Evidence Digest

The Latest Evidence on Smoking CessationInterventions with Diverse Populations

Bernadette Mazurek Melnyk, RN, PhD, CPNP/NPP, FAAN, FNAP

The purpose of the evidence digest, a recurring col-umn in Worldviews, is to provide concise summaries

of well-designed and clinically important recent studiesalong with implications for practice, research, adminis-tration, and/or health policy. Articles highlighted in thiscolumn may include quantitative and qualitative studies,systematic and integrative reviews, as well as consensusstatements by expert panels. Along with relevant impli-cations, the level of evidence generated by the studies orreports highlighted in this column (see Table 1) is includedat the end of each summary so that readers can integratethe strength of evidence into their health care decisions.

Tapppin D.M., Lumsden M.A., Gilmour W.H., Craw-ford F., McIntyre D., Stone D.H., Webber R., MacIndoe S.,& Mohammed E. (2005). Randomised controlled trial ofhome based motivational interviewing by midwives to helppregnant smokers quit or cut down. British Medical Journal,331(7513), 373–377.

Purpose. The purpose of this clinical trial was to evaluatethe effects of motivational-interviewing provided at homeby specially trained midwives on smoking cessation.

Sample. The sample consisted of 762 (out of 1,684)pregnant women who smoked regularly; 351 in the inter-vention group and 411 in the control group. Women wereeligible to participate if they were smoking at the time thatthey telephoned clinics attached to two hospitals in Glas-gow to arrange for an antenatal appointment. Additionalinclusion criteria included that the women had to be lessthan 24 weeks’ gestation. Subjects in the experimental andcontrol groups were similar on baseline clinical and demo-graphic variables.

Design. A randomized clinical trial.Interventions. Women in both the experimental and

control groups received standard health promotion infor-mation. Women in the experimental group also receivedmotivational interviewing (MI) at home by one of four mid-wives, which is a one-on-one counseling strategy based onthe stages of change model. The nurse midwives provid-

Copyright ©2005 Sigma Theta Tau International1545-102X1/05

ing the intervention attended 5 days of training in MI bya consultant. Women in the experimental group receivedtwo to five additional home visits of about 30 minutes’ du-ration from the midwives. Median intervention time was56 minutes, but ranged from 9 to 219 minutes.

Outcomes. Self-reported smoking cessation and plasmaor salivary cotinine concentration of less than 13.7 ng/mlserum or less than 14.2 ng/ml saliva were assessed. Self-reported “cutting down” was measured by self-report ofsmoking half that at booking appointments plus cotinineconcentrations, half the previous measurement. Informa-tion also was collected on attempts to quit and cut downduring pregnancy, changes in commitment to quit and cutdown, birth weight, and costs of maternity care.

Findings. There were no significant differences betweenthe experimental and control groups on smoking cessationor diminishing the number of cigarettes smoked per day.However, fewer women in the experimental group reportedthat they were smoking more. There were no differences ininfant birth weight between the two groups.

Commentary With Implications for Clinical Practice andFuture Research. There are multiple adverse effects ofcigarette smoking on the health outcomes of pregnantwomen and their children, including miscarriage, peri-natal death, low birth weight, childhood asthma, andadult cardiovascular disease. Therefore, the developmentand testing of interventions to diminish or eliminatesmoking behavior during pregnancy is critical. Unlikeother studies that have indicated the positive effect ofMI interventions on smoking cessation, this interventiondid not reduce smoking or result in smoking cessationin pregnant women. One major flaw in this study wasthat the dose of the intervention protocol varied, fromtwo to five visits. Therefore, nonstandardization and aweak dose of the intervention may explain the lack ofintervention effects. Other flaws included that it was anonblinded trial (i.e., women and interventionists knewto which group the women were assigned). In addition, itis not clear whether the same midwives who were deliv-ering the MI intervention were also visiting the women in

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TABLE 1Rating System for the Hierarchy of Evidence (from Melnyk &Fineout-Overholt 2005)

� Level I: Evidence from a systematic review or meta-analysisof all relevant randomized controlled trials (RCTs), orevidence-based clinical practice guidelines basedon systematic reviews of RCTs

� Level II: Evidence obtained from at least one well-designedRCT

� Level III: Evidence obtained from well-designed controlled tri-als without randomization

