Glycemic control during TB treatment among Filipinos: The Starting Anti-Tuberculosis Treatment Cohort Study.

Poor TB treatment outcomes are observed in patients with type 2 diabetes mellitus (DM) comorbidity and glycemic control throughout treatment may play a role. The objective of this study was to investigate glycemic control longitudinally among Filipino adults undergoing TB treatment using mixed-effects linear and logistic regression. Analyses were conducted in 188 DM-TB patients out of 901 enrolled in the Starting Anti-TB Treatment (St-ATT) cohort, with a median baseline glycosylated hemoglobin (HbA1c) of 8.2% (range 4.5-13.3%). Previous versus new DM diagnosis was associated with higher mean HbA1c (worse glycemic control) during treatment, with a smaller effect amongst those with central obesity (coefficient 0.80, 95% confidence interval [CI] 0.26, 1.57, P = 0.043) than amongst those without central obesity (coefficient 3.48, 95% CI 2.16, 4.80, P<0.001). In those with a new DM diagnosis, central obesity was associated with higher blood glucose (coefficient 1.62, 95% CI 0.72, 2.53, P = 0.009). Of 177 participants with ≥2 HbA1c results, 40% had uncontrolled glycemia (≥2 HbA1c results ≥8%). Of 165 participants with ≥3 HbA1c results, 29.9% had consistently-controlled glycemia, 15.3% had initially-uncontrolled glycemia, and 18.6% had consistently-uncontrolled glycemia. Previous versus new DM diagnosis and glucose-lowering medication use versus no use were associated with having uncontrolled versus controlled glycemia (adjusted odds ratio [aOR] 2.50 95%CI 1.61, 6.05, P = 0.042; aOR 4.78 95% CI 1.61,14.23, P<0.001) and more likely to have consistently-uncontrolled versus consistently-controlled glycemia (adjusted relative risk ratio [aRRR] 5.14 95% CI 1.37, 19.20, P = 0.015; aRRR 10.24 95% CI 0.07, 0.95, P = 0.003). Relapse cases of TB were less likely than new cases to have uncontrolled (aOR 0.20 95%CI 0.06, 0.63, P = 0.031) or consistently-uncontrolled (aRRR 0.25 95%CI 0.07, 0.95, P = 0.042) versus controlled glycemia. Those with long-term DM, suggested by previous diagnosis, glucose-lowering medication use and possibly central obesity, may require additional support to manage blood glucose during TB treatment.

Evaluation of cytokine profiles related to Mycobacterium tuberculosis latent antigens using a whole-blood assay in the Philippines.

Introduction: There is no useful method to discriminate between latent tuberculosis infection (LTBI) and active pulmonary tuberculosis (PTB). This study aimed to investigate the potential of cytokine profiles to discriminate between LTBI and active PTB using whole-blood stimulation with Mycobacterium tuberculosis (MTB) antigens, including latency-associated antigens. Materials and methods: Patients with active PTB, household contacts of active PTB patients and community exposure subjects were recruited in Manila, the Philippines. Peripheral blood was collected from the participants and used for whole-blood stimulation (WBS) with either the early secretory antigenic target and the 10-kDa culture filtrate protein (ESAT-6/CFP-10), Rv3879c or latency-associated MTB antigens, including mycobacterial DNA-binding protein 1 (MDP-1), α-crystallin (Acr) and heparin-binding hemagglutinin (HBHA). Multiple cytokine concentrations were analyzed using the Bio-Plex™ multiplex cytokine assay. Results: A total of 78 participants consisting of 15 active PTB patients, 48 household contacts and 15 community exposure subjects were eligible. The MDP-1-specific IFN-γ level in the active PTB group was significantly lower than that in the household contact group (p < 0.001) and the community exposure group (p < 0.001). The Acr-specific TNF-α and IL-10 levels in the active PTB group were significantly higher than those in the household contact (TNF-α; p = 0.001, IL-10; p = 0.001) and community exposure (TNF-α; p < 0.001, IL-10; p = 0.01) groups. However, there was no significant difference in the ESAT-6/CFP-10-specific IFN-γ levels among the groups. Conclusion: The patterns of cytokine profiles induced by latency-associated MTB antigens using WBS have the potential to discriminate between LTBI and active PTB. In particular, combinations of IFN-γ and MDP-1, TNF-α and Acr, and IL-10 and Acr are promising. This study provides the first demonstration of the utility of MDP-1-specific cytokine responses in WBS.

