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Background: The rate of lung-function decline in chronic obstructive pulmonary disease (COPD) varies substantially among individuals. We sought to develop and validate an individualized prediction model for forced expiratory volume at 1 second (FEV 1 ) in current smokers with mild-to-moderate COPD., Methods: Using data from a large long-term clinical trial (the Lung Health Study), we derived mixed-effects regression models to predict future FEV 1 values over 11 years according to clinical traits. We modelled heterogeneity by allowing regression coefficients to vary across individuals. Two independent cohorts with COPD were used for validating the equations., Results: We used data from 5594 patients (mean age 48.4 yr, 63% men, mean baseline FEV 1 2.75 L) to create the individualized prediction equations. There was significant between-individual variability in the rate of FEV 1 decline, with the interval for the annual rate of decline that contained 95% of individuals being -124 to -15 mL/yr for smokers and -83 to 15 mL/yr for sustained quitters. Clinical variables in the final model explained 88% of variation around follow-up FEV 1 . The C statistic for predicting severity grades was 0.90. Prediction equations performed robustly in the 2 external data sets., Interpretation: A substantial part of individual variation in FEV 1 decline can be explained by easily measured clinical variables. The model developed in this work can be used for prediction of future lung health in patients with mild-to-moderate COPD., Trial Registration: Lung Health Study - ClinicalTrials.gov, no. NCT00000568; Pan-Canadian Early Detection of Lung Cancer Study - ClinicalTrials.gov, no. NCT00751660., (© 2016 Canadian Medical Association or its licensors.)

Aims: To assess the effects of adding motivational interviewing (MI) counseling to nicotine patch for smoking cessation among homeless smokers., Design: Two-group randomized controlled trial with 26-week follow-up., Participants and Setting: A total of 430 homeless smokers from emergency shelters and transitional housing units in Minneapolis/St Paul, Minnesota, USA., Intervention and Measurements: All participants received 8-week treatment of 21-mg nicotine patch. In addition, participants in the intervention group received six individual sessions of MI counseling which aimed to increase adherence to nicotine patches and to motivate cessation. Participants in the standard care control group received one session of brief advice to quit smoking. Primary outcome was 7-day abstinence from cigarette smoking at 26 weeks, as validated by exhaled carbon monoxide and salivary cotinine., Findings: Using intention-to-treat analysis, verified 7-day abstinence rate at week 26 for the intervention group was non-significantly higher than for the control group (9.3% versus 5.6%, P = 0.15). Among participants who did not quit smoking, reduction in number of cigarettes from baseline to week 26 was equally high in both study groups (-13.7 ± 11.9 for MI versus -13.5 ± 16.2 for standard care)., Conclusions: Adding motivational interviewing counseling to nicotine patch did not increase smoking rate significantly at 26-week follow-up for homeless smokers., (© 2013 Society for the Study of Addiction.)

Introduction: Smoking prevalence in homeless populations is strikingly high (∼70%); yet, little is known about effective smoking cessation interventions for this population. We conducted a community-based clinical trial, Power To Quit (PTQ), to assess the effects of motivational interviewing (MI) and nicotine patch (nicotine replacement therapy [NRT]) on smoking cessation among homeless smokers. This paper describes the smoking characteristics and comorbidities of smokers in the study., Methods: Four hundred and thirty homeless adult smokers were randomized to either the intervention arm (NRT + MI) or the control arm (NRT + Brief Advice). Baseline assessment included demographic information, shelter status, smoking history, motivation to quit smoking, alcohol/other substance abuse, and psychiatric comorbidities., Results: Of the 849 individuals who completed the eligibility survey, 578 (68.1%) were eligible and 430 (74.4% of eligibles) were enrolled. Participants were predominantly Black, male, and had mean age of 44.4 years (S D = 9.9), and the majority were unemployed (90.5%). Most participants reported sleeping in emergency shelters; nearly half had been homeless for more than a year. Nearly all the participants were daily smokers who smoked an average of 20 cigarettes/day. Nearly 40% had patient health questionnaire-9 depression scores in the moderate or worse range, and more than 80% screened positive for lifetime history of drug abuse or dependence., Conclusions: This study demonstrates the feasibility of enrolling a diverse sample of homeless smokers into a smoking cessation clinical trial. The uniqueness of the study sample enables investigators to examine the influence of nicotine dependence as well as psychiatric and substance abuse comorbidities on smoking cessation outcomes.

