Felix Naughton

Randomized Controlled Trial Evaluation of a Tailored Leaflet and SMS Text Message Self-help Intervention for Pregnant Smokers (MiQuit)

INTRODUCTION Study aims were to assess the feasibility and acceptability of a tailored self-help smoking cessation intervention for pregnant smokers (MiQuit). Secondary aims were to assess whether MiQuit affected cognitive determinants of quitting and to provide a range of potential effect sizes of the intervention effect on smoking abstinence. METHODS A randomized controlled trial was undertaken in which pregnant smokers were allocated to either receive MiQuit, a tailored self-help leaflet followed by an 11-week program of tailored text messages, or to a control group, receiving a nontailored self-help leaflet. Participants were 207 pregnant smokers identified by community midwives across 7 NHS Trusts (United Kingdom). At 3-month follow-up, intervention acceptability, cognitive determinants of quitting, and smoking outcomes (self-reported and cotinine-validated 7-day point prevalence abstinence) were assessed. RESULTS Feasibility: 94% (95% CI 89%-99%) of MiQuit participants reported receiving both intervention components. Acceptability: 9% (95% CI 4%-15%) of MiQuit participants opted to discontinue the text messages. Mechanism: compared with controls, MiQuit participants were more likely to set a quit date (p = .049) and reported higher levels of self-efficacy (p = .024), harm beliefs (p = .052), and determination to quit (p = .019). Potential efficacy: self-reported abstinence-MiQuit 22.9%, control 19.6%; odds ratio (OR) = 1.22, 95% CI 0.62-2.41; cotinine-validated abstinence-MiQuit 12.5%, control 7.8%; OR = 1.68, 95% CI 0.66-4.31. CONCLUSIONS Delivering tailored smoking cessation support to pregnant smokers via leaflet and text message is feasible and acceptable. The positive effects of MiQuit on cognitive determinants and the likelihood of setting a quit date are encouraging. A larger efficacy trial is warranted.

Exposure to secondhand smoke and cognitive impairment in non-smokers: national cross sectional study with cotinine measurement

Objective To examine the association between a biomarker of exposure to secondhand smoke (salivary cotinine concentration) and cognitive impairment. Design Cross sectional analysis of a national population based study. Setting Stratified random sample of households throughout England. Participants 4809 non-smoking adults aged 50 years or more from the 1998, 1999, and 2001 waves of the Health Survey for England who also participated in the 2002 wave of the English Longitudinal Study of Ageing and provided saliva samples for cotinine assay and a detailed smoking history. Main outcome measure Cognitive impairment as defined by the lowest 10% of scores on a battery of neuropsychological tests. Results Participants who did not smoke, use nicotine products, or have salivary cotinine concentrations of 14.1 ng/ml or more were divided into four equal size groups on the basis of cotinine concentrations. Compared with the lowest fourth of cotinine concentration (0.0-0.1 ng/ml) the odds ratios (95% confidence intervals) for cognitive impairment in the second (0.2-0.3 ng/ml), third (0.4-0.7 ng/ml), and highest fourths (0.8-13.5 ng/ml) were 1.08 (0.78 to 1.48), 1.13 (0.81 to 1.56), and 1.44 (1.07 to 1.94; P for trend 0.02), after adjustment for a wide range of established risk factors for cognitive impairment. A similar pattern of associations was observed for never smokers and former smokers. Conclusions Exposure to secondhand smoke may be associated with increased odds of cognitive impairment. Prospective nationally representative studies relating biomarkers of exposure to cognitive decline and risk of dementia are needed.

Does sleep quality predict pain-related disability in chronic pain patients? The mediating roles of depression and pain severity

Abstract Disrupted sleep has long been associated with physical functioning and disability in chronic pain populations and recent research shows that patterns of sleep and rest can predict physical disability, independent of depression and pain levels in this group. However, it is unknown whether sleep quality may independently predict disability in this way. The aim of the present study was to examine the self‐reported relationship between sleep and disability in 155 chronic pain patients attending a pain management service. The sample had an average age of 52.9 years and 69% were female with mean pain duration of 10.5 years. Disrupted sleep and rest patterns and poor sleep quality were positively correlated with depression and pain‐related disability. Hierarchical regression analyses showed that sleep quality did not predict pain‐related disability when depression and pain severity were taken into consideration. Separate mediation analyses of depression and pain severity revealed that both variables were important partial mediators of the relationship between sleep quality and disability. Depression was found to be a stronger mediator than pain severity. These findings highlight the important role of sleep in chronic pain suffering. However, due to the cross sectional nature of this study, the mediation pathways proposed require testing by further research adopting a prospective design. Ideally, future research should evaluate whether targeted interventions to improve sleep can reduce pain severity, depression and ultimately, pain‐related disability.

Self‐help smoking cessation interventions in pregnancy: a systematic review and meta‐analysis

AIMS Self-help smoking cessation interventions for pregnant smokers are of importance due to their potential to be wide-reaching, low-cost and their appeal to pregnant smokers who are interested in quitting smoking. To date, however, there has been no systematic assessment of their efficacy. This systematic review aimed to assess the efficacy of self-help interventions for pregnant smokers and to investigate whether self-help material intensity, type or delivery are associated with cessation. METHODS The literature was searched for randomized and quasi-randomized controlled trials of self-help smoking cessation interventions for pregnant smokers without significant cessation counselling. Fifteen trials met the inclusion criteria and relevant data were extracted independently. RESULTS The primary meta-analysis pooled 12 trials comparing usual care (median quit rate 4.9%) with self-help (median quit rate 13.2%) and yielded a pooled odds ratio (OR) of 1.83 [95% confidence interval (CI) 1.23-2.73], indicating that self-help interventions on average nearly double the odds of quitting compared with standard care. However, a further meta-analysis failed to find evidence that intervention materials of greater intensity increase quitting significantly over materials of lesser intensity (pooled OR = 1.25, 95% CI 0.81-1.94). There was insufficient evidence to determine whether the tailoring of materials or levels of one-to-one contact were related to intervention efficacy. CONCLUSIONS Self-help interventions appear to be more effective than standard care although, due mainly to a lack of trials, it is unclear whether more sophisticated and intensive approaches increase intervention effectiveness.

Randomized controlled trial to assess the short-term effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care (iQuit in practice).

Aims To estimate the short-term effectiveness, feasibility and acceptability of a smoking cessation intervention (the iQuit system) that consists of tailored printed and Short Message Service (SMS) text message self-help delivered as an adjunct to cessation support in primary care to inform the design of a definitive trial. Design A stratified two parallel-group randomized controlled trial comparing usual care (control) with usual care plus the iQuit system (intervention), delivered by primary care nurses/healthcare assistants who were blinded to the allocation sequence. Setting Thirty-two general practice (GP) surgeries in England, UK. Participants A total of 602 smokers initiating smoking cessation support from their local GP surgery were randomized (control n = 303, intervention n = 299). Measurements Primary outcome was self-reported 2-week point prevalence abstinence at 8 weeks follow-up. Secondary smoking outcomes and feasibility and acceptability measures were collected at 4 weeks after quit date, 8 weeks and 6 months follow-up. Findings There were no significant between-group differences in the primary outcome [control 40.3%, iQuit 45.2%; odds ratio (OR) = 1.22, 95% confidence interval (CI) = 0.88–1.69] or in secondary short-term smoking outcomes. Six-month prolonged abstinence was significantly higher in the iQuit arm (control 8.9%, iQuit 15.1%; OR = 1.81, 95% CI = 1.09–3.01). iQuit support took on average 7.7 minutes (standard deviation = 4.0) to deliver and 18.9% (95% CI = 14.8–23.7%) of intervention participants discontinued the text message support during the programme. Conclusions Tailored printed and text message self-help delivered alongside routine smoking cessation support in primary care does not significantly increase short-term abstinence, but may increase long-term abstinence and demonstrated feasibility and acceptability compared with routine cessation support alone.

A Context-Sensing Mobile Phone App (Q Sense) for Smoking Cessation: A Mixed-Methods Study.

Background A major cause of lapse and relapse to smoking during a quit attempt is craving triggered by cues from a smokers immediate environment. To help smokers address these cue-induced cravings when attempting to quit, we have developed a context-aware smoking cessation app, Q Sense, which uses a smoking episode-reporting system combined with location sensing and geofencing to tailor support content and trigger support delivery in real time. Objective We sought to (1) assess smokers’ compliance with reporting their smoking in real time and identify reasons for noncompliance, (2) assess the apps accuracy in identifying user-specific high-risk locations for smoking, (3) explore the feasibility and user perspective of geofence-triggered support, and (4) identify any technological issues or privacy concerns. Methods An explanatory sequential mixed-methods design was used, where data collected by the app informed semistructured interviews. Participants were smokers who owned an Android mobile phone and were willing to set a quit date within one month (N=15). App data included smoking reports with context information and geolocation, end-of-day (EoD) surveys of smoking beliefs and behavior, support message ratings, and app interaction data. Interviews were undertaken and analyzed thematically (N=13). Quantitative and qualitative data were analyzed separately and findings presented sequentially. Results Out of 15 participants, 3 (20%) discontinued use of the app prematurely. Pre-quit date, the mean number of smoking reports received was 37.8 (SD 21.2) per participant, or 2.0 (SD 2.2) per day per participant. EoD surveys indicated that participants underreported smoking on at least 56.2% of days. Geolocation was collected in 97.0% of smoking reports with a mean accuracy of 31.6 (SD 16.8) meters. A total of 5 out of 9 (56%) eligible participants received geofence-triggered support. Interaction data indicated that 50.0% (137/274) of geofence-triggered message notifications were tapped within 30 minutes of being generated, resulting in delivery of a support message, and 78.2% (158/202) of delivered messages were rated by participants. Qualitative findings identified multiple reasons for noncompliance in reporting smoking, most notably due to environmental constraints and forgetting. Participants verified the app’s identification of their smoking locations, were largely positive about the value of geofence-triggered support, and had no privacy concerns about the data collected by the app. Conclusions User-initiated self-report is feasible for training a cessation app about an individual’s smoking behavior, although underreporting is likely. Geofencing was a reliable and accurate method of identifying smoking locations, and geofence-triggered support was regarded positively by participants.

Provision of smoking cessation support for pregnant women in England: results from an online survey of NHS stop smoking services for pregnant women

BackgroundSmoking during pregnancy is a major public health concern and an NHS priority. In 2010, 26% of UK women smoked immediately before or during their pregnancy and 12% smoked continuously. Smoking cessation support is provided through free at the point of use Stop Smoking Services for Pregnant women (SSSP). However, to date, little is known of how these services provide support across England. The aim of this study was to describe the key elements of support provided through English SSSP.MethodsSSSP managers were invited to participate in this survey by email. Data were then collected via an online questionnaire; one survey was completed for each SSSP. Up to four reminder emails were sent over a two month period.Results86% (121 of 141) of services completed the survey. Responding services were, on average, larger than non-responding services in terms of the number of pregnant women setting quit dates and successfully quitting (p < 0.01). In line with the 2010 NICE guidelines, Stop Smoking in Pregnancy and following Childbirth, one in five SSSP identified pregnant smokers using carbon monoxide (CO) testing and refer via an opt-out pathway. All services offered nicotine replacement therapy (NRT) to pregnant women and 87% of services also offered dual therapy NRT, i.e. combination of a patch and short acting NRT product.. The 2010 NICE guidelines note that services should be flexible and client-centred. Consistent with this, SSSP offer pregnant women a range of support types (median 4) including couple/family, group (open or closed) or one-to-one. These are available in a number of locations (median 5), including in community venues, clinics and women’s homes.ConclusionsEnglish Stop Smoking Services offer behavioural support and pharmacotherapy to pregnant women motivated to quit smoking. Interventions provided are generally evidence-based and delivered in a variety of both social and health care settings.

Study protocol for iQuit in Practice: a randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care

BackgroundPrimary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker’s mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone.Methods/designThe design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking.DiscussionThis trial will focus on acceptability, feasibility and short-term effectiveness. The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness.Trial registrationISRCTN56702353

Longitudinal cohort survey of women's smoking behaviour and attitudes in pregnancy: study methods and baseline data

Objectives To report the methods used to assemble a contemporary pregnancy cohort for investigating influences on smoking behaviour before, during and after pregnancy and to report characteristics of women recruited. Design Longitudinal cohort survey. Setting Two maternity hospitals, Nottingham, England. Participants 3265 women who attended antenatal ultrasound scan clinics were offered cohort enrolment; those who were 8–26 weeks pregnant and were currently smoking or had recently stopped smoking were eligible. Cohort enrollment took place between August 2011 and August 2012. Primary and secondary outcome measures Prevalence of smoking at cohort entry and at two follow-up time points (34–36 weeks gestation and 3 months postnatally); response rate, participants’ sociodemographic characteristics. Results 1101 (33.7%, 95% CI 32.1% to 35.4%) women were eligible for inclusion in the cohort, and of these 850 (77.2%, 95% CI 74.6% to 79.6%) were recruited. Within the cohort, 57.4% (N=488, 95% CI 54.1% to 60.7%) reported to be current smokers. Current smokers were significantly younger than ex-smokers (p<0.05), more likely to have no formal qualifications and to not be in current paid employment compared to recent ex-smokers (p<0.001). Conclusions This contemporary cohort, which seeks very detailed information on smoking in pregnancy and its determinants, includes women with comparable sociodemographic characteristics to those in other UK cross-sectional studies and cohorts. This suggests that future analyses using this cohort and aimed at understanding smoking behaviour in pregnancy may produce findings that are broadly generalisable.

Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

Abstract Aims To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Design Multi‐centre, parallel‐group, single‐blinded, individual randomized controlled trial. Setting Sixteen antenatal clinics in England. Participants Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre‐pregnancy), were able to receive and understand English SMS texts and were not already using text‐based cessation support. Intervention All participants received a smoking cessation leaflet; intervention participants also received a 12‐week programme of individually tailored, automated, interactive, self‐help smoking cessation text messages (MiQuit). Outcome measurements Seven smoking outcomes, including validated continuous abstinence from 4 weeks post‐randomization until 36 weeks gestation, design parameters for a future trial and cost‐per‐quitter. Findings Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93–9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow‐up at 36 weeks gestation was similar in both groups; provision of self‐report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost‐per‐quitter was £133.53 (95% CI = –£395.78 to 843.62). Conclusions There was some evidence, although not conclusive, that a text‐messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care.