Characterising smoking and nicotine use behaviours among women of reproductive age: a 10-year population study in England.

BACKGROUND: Tobacco smoking affects women's fertility and is associated with substantial risks of adverse pregnancy outcomes. This study explored trends by socioeconomic position in patterns of smoking, use of non-combustible nicotine products, and quitting activity among women of reproductive age in England. METHODS: Data come from a nationally representative monthly cross-sectional survey. Between October 2013 and October 2023, 197,266 adults (≥ 18 years) were surveyed, of whom 44,052 were women of reproductive age (18-45 years). Main outcome measures were current smoking, vaping, and use of nicotine replacement therapy (NRT), heated tobacco products (HTPs), and nicotine pouches; mainly/exclusively smoking hand-rolled cigarettes and level of dependence among current smokers; past-year quit attempts among past-year smokers; and success of quit attempts among those who tried to quit. We modelled time trends in these outcomes, overall and by occupational social grade (ABC1 = more advantaged/C2DE = less advantaged). RESULTS: Smoking prevalence among women of reproductive age fell from 28.7% [95%CI = 26.3-31.2%] to 22.4% [19.6-25.5%] in social grades C2DE but there was an uncertain increase from 11.7% [10.2-13.5%] to 14.9% [13.4-16.6%] in ABC1. By contrast, among all adults and among men of the same age, smoking prevalence remained relatively stable in ABC1. Vaping prevalence among women of reproductive age more than tripled, from 5.1% [4.3-6.0%] to 19.7% [18.0-21.5%], with the absolute increase more pronounced among those in social grades C2DE (reaching 26.7%; 23.3-30.3%); these changes were larger than those observed among all adults but similar to those among men of the same age. The proportion of smokers mainly/exclusively smoking hand-rolled cigarettes increased from 40.5% [36.3-44.9%] to 61.4% [56.5-66.1%] among women of reproductive age; smaller increases were observed among all adults and among men of the same age. Patterns on other outcomes were largely similar between groups. CONCLUSIONS: Among women of reproductive age, there appears to have been a rise in smoking prevalence in the more advantaged social grades over the past decade. Across social grades, there have been substantial increases in the proportion of women of reproductive age who vape and shifts from use of manufactured to hand-rolled cigarettes among those who smoke. These changes have been more pronounced than those observed in the general adult population over the same period.

Intersection of gambling with smoking and alcohol use in Great Britain: a cross-sectional survey in October 2022.

OBJECTIVES: Gambling is associated with cigarette smoking and alcohol consumption. We explored the intersection of gambling across all risk levels of harm with smoking and alcohol use among adults in Great Britain. DESIGN: A nationally representative cross-sectional survey in October 2022. SETTING: Great Britain. PARTICIPANTS: A weighted total of 2398 adults (18+ years). OUTCOME MEASURES: We examined the prevalence of past-year gambling and, among those reporting gambling, assessed the associations between the outcome of any risk of harm from gambling (scoring >0 on the Problem Gambling Severity Index) and the binary predictor variables of current cigarette smoking and higher risk alcohol consumption (AUDIT-C score≥4). We also explored data on weekly expenditure on gambling with smoking and alcohol use among those categorised at any-risk of harm from gambling. RESULTS: Overall, 43.6% (95% CI 41.2% to 45.9%) of adults gambled in the past year. Among these, 7.3% (95% CI 5.3% to 9.3%) were classified at any-risk of harm from gambling, 16.0% (95% CI 13.2% to 18.8%) were currently smoking and 40.8% (95% CI 37.2% to 44.4%) were drinking at increasing and higher risk levels. There were no associations between any risk of harm from gambling and current smoking (OR adjusted=0.80, 95% CI 0.35 to 1.66) or drinking at increasing and higher risk levels (OR adjusted=0.94, 95% CI 0.52 to 1.69), respectively. Analyses using Bayes factors indicated that these data were insensitive to distinguish no effect from a range of associations (OR=95% CI 0.5 to 1.9). The mean weekly spend on gambling was £7.69 (95% CI £5.17 to £10.21) overall, £4.80 (95% CI £4.18 to £5.43) among those classified as at no risk and £45.68 (95% CI £12.07 to £79.29) among those at any risk of harm from gambling. CONCLUSIONS: Pilot data in a population-level survey on smoking and alcohol use yielded similar estimates to other population-level surveys on gambling participation and at-risk gambling. Further data are needed to elucidate the intersections more reliably between gambling, smoking and alcohol use and inform population-level approaches to reduce harm.

