Dataset Information

Compliance in Controlled E-cigarette Studies.

ABSTRACT:

Introduction

E-cigarette studies have found that the use of a variety of flavors and customizable devices results in greater use frequency and user satisfaction. However, standardized research e-cigarettes are being developed as closed systems with limited flavor options, potentially limiting user satisfaction. In this study, we explore protocol compliance in an e-cigarette study using a standardized, assigned device with puff time and duration tracking (controlled e-cigarette) and potential limitations that controlled devices and e-liquids can introduce.

Methods

In a crossover study, 49 young adult e-cigarette users were recruited using convenience sampling and assigned a controlled e-cigarette device and flavored or unflavored e-liquids on standardized protocols. E-cigarette use frequency (number of puffs per day, collected from the device) and serum cotinine levels were obtained at each of three study visits over 3 weeks. The correlation of cotinine and e-cigarette use over the preceding week was calculated at each study visit.

Results

Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (R2 = 0.53 and p ? .01 in week 1, R2 < 0.5 and p > .05 for remaining weeks).

Conclusions

There is an emerging need for controlled e-cigarette exposures studies, but low compliance in the use of assigned devices and e-liquids may be a limitation that needs to be mitigated in future studies.

Implications

This study is the first to analyze compliance with instructions to use a standardized e-cigarette device with puff time and duration tracking (controlled e-cigarette) across all subjects and an assigned e-liquid flavor over a 3-week period. We find that protocol compliance, as measured by correlations between e-cigarette use measures and cotinine levels, was only achieved in the first week of the study and declined thereafter. These findings indicate that the assignment of a study device and instruction to only use the study device with assigned e-liquid flavor may not be sufficient to ensure participant compliance with the study protocol. We suggest that additional measures, including behavioral and biological markers, are needed to ensure sole use of the study e-cigarette and e-liquid and to be able to interpret results from controlled e-cigarette studies.

SUBMITTER: Rebuli ME

PROVIDER: S-EPMC7885789 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Compliance in Controlled E-cigarette Studies.

Rebuli Meghan E ME Liu Feifei F Urman Robert R Barrington-Trimis Jessica L JL Eckel Sandrah P SP McConnell Rob R Jaspers Ilona I

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20210201 3

<h4>Introduction</h4>E-cigarette studies have found that the use of a variety of flavors and customizable devices results in greater use frequency and user satisfaction. However, standardized research e-cigarettes are being developed as closed systems with limited flavor options, potentially limiting user satisfaction. In this study, we explore protocol compliance in an e-cigarette study using a standardized, assigned device with puff time and duration tracking (controlled e-cigarette) and poten ...[more]

PMID: 31993664

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Project description:INTRODUCTION Tobacco remains the world’s leading preventable cause of death, with the majority of tobacco-caused deaths occurring in low- and middle-income countries. The first global health treaty, the Framework Convention on Tobacco Control (FCTC), outlines a set of policy initiatives that have been demonstrated as effective in reducing tobacco use. Article 11 of the FCTC focuses on using the tobacco package to communicate tobacco-caused harms; it also seeks to restrict the delivery of misleading information on the pack about the product. The objective of his study is to establish a surveillance system for tobacco packs in Nigeria to assess pack compliance with in-country health warning label requirements. The Tobacco Pack Surveillance System (TPackSS) monitors whether required health warnings on tobacco packages are being implemented as intended and identifies pack designs that might violate the communication of harm-related information and undermine the impact of the country’s tobacco packaging laws. METHODS Tobacco cigarette packs were collected in three cities in 2019–2020. The intention was, to the extent possible, to construct a census of ‘unique’ pack presentations available for purchase in Nigeria. We implemented the TPackSS standardized Protocol for acquiring packs from 36 diverse neighborhoods across three cities. At the time of purchase, data on the price and place of acquisition of each pack were recorded. We photographed packs, coded, and archived them. Each pack was coded for compliance according to the current health warning label laws. Each pack was coded by two independent coders consistently. We routinely measured intercoder reliability and only retained variables for which a good level of reliability was achieved. RESULTS Across the three cities in Nigeria, the team collected 90 tobacco packs. Overall, 77% of packs evaluated for HWL compliance complied with all the relevant common indicators of HWL compliance. There was a 92% compliance with the location of the HWL (e.g. top or bottom of pack, front or back panel) with in-country requirements. Of the four compliance indicators, the size of the HWL (the minimum required coverage) showed the lowest compliance (31%) (i.e. the HWL was too small on most of the packs). Label elements (such as color contrast or content of warnings) showed 85% compliance overall. CONCLUSIONS The analysis of the packs showed various levels of compliance with Health Warning Label provisions for Nigeria. Periodic evaluations are required to ensure that minimum requirements are met.