� Level IV: Evidence from well-designed case-control and co-hort studies

� Level V: Evidence from systematic reviews of descriptive andqualitative studies

� Level VI: Evidence from a single descriptive or qualitativestudy

� Level VII: Evidence from the opinion of authorities and/or re-ports of expert committees

Modified from Guyatt & Rennie 2002; Harris et al. 2001

the control group. If this is the case, cross-contaminationmay have occurred, leading to a “washing out” of inter-vention effects. In the discussion section of the article,the authors stated that their study included heavier, moredependent smokers, which may be the reason for the lackof intervention effects on smoking cessation. Therefore,it was recommended that more intensive interventionis probably necessary for these women. Future trials areurgently needed for this high-risk population of women,with standardized protocols that have a uniform num-ber of more intensive behavioral intervention sessions.It also would be interesting to note if being a heavy orlight smoker moderated the effects of the interventionin this trial (e.g., whether women who smoked less quitsmoking more than the women who were heavy smok-ers).

Level of Evidence: II.

Dar R., Stronguin F., & Etter J-F. (2005). Assigned versusperceived placebo effects in nicotine replacement therapyfor smoking reduction in Swiss smokers. Journal of Con-sulting and Clinical Psychology, 73(2), 350–353.

Purpose. The purpose of this secondary data analysiswas to explore the relationships of perceived treatment tooutcome in a large, placebo-controlled trial of nicotine re-placement treatment for smoking reduction (i.e., to exam-ine the difference in outcomes between those individualswho believed that they had received nicotine versus thosewho believed that they had received a placebo).

Sample. The sample in the primary study (Etter et al.2002) from which this secondary data analysis was con-ducted consisted of 923 smokers who were randomly as-signed to receive nicotine, matching placebo products, orno intervention. The subjects were all considered adultheavy smokers (i.e., a mean of 30 cigarettes per day) whowere not prepared to quit smoking. They were recruitedfrom the general population of French-speaking individ-uals in Switzerland between 1999 and 2001 and were re-quired to state that they had no intention of quitting smok-ing in the next 6 months. The majority of participants wereCaucasian with a mean age of 42.8 years.

Design. Secondary data analysis of an RCT.Interventions in the Primary Study. Participants in the

primary RCT received either a nicotine intervention (e.g.,a transdermal patch, gum, inhaler, or a combination ofthese), or a placebo intervention (e.g., placebo patch, gum,inhaler, or a combination of these).

Outcomes. At the end of the 6-month study, participantswere asked to guess whether they were in the nicotine orplacebo intervention group.

Findings. Smokers who believed that they had receivednicotine had significantly greater reductions in smokingthan those who did not.

Commentary with Implications for Clinical Practice andFuture Research. An individual’s beliefs are a highly po-tent moderator of the effects of smoking cessation inter-ventions. Therefore, clinicians should assess these be-liefs (e.g., beliefs about an individual’s ability to stopsmoking) prior to commencing smoking cessation in-terventions. Prior intervention work in other areas hasprovided evidence supporting that an individual’s beliefscan have substantial influence on health outcomes andthat interventions can strengthen those beliefs (Melnyk& Feinstein 2001). Caution must be exercised in inter-preting the results of this study as individuals who be-lieved that they received the nicotine intervention mighthave been biased in reporting on how they decreasedtheir cigarette consumption. Inclusion of self-report aswell as objective measures of the outcome is indicatedin future studies. In addition, beliefs should be includedin future randomized trials that are testing the effects ofan intervention on outcomes.

Level of Evidence: VI.

Jonsdottir H., Jonsdottir R., Geirsdottir T., SveinsdottirK., Sigridur K., Sigurdardottir T. (2004). Multicomponentindividualized smoking cessation intervention for patientswith lung disease. Journal of Advanced Nursing, 48(6), 594–604.

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Purpose. The purpose of this study was to determine theefficacy of a long-term, multicomponent smoking cessationintervention for patients with lung disease initiated whilehospitalized and provided up to 1 year following discharge.

Sample. The sample was composed of 85 acutely ill pa-tients admitted to a pulmonary unit in Iceland over a 2-yearperiod of time. The only criterion for participation was thatpatients were smokers. The majority of patients had COPDor asthma. Sixty-three percent were women, and the meannicotine dependence score was 4.4 (on a scale of 0–10).

