A Clinical Practice Guideline for Treating Tobacco Use and Dependence: Title and subTitle BreakA US Public Health Service Report

Primary care clinicians, tobacco dependence treatment specialists, and health care administrators, insurers, and purchasers now have an unprecedented opportunity to reduce tobacco use rates in the United States and consequently the burden of illness, death, and economic cost resulting from tobacco use. This opportunity is the result of an unusual confluence of circumstances: 70% of smokers now want to quit smoking completely, and 46% try to quit each year¹ ; more than 70% of smokers visit a health care setting each year^{2 - 4} ; and effective treatments now exist.

Indeed, these circumstances challenge clinicians and health care delivery systems to fulfill the mandate of an unspoken contract regarding health care—to provide patients with effective interventions that will prevent needless illness and death. Both clinicians and health care delivery systems are at risk of breaking this fundamental contract. Currently, neither ensures that smokers consistently receive effective tobacco interventions. Therefore, most smokers trying to quit do so on their own, without the benefit of highly effective treatments. The health care system's neglect of the tobacco user exacts costs that sum to thousands of lives and billions of dollars in added health care expenditures each year.

In the past, a failure to intervene with tobacco users could have been attributed to a lack of effective treatments. The last 2 decades, however, have witnessed an explosion in research that has clarified the nature of tobacco dependence as a chronic disease, the addictive nature of nicotine, and the availability of numerous, effective pharmacotherapeutic and counseling strategies for tobacco dependence. Some of these findings led to the release of the Agency for Health Care Policy and Research Smoking Cessation Clinical Practice Guideline in 1996.⁵ The development of new treatments since that time now warrants an update of that original guideline.

In 1998, a consortium of 7 governmental and nonprofit organizations agreed to sponsor an update to the original Smoking Cessation Clinical Practice Guideline, which was based on a review of published literature through 1994. These agencies—the US Agency for Healthcare Research and Quality; the Office on Smoking and Health at the Centers for Disease Control and Prevention; the National Cancer Institute; the National Institute on Drug Abuse; the National Heart, Lung, and Blood Institute; the Robert Wood Johnson Foundation; and the University of Wisconsin Medical School's Center for Tobacco Research and Intervention—reconvened the original expert panel to examine the tobacco dependence treatment literature published through 1999. Given the importance of this issue to the health of all Americans, the updated guideline has been published as a United States Public Health Service Report.⁶

The updated clinical practice guideline, Treating Tobacco Use and Dependence, is a product of the 18-member Tobacco Use and Dependence Clinical Practice Guideline Panel, consortium representatives, consultants, and staff. These groups comprise more than 30 individuals charged with the responsibility of identifying effective, experimentally validated tobacco dependence treatments and practices. This article summarizes the key recommendations of the updated guideline and highlights differences between the original and updated guidelines. This article is intended to serve as a primer for effective clinic-based tobacco intervention treatments. Readers interested in more details regarding the literature review, data analytic methods, and the consensus process may refer to the updated guideline,⁶ which is also located on the Agency for Healthcare Research and Quality Web site (http://www.ahrq.gov). Both this article and the updated guideline target 3 principal audiences: the broad range of primary care clinicians for whom tobacco dependence treatment is just 1 of many activities; tobacco dependence treatment specialists for whom the treatment of tobacco use is a major professional activity; and health care administrators, insurers, and purchasers who have the capacity to implement systems changes that support and encourage tobacco dependence treatments, including reimbursing for these cost-effective treatments.

An overarching theme of the updated guideline is the need to coordinate care among the 3 audiences. Although some particular interventions may be more relevant for certain audiences, all audiences should be aware of and implement, where possible, the full range of effective treatments. Therefore, the updated guideline dissociates the intervention strategies from audience type. Major intervention categories outlined in the updated guideline are brief interventions, intensive interventions, and systems interventions.

One notable change in the updated clinical practice guideline is that the new title, Treating Tobacco Use and Dependence, underscores 3 truths about tobacco use.⁷ First, all tobacco products, not just cigarettes, exact devastating costs on the nation's health and welfare. Second, for most users, tobacco use results in true drug dependence, one comparable to the dependence caused by opiates, amphetamines, and cocaine. Third, chronic tobacco use warrants repeated clinical intervention just as do other addictive disorders.

The updated guideline is intended to identify empirically based and validated assessments and treatments for tobacco dependence. The principal steps in the guideline development were similar for both the original and the updated guidelines.

