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JAMA Netw Open
JAMA Netw Open
JAMA Network Open
2574-3805
American Medical Association

39287950
10.1001/jamanetworkopen.2024.33802
zld240155
Research
Research Letter
Online Only
Public Health
Desire to Quit Smoking, Opt-Out Tobacco Treatment, and Cessation
A Secondary Analysis of a Randomized Clinical Trial
Desire to Quit Smoking, Opt-Out Tobacco Treatment, and Cessation
Desire to Quit Smoking, Opt-Out Tobacco Treatment, and Cessation
Gajewski Byron PhD 1 3
Faseru Babalola MD MPH 2 3
Richter Kimber P. PhD MPH 2 3
1 Department of Biostatistics and Data Science, University of Kansas School of Medicine, Kansas City
2 Department of Population Health, University of Kansas School of Medicine, Kansas City
3 University of Kansas Cancer Center, Kansas City
Article Information

Accepted for Publication: July 20, 2024.

Published: September 17, 2024. doi:10.1001/jamanetworkopen.2024.33802

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2024 Gajewski B et al. JAMA Network Open.

Corresponding Author: Byron Gajewski, PhD, Department of Biostatistics and Data Science, University of Kansas School of Medicine, 3901 Rainbow Blvd, Kansas City, KS 66160 (bgajewski@kumc.edu).
Author Contributions: Dr Richter had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Gajewski.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Gajewski.

Obtained funding: Gajewski, Richter.

Administrative, technical, or material support: Faseru, Richter.

Conflict of Interest Disclosures: None reported.

Funding/Support: This project was funded by grants R01HL131512 from the National Heart, Lung, and Blood Institute to Dr Richter; P20GM139733 from the National Institute of General Medical Sciences of the National Institutes of Health to Dr Richter; and P30CA168524 for use of the Biostatistics and Informatics Shared Resource and Clinical Pharmacology Shared Resource from the Comprehensive University of Kansas Cancer Center.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Data Sharing Statement: See Supplement 2.

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https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the CC-BY License.
jamanetwopen-e2433802.pdf

This secondary analysis of a randomized clinical trial examines whether an individual’s desire to quit interacts with the association between opt-out tobacco treatment and 1-month quit rates.
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pmcIntroduction

A randomized clinical trial (RCT) demonstrated that opt-out treatment achieved higher verified quit rates (22%) than opt-in treatment (16%) 1 month after randomization.1 When people who smoke have a higher desire to quit before treatment, they have a higher rate of smoking cessation.2 Understanding how individuals respond to different smoking cessation treatment approaches could guide clinical personalized decision-making. We wanted to know if the opt-out effect was diminished if the participant had less desire to quit when initially approached.

Methods

The parent study for this secondary analysis of an RCT (not prespecified) was a bayesian adaptive population-based RCT among people who smoked who were patients at a hospital. The trial protocol was previously published (Supplement 1).1 Patients were randomized to opt-out treatment (counselors and medical staff provided inpatient nicotine replacement therapy, prescriptions for postdischarge medications, a 2-week medication starter kit, treatment planning, and 4 outpatient counseling calls) or opt-in treatment (counselors and medical staff provided the same only to patients willing to quit) and consented to participation at a 1-month follow-up. For patients receiving opt-out treatment, staff arranged for inpatient medications to manage withdrawal, completed a treatment plan with patients, assisted patients in selecting a cessation medication for prescription on discharge, and described outpatient follow-up. Unless patients opted out of all elements of the treatment plan, they received all elements of care. Patients in the opt-in group were offered and received the elements of care they opted in to receive. The original study was approved by the University of Kansas Medical Center Institutional Review Board and followed the CONSORT reporting guideline.1 The University of Kansas Medical Center determined that this study did not require additional review, approval, or consent given that data were deidentified.

Patients were asked to “Choose a number between zero and ten that indicates where you are now at in thinking about quitting smoking, 0 = I have no thoughts about quitting smoking, 10 = I am taking action to quit smoking” (Figure 1). We assessed the association of the desire to quit and its interaction with the group with month 1 of abstinence using bayesian logistic regression. We explored multiple models with various complexities, including a normal dynamic linear model (NDLM), an aggregate model, an NDLM but with a fixed opt-out effect, a separate model, and a pooled model. We selected the best model (ie, with the lowest deviance information criteria) for final inference. Analyses were conducted for consented participants only using OpenBUGS software version 3.2.3 revision 1012 (OpenBUGS Foundation). For each level of desire to quit smoking, we calculated the 1-sided posterior probability that opt-out was better than opt-in treatment. The level of significance was 5% in the original trial design.

Figure 1. Baseline Desire to Quit Smoking

Results

Among 739 participants (mean [SD] age, 51.4 [14.7] years; 349 females [47.2%]), as the desire to quit increased, smoking abstinence rates increased. However, the treatment effect of opt-out treatment stayed at a posterior probability of 0.976 (opt-out at level 0 desire to quit, 8% [95% CI, 3%-16%]; opt-out at level 10 desire to quit, 32% [95% CI, 25%-40%]). Figure 2 shows the NDLM with a fixed-effect opt-out effect for both groups.

Figure 2. Normal Dynamic Linear Model of Opt-Out Effect

Opt-in and opt-out groups are shown. Circles indicate observed rates.

Discussion

In this secondary analysis of an RCT, the lower baseline desire to quit smoking had an approximately 25–percentage point absolute lower abstinence rate than the highest desire to quit smoking. The opt-out effect was not diminished if the participant had less desire to quit when initially approached. These findings may inform clinical decision-making. Even though people with a lower desire to quit had lower quit rates, the advantage of opt-out treatment was constant. This suggests that people may benefit from opt-out treatment regardless of their level of desire to quit. This study was limited to people who were hospitalized and smoked from a Midwestern hospital, and the outcome was relatively short, at 1 month.

Supplement 1. Trial Protocol and Statistical Analysis Plan

Supplement 2. Data Sharing Statement
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References

1 Richter KP, Catley D, Gajewski BJ, . The effects of opt-out vs opt-in tobacco treatment on engagement, cessation, and costs: a randomized clinical trial. JAMA Intern Med. 2023;183 (4 ):331-339. doi:10.1001/jamainternmed.2022.7170 36848129
2 US Public Health Service Office of the Surgeon General; US National Center for Chronic Disease Prevention and Health Promotion Office on Smoking and Health. Chapter 6: interventions for smoking cessation and treatments for nicotine dependence. In: US Public Health Service Office of the Surgeon General; US National Center for Chronic Disease Prevention and Health Promotion Office on Smoking and Health, eds. Smoking Cessation: A Report of the Surgeon General. US Department of Health and Human Services; 2020:493-575. Accessed August 12, 2024. https://www.ncbi.nlm.nih.gov/books/NBK555591/pdf/Bookshelf_NBK555591.pdf