Design. Preexperimental study: one group; no random-ization or control group. The authors reported that thedecision not to have a control group was made because itwas felt that it was unethical to not be able to provide allpatients with the best possible smoking cessation interven-tion because of their lung condition.

Intervention. The experimental intervention consistedof nicotine replacement therapy as well as individual coun-seling and support by nurses during hospitalization thatwas grounded in caring relationships with the patients andguided by the transtheoretical model of change. Weeklysupport groups and group teaching about lifestyles, includ-ing stress management and relaxation techniques, also wereconducted. After discharge, telephone interventions wereprovided at 1 week as well as 1, 3, 6, and 12 months follow-ing hospitalization. The number and length of interven-tions during hospitalization varied, with the first sessiontypically lasting 30–60 minutes. After the initial interven-tion, most participants received four to six 10–15-minutesessions. The nicotine replacement therapy was adminis-tered by the nurses who provided counseling and support.The main purpose of the postdischarge interventions wasto discuss any concerns about smoking cessation and tofurther support the participants in their quit attempts incases of relapse.

Outcomes. Self-report of smoking behaviors (e.g., ab-stinence, number of times that participants attempted toquit).

Findings. One year following discharge from the hos-pital, 39% of the patients reported continuous abstinencefrom smoking, and 52% were not smoking at that time.No relationships were found between abstinence and thenumber of times the participants tried to quit, their readi-ness to quit, nicotine dependency, and length of hospitalstay. Readiness to quit had increased, and nicotine depen-dence was significantly decreased by the end of the pro-gram. There were no gender differences in outcomes.

Commentary with Implications for Clinical Practice andFuture Research. Since smoking cessation results in im-provement in lung function and a reduction in decline for

patients with mild-to-moderate chronic obstructive lungdisease, implementation of smoking cessation inter-ventions in clinical practice with hospitalized patientsshould be a very high priority. A major flaw in this studyis that it is a one-group design as well as that the inter-vention had several components, which make it difficultto discern what pieces of the intervention were mainlyresponsible for the positive outcomes. A stronger designwould have been a two-group experiment in which pa-tients were randomly assigned to a nicotine interventiongroup alone or a multicomponent intervention as de-livered in this study (e.g., nicotine plus the other com-ponents of the intervention). Because of the extensiveintervention protocol, which was not standardized, theintervention may be difficult to transport and replicate inother hospitals. Despite these limitations, this interven-tion was found to be very effective with this very high-risk population. Measurement of cost outcomes wouldbe particularly important in assisting hospital adminis-trators in deciding whether this type of multicomponentintervention would be feasible in their settings. Objec-tive measures of smoking cessation also would have en-hanced the strength of the findings.

Level of Evidence: VI.

Thomas R. (2005). School-based programmes for pre-venting smoking. Cochrane Database of Systematic Reviews,3, Accession number 00075320-100000000-00217.

Purpose. The purpose of this study was to examine allRCTs of behavioral interventions in schools to prevent chil-dren (ages 5–12 years) and adolescents (13–18 years) fromthe initiation of smoking to determine efficacy of the inter-ventions.

Sample. Study inclusion criteria included RCTs in whichstudents, classes, schools, or school districts were ran-domly assigned to an intervention or control group andfollowed for at least 6 months.

Design. Narrative systematic review; not meta-analysis.Interventions. The interventions delivered in the RCTs

included classroom programs or curricula to prevent to-bacco use. Some of the programs included family and com-munity interventions. Programs with a drug or alcohol fo-cus also were included if tobacco use was reported.

Outcomes. Measures included prevalence of nonsmok-ing at follow-up among those who reported that they werenot smoking at baseline data collection.

Findings. Seventy-six RCTs were identified and 16 wereclassified as category one (i.e., the most valid). There werea total of 15 valid studies that delivered social influences in-terventions. Of those 15, eight showed some positive effecton smoking prevalence. The most rigorous study found no

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long-term effect of an 8-year prevention program on smok-ing behavior.