Purpose: To describe the factors associated with interest of homeless former smokers in helping homeless smokers quit., Methods: A cross-sectional survey administered to an optimized convenience sample of homeless persons (n  =  4570) at emergency shelters, transitional housing units, and open encampments in 80 cities across Minnesota. The in-person survey response rate was 90%., Analysis: Chi-square tests and t-tests for univariate analysis., Results: Of 4534 participants completing the smoking questions, 546 participants (12%) self-identified as former smokers, of which 59% expressed interest in helping homeless smokers quit. Significant predictors of reported interest in helping included racial/ethnic background (p < .05), number of people known who had quit smoking (p < .01), and receiving social services as an adult (p < .01)., Conclusion: Homeless former smokers are a potential resource for peer support programs to promote smoking cessation among homeless current smokers.

Rationale: The course of lung function decline for smokers with early airflow obstruction remains undefined. It is also unclear which early spirometric characteristics identify individuals at risk for rapid decline and increased mortality., Objectives: To determine the association between spirometric measures and 5-year decline in FEV(1) and 12-year mortality., Methods: We analyzed longitudinal data from the Lung Health Study, a clinical trial of intensive smoking cessation intervention with or without bronchodilator therapy in 5,887 smokers with mild to moderate airflow obstruction. Participants were stratified into bins of baseline FEV(1) to FVC ratio, using bins of 5%, and separately into bins of Z-score (difference between actual and predicted FEV(1)/FVC, normalized to SD of predicted FEV(1)/FVC). Associations between spirometric measures and FEV(1) decline and mortality were determined after adjusting for baseline characteristics and time-varying smoking status., Measurements and Main Results: The cohort was approximately two-thirds male, predominantly of white race (96%), and with mean age of 49 ± 7 years. In general, individuals with lower lung function by any metric had more rapid adjusted FEV(1) decline. A threshold for differential decline was present at FEV(1)/FVC less than 0.65 (P < 0.001) and Z-score less than -2 (2.3 percentile) (P < 0.001). At year 12, 575 (7.2%) of the cohort had died. Lower thresholds of each spirometric metric were associated with increasing adjusted hazard of death., Conclusions: Smokers at risk or with mild to moderate chronic obstructive pulmonary disease have accelerated lung function decline. Individuals with lower baseline FEV(1)/FVC have more rapid decline and worse mortality.

Participant attrition and attendance at follow-up were examined in a multicenter, randomized, clinical trial. The Lung Health Study (LHS) enrolled a total of 5887 adults to examine the impact of smoking cessation coupled with the use of an inhaled bronchodilator on chronic obstructive pulmonary disease (COPD). Of the initial LHS 1 volunteers still living at the time of enrolment in LHS 3 (5332), 4457 (84%) attended the LHS 3 clinic visit, a follow-up session to determine current smoking status and lung function. The average period between the beginning of LHS 1 and baseline interview for LHS 3 was 11 years. In univariate analyses, attenders were older, more likely female, more likely to be married, smoked fewer cigarettes per day, and were more likely to have children who smoked at the start of LHS 1 than non-attenders. Attenders were also less likely to experience respiratory symptoms, such as cough, but had decreased baseline lung function compared with non-attenders. Volunteers recruited via mass mailing were more likely to attend the long-term follow-up visit. Those recruited by public site, worksite, or referral methods were less likely to attend. In multivariate models, age, gender, cigarettes smoked per day, married status, and whether participants' children smoked were identified as significant predictors of attendance versus non-attendance at LHS 3 using stepwise logistic regression. Treatment condition (smoking intervention or usual care) was not a significant predictor of attendance at LHS 3. Older females who smoked less heavily were most likely to participate. These findings may be applied to improve participant recruitment and retention in future clinical trials.

