapy. As noted above, even brief advice from a physician increased quit rates significantly, relative to no advice. Meta-analyses of over 50 studies, however, suggested that the optimal smoking cessation program involves 4 to 7 sessions of person-to-person contact, spread out over a period of 8 or more weeks, with counseling sessions lasting 10 minutes or more. Noting the results of these analyses suggested that "more is more" when it comes to smoking cessation counseling, the Guideline also stressed that very brief interventions are effective, and should be considered as the minimum standard of care for all persons who smoke.

PERSON-TO-PERSON: WHO, WHAT, AND WHAT NOT

Given the clear superiority of counseling treatments vis-a -vis self-help treatments, the question of who should deliver person-to-person interventions

Because individual and group counseling can vary widely in content, additional analyses were undertaken to attempt to identify specific types of treatment content associated with better long term cessation outcomes. Eleven types of content, including cigarette fading, relaxation, exercise, and diet, were entered into a meta-analysis of 39 studies. Two specific content areas were significantly associated with higher smoking cessation rates. These were problem solving/skills training (OR = 1.6, CI = 1.2-2.2) and intratreatment social support (OR = 1.8, CI = 1.4-2.5). ^[5] Specialized smoking cessation programs routinely incorporate these elements into treatment programs, but they can also be incorporated into primary care practice to the extent that time allows.

The clinician begins by helping the patient set a quit date. This should be a date ideally within the next 2 weeks that will optimize chances of success. For example, if the person is in a smoke-free workplace from Monday through Friday, a quit date at the beginning of the work week may take advantage of a helpful environment. Conversely, if work is associated with stress as a cue for smoking, quitting on a weekend or at the beginning of a vacation may be preferred. If the date can be linked to a birthday, anniversary, holiday, or other date with personal significance, so much the better. The night before the quit date, all cigarettes in the person's environment (e.g., home, car) should be located and destroyed. This includes emptying ashtrays and checking clothing, bags, and other places where cigarettes may have been forgotten.

Problem solving can be approached in at least two useful ways. One is to ask the person to anticipate urge situations on and following the quit date. A typical question might be, "When you think about a typical day, when do you most want to smoke?" Typical responses might include: when I first get up in the morning, on break at work, after meals, when I'm driving, when I feel stressed, with a cup of coffee, the end of the day. Knowing when urges are likely to arise, the person can plan ahead to have something to distract her or him for the 2 to 3 minutes the urge is likely to last. Distractions, or coping skills, may involve behaviors such as leaving a situation, deep breathing, doodling on a piece of paper, or sucking on a piece of hard candy. The critical feature is not the specific coping skill chosen, but the process of anticipating urges and having a distraction ready to use. Another way to elicit similar information is to ask about past quit attempts (if any), and determine what was most difficult for the individual, especially if it led to relapse to smoking. An example of the latter might be alcohol use, a factor in a large number of relapses to smoking. The person may need to plan on avoiding alcohol, or socializing in bars, for several weeks following the quit date.

Intratreatment social support refers to the support and encouragement provided by the clinician(s) involved in the smoking cessation attempt. By asking about smoking status, giving brief advice, and working collaboratively to assist the person in developing a quit plan, the fundamentals of this support are already in place. Remember to be accepting of the person's feelings, including ambivalence about quitting. The patient may express doubt about her or his ability to stay quit, or mention things about smoking that are enjoyable. Do not disparage these statements. Rather, acknowledge them then redirect.

"Quitting smoking is seldom easy, but it seems 
that you learned some valuable lessons from your last try, and you'll be 
prepared for it this time around."

Additional information on providing support is discussed later in the section on follow up.

Two additional treatment contents were examined in separate meta-analyses: hypnosis and acupuncture. These types of treatment are popular with some persons who smoke because of a perception that they work independent of a personal motivation to stop smoking. For both hypnosis and acupuncture, the available evidence was judged insufficient to assess effectiveness. ^[5]

PHARMACOTHERAPY RECOMMENDATIONS

During the time period covered by the Guideline literature review, two forms of nicotine replacement were approved as safe and effective for smoking cessation by the United States Food and Drug Administration (FDA): nicotine gum and the nicotine patch. Unlike the other aspects of clinical intervention assessed by the Guideline, several published meta-analyses existed for both forms of nicotine replacement therapy. These formed the basis for the Guideline recommendations.

One important conclusion drawn by the Guideline panel was that nicotine replacement therapies generally increase rates of smoking cessation. As such, the Guideline recommended that such therapies be offered to all smokers motivated to make a quit attempt, in the absence of specific circumstances. ^[5] Such circumstances included pregnancy (where cessation using purely behavioral means should be attempted first), and cardiovascular disease (e.g., within 4 weeks of a myocardial infarct, serious arrhythmia, or severe or worsening angina pectoris). Since the publication of the Guideline, a published report on a large number of veterans with current cardiovascular disease suggested that nicotine patch therapy posed less risk of adverse outcomes than continued smoking, suggesting that the latter circumstance may be unnecessarily conservative. ^[11] Special circumstances notwithstanding, there was no significant evidence that patients derive any benefit from trying to quit without nicotine replacement therapy.