Commentary with Implications for Clinical Practice andFuture Research. Tobacco use in teens is on the rise inmany countries throughout the globe. Therefore, thereis an urgent need to test smoking prevention programswith school-age children and teens on both short- andlong-term smoking outcomes. Of all programs tested,it appears that those who use social-influences inter-ventions lead to the best outcomes. However, it is notknown whether information-only programs can resultin less prevalence of this problem. School-based inter-vention programs are one key way to influence smokingbehavior, but once evidence supports efficacy, dissem-ination/implementation studies need to be conductedto determine how best to transport these interventionsinto other schools throughout the globe. School nursesare excellent health providers to deliver these types ofinterventions. In future trials, cost analyses should beperformed in order to determine the cost-benefit ratio ofthe interventions.

Level of Evidence: I.

Moher M., Hey K., & Lancaster T. (2005). Workplaceinterventions for smoking cessation. Cochrane Databaseof Systematic Reviews, 3, Accession number 00075320-100000000-02403.

Purpose. The purpose of this study was to categorizeinterventions for smoking cessation in the workplace (i.e.,interventions aimed at the individual and those aimed atthe workplace as a whole) and to evaluate the efficacy ofthese interventions on smoking cessation and the reductionof tobacco consumption.

Sample. For interventions targeted at helping individu-als to stop smoking, 31 RCTs were included that random-ized individuals, workplaces, or companies to interventionor control groups. For studies of smoking restriction in theworkplace, 28 controlled trials with baseline and postinter-vention outcomes and interrupted time series design stud-ies were used.

Design. Narrative systematic review.Interventions. Individual workplace interventions tar-

geted helping individuals to stop smoking and includedgroup therapy, individual counseling, self-help programs,and nicotine replacement therapy. Workplace interventionsas a whole focused on tobacco bans, social support, envi-ronmental support, incentive, and multicomponent treat-ments.

Outcomes. Measures included prevalence of nonsmok-ing at follow-up among those who reported that they werenot smoking at baseline data collection.

Findings. Regarding individual workplace interven-tions, group programs, individual counseling, and nico-tine replacement therapy were more effective with ces-sation rates versus no treatment or minimal interventioncontrols. Self-help programs were less effective. Banningtobacco in the workplace decreased cigarette consump-tion in the day, but whether it decreased overall consump-tion was uncertain. Evidence was lacking regarding theeffectiveness of comprehensive programs. In addition, al-though competitions and incentives increased attempts tostop smoking, there is less evidence for actual quit rates ofsmoking.

Commentary with Implications for Clinical Practice andFuture Research. Evidence is strongest for interventionstargeted individually to smokers, including advice froma health professional and individual and group counsel-ing as well as nicotine replacement. This seems to holdtrue whether delivered in the workplace or in other set-tings. Although bans on smoking are an effective meansof decreasing cigarette consumption in the workplace, itis important to note that this strategy may not decreasethe overall consumption of cigarettes by tobacco users.Therefore, it is important that individual interventionsbe instituted in the workplace along with environmen-tal bans. Because the workplace contains large numbersof individuals, it is an excellent setting for implemen-tation of individualized and group interventions to re-duce the consumption of cigarettes. Increasing the num-ber of nurses/advanced practice nurses in the workplaceto deliver individually targeted interventions for smok-ing cessation and other health risk behaviors could be acost-effective strategy for preventing and reducing healthproblems.

Level of Evidence: I.

ReferencesEtter J.F., Laszlo E., Zellweger J.P., Perrot C., & Perneger

T.V. (2002). Nicotine replacement to reduce cigaretteconsumption in smokers who are unwilling to quit: Arandomized trial. Journal of Clinical Psychopharmacol-ogy, 22(5), 487–495.

Guyatt G. & Rennie D. (2002). Users’ guides to the medicalliterature. Washington, DC: American Medical Associa-tion Press.

Harris R.P., Hefland M., Woolf S.H., Lohr K.N., MulrowC.D., Teutsch S.M., et al. (2001). Current methods ofthe U.S. Preventive Services Task Force: A review of theprocess. American Journal of Preventive Medicine, 20(3Suppl.), 21–35.

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Melnyk B.M. & Feinstein N.F. (2001). Mediating functionsof maternal anxiety and participation in care on youngchildren’s posthospital adjustment. Research in Nursing& Health, 24(1), 18–26.

Melnyk B.M., & Fineout-Overholt E. (2005). Evidence-based practice in nursing & healthcare. A guide tobest practice. Philadelphia: Lippincott, Williams &Wilkins.

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