INTRODUCTION

The 2003 VA/DoD Clinical Practice Guideline for the Management of Tobacco Use is a modification of the 1999 VHA/DoD Clinical Practice Guideline for the Management of Tobacco Use Cessation in the Primary Care Setting and reflects tobacco research published since the completion of the previous version.

In the development of this guideline, the Working Group heavily relied on the following evidence-based guidelines:

• 1999 VHA/DoD Clinical Practice Guideline to Promote Tobacco Use Cessation in the Primary Care Setting (v1.0)
• Clinical Practice Guideline for Treating Tobacco Use and Dependence. U.S. Department of Health and Human Services - Public Health Service (PHS); June 2000
• Recommendations Regarding Interventions to Reduce Tobacco Use and Exposure to Environmental Tobacco Smoke. Task Force on Community Preventive Services; 2001

The PHS guideline, published in 2000, includes an extensive review of the literature and 26 new meta-analyses that were used to formulate new recommendations. A comparison of the research findings in the PHS guideline and in additional research published after 2000 with the previous 1999 VHA/DoD guideline reveals that considerable progress has been made in tobacco research over the brief period separating these two works. The research in recent years shows:

• Strong evidence of the association between counseling intensity and successful treatment outcomes. It also reveals evidence of additional effective counseling strategies, to include telephone counseling and counseling that helps smokers enlist support outside the treatment context.
• Many more effective pharmacologic treatment strategies available to the provider than were identified in the previous guideline. There are now seven different effective smoking cessation medications, allowing the provider and patient many more treatment options. Further information is available on the efficacy of combinations of nicotine replacement therapies (NRTs) and pharmacotherapies that are obtained over-the-counter.
• Strong evidence that smoking cessation treatments shown to be effective in this guideline (both pharmacotherapy and counseling) are cost-effective relative to other routinely reimbursed medical interventions (e.g., treatment of hyperlipidemia and mammography screening).

A conclusion of these findings suggests that smoking cessation treatments should not be withheld from patients when other less cost-effective medical interventions are routinely delivered. Furthermore, access to tobacco treatment should be as easy as purchasing tobacco products.

The changes to the 2003 guideline provide a more comprehensive approach to the problem of tobacco use among veterans, military personnel, and their families. The Working Group hopes that this updated guideline assists providers and tobacco specialists in delivering more effective treatments that reduce the prevalence of tobacco use among the beneficiaries of the Veterans Health Administration and the Department of Defense.

Population health:
The emphasis on population health represents a major change to this guideline. The prior version focused on ensuring that tobacco users were encouraged to attend a cessation program, generally regarded as the most effective treatment available. Despite major improvements in care for tobacco users, the prevalence of tobacco use remains high. Cessation programs are broadly available but are currently used by only a small proportion of tobacco users. Why then are we shifting the emphasis from cessation programs to primary care-based treatment, with a much lower rate of success? The answer is that it should lead to more people becoming abstinent from tobacco. To see this, it is necessary to assess the impact of a program on the entire population of tobacco users attending a health care facility. From a population perspective, the impact can be thought of as a product of the reach (percentage of population using a service) and the effectiveness of the service. Consider two examples. First, an institution that was able to get 5 percent of tobacco users to attend a cessation program with a 20 percent long-term success rate would achieve abstinence in 1 percent of the population. Alternatively, if treatment within primary care has a 7.5 percent long-term success rate and 40 percent of tobacco users are treated, the number of tobacco users who become abstinent is three times that of the first example. Therefore, population health means focusing on interventions that have broad reach and will help support all tobacco users’ efforts to quit.

Access to counseling and pharmacotherapy:
Tobacco use is the targeted behavior and tobacco users are the clinical population of interest. Ensuring that all tobacco users have convenient access to counseling and pharmacotherapy is a necessary concomitant of the population health approach. It would be pointless to aim for high rates of treatment within primary care for treatments that are not easily available. This shift in emphasis mirrors one occurring in managed care nationwide, as newer quality measures emphasize ensuring that all tobacco users are offered treatment. In addition, it encourages intervening in a variety of medical settings, including primary care, pediatrics, and dental clinics. Recommendations also include the use of telephone Quitlines and other community resources to attempt to reach the entire population of tobacco users. This is especially relevant to a military population that tends to be young and healthy and therefore, may utilize medical clinics less frequently. The definition of the target population has been expanded in this version to include children, teenagers, and young adults (age >12 years.)

Prevention:
Because the goal of this guideline is to reduce the overall prevalence of tobacco use in the beneficiary population, prevention is included as a major emphasis area. A separate pathway for prevention has been added to the guideline to address not only those who have recently quit using tobacco, but also to reinforce those who don’t use tobacco, to stay tobacco-free.

Prevention is especially important for the DoD population of new recruits, who have the highest overall prevalence of tobacco use in the DoD. Over 80 percent of smokers begin before age 18, and those who start tobacco use at an early age are most likely to continue to smoke into adult life. Every year, over 200,000 new recruits to the military are required to be tobacco-free for a minimum of six weeks while they go through their initial training (CDC, 1998). Every graduating recruit is tobacco-free when they complete recruit training. Prevention efforts are critical to help reinforce the decision to stay quit. Interventions for the primary prevention of tobacco use are included only if they are directly relevant to clinical practice. Community-level interventions (e.g., mass media campaigns) that are not usually implemented in primary care practice settings are not addressed.