Mitochondrial and Nuclear DNA Variants in Amyotrophic Lateral Sclerosis: Enrichment in the Mitochondrial Control Region and Sirtuin Pathway Genes in Spinal Cord Tissue.

Amyotrophic Lateral Sclerosis (ALS) is a progressive disease with prevalent mitochondrial dysfunctions affecting both upper and lower motor neurons in the motor cortex, brainstem, and spinal cord. Despite mitochondria having their own genome (mtDNA), in humans, most mitochondrial genes are encoded by the nuclear genome (nDNA). Our study aimed to simultaneously screen for nDNA and mtDNA genomes to assess for specific variant enrichment in ALS compared to control tissues. Here, we analysed whole exome (WES) and whole genome (WGS) sequencing data from spinal cord tissues, respectively, of 6 and 12 human donors. A total of 31,257 and 301,241 variants in nuclear-encoded mitochondrial genes were identified from WES and WGS, respectively, while mtDNA reads accounted for 73 and 332 variants. Despite technical differences, both datasets consistently revealed a specific enrichment of variants in the mitochondrial Control Region (CR) and in several of these genes directly associated with mitochondrial dynamics or with Sirtuin pathway genes within ALS tissues. Overall, our data support the hypothesis of a variant burden in specific genes, highlighting potential actionable targets for therapeutic interventions in ALS.

Smoking prevalence and purchasing of menthol cigarettes since the menthol flavour ban in Great Britain: a population-based survey between 2020 and 2023.

BACKGROUND: Menthol cigarettes have been banned in Great Britain (GB) since May 2020. Still, menthol accessories and unlabelled cigarettes perceived as mentholated are available, and people can buy menthol cigarettes overseas or illicitly. This study assessed: trends in smoking menthol cigarettes among all adults and 18-24-year-olds in GB between October 2020 and March 2023; trends in and differences between England, Scotland and Wales during the same period and purchase sources among people smoking menthol versus non-flavoured cigarettes. METHODS: Population-weighted data were from a monthly cross-sectional survey of adults in GB. Among people smoking cigarettes, we calculated the proportion smoking menthol cigarettes across all adults and 18-24-year-olds, and prevalence ratios (PR) between the first and last quarter. We also calculated the proportions of people smoking menthol/non-flavoured cigarettes by purchase source (including illicit sources). RESULTS: In the first quarter, 16.2% of adults smoking cigarettes reported menthol cigarette smoking with little to no decline throughout the study (PR 0.85, 95% CI 0.71 to 1.01), while it declined among 18-24-year-olds (PR 0.75, 95% CI 0.63 to 0.89). The prevalence of menthol cigarette smoking fell by two-thirds in Wales (PR 0.36, 95% CI 0.19 to 0.62) but remained relatively stable in England (PR 0.88, 95% CI 0.72 to 1.06) and Scotland (PR 0.94, 95% CI 0.59 to 1.53). The main purchasing sources were licit (93.9%), 14.8% reported illicit sources and 11.5% cross-border purchases, without notable differences from people smoking non-flavoured cigarettes. CONCLUSIONS: Roughly one million adults in GB still smoke menthol cigarettes and, with the exception of Wales and young people, there were no noteworthy changes in the post-ban period. There was no indication that the overall persistence of menthol smoking was driven by illicit purchases.

Researchers' experiences of the design and conduct challenges associated with parallel-group cluster-randomised trials and views on a novel open-cohort design.