Background: Randomized clinical trials have not yet demonstrated the mortality benefit of smoking cessation., Objective: To assess the long-term effect on mortality of a randomly applied smoking cessation program., Design: The Lung Health Study was a randomized clinical trial of smoking cessation. Special intervention participants received the smoking intervention program and were compared with usual care participants. Vital status was followed up to 14.5 years., Setting: 10 clinical centers in the United States and Canada., Patients: 5887 middle-aged volunteers with asymptomatic airway obstruction., Measurements: All-cause mortality and mortality due to cardiovascular disease, lung cancer, and other respiratory disease., Intervention: The intervention was a 10-week smoking cessation program that included a strong physician message and 12 group sessions using behavior modification and nicotine gum, plus either ipratropium or a placebo inhaler., Results: At 5 years, 21.7% of special intervention participants had stopped smoking since study entry compared with 5.4% of usual care participants. After up to 14.5 years of follow-up, 731 patients died: 33% of lung cancer, 22% of cardiovascular disease, 7.8% of respiratory disease other than cancer, and 2.3% of unknown causes. All-cause mortality was significantly lower in the special intervention group than in the usual care group (8.83 per 1000 person-years vs. 10.38 per 1000 person-years; P = 0.03). The hazard ratio for mortality in the usual care group compared with the special intervention group was 1.18 (95% CI, 1.02 to 1.37). Differences in death rates for both lung cancer and cardiovascular disease were greater when death rates were analyzed by smoking habit., Limitations: Results apply only to individuals with airway obstruction., Conclusion: Smoking cessation intervention programs can have a substantial effect on subsequent mortality, even when successful in a minority of participants.

Background: The Lung Health Study (LHS), a 5-year, randomized, prospective clinical trial, studied the effects of smoking intervention and therapy with inhaled anticholinergic bronchodilators on FEV(1) in participants who were 35 to 60 years of age and had mild COPD. Participants were randomized into the following three groups: usual care; smoking cessation plus inhaled ipratropium bromide; and smoking cessation plus placebo inhaler. This report evaluates the effects of these interventions, demographic characteristics, smoking status, and FEV(1) changes on airway responsiveness (AR)., Methods and Results: Of 5,887 participants, 4,201 underwent methacholine challenge testing both at study entry and study completion. All groups increased AR during the 5-year period. The increase in AR was greatest in continuing smokers and was associated with a greater FEV(1) decline. An intent-to-treat analysis indicated no significant differences in AR changes among the three groups., Conclusions: Changes in AR over a 5-year period in the LHS were primarily related to changes in the FEV(1). The greater the decline in FEV(1), the greater the increase in AR. Smoking cessation had a small additional benefit in AR beyond its favorable effects on FEV(1) changes.

Lung Health Study participants were smokers aged 35-60 years with mild lung function impairment who participated in a 5-year, 10-center (nine in the United States, one in Canada) clinical trial in 1986-1994. The authors compared the relation of randomized treatment assignments and of smoking history during the study with changes in lung function between men and women. Spirometry was performed annually, and 3,348 men and 1,998 women attended the follow-up clinic visit that included spirometry at year 5. This paper reports on an analysis of changes in lung function by gender, treatment group, and three smoking history categories: sustained quitters, intermittent quitters, and continuing smokers. Among participants who quit smoking in the first year, mean forced expiratory volume in 1 second (FEV(1)) expressed as a percentage of the predicted value of FEV(1 )given the person's age, height, gender, and race (FEV(1)%) increased more in women (3.7% of predicted) than in men (1.6% of predicted) (p < 0.001). Across the 5-year follow-up period, among sustained quitters, women gained more in FEV(1)% of predicted than did men. Methacholine reactivity was more strongly related to rates of decline in women than in men (p < 0.001). Therefore, among persons at risk for chronic obstructive pulmonary disease, smoking cessation has an even clearer advantage for women than it does for men.

