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A systematic approach to subgroup analyses in a smoking cessation trial.

ABSTRACT: BACKGROUND:Traditional approaches to subgroup analyses that test each moderating factor as a separate hypothesis can lead to erroneous conclusions due to the problems of multiple comparisons, model misspecification, and multicollinearity. OBJECTIVE:To demonstrate a novel, systematic approach to subgroup analyses that avoids these pitfalls. METHODS:A Best Approximating Model (BAM) approach that identifies multiple moderators and estimates their simultaneous impact on treatment effect sizes was applied to a randomized, controlled, 11-week, double-blind efficacy trial on smoking cessation of adult smokers with attention-deficit/hyperactivity disorder (ADHD), randomized to either OROS-methylphenidate (n?=?127) or placebo (n?=?128), and treated with nicotine patch. Binary outcomes measures were prolonged smoking abstinence and point prevalence smoking abstinence. RESULTS:Although the original clinical trial data analysis showed no treatment effect on smoking cessation, the BAM analysis showed significant subgroup effects for the primary outcome of prolonged smoking abstinence: (1) lifetime history of substance use disorders (adjusted odds ratio [AOR] 0.27; 95% confidence interval [CI] 0.10-0.74), and (2) more severe ADHD symptoms (baseline score >36; AOR 2.64; 95% CI 1.17-5.96). A significant subgroup effect was also shown for the secondary outcome of point prevalence smoking abstinence--age 18 to 29 years (AOR 0.23; 95% CI 0.07-0.76). CONCLUSIONS:The BAM analysis resulted in different conclusions about subgroup effects compared to a hypothesis-driven approach. By examining moderator independence and avoiding multiple testing, BAMs have the potential to better identify and explain how treatment effects vary across subgroups in heterogeneous patient populations, thus providing better guidance to more effectively match individual patients with specific treatments.

SUBMITTER: Westover AN

PROVIDER: S-EPMC4817346 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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A systematic approach to subgroup analyses in a smoking cessation trial.

Westover Arthur N AN Kashner T Michael TM Winhusen Theresa M TM Golden Richard M RM Nakonezny Paul A PA Adinoff Bryon B Henley Steven S SS

The American journal of drug and alcohol abuse 20150611 6

<h4>Background</h4>Traditional approaches to subgroup analyses that test each moderating factor as a separate hypothesis can lead to erroneous conclusions due to the problems of multiple comparisons, model misspecification, and multicollinearity.<h4>Objective</h4>To demonstrate a novel, systematic approach to subgroup analyses that avoids these pitfalls.<h4>Methods</h4>A Best Approximating Model (BAM) approach that identifies multiple moderators and estimates their simultaneous impact on treatme ...[more]

PMID: 26065433

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Project description:IntroductionHispanic/Latinx smokers in the United States are often treated as a homogeneous group. However, population-based studies suggest that cigarette use differs among Hispanic/Latinx subgroups by sociodemographic or sociocultural characteristics. This secondary analysis aimed to advance the limited literature by examining differences in smoking-related variables.Aims and methodsWe used baseline data from a randomized controlled trial testing a self-help Spanish-language smoking cessation intervention. Puerto Rican (PR), Mexican, and Cuban, the three largest Hispanic/Latinx subgroups in the sample (N = 1028), were first compared on sociodemographic and sociocultural variables (acculturation and familism). Primary analyses assessed subgroup differences in cigarette use variables (eg, cigarettes per day [CPD], nicotine dependence [Fagerström Test for Nicotine Dependence], and daily smoking) and smoking-related cognitive constructs (motivation to quit, smoking outcome expectancies, and abstinence self-efficacy) controlling for sociodemographic and sociocultural variables. Additional analyses explored differences between men and women within subgroups.ResultsMexicans exhibited the lowest levels of daily smoking (90% vs. 95% Cubans and 96% PR; p = .001), CPD (M = 13.5, SD = 9.5 vs. M = 20.1, SD = 9.9 Cubans and M = 16.7, SD = 10.1 PR; p = .016), and nicotine dependence (M = 4.2, SD = 2.3 vs. M = 6.0, SD = 2.1 Cubans and M = 5.7, SD = 2.2 PR; p < .001), with no differences between PRs and Cubans. Within-subgroup comparisons between men and women showed the most differences among PRs (eg, men were more nicotine dependent [M = 6.0, SD = 1.9] than women [M = 5.4, SD = 2.3; p = .041]) and Cubans (eg, men smoked more CPD [M = 22.2, SD = 12.2] than women [M = 19.3, SD = 12.0; p = .042]), and the fewest among Mexicans.ConclusionsFindings support heterogeneity within Hispanic/Latinx smokers and highlight the potential utility of examining sociodemographic, sociocultural, and smoking characteristics important for developing salient cessation interventions.ImplicationsFindings demonstrate that treatment-seeking Hispanic/Latinx smokers in the United States differ in sociodemographic, sociocultural, and smoking-related variables (cigarette use and smoking-related cognitive constructs) by subgroup (ie, PR, Mexican, and Cuban) and within subgroups by sex. These differences suggest that heterogeneity among subgroups should be considered when developing cessation interventions for Hispanics/Latinxs. Future research should examine how differences in sociodemographic and smoking-related variables impact intervention outcomes and explore the role of sociocultural factors (eg, acculturation and familism) as determinants of cessation.

Project description:The focus on acute care, time pressure, and lack of resources hamper the delivery of smoking cessation interventions in the emergency department (ED). The aim of this study was to 1) determine the effect of an emergency nurse-initiated intervention on delivery of smoking cessation counseling based on the 5As framework (ask-advise-assess-assist-arrange) and 2) assess ED nurses' and physicians' perceptions of smoking cessation counseling.The authors conducted a pre-post trial in 789 adult smokers (five or more cigarettes/day) who presented to two EDs. The intervention focused on improving delivery of the 5As by ED nurses and physicians and included face-to-face training and an online tutorial, use of a charting/reminder tool, fax referral of motivated smokers to the state tobacco quitline for proactive telephone counseling, and group feedback to ED staff. To assess ED performance of cessation counseling, a telephone interview of subjects was conducted shortly after the ED visit. Nurses' and physicians' self-efficacy, role satisfaction, and attitudes toward smoking cessation counseling were assessed by survey. Multivariable logistic regression was used to assess the effect of the intervention on performance of the 5As, while adjusting for key covariates.Of 650 smokers who completed the post-ED interview, a greater proportion had been asked about smoking by an ED nurse (68% vs. 53%, adjusted odds ratio [OR] = 2.0, 95% confidence interval [CI] = 1.3 to 2.9), assessed for willingness to quit (31% vs. 9%, adjusted OR= 4.9, 95% CI = 2.9 to 7.9), and assisted in quitting (23% vs. 6%, adjusted OR = 5.1, 95% CI = 2.7 to 9.5) and had arrangements for follow-up cessation counseling (7% vs. 1%, adjusted OR = 7.1, 95% CI = 2.3 to 21) during the intervention compared to the baseline period. A similar increase was observed for emergency physicians (EPs). ED nurses' self-efficacy and role satisfaction in cessation counseling significantly improved following the intervention; however, there was no change in "pros" and "cons" attitudes toward smoking cessation in either ED nurses or physicians.Emergency department nurses and physicians can effectively deliver smoking cessation counseling to smokers in a time-efficient manner. This trial also provides empirical support for expert recommendations that call for nursing staff to play a larger role in delivering public health interventions in the ED.

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A systematic approach to subgroup analyses in a smoking cessation trial.

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A systematic approach to subgroup analyses in a smoking cessation trial.

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