Of the two pharmacotherapies evaluated, the nicotine patch (transdermal nicotine) was recommended as the treatment of choice for most smokers. In part, this was caused by the efficacy of the patch. Five different meta-analyses of nicotine patch efficacy, examining between 6 and 16 studies each, found that relative to placebo, nicotine patches approximately doubled long term abstinence rates (ORs = 2.1-2.6). ^{[8] [9] [14] [15] [16]} Treatment regimens of 8 weeks (varied by available doses) were recommended, based on a meta-analytic finding that treatment periods of 8 weeks or less were as efficacious as longer treatment periods. ^[8] The other reason for recommending the patch was that it was more effective than placebo across a wide range of psychosocial treatment intensities; that is, the patch was more likely to produce long term abstinence than placebo, when used with treatments ranging from brief advice to intensive group smoking cessation counseling. It is important to note that as the more intensive behavioral treatments produced greater absolute abstinence rates (as discussed above), the differential between active and placebo quit rates was shifted upwards on the curve. The effectiveness of the patch across a range of behavioral intensities may be caused in part by greater ease of use, relative to nicotine gum.

Nicotine gum was also found to be an efficacious smoking cessation therapy. Three recent meta-analyses found that active versus placebo gum odds ratios at 12 months ranged between 1.4 and 1.6. ^{[4] [15] [16]} As noted in the discussion of the nicotine patch, the meta-analyses found that active nicotine gum was much more effective when used with more intense behavioral treatments than with brief advice. This may be caused by the increased need to teach patients how to use nicotine gum effectively, in comparison with the ease of use of the nicotine patch. Nicotine gum was recommended in cases of patient preference, previous failure with the nicotine patch, or specific contraindications to the nicotine patch (such as severe skin reactions). A secondary recommendation was that more highly nicotine dependent smokers (i.e., those smoking 20 cigarettes or more per day, who find it difficult to refrain from smoking where it is prohibited, or who smoke within 30 minutes of rising) should use 4-mg gum rather than the 2-mg dose. ^[5] The dosing flexibility of nicotine gum may also be helpful with light smokers (those smoking 10 to 15 cigarettes per day).

Since the release of the Guideline, both 2-mg and 4-mg nicotine gum, as well as two brands of nicotine patch (Nicoderm and Nicotrol), have become available over the counter (OTC) in the United States. Although a prescription is no longer required for these products, clinicians may use the recommendations of the Guideline to suggest courses of treatment for patients using OTC therapies. The clinician's role in providing support, information, and skills training remains as vital as ever. It should also be noted that pharmacotherapy meta-analyses did not support the use of either clonidine or silver acetate for smoking cessation. ^[5] There were insufficient data available to draw conclusions on the efficacy of antidepressants and anxiolytics/benzodiazepines for smoking cessation. ^[5]

To recap the steps of assisting with a smoking cessation plan

Set a quit date

Make appropriate arrangements for pharmacotherapy, except in special circumstances

Help to anticipate difficult situations and plan alternate coping strategies

Provide social support for the quit attempt

ARRANGING FOLLOW UP

As with all addictive behaviors, relapse (return to smoking) is part of the clinical picture with smoking cessation. Even with the most intensive treatments currently available, a large number of patients will return to smoking within 6 to 12 months following the initiation of treatment. Many of these eventual relapsers declare themselves early in the process; one study found that of those persons having even a puff on a cigarette in the first 2 weeks following their quit date, more than 80% were smoking at the 6-month follow up point. ^[12] For this reason, the Guideline recommends a follow-up contact within the first week following the quit date, and if possible, a second contact within the first month. These contacts may be either in-person visits or telephone calls.

The goals of follow-up contacts are designed primarily to reinforce success in the recently quit smoker. Success should be praised, even early in the process. For some people, 48 to 72 hours of abstinence may be a personal best. It may be helpful to ask about the perceived benefits of being smoke-free. Within a few days of quitting smoking, many people find their sense of smell and taste improves. They may feel more in control of their lives, and will certainly have extra money that is not being spent to buy cigarettes. If possible, providing feedback on physical changes caused by smoking cessation can be very helpful. Expired carbon monoxide levels drop to the level of never smokers within 48 to 72 hours, and many people will experience decreases in heart rate and blood pressure (although nicotine replacement therapy may affect the latter two). Finally, assess any current or anticipated difficulties related to maintaining abstinence. If the patient reports increasing withdrawal symptom intensity, it may be appropriate to consider an adjustment in pharmacotherapy or referral to a support group. Encourage the patient to anticipate difficult situations that may arise in the near-term future. An example of this would be someone who quits smoking during the winter months, but who smoked heavily while playing golf; as the golfing season approaches, urges to smoke may reemerge, even if the person has been smoke-free for several months.

For persons who have returned to regular smoking, a different approach is required. The most important determination to make is what their current level of motivation is. Someone who is actively restricting their smoking to a few cigarettes per day may be more willing to recommit to a new quit date. For those who are unwilling to set a new quit date, convey the message that you will be supportive when they are ready to try again. Relapse prevention is an important goal of any smoking cessation intervention. However, the extant literature lacks examples of interventions that have a sustained positive influence on relapse. For this reason, the Guideline gave the weakest level of evidentiary support to relapse prevention.

UPDATING THE AHCPR GUIDELINE

Innovations in smoking cessation treatment did not end in 1994 (at the end of the meta-analytic literature review), or with the publication of the Guideline in 1996. In fact, the FDA approved nicotine nasal spray for smoking cessation in the United States just weeks before the publication of the Guideline in April, 1996. Since that time, the FDA has approved another nicotine delivery system (the nicotine inhaler), and the first non-nicotine smoking cessation therapy, bupropion SR (Zyban). Reports of success with another antidepressant, nortriptyline, have been published. ^[10] At the time of this article's writing, an effort is underway to update the AHCPR Smoking Cessation Clinical Practice Guideline to encompass new findings in the literature from 1994 to the end of 1998. The update will certainly encompass the new pharmacotherapy options and their integration into clinical practice. In addition, it will probably examine behavioral interventions targeted at specific populations (pregnant women, adolescents, etc.), and interventions designed at increasing the motivation of persons not yet willing to make a quit attempt. The updated Guideline is projected to be available during the first half of 2000.

PUTTING IT ALL TOGETHER

Primary care clinicians are uniquely situated to provide smoking cessation advice and assistance to their patients who smoke. The following steps, can help ensure that clinicians become successful at smoking cessation counseling in their practices.

1. Clinicians need to systematically identify all tobacco users at every visit. This can be accomplished by using preprinted progress note paper that includes tobacco status with the other vital signs, by using a vital sign stamp that includes tobacco use status, or by stickers or other chart reminders.
2. Clinicians need to provide clear, strong and personalized advice urging the smoker to quit. Even brief advice that is clear, strong and personalized may be effective, especially if combined with an office-wide approach where clinic staff reinforce the cessation message.
3. Clinicians should identify smokers' current willingness to quit and tailor assistance based on the patients' motivation. If a patient seems willing to quit now, the clinician can provide assistance (see Step 4). If an intensive treatment approach is needed, the clinician can refer the patient to such a program or offer additional follow-up visits to provide the intervention at the clinic. If the patient is not currently motivated to quit, the clinician can tell the patient that the clinician will be available at future visits to discuss smoking cessation when the patient is ready. In addition, the clinician can enhance motivation by reviewing the long and short term risks of smoking with the patient (long term risks are lung cancer; short term risks are asthma exacerbations) as well as the long and short term rewards of quitting (long term rewards are reduction of disease risks; short term rewards are improved sense of taste and smell). Techniques to enhance motivation include reviewing the Relevance of smoking cessation to the individual smoker; long and short term Risks of smoking; and Rewards of quitting. This message should be repeated to the smoker at each visit. (The 4 R's).
4. The next step is assisting the motivated quitter. This involves helping the patient devise a quit plan, including setting a quit date; encouraging nicotine replacement therapy; giving key advice or "quit tips"; and providing supplementary materials. In general, the more intense the treatment and assistance, the more effective it is in producing long term abstinence from tobacco use. In this regard, self-help materials are the least effective means to promote success, and should be culturally, racially and educationally relevant to the patient. At the other extreme, the optimal smoking cessation program involves 4 to 7 visits of person-to-person contact spread out over a period of 8 weeks, with counseling lasting 10 minutes or more.
5. Finally, clinicians should arrange follow-up with motivated quitters as soon after the quit date as possible, preferably within the first week. At this visit, clinicians should praise abstinence and give anticipatory guidance regarding future difficulties with quitting . Relapses can be addressed by letting the patient know this is not a failure but a learning experience. Reviewing the circumstances in which the relapse occurred and eliciting a renewed commitment to total abstinence is important. If current problems such as withdrawal symptoms exist, nicotine dosage can be adjusted.

CONCLUSION

At the end of the 20th century, tobacco use remains the leading preventable cause of illness and premature death throughout North America. Although there is room for improvement with smoking cessation therapies, there exists a robust, empirically-validated strategy for helping patients achieve a smoke-free future. At a minimum, all health care providers can adopt the paired strategies of screening all patients for tobacco use status and providing brief cessation advice to all persons who smoke. With the addition of pharmacotherapy and person-to-person contact using problem solving and social support approaches, cessation rates can be increased by a factor of two or more. Investing a few minutes of time in smoking cessation can result in significant improvements in life expectancy and quality of life, a return few clinicians or patients would choose to ignore.

References