BACKGROUND: Two accepted designs exist for parallel-group cluster-randomised trials (CRTs). Closed-cohort designs follow the same individuals over time with a single recruitment period before randomisation, but face challenges in settings with high attrition. (Repeated) cross-sectional designs recruit at one or more timepoints before and/or after randomisation, collecting data from different individuals present in the cluster at these timepoints, but are unsuitable for assessment of individual change over time. An 'open-cohort' design allows individual follow-up with recruitment before and after cluster-randomisation, but little literature exists on acceptability to inform their use in CRTs. AIM: To document the views and experiences of expert trialists to identify: a) Design and conduct challenges with established parallel-group CRT designs,b) Perceptions of potential benefits and barriers to implementation of open-cohort CRTs,c) Methods for minimising, and investigating the impact of, bias in open-cohort CRTs. METHODS: Qualitative consultation via two expert workshops including triallists (n = 24) who had worked on CRTs over a range of settings. Workshop transcripts were analysed using Descriptive Thematic Analysis utilising inductive and deductive coding. RESULTS: Two central organising concepts were developed. Design and conduct challenges with established CRT designs confirmed that current CRT designs are unable to deal with many of the complex research and intervention circumstances found in some trial settings (e.g. care homes). Perceptions of potential benefits and barriers of open cohort designs included themes on: approaches to recruitment; data collection; analysis; minimising/investigating the impact of bias; and how open-cohort designs might address or present CRT design challenges. Open-cohort designs were felt to provide a solution for some of the challenges current CRT designs present in some settings. CONCLUSIONS: Open-cohort CRT designs hold promise for addressing the challenges associated with standard CRT designs. Research is needed to provide clarity around definition and guidance on application.

Comparing disease specific catastrophic cost estimates using longitudinal and cross-sectional designs: The example of tuberculosis.

BACKGROUND: There has been an increasing interest in assessing disease-specific catastrophic costs incurred by affected households as part of economic evaluations and to inform joint social/health policies for vulnerable groups. Although the longitudinal study design is the gold standard for estimating disease-specific household costs, many assessments are implemented with a cross-sectional design for pragmatic reasons. We aimed at identifying the potential biases of a cross-sectional design for estimating household cost, using the example of tuberculosis (TB), and exploring optimal approaches for sampling and interpolating cross-sectional cost data to estimate household costs. METHODS: Data on patient incurred costs, household income and coping strategies were collected from TB patients in Negros Occidental and Cebu in the Philippines between November 2018 and October 2020. The data collection tools were developed by adapting WHO Tuberculosis Patient Cost Surveys: A Handbook into a longitudinal study design. TB-specific catastrophic cost estimates were compared between longitudinal and simulated cross-sectional designs using different random samples from different times points in treatment (intensive and continuation phases). RESULTS: A total of 530 adult TB patients were enrolled upon TB diagnosis in this study. Using the longitudinal design, the catastrophic cost estimate for TB-affected households was 69 % using the output approach. The catastrophic cost estimates with the simulated cross-sectional design were affected by the reduction and recovery in household income during the episode of TB care and ranged from 40 to 55 %. CONCLUSION: Using longitudinally collected costs incurred by TB-affected households, we illustrated the potential limitations and implications of estimating household costs using a cross-sectional design. Not capturing changes in household income at multiple time points during the episode of the disease and estimating from inappropriate samples may result in biases that underestimates catastrophic cost.

Trends in Harm Perceptions of E-Cigarettes vs Cigarettes Among Adults Who Smoke in England, 2014-2023.