The guideline panel, aided by additional experts in the field, formulated clinically significant questions to be addressed in literature reviews and analyses. Approximately 6000 research articles and abstracts, including 3000 from the original guideline, were reviewed to identify studies appropriate for evaluation. Articles that were relevant were coded for possible use in meta-analyses if they: (1) reported the results of a placebo/comparison-controlled trial evaluating a tobacco use assessment or treatment randomized on the patient level; (2) provided follow-up results at least 5 months after the quit date; (3) were published in a peer-reviewed journal; (4) were published between January 1, 1975, and January 1, 1999; and (5) were published in English. Three independent raters coded features of all articles accepted for possible use in the meta-analyses. Where possible, efficacy analyses used point-prevalence abstinence data that reflected the intent-to-treat principle. Except for pregnancy studies, all follow-up data reflected smoking status at least 5 months following the quit day and included both biochemically confirmed and self-reported data. Pregnancy analyses used preparturition outcomes and data that were exclusively biochemically confirmed. Random-effects logistic regression was used for meta-analysis. Between the original and updated guidelines, many analyses were repeated, but with updated data sets. New studies were added, and a careful application of screening criteria resulted in the exclusion of a small number of studies that had been included in the original guideline analyses. In general, meta-analytic findings were consistent across the original and updated guidelines. Overall, more than 50 separate meta-analyses were conducted in the preparation of the updated guideline. A listing of the articles used in the meta-analyses can be found on the Agency for Healthcare Research and Quality Web site.

The results of the new meta-analyses and other relevant data (eg, meta-analyses from the original guideline, other published meta-analyses, background, and review articles), were presented to the guideline panel, who examined the findings and made requests for additional data and analyses as needed. The guideline panel generated consensus recommendations from the findings and assigned strength-of-evidence ratings to each recommendation. Ratings reflected the quality and amount of evidence supporting a recommendation and can be found in the updated guideline.

A draft of the updated clinical practice guideline, Treating Tobacco Use and Dependence, was reviewed by more than 70 external experts in the field of tobacco research and treatment and was modified accordingly.

Tobacco dependence has many features typical of a chronic disease. While a minority of tobacco users achieve permanent abstinence in an initial quit attempt, the majority persist in tobacco use for many years and typically cycle through multiple periods of relapse and remission. A failure to appreciate the chronic nature of tobacco dependence may undercut clinicians' motivation to treat tobacco use consistently. If tobacco dependence is recognized as a chronic condition, clinicians will better understand the relapsing nature of the ailment and the requirement for ongoing care. As with chronic diseases such as diabetes, hypertension, or hyperlipidemia, clinicians encountering a patient dependent on tobacco must provide that patient with simple counseling advice, support, and appropriate pharmacotherapy. Finally, clinicians should recognize that relapse is common and that it reflects the chronic nature of dependence, not their own or their patients' failure.

While tobacco use can be a chronic condition, the updated guideline analyses reveal that it can be treated effectively. Although only about 7% of smokers achieve long-term success when trying to quit on their own, updated guideline analyses revealed that success rates can be increased to 15% to 30% by using guideline-recommended treatments. The most effective treatments were intensive counseling and pharmacotherapies. However, even brief treatments such as physician advice to quit can increase abstinence rates significantly.

Moreover, the data document that the full range of interventions is cost-effective. Over time, people who successfully quit use fewer health care resources. In addition, many of the treatments are reimbursable, providing an additional incentive for individual physicians to provide treatment.

The first step in treating tobacco use and dependence is to identify tobacco users. At least 70% of smokers visit a physician each year, more than 50% visit a dentist, and many visit other clinicians.^{2 - 4} Therefore, clinicians are well positioned to intervene with patients who use tobacco. Effective identification of tobacco use status not only opens the door for successful interventions (eg, physician advice), but it guides clinicians to identify appropriate interventions based on patients' tobacco use status and willingness to quit. Finally, smokers cite a physician's advice to quit as an important motivator for attempting to stop smoking. Screening methods along with brief interventions are presented in Figure 1 and in Table 1.

Brief interventions can be provided by any clinician but are most relevant to primary care clinicians who treat a wide variety of patients and face severe time constraints. The updated guideline analyses suggest that a wide variety of clinicians can effectively implement these strategies and that interventions as brief as 3 minutes can increase cessation rates significantly. In addition, the updated guideline recommends that these interventions be used with all populations, including adolescents, pregnant women, older smokers, and racial and ethnic minorities. However, special consideration should be given to the appropriateness of pharmacotherapy in certain populations (eg, those with medical contraindications, those smoking fewer than 10 cigarettes per day, pregnant/breastfeeding women, and adolescent smokers). The goal is to ensure that every patient who uses tobacco is identified and offered at least a brief intervention at each clinical visit.

