Publications

BACKGROUND

Tobacco companies are introducing new 'heat-not-burn' cigarettes in dozens of countries. Historically, these products failed commercially, and independent researchers contested their health claims. The most prominent early heat-not-burn cigarette was RJ Reynolds's (RJR's) Premier, introduced in the USA in 1988. Curiously, endorsed Premier as a 'near-perfect low tar cigarette' in a 1991 editorial, 2 years after Premier had been removed from the market. We examined the context of this endorsement.

METHODS

To ascertain what RJR knew about this endorsement, we systematically searched and analysed previously secret RJR documents in public archives and triangulated the industry document data with other published work.

RESULTS

RJR had a long-standing interest in collaborating with outside scientists to endorse potentially reduced harm cigarettes. The author of editorial had previously corresponded with RJR regarding Premier's health effects and market potential. Internally, RJR regarded 's editorial, its stance on novel tobacco products, and its endorsement of Premier as major successes. While the editorial came too late to save Premier, RJR saw future business opportunities for novel products if endorsed by health authorities.

CONCLUSIONS

Endorsement by high-impact medical journals and health authorities may be critical in helping heat-not-burn' products succeed where previous attempts have failed. Conflicts of interest influenced these endorsements in the past. Health leaders and academic journals should consider both conflicts of interest and the ethics of endorsing tobacco product substitution, as tobacco companies simultaneously work to promote cigarette smoking and undermine tobacco control globally.

Introduction

Electronic nicotine delivery systems (ENDS) are used to aid smoking cessation attempts; however, many smokers continue to smoke while using an ENDS (dual use). Although uncertainty remains regarding whether specific ENDS patterns hinder or support successful smoking cessation, recent advances in "smart" technology allow passive and active recording of behaviors in real time, enabling more detailed insights into how smoking and vaping patterns may coevolve. We describe patterns of ENDS initiation, and subsequent use, including any changes in cigarette consumption, among daily smokers using a "smart" ENDS (S-ENDS) to quit smoking.

Method

An 8-week long mixed-methods feasibility study used Bluetooth-enabled S-ENDS that passively recorded real-time device use by participants (n = 11). Daily surveys administered via smartphones collected data on self-reported cigarette consumption.

Results

All 11 participants were dual users, at least initially, during their quit attempt. We observed three provisional vaping and smoking patterns: immediate and intensive ENDS initiation coupled with immediate, dramatic, and sustained smoking reduction, leading to smoking abstinence; gradual ENDS uptake with gradual smoking reductions, leading to daily dual use throughout the study period; and ENDS experimentation with return to exclusive smoking. For six participants, the patterns observed in week 1 were similar to the vaping and smoking patterns observed throughout the rest of the study period.

Conclusion

Technological advances now allow fine-grained description of ENDS use and smoking patterns. Larger and longer studies describing smoking-to-vaping patterns, and estimating associations with smoking outcomes, could inform ENDS-specific cessation advice promoting full transition from smoking to exclusive ENDS use.

Implications

The use of an S-ENDS that recorded real-time device use among daily smokers engaged in a quit attempt provides insight into patterns and trajectories of dual use (continuing to smoke while using ENDS), and the possible associations between ENDS initiation, subsequent use, and smoking cessation outcomes. Such work could support more targeted cessation counseling and technical advice for smokers using ENDS to quit smoking, reduce the risk of users developing long-term dual use patterns, and enhance the contributions ENDS may make to reducing smoking prevalence.

Background

Primary care models that offer comprehensive, accessible care to all patients may provide insufficient resources to meet the needs of patients with complex conditions who have the greatest risk for hospitalization.

Objective

To assess whether augmenting usual primary care with team-based intensive management lowers utilization and costs for high-risk patients.

Design

Randomized quality improvement trial. (ClinicalTrials.gov: NCT03100526).

Setting

5 U.S. Department of Veterans Affairs (VA) medical centers.

Patients

Primary care patients at high risk for hospitalization who had a recent acute care episode.

Intervention

Locally tailored intensive management programs providing care coordination, goals assessment, health coaching, medication reconciliation, and home visits through an interdisciplinary team, including a physician or nurse practitioner, a nurse, and psychosocial experts.

Measurements

Utilization and costs (including intensive management program expenses) 12 months before and after randomization.

Results

2210 patients were randomly assigned, 1105 to intensive management and 1105 to usual care. Patients had a mean age of 63 years and an average of 7 chronic conditions; 90% were men. Of the patients assigned to intensive management, 487 (44%) received intensive outpatient care (that is, ≥3 encounters in person or by telephone) and 204 (18%) received limited intervention. From the pre- to postrandomization periods, mean inpatient costs decreased more for the intensive management than the usual care group (-$2164 [95% CI, -$7916 to $3587]). Outpatient costs increased more for the intensive management than the usual care group ($2636 [CI, $524 to $4748]), driven by greater use of primary care, home care, telephone care, and telehealth. Mean total costs were similar in the 2 groups before and after randomization.

Limitations

Sites took up to several months to contact eligible patients, limiting the time between treatment and outcome assessment. Only VA costs were assessed.

Conclusion

High-risk patients with access to an intensive management program received more outpatient care with no increase in total costs.

Primary Funding Source

Veterans Health Administration Primary Care Services.