Importance: Electronic cigarettes (e-cigarettes) are less harmful to users than combustible cigarettes. However, public health and media reporting have often overstated the potential risks of e-cigarettes, and inaccurate perceptions of the harms of vaping relative to smoking are pervasive. Objective: To examine time trends in harm perceptions of e-cigarettes compared with combustible cigarettes among adults who smoke. Design, Setting, and Participants: This nationally representative monthly cross-sectional survey study was conducted from November 2014 to June 2023 in England. Participants were adults who currently smoke. Main Outcomes and Measures: Participants were asked whether they thought e-cigarettes were less harmful, equally harmful, or more harmful than cigarettes, or did not know, with the proportion responding less harmful (vs all other responses) as the primary outcome. Logistic regression was used to test associations between survey wave and participants' perceptions of the harms of e-cigarettes. Results: Data were collected from 28 393 adults who smoke (mean [SD] age, 43.5 [17.3] years; 13 253 [46.7%] women). In November 2014, 44.4% (95% CI, 42.0%-46.8%) thought e-cigarettes were less harmful than cigarettes, 30.3% (95% CI, 28.2%-32.6%) thought e-cigarettes were equally harmful, 10.8% (95% CI, 9.4%-12.3%) thought they were more harmful, and 14.5% (95% CI, 12.9%-16.4%) did not know. However, by June 2023, the proportion who thought e-cigarettes were less harmful had decreased by 40% (prevalence ratio, 0.60; 95% CI, 0.55-0.66), and the proportion who thought e-cigarettes were more harmful had more than doubled (prevalence ratio, 2.16; 95% CI, 1.84-2.54). Changes over time were nonlinear: late 2019 saw a sharp decline in the proportion who thought e-cigarettes were less harmful and increases in the proportions who thought they were equally or more harmful. These changes were short-lived, returning to pre-2019 levels by the end of 2020. However, perceptions worsened again from 2021 up to the end of the study period: the proportion who thought e-cigarettes were more harmful increased to a new high, and the proportion who thought e-cigarettes were less harmful decreased to levels comparable to those in late 2019. As a result, in June 2023, the perception that e-cigarettes were equally as harmful as cigarettes was the most commonly held view among adults who smoke (33.7%; 95% CI, 31.4%-36.1%), with roughly similar proportions perceiving e-cigarettes to be less (26.7%; 95% CI, 24.6%-28.9%) and more (23.3%; 95% CI, 21.1%-25.7%) harmful. Conclusions and Relevance: This survey study of adults who smoke in England found that harm perceptions of e-cigarettes have worsened substantially over the last decade, such that most adults who smoked in 2023 believed e-cigarettes to be at least as harmful as cigarettes. The timing of the 2 most notable changes in harm perceptions coincided with the e-cigarette, or vaping product, use-associated lung injury outbreak in 2019 and the recent increase in youth vaping in England since 2021.

OPA1 mutation affects autophagy and triggers senescence in autosomal dominant optic atrophy plus fibroblasts.

In several cases of mitochondrial diseases, the underlying genetic and bioenergetic causes of reduced oxidative phosphorylation (OxPhos) in mitochondrial dysfunction are well understood. However, there is still limited knowledge about the specific cellular outcomes and factors involved for each gene and mutation, which contributes to the lack of effective treatments for these disorders. This study focused on fibroblasts from a patient with Autosomal Dominant Optic Atrophy (ADOA) plus syndrome harboring a mutation in the Optic Atrophy 1 (OPA1) gene. By combining functional and transcriptomic approaches, we investigated the mitochondrial function and identified cellular phenotypes associated with the disease. Our findings revealed that fibroblasts with the OPA1 mutation exhibited a disrupted mitochondrial network and function, leading to altered mitochondrial dynamics and reduced autophagic response. Additionally, we observed a premature senescence phenotype in these cells, suggesting a previously unexplored role of the OPA1 gene in inducing senescence in ADOA plus patients. This study provides novel insights into the mechanisms underlying mitochondrial dysfunction in ADOA plus and highlights the potential importance of senescence in disease progression.

Kidney and urine cell transcriptomics in IgA nephropathy and lupus nephritis: a narrative review.

This narrative review sheds light on the use of transcriptomics in the analysis of kidney biopsies and urinary cell samples from patients with immunoglobulin A nephropathy or lupus nephritis. The conventional methods of examining kidney biopsy through light microscopy, immunofluorescence and electron microscopy provide valuable clinical information for diagnosis and prognosis but have some limitations that transcriptomics can address. Some recent studies have reported that kidney transcriptomics has uncovered new molecular biomarkers implicated in the inflammatory process induced by the deposition of circulating immune complexes in the investigated kidney diseases. In addition, transcriptomics applied to urinary cells mirrors the inflammatory process that occurs in the kidney. This means that we can study urinary cell transcriptomics in clinical practice to diagnose the stage of the inflammatory process. Furthermore, the transcriptomics of urinary cells can be used to make therapy decisions during patient follow-up to avoid the stress of a second kidney biopsy. The studies analyzed in this review have a significant limitation. Biomarkers have been identified in small cohorts of patients but none of them has been validated in independent external cohorts. Further prospective studies in large cohorts of patients are necessary for accurate and complete validation. Only after that can these biomarkers be widely used in clinical practice.