Background: Research on the long-term persistence of effects of interventions aimed at smoking cessation is limited. This paper examined the quitting behavior of individuals who were randomized to a smoking cessation intervention (SI) or to usual care (UC), at a point approximately 11 years later., Methods: The initial sample consisted of 5,887 adult smokers in 10 clinics who had evidence of airways obstruction. Two-thirds of the original participants were offered an intensive 12-week smoking cessation intervention. Of these, 4,517 were enrolled in the long-term follow-up study., Results: Randomized group assignment was a strong predictor of smoking behavior after 11 years, in that 21.9% of SI participants and only 6.0% of UC participants maintained abstinence throughout the interval. Logistic regressions identified covariates associated with abstinence. A higher proportion of abstinence was observed in participants that had been assigned to SI (OR = 4.45), were older (OR = 1.11, increment 5 years), had more years of education (OR = 1.05), and fewer cigarettes/day at baseline (OR = 0.90, increment 10 cigarettes)., Conclusions: Smokers exposed to an aggressive smoking intervention program and who sustain abstinence for a five-year period are very likely to still be abstinent after 11 years., (Copyright 2002 American Health Foundation and Elsevier Science (USA))

Eleven years after Lung Health Study (LHS) entry, we performed spirometry in 77.4% of surviving participants who enrolled in a long-term follow-up study. Those not enrolling tended to be younger male heavy smokers who continued to smoke during the LHS. Their initial LHS lung function, after adjustment for these factors, did not differ from that of enrollees. Smoking habits by original LHS treatment groups (smoking intervention vs. usual care) tended to converge, but 93% of participants who were abstinent throughout the LHS were still abstinent at 11 years. Differences in lung function between treatment groups persisted; smoking intervention participants had less decline in FEV(1) than usual care participants. Men who quit at the beginning of the LHS had an FEV(1) rate of decline of 30.2 ml/year, whereas women who quit declined at 21.5 ml/year. Men continuing to smoke throughout the 11 years declined by 66.1 ml/year, and women continuing to smoke declined by 54.2 ml/year. When decline in FEV(1) was expressed as a percentage of predicted normal value, no significant sex-based difference was apparent among continuing smokers. At 11 years, 38% of continuing smokers had an FEV(1) less than 60% of the predicted normal value compared with 10% of sustained quitters.

We describe the persistence of discrepancies between biochemical measures of smoking and self-reported smoking status in a cohort of clinical trial participants across 5 years. The Lung Health Study, a randomized trial in 10 clinical centers in North America, enrolled 3923 participants in smoking intervention and 1964 in usual care in 1987 and 1988. Smoking status was assessed at baseline and at five annual follow-up visits by self-report, salivary cotinine and expired-air carbon monoxide. Compared to self-report, sensitivity and specificity of cotinine and carbon monoxide were similar across 5 years. Evidence of error in self-reports of quitting smoking persisted across 5 years, although it declined over time. Multivariate models confirmed that self-report bias was characteristic of the early years in the study. Significant covariates differed between cotinine and carbon monoxide models. When cotinine was used for verification, about half of the individuals in the smoking intervention group with self-report bias at the first year continued to exhibit bias for 5 years. In absolute terms, the errors associated with measurement were small, but they persisted over 5 years. Some differences appeared to be related to the distinction that carbon monoxide verification was immediate, while cotinine verification was deferred.

This report deals with deaths and hospitalizations during the 5-year Lung Health Study, as documented by examination of appropriate records. There were 149 deaths (2.5%) during the study, caused largely by lung cancer and cardiovascular disease, particularly coronary heart disease. A total of 12.8% of participants were hospitalized, with cancer, cardiovascular disease, and nonmalignant respiratory disease accounting for 75% of hospitalizations. There were no significant differences among the original treatment groups for all-cause mortality, lung cancer, or hospitalizations for respiratory disease. Deaths and hospitalizations for cardiovascular disease and coronary artery disease were more common in the smoking intervention plus Atrovent inhaler (SI-A) group, which received ipratropium bromide, than in the smoking intervention plus placebo inhaler (SI-P) group, which received placebo, and the differences approached statistical significance. However, we were unable to find a dose effect, in that differences were not related to self-reported inhaler compliance. In the SI-A group, nine participants were hospitalized for supraventricular tachycardia as compared with two in the SI-P group, and SI-A participants with this condition were unusually compliant with their inhaled medication. When all participants were considered and smoking status considered as a time-dependent covariate, smoking cessation was associated with significant reductions in fatal or nonfatal cardiovascular disease and coronary artery disease.