Change in format:
Great effort was taken in this update to provide clear objectives and direct recommendations in a behavioral format. Establishing a set of desired treatment behaviors will hopefully make implementation much easier. Elaboration of the recommendations and a review of the evidence are included in the Discussion section of each annotation. The guideline update also emphasizes the importance of a collaborative approach between the provider and patient. Tobacco dependence is a chronic disease that often requires repeated interventions. The treatment of tobacco use carries with it the vulnerability to lapse and relapse, and the actual process of establishing long-term abstinence takes many months. Because of the chronic nature of tobacco use, the patient must be a partner and willing participant in all aspects of treatment. This underlies the shift in emphasis within the guideline, from recommending the best treatment in the prior version to arriving at a mutually agreeable treatment plan in the current version. In addition to a focus on interventions for the motivated patient, we have also included intervention strategies aimed at increasing readiness to quit for those tobacco users not yet willing to stop.

To facilitate the provision of brief advice by providers, the guideline includes several examples and scripts for successful strategies experienced in other institutions or adopted from the PHS (see Appendix A). Several Annotations in the update of the VA/DoD guideline have been adapted from the Clinical Practice Guideline for Treating Tobacco Use and Dependence, Clinical Practice Guideline. Rockville, MD: US Department of Health and Human Services, Public Health Service (PHS); 2000. Meta-analysis tables included in the PHS guideline and the respective list of studies included in the meta-analyses is cited in these annotations using the format: “PHS Table # _”.

Guideline Development
The development process of this update follows a systematic approach described in “Guideline-for-Guideline,” an internal working document of VHA’s National Clinical Practice Guideline Counsel. Appendix B clearly describes the guideline development process.

Although most of the tobacco research involves ‘smoking’, the Working Group believes that the findings are relevant to all forms of tobacco use. Providers should identify smokeless/spit tobacco users and users of cigars, pipes and other noncigarette combustible forms of tobacco, strongly urge them to quit and treat them with the same cessation interventions recommended for cigarette smokers. The term ‘tobacco user’ refers to anyone who uses cigarettes, non-cigarette tobacco products (cigars, pipes), and smokeless/spit tobacco products (chewing tobacco and snuff).

Evidence from randomized controlled trials (RCTs) has demonstrated that repeated advice, from different types of providers, over time has a significant effect on increasing the numbers of tobacco users who will try to quit, and has shown an increase in abstinence rates. This guideline is designed for three main audiences: primary care providers/managers (including dental providers); tobacco dependence treatment specialists; and health care team members and administrators across the health care systems of the VA and DoD. When referring to any of these providers of care the term “provider” is used throughout the guideline.

Implementation
The guideline and algorithms are designed to be adapted to the individual facility’s needs and resources. They will be updated periodically or when relevant research results become available. They should be used as an impetus for administrators in the Department of Veterans Affairs or at each Veterans Integrated Services Network (VISN) facility or Department of Defense (DoD), medical center or medical treatment facility (MTF), and other care access sites to develop innovative plans to remove barriers that prevent primary care providers, sub specialists, and allied health professionals from working together, and barriers that prevent tobacco users from having convenient access to counseling and pharmacotherapy to help them quit.

There is increasing evidence that the success of any tobacco dependence treatment strategy cannot be divorced from the health care system in which it is embedded. Data strongly indicate that the consistent and effective delivery of tobacco interventions requires coordinated interventions. Just as a provider must intervene with his or her patient, so must the health care administrator, insurer, and purchaser foster and support tobacco dependence treatment as an integral element of health care delivery.

The implementation of strategies for cessation and prevention of tobacco use is dependent on a systematic and consistent approach of the health care system itself. Leadership support in the local facility, as well as at the national level, is essential to achieve the challenge of tobacco use reduction. The utmost goal of the individual providers and the health care system is to eliminate the barriers to implementation of those treatments, which have proven to be effective in reducing tobacco use. Hence, the Working Group decided to include a list of evidence-based recommendations aimed at the system level (see Appendix E). Success should be celebrated at the individual level as well as at the system level at large.

Performance Measurement
The inability of consumers and health care purchasers to determine if medical care is appropriate and effective has given rise to the concept that the health care system should be held accountable for what is done and the outcomes achieved. This principle of accountability has resulted in the development of so-called “performance and outcome measures” which are administered through “report card” systems. Measures must be seen as fair and reasonable and must be achievable in various practice settings, when carried out either by providers or tobacco dependence treatment specialists.

Performance measures are indicators or tools to assess the level of care provided within systems of care to populations of patients who use tobacco products. The measures are constructed to best utilize the available evidence for assessing care or outcomes of care in systems where test reliability, patient characteristics, (co-morbidity), and compliance cannot be easily determined and taken fully into consideration (i.e., the measures are not case-mix adjusted). The current state of the art measurement system does not allow full adjustment for factors outside the control of the health care system.

The Working Group suggests that the following indicators be considered in establishing the performance measurerment system:

• Decrease number of tobacco users.
• Increase number of patients screened for tobacco use.
• Increase number of patients advised to quit.
• Increase documentation of patient smoking status and treatment outcomes.
• Increase number of tobacco users enrolled in treatment (e.g., prescribed pharmacotherapy)
• Increase level of trained providers.

TECHNICAL CONSULTANTS
Lara Bainbridge
Oneil Brown
Sara Thomas