Brief interventions can be used with 3 types of patients: current tobacco users now willing to make a quit attempt; current tobacco users unwilling to make a quit attempt at this time; and former tobacco users who have recently quit. Adults who have never used tobacco or who have been abstinent for an extended period do not require intervention.

For the Patient Willing to Quit. Given that so many tobacco users visit a primary care clinician each year, it is important that these clinicians be prepared to intervene with tobacco users who are willing to quit. The 5 major steps (the "5 As") to intervention in the primary care setting are: (1) ask the patient if he or she uses tobacco; (2) advise him or her to quit; (3) assess willingness to make a quit attempt; (4) assist those who are willing to make a quit attempt; and (5) arrange for follow-up contact to prevent relapse (Table 1). These strategies are designed to be brief, requiring 3 minutes or less of direct clinician time. Office systems that institutionalize tobacco use assessment and intervention will foster the adoption of these strategies. These strategies are consistent with those of the National Cancer Institute,^{8 - 9} the American Medical Association,¹⁰ and others.

The updated guideline urges clinicians to provide both counseling and pharmacotherapy for every patient making a quit attempt. The 3 recommended components of counseling (practical counseling, intratreatment social support, and extratreatment social support) are described in Table 2. In addition to counseling, all smokers making a quit attempt should receive pharmacotherapy, except in cases in which pharmacotherapy use requires special consideration (eg, those with medical contraindications, those smoking fewer than 10 cigarettes per day, pregnant/breastfeeding women, and adolescent smokers). Table 3 describes general pharmacotherapy guidelines for smoking cessation and Table 4 provides prescribing instructions for specific medications.

For the Patient Unwilling to Make a Quit Attempt at This Time. For patients not ready to make a quit attempt, clinicians should provide a brief intervention designed to promote the motivation to quit. Patients unwilling to make a quit attempt during a visit may lack information about the harmful effects of tobacco, may lack the required financial resources, may have fears or concerns about quitting, or may be demoralized because of previous relapse.¹¹ Such patients may respond to a motivational intervention designed to educate, reassure, and motivate. Table 5 outlines the components of such a motivational intervention built around the "5 Rs": relevance, risks, rewards, roadblocks, and repetition. Evidence suggests motivational interventions are most likely to be successful when the clinician is empathic, promotes patient autonomy (eg, choice among options), avoids arguments, and supports the patient's self-efficacy (eg, by identifying previous successes in efforts to change behavior).^{12 - 14}

For the Patient Who Has Recently Quit. Because of the chronic relapsing nature of tobacco dependence, clinicians should provide brief relapse prevention treatment for recent quitters. When clinicians encounter such a patient, they should reinforce the patient's decision to quit, review the benefits of quitting, and assist the patient in resolving any residual problems arising from quitting. Although most relapse occurs early in the quitting process,^{15 - 17} some relapse occurs months or even years after the quit date.^{18 - 19}

Relapse prevention interventions are especially important soon after quitting and can be delivered by means of either scheduled clinic visits, telephone calls, or any time the clinician encounters an ex–tobacco user. A systematic, institutionalized mechanism to identify recent quitters and contact them is essential to deliver relapse prevention messages effectively. Relapse prevention interventions can be divided into 2 categories: minimal practice for all quitters, and prescriptive interventions for patients with problems maintaining abstinence (Table 6).

Intensive tobacco dependence treatment can be provided by any trained clinician who has the resources available to provide intensive interventions. There is substantial evidence that more intensive interventions produce higher success rates and are more cost-effective than less-intensive interventions. Therefore, intensive interventions are appropriate for any tobacco user willing to participate in them and should not be limited to any subpopulation of tobacco users (eg, heavily dependent smokers).²⁰ Table 7 lists components of an intensive intervention.

An increasing number of Americans receive their health care in managed care settings. As a consequence, agents such as health system administrators, insurers, and health care purchasers now play an expanded role in the delivery of health care to most Americans. For example, managed care organizations and other insurers influence medical care through restrictive formularies, performance feedback to clinicians, and marketing approaches that prompt patient demand for particular services.