Project description:IntroductionNon-compliance is a common challenge for researchers and may reduce the power of an intention-to-treat analysis. Whilst a per protocol approach attempts to deal with this issue, it can result in biased estimates. Several methods to resolve this issue have been identified in previous reviews, but there is limited evidence supporting their use. This review aimed to identify simulation studies which compare such methods, assess the extent to which certain methods have been investigated and determine their performance under various scenarios.MethodsA systematic search of several electronic databases including MEDLINE and Scopus was carried out from conception to 30th November 2022. Included papers were published in a peer-reviewed journal, readily available in the English language and focused on comparing relevant methods in a superiority randomised controlled trial under a simulation study. Articles were screened using these criteria and a predetermined extraction form used to identify relevant information. A quality assessment appraised the risk of bias in individual studies. Extracted data was synthesised using tables, figures and a narrative summary. Both screening and data extraction were performed by two independent reviewers with disagreements resolved by consensus.ResultsOf 2325 papers identified, 267 full texts were screened and 17 studies finally included. Twelve methods were identified across papers. Instrumental variable methods were commonly considered, but many authors found them to be biased in some settings. Non-compliance was generally assumed to be all-or-nothing and only occurring in the intervention group, although some methods considered it as time-varying. Simulation studies commonly varied the level and type of non-compliance and factors such as effect size and strength of confounding. The quality of papers was generally good, although some lacked detail and justification. Therefore, their conclusions were deemed to be less reliable.ConclusionsIt is common for papers to consider instrumental variable methods but more studies are needed that consider G-methods and compare a wide range of methods in realistic scenarios. It is difficult to make conclusions about the best method to deal with non-compliance due to a limited body of evidence and the difficulty in combining results from independent simulation studies.Prospero registration numberCRD42022370910.

Project description:BACKGROUND:A newly developed multiple use applicator for vaginal tablets/vaginal inserts* was evaluated for its general suitability. There are no standard procedures described in guidelines or general accepted publications as to how this kind of product should be tested for suitability of purpose. METHODS:Due to the lack of existing standard procedures, three separate tests were designed and successful executed: (a) First, a patient acceptability evaluation was carried out as part of a phase III trial (registered in EudraCT on 9 Jan 2017, number 2017-000142-22 2. https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number%3A2017-000142-22 ). (b) Secondly, a cleaning procedure for the applicator after simulated multiple use was developed and verified in order to prove a minimized risk of microbiological contamination of the device. A newly developed vaginal fluid to simulate multiple applications was applied for this trial. (c) Lastly, a third trial evaluated the mechanical stability and proper functionality of the applicator after multiple simulated uses. Even potential abrasion of material of the device was checked. RESULTS:Acceptable patient compliance of the new multiple use applicator was verified after 2 weeks of daily use. Furthermore, diary data assessments of patients participating in the Pharmacodynamic part of the trial were evaluated as well. Overall, patient acceptability of the new applicator was proven. The easy-to-use cleaning procedure for the applicator, which can even be carried out in a domestic environment, was developed and successfully verified for effectiveness, meeting all microbiological acceptance criteria for vaginal products of the European Pharmacopeia. The mechanical stability and proper functionality of the applicator after 50 simulated uses was also evaluated. All tested applicator batches (fresh and aged) passed the final evaluation, with no limitations in functionality. CONCLUSION:The tests developed and executed consider various compliance aspects of the newly developed applicator. Results of these individual tests met the expectations and/or the predefined acceptance criteria. All included trials performed produced results justifying and qualifying the applicator for the intended multiple-use. The procedures outlined may also be a guide as to how this kind of medical device can be tested for suitability. Trial registration Registered in EudraCT, number 2017-000142-22, start date 24 May 2017.

Project description:Pulmonary arterial compliance is a measure of the pulsatile afterload of the right ventricle. Lower pulmonary arterial compliance is associated with reduced right ventricular function and worse prognosis in pulmonary hypertension. The effect of pulmonary vasodilators on pulmonary arterial compliance has not been evaluated in detail in pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. In this post hoc analysis of patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension in the PATENT and CHEST studies, we evaluated the change in pulmonary arterial compliance with riociguat versus placebo. Association of pulmonary arterial compliance with clinical outcomes was assessed using Kaplan-Meier and Cox proportional hazards analyses. Compared with placebo, riociguat significantly improved pulmonary arterial compliance in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulmonary arterial compliance at baseline was associated with survival and clinical worsening-free survival in pulmonary arterial hypertension but only with clinical worsening-free survival in chronic thromboembolic pulmonary hypertension. In patients with pulmonary arterial hypertension, pulmonary arterial compliance at follow-up ≥1.6 mL/mmHg was associated with better outcomes than pulmonary arterial compliance <1.6 mL/mmHg. In patients with chronic thromboembolic pulmonary hypertension, pulmonary arterial compliance at follow-up did not predict outcomes. Cox proportional hazards analyses showed no association between change in pulmonary arterial compliance and outcomes in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. In conclusion, riociguat improved pulmonary arterial compliance in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulmonary arterial compliance at baseline or follow-up, rather than change in pulmonary arterial compliance, is of prognostic importance for outcomes.

Project description:BackgroundObservational evidence suggests that cigarette pack size - the number of cigarettes in a single pack - is associated with consumption but experimental evidence of a causal relationship is lacking. The tobacco industry is introducing increasingly large packs, in the absence of maximum cigarette pack size regulation. In Australia, the minimum pack size is 20 but packs of up to 50 cigarettes are available. We aimed to estimate the impact on smoking of reducing cigarette pack sizes from ≥25 to 20 cigarettes per pack.MethodA two-stage adaptive parallel group RCT in which Australian smokers who usually purchase packs containing ≥25 cigarettes were randomised to use only packs containing either 20 (intervention) or their usual packs (control) for four weeks. The primary outcome, the average number of cigarettes smoked per day, was measured through collecting all finished cigarette packs, labelled with the number of cigarettes participants smoked. An interim sample size re-estimation was used to evaluate the possibility of detecting a meaningful difference in the primary outcome.ResultsThe interim analysis, conducted when 124 participants had been randomised, suggested 1122 additional participants needed to be randomised for sufficient power to detect a meaningful effect. This exceeded pre-specified criteria for feasible recruitment, and data collection was terminated accordingly. Analysis of complete data (n = 79) indicated that the mean cigarettes smoked per day was 15.9 (SD = 8.5) in the intervention arm and 16.8 (SD = 6.7) among controls (difference - 0.9: 95%CI = - 4.3, 2.6).ConclusionIt remains unclear whether reducing cigarette pack sizes from ≥25 to 20 cigarettes reduces cigarette consumption. Importantly, the results of this study provide no evidence that capping cigarette pack sizes would be ineffective at reducing smoking. The limitations identified in this study can inform a more efficient RCT, which is urgently required to address the dearth of experimental evidence on the impact of large cigarette pack sizes on smoking.Trial registrationhttps://doi.org/10.1186/ISRCTN34202533.

Project description:IntroductionThe advertising of e-cigarettes in the UK is regulated through the revised EU Tobacco Products Directive and the Tobacco and Related Products Regulations, with further rules set out in the Advertising Standards Authority (ASA) Committees of Advertising (CAP) Code. Focusing on the ASA CAP Code Rules, we examined e-cigarette advertising regulation compliance in traditional advertising channels and on social media.MethodsWe conducted a content analysis of UK e-cigarette and related product advertising using a randomly selected sample (n = 130) of advertising in traditional channels and on Instagram which appeared between January and December 2019. All ads were independently double-coded to assess compliance with each CAP Code Rule.ResultsIn traditional channels, our sample of advertising had largely good compliance. Only very small numbers of these ads appeared to be clearly in breach of any of the ASA rules (5% were in breach of Rule 22.7; 2% of Rule 22.9; and 1% of Rule 22.10). In contrast, we judged that all of the Instagram sample (n = 30) was in breach of Rule 22.12. For some rules, it was not possible to make definitive judgments about compliance, given uncertainty regarding how a rule should be interpreted and applied.ConclusionsWe found overall good compliance for advertising in traditional channels, but assessed all of our social media advertising samples was in breach of regulations. Current guidance on e-cigarette advertising could be improved to facilitate e-cigarette advertising assessment and regulation. It would be beneficial to bring consumer perspectives into the assessment of regulation compliance.ImplicationsThe regulation of e-cigarette advertising is a global concern. The UK Government has a statutory obligation to review the Tobacco and Related Products Regulations by May 2021. This study assessed compliance with current UK e-cigarette advertising regulations on placement and content. We identified areas where greater clarity is needed and outlined implications for future regulation.

Dataset Information

Compliance in Controlled E-cigarette Studies.

Introduction

Methods

Results

Conclusions

Implications

Publications

Compliance in Controlled E-cigarette Studies.

Similar Datasets

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