Whether menthol cigarettes confer a higher risk of death than plain cigarettes is not known. The Lung Health Study (LHS) enrolled 5,887 adult smokers in a clinical trial of smoking cessation and ipratropium in the prevention of chronic obstructive pulmonary disease. LHS participants have been subjected to surveillance for mortality from all causes for 14 years. We examined these data for differences between self-reported smokers of menthol cigarettes versus plain cigarettes. Using proportional hazards regression methods, we found no differences in hazard ratios for coronary heart disease, cardiovascular disease, lung cancer, or death from any cause. Contrary to expectations about nicotine dependence, we found that users of menthol cigarettes had smoked fewer pack-years at baseline. We found no difference in success at smoking cessation with or without menthol. We conclude that our data contain no evidence that mentholation of cigarettes increases the hazards of smoking. [ABSTRACT FROM AUTHOR]

We examined the ability of smokers who failed to quit smoking in the Lung Health Study to reduce the number of cigarettes per day and maintain this reduction and whether reduction predicted increased or decreased future cessation. In the Lung Health Study, among smokers with early lung disease who wished to stop smoking, 3,923 were randomized to a special intervention of counseling and nicotine gum for smoking cessation and to bronchodilator therapy or placebo. Among the 1,722 who were still smoking at the first year follow-up, 27% smoked the same, 43% smoked 1%-49% fewer, and 30% smoked at least 50% fewer cigarettes per day. Reduction in cigarettes per day was accompanied by reduction in expired-air carbon monoxide. About half of the less-than-50% reducers and one-fifth of the at-least-50% reducers maintained or exceeded this reduction over the next 4 years. Reduction was associated with nicotine gum use. Greater reduction at year 1 predicted more quit attempts in year 2 but not more point prevalence abstinence at year 2 nor more quits or abstinence between years 2 and 5. We conclude that reduction can be maintained but such reduction neither predicts an increased nor decreased probability of future cessation. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effects of randomly assigning smokers who have early chronic obstructive pulmonary disease (COPD) to a smoking-cessation intervention on the symptoms of chronic cough, chronic phlegm production, wheezing and shortness of breath, and to determine the effects of quitting smoking on these symptoms.Subjects and Methods: A total of 5,887 male and female smokers 35 to 60 years of age with early COPD [defined as a forced expiratory volume in the first second (FEV1) of 55% to 90% of predicted and FEV1/forced vital capacity (FVC) <0.70] were enrolled in a 5-year clinical trial. Two-thirds of participants were randomly assigned to smoking-intervention groups and one-third to a usual-care group. The intervention groups attended 12 intensive smoking-cessation sessions that included behavior modification techniques and the use of nicotine chewing gum. One intervention group was treated with ipratropium bromide by inhaler; the other intervention group received placebo inhalers. The usual-care group was advised to stop smoking. All participants were followed annually. Smoking status was biochemically validated by salivary cotinine measurements or exhaled carbon monoxide values.Results: Validated 5-year sustained smoking cessation occurred in 22% of participants in the intervention compared with only 5% of participants in the usual-care group. At the end of the study, the prevalence of each of the four symptoms in the two intervention groups was significantly less than in the usual-care group (P <0.0001). For example, among participants who did not report cough at baseline, 15% of those in the intervention groups had cough at least 3 months during the year, compared with 23% of those in usual care. Sustained quitters had the lowest prevalence of all four symptoms, whereas continuous smokers had the greatest prevalence of these symptoms. Changes in symptoms occurred primarily in the first year after smoking cessation. Respiratory symptoms were associated with greater declines in FEV1 during the study (P <0.001). Ipratropium bromide had no long-term effects on respiratory symptoms.Conclusions: In this prospective randomized trial using an intention-to-treat analysis, smokers with early COPD who were assigned to a smoking-cessation intervention had fewer respiratory symptoms after 5 years of follow-up. [ABSTRACT FROM AUTHOR]

Objectives. Sources of measurement error in assessing smoking status are examined. Methods. The Lung Health Study, a randomized trial in 10 clinical centers, includes 3923 participants in a smoking cessation program and 1964 usual care participants. Smoking at first annual follow-up was assessed by salivary cotinine, expired air carbon monoxide, and self-report. Each of these measures is known to contain some error. Sensitivity and specificity were calculated by comparing a biochemical measure with self-report to produce an undifferentiated estimate of error. Classification error rates due to imprecision of the biochemical measures and to the error in self-report were estimated separately. Results. For cotinine compared with self-report, the sensitivity was 99.0% and the specificity 91.5%. For carbon monoxide compared with self-report the sensitivity was 93.7% and the specificity 87.2%. The classification error attributed to self-report, estimated by comparing the results from intervention and control groups, was associated with the responses of 3% and 5% of participants, indicating a small but significant bias towards a socially desirable response. Conclusions. In absolute terms in these data, both types of error were small. [ABSTRACT FROM AUTHOR]

Investigates the effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of forced expiratory volume in one second (FEV1). Profile of subjects; Features of the 12-session smoking cessation program; Spirometry; Compliance monitoring.

Objectives. An analysis of gender differences in smoking cessation was conducted among 3923 participants in the Special Intervention group of the Lung Health Study. This report focuses on gender differences in sustained quit rates at 12 and 36 months. Methods. Special Intervention participants were offered a 12-session, 12-week smoking cessation program using nicotine gum and were followed for 3 years. Self-reported smoking status was validated with carbon monoxide and salivary cotinine. Results. Men had higher sustained quit rates at 12 and 36 months; gender differences were found in baseline variables that also predicted sustained abstinence; and controlling for selected baseline variables reduced the association between gender and sustained abstinence. When other variables were controlled, gender predicted sustained abstinence at 36 months (odds ratio [OR] = 1.24, 95% confidence interval [CI] = 1.04, 1.48) but not 12 months (OR = 1.08, 95% CI = 0.92,1.27), reflecting more late relapse among women. Conclusions. Demographics and smoking history were more important than gender per se in sustained smoking cessation in the Lung Health Study. Programs tailoring smoking cessation by gender need to include coping skills for problems associated with less education and social support and for improving persistence with quit attempts. [ABSTRACT FROM AUTHOR]

The authors examine weight gains associated with smoking cessation in the Lung Health Study (1986–1994) over a 5-year follow-up period. A cohort of 5,887 male and female smokers in the United States and Canada, aged 35–60 years, were randomized to either smoking intervention or usual care. Among participants who achieved sustained quitting for 5 years, women gained a mean of 5.2 (standard error, 5.0) kg in year 1 and a mean of 3.4 (standard error, 5.5) kg in years 1–5. Men gained a mean of 4.9 (standard error, 4.9) kg in year 1 and a mean of 2.6 (standard error, 5.8) kg in years 1–5. In regression analyses, smoking-change variables were the most potent predictors of weight change. Participants going from smoking to quit-smoking in a given year had mean weight gains of 2.95 kg/year (3.61%) in men and 3.09 kg/year (4.69%) in women. Over 5 years, 33% of sustained quitters gained ≥10 kg compared with 6% of continuing smokers. Also among sustained quitters, 7.6% of men and 19.1% of women gained ≥20% of baseline weight; 60% of the gain occurred in year 1, although significant weight gains continued through year 5. The average gains and the high proportions of sustained and intermittent quitters who gained excessive weight suggest the need for more effective early interventions that address both smoking cessation and weight control. Am J Epidemiol 1998; 148:821–30. [ABSTRACT FROM AUTHOR]