Costs incurred by people with co-morbid tuberculosis and diabetes and their households in the Philippines.

OBJECTIVE: Diabetes is a risk factor for TB mortality and relapse. The Philippines has a high TB incidence with co-morbid diabetes. This study assessed the pre- and post-TB diagnosis costs incurred by people with TB and diabetes (TB-DM) and their households in the Philippines. METHODS: Longitudinal data was collected for costs, income, and coping mechanisms of TB-affected households in Negros Occidental and Cebu, the Philippines. Data collection was conducted four times during TB treatment. The data collection tools were developed by adapting WHO's cross-sectional questionnaire in the Tuberculosis Patient Cost Surveys: A Handbook into a longitudinal study design. Demographic and clinical characteristics, self-reported household income, number of facility visits, patient costs, the proportion of TB-affected households facing catastrophic costs due to TB (>20% of annual household income before TB), coping mechanisms, and social support received were compared by diabetes status at the time of TB diagnosis. RESULTS: 530 people with TB were enrolled in this study, and 144 (27.2%) had TB-DM based on diabetes testing at the time of TB diagnosis. 75.4% of people with TB-DM were more than 45 years old compared to 50.3% of people with TB-only (p<0.001). People with TB-DM had more frequent visits for TB treatment (120 vs 87 visits, p = 0.054) as well as for total visits for TB-DM treatment (129 vs 88 visits, p = 0.010) compared to those with TB-only. There was no significant difference in the proportion of TB-affected households facing catastrophic costs between those with TB-DM (76.3%) and those with TB-only (68.7%, p = 0.691). CONCLUSION: People with TB-DM in the Philippines face extensive health service use. However, this does not translate into substantial differences in the incidence of catastrophic cost. Further study is required to understand the incidence of catastrophic costs due to diabetes-only in the Philippines.

Prevalence and characteristics of co-occurrence of smoking and increasing-and-higher-risk drinking: A population survey in England.

BACKGROUND: Smoking and drinking alcohol both significantly contribute to mortality and morbidity, and there is a need to characterise the sociodemographic and health-related characteristics (e.g. mental distress) of people who do both in order to target resources. This study reports the prevalence and characteristics of adults in the general population in England who both drink alcohol at increasing-and-higher-risk levels and smoke. METHODS: We used cross-sectional data from a monthly, nationally representative survey of adults in England (n = 37,258; April 2020-March 2022). Weighted data were used to report prevalence and unweighted data were used to report descriptive statistics for sociodemographic and health-related characteristics. RESULTS: The prevalence of both smoking and increasing-and-higher-risk drinking was 4.6% (95% CI = 4.4-4.9; n = 1,574). They smoked a mean of 10.4 (SD = 8.86) cigarettes per day and had a mean AUDIT score of 12.8 (SD = 5.18). Nearly half (48.2%, n = 751) were trying to cut down on their smoking and 28.0% (n = 441) on their drinking. A quarter (25.3%, n = 397) had received General Practitioner advice on smoking while 8.7% (n = 76) had received advice on their drinking. Nearly half (48.6%, n = 745) reported experiencing psychological distress in the past month and 44.6% (n = 529) had a diagnosed mental health condition, both of which were higher than among all adults (28.1% and 29.1%, respectively). CONCLUSION: In England, from April 2020 to March 2022, the prevalence of both smoking and increasing-and-higher-risk drinking was 4.6%. This group appears to experience high rates of mental health problems and targeted support is needed.

Examining acute psychopharmacological effects of nicotine vaping versus heated tobacco products in a randomised crossover study of product naïve adult smokers.

Nicotine vaping products (NVPs) and heated tobacco products (HTPs) are designed to replicate the sensory and behavioural aspects of smoking cigarettes while avoiding combustion. The success of these products as harm reduction tools will partially depend on their ability to satisfy smokers and alleviate nicotine-related withdrawal symptoms. This study aims to compare short-term effects of NVPs (Juul and Aspire PockeX) versus HTPs (IQOS) on smoking-related withdrawal relief, product satisfaction, intention to switch to NVP/HTP, perceptions and attitudes in UK adult cigarette smokers naïve to these products. In a randomized cross-over study, 45 participants visited the lab twice, at each visit trying one of the two products (NVP/HTP) and completing a questionnaire. Responses were normalized on a 0-100% scale and mean differences (MD) between NVP and HTP scores computed, with positive and negative MD values indicating greater endorsement for NVP and HTP, respectively. Cigarette cravings were reduced similarly (~ 20.0%) by both products (MD = 4.5%, 95%Confidence Interval (CI) - 4.8, 13.8). Direct positive effects (MD = - 3.5%, 95%CI - 7.2, 0.2) and adverse side effects (MD = 1.8%, 95%CI - 0.3, 3.8) were comparable after each product use, though marginally favouring HTPs. HTPs were perceived as more satisfying overall (MD = - 13.2%, 95%CI - 20.3 - 6.1) than NVPs but both were perceived as similarly addictive (MD = 3.6%, 95%CI - 4.6, 11.8), relative to cigarettes. Intention to switch to either product was comparable (MD = 4.0%, 95%CI - 5.7, 13.8). Comparison of acute use of NVP versus HTP in a sample of UK smokers naïve to these products suggests that HTPs are perceived as more satisfying than NVPs, though still less satisfying than cigarettes.Registration: The analysis plan was pre-registered, and it is available at https://osf.io/6ymdu.

Mobile Phone Text Messages to Support People to Stop Smoking by Switching to Vaping: Codevelopment, Coproduction, and Initial Testing Study.

BACKGROUND: SMS text messages are affordable, scalable, and effective smoking cessation interventions. However, there is little research on SMS text message interventions specifically designed to support people who smoke to quit by switching to vaping. OBJECTIVE: Over 3 phases, with vapers and smokers, we codeveloped and coproduced a mobile phone SMS text message program. The coproduction paradigm allowed us to collaborate with researchers and the community to develop a more relevant, acceptable, and equitable SMS text message program. METHODS: In phase 1, we engaged people who vape via Twitter and received 167 responses to our request to write SMS text messages for people who wish to quit smoking by switching to vaping. We screened, adjusted, refined, and themed the messages, resulting in a set of 95 that were mapped against the Capability, Opportunity, and Motivation-Behavior constructs. In phase 2, we evaluated the 95 messages from phase 1 via a web survey where participants (66/202, 32.7% woman) rated up to 20 messages on 7-point Likert scales on 9 constructs: being understandable, clear, believable, helpful, interesting, inoffensive, positive, and enthusiastic and how happy they would be to receive the messages. In phase 3, we implemented the final set of SMS text messages as part of a larger randomized optimization trial, in which 603 participants (mean age 38.33, SD 12.88 years; n=369, 61.2% woman) received SMS text message support and then rated their usefulness and frequency and provided free-text comments at the 12-week follow-up. RESULTS: For phase 2, means and SDs were calculated for each message across the 9 constructs. Those with means below the neutral anchor of 4 or with unfavorable comments were discussed with vapers and further refined or removed. This resulted in a final set of 78 that were mapped against early, mid-, or late stages of quitting to create an order for the messages. For phase 3, a total of 38.5% (232/603) of the participants provided ratings at the 12-week follow-up. In total, 69.8% (162/232) reported that the SMS text messages had been useful, and a significant association between quit rates and usefulness ratings was found (χ21=9.6; P=.002). A content analysis of free-text comments revealed that the 2 most common positive themes were helpful (13/47, 28%) and encouraging (6/47, 13%) and the 2 most common negative themes were too frequent (9/47, 19%) and annoying (4/47, 9%). CONCLUSIONS: In this paper, we describe the initial coproduction and codevelopment of a set of SMS text messages to help smokers stop smoking by transitioning to vaping. We encourage researchers to use, further develop, and evaluate the set of SMS text messages and adapt it to target populations and relevant contexts.