These agents can also craft and implement systems, policies, and environmental prompts (eg, posters, clinician tear sheets, chart stickers, signs) that render tobacco use assessment and treatment an integral part of health care. Indeed, research has shown that systems-level change can increase utilization of tobacco dependence treatment and reduce smoking prevalence among enrollees of managed health care plans.²¹

Without supportive systems, policies, and environmental prompts, the individual clinician may not assess and treat tobacco use consistently. Therefore, just as clinicians must assume responsibility to treat their patients for tobacco use, so must health care administrators, insurers, and purchasers assume responsibility to craft policies, provide resources, and display leadership that results in consistent and effective tobacco use treatment. The updated guideline describes 6 strategies for systems-level interventions: (1) implement a tobacco user identification system in every clinic (Table 1, Step 1); (2) provide education, resources, and feedback to promote provider intervention; (3) dedicate staff to provide tobacco dependence treatment and assess the delivery of this treatment in staff performance evaluations; (4) promote hospital policies that support and provide tobacco dependence services; (5) include tobacco dependence treatments (both counseling and pharmacotherapy) identified as effective in the updated guideline as paid or covered services for all subscribers or members of health insurance packages; and (6) reimburse clinicians and specialists for delivery of effective tobacco dependence treatments, and include these interventions among the defined duties of clinicians.

Clinicians report the lack of relevant knowledge as a significant barrier to intervening with their patients who use tobacco.^{22 - 25} The updated guideline, therefore, recommends that all clinicians and clinicians-in-training be trained in effective strategies to assist tobacco users to make a quit attempt and to motivate those who are unwilling to quit. A review of the published literature concluded that training appears to be most effective when coupled with other systems changes, such as clinic reminder systems and staff education. Training in tobacco use interventions should not only transmit essential treatment skills but also inculcate the belief that tobacco dependence treatment is a standard of good practice.²⁶

Smoking cessation treatments ranging from brief clinician advice to specialist-delivered intensive programs are not only clinically effective but are also extremely cost-effective relative to other common disease prevention interventions and medical treatments, such as the treatment of hypertension and hypercholesterolemia, and preventive screening interventions, such as periodic mammography and Papanicolaou tests.^{27 - 34} Treating tobacco dependence is particularly important economically, in that it can prevent a variety of costly chronic diseases and complications, such as heart disease, cancer, pulmonary disease, and delayed wound healing.

Smoking cessation treatments are also cost-effective in special populations such as hospitalized patients and pregnant women. For hospitalized patients, successful tobacco abstinence not only reduces general medical costs in the short-term but also reduces the number of future hospitalizations.³⁵ Smoking cessation interventions for pregnant women are especially favorable because they result in fewer low-birth-weight newborns and perinatal deaths; fewer physical, cognitive, and behavioral problems during infancy and childhood; and important health benefits for the woman.^{36 - 37}

The failure of health plans or insurers to cover tobacco dependence treatment could reduce access to these services and reduce the number of people seeking these services. Moreover, the presence of prepaid or discounted prescription drug benefits increases patients' receipt of pharmacotherapy and smoking abstinence rates.^{21 ,38 - 40} Therefore, the guideline suggests that those tobacco dependence treatments identified as effective in the updated guideline be a covered benefit of all insurance plans, both public and private.

Primary care clinicians frequently cite insufficient insurance reimbursement as a barrier to the provision of preventive services such as tobacco dependence treatment.⁴¹ Therefore, the updated guideline suggests that sufficient resources should be allocated for clinician reimbursement and systems support to ensure the delivery of efficacious tobacco use treatments.

The provision of tobacco dependence treatment may also be increased by ensuring that health plan "report cards" (eg, the National Committee for Quality Assurance Health Plan Employer Data and Information Set)^{42 - 43} support smoker identification and treatment and by mandating that the accreditation criteria used by Joint Commission on Accreditation of Healthcare Organizations and other accrediting bodies include an evaluation of the availability and utilization of effective tobacco assessment and intervention policies. To achieve this goal, interventions based on the updated guideline should be included in standard ratings and measures of overall health care quality (eg, the National Committee for Quality Assurance Health Plan Employer Data and Information Set and the Foundation for Accountability).

The updated guideline addressed the treatment of tobacco use as it relates to special populations (such as women, pregnant smokers, racial and ethnic minorities, hospitalized smokers, smokers with comorbidity and/or chemical dependency, children and adolescents, and older smokers) and specific topics (such as weight gain after smoking cessation, and noncigarette tobacco products). Readers interested in a detailed discussion of these topics are referred to the updated guideline.

In summary, the updated Guideline Panel's major conclusions and recommendations are as follows: