Search

Aims: The aim of this study was to examine the safety of e‐cigarettes (EC) and nicotine patches (NRT) when used to help pregnant smokers quit. Design: A recent trial of EC versus NRT reported safety outcomes in the randomized arms. We conducted a further analysis based on product use. Setting: Twenty‐three hospitals in England and a stop‐smoking service in Scotland took part. Participants: The participants comprised 1140 pregnant smokers. Interventions: We compared women using and not using EC and NRT regularly during pregnancy. Measurements Measurements included nicotine intake compared with baseline, birth weight, other pregnancy outcomes, adverse events, maternal respiratory symptoms and relapse in early abstainers. Findings Use of EC was more common than use of NRT (47.3% vs 21.6%, P < 0.001). Women who stopped smoking (abstainers) and used EC at the end‐of‐pregnancy (EOP) reduced their salivary cotinine by 45% [49.3 ng/ml, 95% confidence interval (CI) = −79.8 to −10]. Only one abstainer used NRT at EOP. In dual users, cotinine increased by 19% (24 ng/ml, 95% CI = 3.5–68). In women reporting a reduction of at least 50% in cigarette consumption, cotinine levels increased by 10% in those using nicotine products and by 9% in those who did not. Birth weights in dual users and exclusive smokers were the same (3.1 kg). Birth weight in abstainers using either nicotine product was higher than in smokers [3.3 kg, standard deviation (SD) = 0.7] versus 3.1 kg, SD = 0.6; difference = 0.15 kg, 95% CI = 0.05–0.25) and not different from abstainers not using nicotine products (3.1 kg, SD = 0.8). Abstainers and smokers using nicotine products had no worse pregnancy outcomes or more adverse events than abstainers and smokers not using them. EC users reported more improvements than non‐users in cough [adjusted relative risk (aRR) = 0.59, 95% CI = 0.37–0.93] and phlegm (aRR = 0.53, 95% CI = 0.31–0.92), controlling for smoking status. EC or NRT use had no association with relapse. Conclusions: Regular use of e‐cigarettes or nicotine patches by pregnant smokers does not appear to be associated with any adverse outcomes. [ABSTRACT FROM AUTHOR]

Background and aims: Smoking is extremely common among adults experiencing homelessness, but there is lack of evidence for treatment efficacy. E‐cigarettes are an effective quitting aid, but they have not been widely tested in smokers with complex health and social needs. Here we build upon our cluster feasibility trial and evaluate the offer of an e‐cigarette or usual care to smokers accessing a homeless centre. Design, Setting and Participants: Multi‐centre two‐arm cluster‐randomized controlled trial with mixed‐method embedded process and economic evaluation in homeless centres in England, Scotland and Wales. Adult smokers (18+ years; n = 480) accessing homeless centres and who are known to centre staff and willing to consent. Intervention and Comparator: Clusters (n = 32) will be randomized to either an e‐cigarette starter pack with weekly allocations of nicotine containing e‐liquid for 4 weeks [choice of flavours (menthol, fruit and tobacco) and strengths 12 mg/ml and 18 mg/ml] or the usual care intervention, which comprises very brief advice and a leaflet signposting to the local stop smoking service. Measurements The primary outcome is 24‐week sustained carbon monoxide‐validated smoking cessation (Russell Standard defined, intention‐to‐treat analysis). Secondary outcomes: (i) 50% smoking reduction (cigarettes per day) from baseline to 24 weeks; (ii) 7‐day point prevalence quit rates at 4‐, 12‐ and 24‐week follow‐up; (iii) changes in risky smoking practices (e.g. sharing cigarettes, smoking discarded cigarettes) from baseline to 4, 12 and 24 weeks; (iv) cost‐effectiveness of the intervention; and (v) fidelity of intervention implementation; mechanisms of change; contextual influences and sustainability. Conclusions: This is the first study, to our knowledge, to randomly assign smokers experiencing homelessness to an e‐cigarette and usual care intervention to measure smoking abstinence with embedded process and economic evaluations. If effective, its results will be used to inform the larger‐scale implementation of offering e‐cigarettes throughout homeless centres to aid smoking cessation. [ABSTRACT FROM AUTHOR]

Background and aims: The majority of smokers accessing the current best treatments continue to smoke. We aimed to test if e‐cigarettes (EC) compared with nicotine replacement treatment (NRT) can help such smokers to reduce smoking. Design Randomized controlled trial of EC (n = 68) versus NRT (n = 67) with 6‐month follow‐up. Setting: Stop smoking service in London, UK. Participants: A total of 135 smokers (median age = 40 years, 51% male) previously unable to stop smoking with conventional treatments. Interventions: Participants received either NRT of their choice (8‐week supply) or an EC starter pack and instructions to purchase further e‐liquids of strength and flavours of their choice themselves. Products were accompanied by minimal behavioural support. Measurements Participants who reported that they stopped smoking or reduced their daily cigarette consumption by at least 50% at 6‐month follow‐up were invited to provide a carbon monoxide (CO) reading. The primary outcome was biochemically validated reduction in smoke intake of at least 50% at 6 months and the main secondary outcome was sustained validated abstinence at 6 months. Drop‐outs were included as 'non‐reducers'. Findings Validated smoking reduction (including cessation) was achieved by 26.5 versus 6.0% of participants in the EC and NRT study arms, respectively [relative risk (RR) = 4.4, P = 0.005, 95% confidence interval (CI) = 1.6–12.4]. Sustained validated abstinence rates at 6 months were 19.1 versus 3.0% (RR = 6.4, P = 0.01, 95% CI = 1.5–27.3). Product use was high and equal in both study arms initially, but at 6 months allocated product use was 47% in the EC arm versus 10% in the NRT arm (χ2(1) = 22.0, P < 0.001), respectively. Adverse events were minor and infrequent. Conclusions: In smokers unable to quit using conventional methods, e‐cigarettes were more effective than nicotine replacement therapy in facilitating validated long‐term smoking reduction and smoking cessation when limited other support was provided. [ABSTRACT FROM AUTHOR]

Objective: The 5:2 diet is a popular intermittent energy restriction method of weight management that awaits further evaluation. We compared the effects of one-off 5:2 instructions with the effects of one-off standard multicomponent weight-management advice; and also examined whether additional behavioural support enhances 5:2 adherence and efficacy compared to one-off instructions. Methods: Three hundred adults with obesity were randomised to receive a Standard Brief Advice (SBA) covering diet and physical activity (N = 100); 5:2 self-help instructions (5:2SH) (N = 100); or 5:2SH plus six once-weekly group support sessions (N = 100). Participants were followed up for one year. Results: Adherence to 5:2SH was initially high (74% at 6 weeks), but it declined over time (31% at 6 months and 22% at one year). 5:2SH and SBA achieved similar weight-loss at six months (-1.8kg (SD = 3.5) vs -1.7kg (SD = 4.4); b = 0.23, 95%CI:-0.79–1.27, p = 0.7) and at one year (-1.9kg (SD = 4.9) vs -1.8kg (SD = 5.7), b = 0.20, 95%CI:-1.21–1.60, p = 0.79), with 18% vs 15% participants losing ≥5% of their body weight with 5:2SH and SBA, respectively at one year (RR = 0.83, 95%CI:0.44–1.54, p = 0.55). Both interventions received positive ratings, but 5:2SH ratings were significantly higher. 5:2SH had no negative effect on fat and fiber intake and physical activity compared to SBA. Compared to 5:2SH, 5:2G generated a greater weight loss at 6 weeks (-2.3kg vs -1.5kg; b = 0.74, 95%CI:1.37–0.11, p = 0.02), but by one year, the difference was no longer significant (-2.6kg vs -1.9kg, p = 0.37; ≥5% body weight loss 28% vs 18%, p = 0.10). Conclusions: Simple 5:2 advice and multicomponent weight management advice generated similar modest results. The 5:2 diet did not undermine other health behaviours, and it received more favourable ratings. Adding initial group support enhanced 5:2 adherence and effects, but the impact diminished over time. Health professionals who provide brief weight management advice may consider including the 5:2 advice as an option. Trial registration: ISRCTN registry (ISRCTN79408248). [ABSTRACT FROM AUTHOR]

Aim: To evaluate the cost‐effectiveness of e‐cigarettes as a smoking cessation aid used in routine stop smoking services in England. Design Cost‐effectiveness analysis was performed from the National Health Service (NHS) and Personal Social Services (PSS) perspective for 12‐month periods and life‐time. Costs, including that of both treatments, other smoking cessation help and health‐care services, and health benefits, estimated from EQ‐5D‐5L and measured in quality‐adjusted life‐years (QALYs), for the 12‐month analysis, came from a randomized controlled trial. Life‐time analysis was model‐based with input from both trial data and published secondary data sources. Cost‐effectiveness was measured by an incremental cost‐effectiveness ratio (ICER). Setting: Three stop‐smoking service sites in England. Participants: Adult smokers (n = 886) who sought help to quit in the participating sites. Intervention and comparator: An e‐cigarette (EC) starter kit versus provision of nicotine replacement therapy (NRT) for up to 3 months, both with standard behavioural support. A total of 886 participants were randomized (439 in the EC arm, 447 in the NRT arm). Excluding one death in each arm, the 1‐year quit rate was 18.0 and 9.9%, respectively. Measurements Cost of treatments was estimated from the treatment log. Costs of other smoking cessation help and health‐care services and EQ‐5D‐5 L were collected at baseline, 6‐ and 12‐month follow‐ups. Incremental costs and incremental QALYs were estimated using regression adjusting for baseline covariates and their respective baseline values. Findings The ICER was £1100 per QALY gained at the 12 months after quit date (87% probability below £20 000/QALY). Markov model estimated the life‐time ICER of EC to be £65 per QALY (85% probability below £20 000/QALY). Conclusion: Using e‐cigarettes as a smoking cessation aid with standard behavioural support in stop‐smoking services in England is likely to be more cost‐effective than using nicotine replacement therapy in the same setting. [ABSTRACT FROM AUTHOR]

Background: Early detection of oesophageal cancer improves outcomes; however, the optimal strategy for identifying patients at increased risk from the pre-cancerous lesion Barrett's oesophagus (BE) is not clear. The Cytosponge, a novel non-endoscopic sponge device, combined with the biomarker Trefoil Factor 3 (TFF3) has been tested in four clinical studies. It was found to be safe, accurate and acceptable to patients. The aim of the BEST3 trial is to evaluate if the offer of a Cytosponge-TFF3 test in primary care for patients on long term acid suppressants leads to an increase in the number of patients diagnosed with BE.Methods: The BEST3 trial is a pragmatic multi-site cluster-randomised controlled trial set in primary care in England. Approximately 120 practices will be randomised 1:1 to either the intervention arm, invitation to a Cytosponge-TFF3 test, or the control arm usual care. Inclusion criteria are men and women aged 50 or over with records of at least 6 months of prescriptions for acid-suppressants in the last year. Patients in the intervention arm will receive an invitation to have a Cytosponge-TFF3 test in their general practice. Patients with a positive TFF3 test will receive an invitation for an upper gastro-intestinal endoscopy at their local hospital-based endoscopy clinic to test for BE. The primary objective is to compare histologically confirmed BE diagnosis between the intervention and control arms to determine whether the offer of the Cytosponge-TFF3 test in primary care results in an increase in BE diagnosis within 12 months of study entry.Discussion: The BEST3 trial is a well-powered pragmatic trial testing the use of the Cytosponge-TFF3 test in the same population that we envisage it being used in clinical practice. The data generated from this trial will enable NICE and other clinical bodies to decide whether this test is suitable for routine clinical use.Trial Registration: This trial was prospectively registered with the ISRCTN Registry on 19/01/2017, trial number ISRCTN68382401 . [ABSTRACT FROM AUTHOR]

Background: Graded exercise therapy is an effective and safe treatment for chronic fatigue syndrome, but it is therapist intensive and availability is limited. We aimed to test the efficacy and safety of graded exercise delivered as guided self-help.Methods: In this pragmatic randomised controlled trial, we recruited adult patients (18 years and older) who met the UK National Institute for Health and Care Excellence criteria for chronic fatigue syndrome from two secondary-care clinics in the UK. Patients were randomly assigned to receive specialist medical care (SMC) alone (control group) or SMC with additional guided graded exercise self-help (GES). Block randomisation (randomly varying block sizes) was done at the level of the individual with a computer-generated sequence and was stratified by centre, depression score, and severity of physical disability. Patients and physiotherapists were necessarily unmasked from intervention assignment; the statistician was masked from intervention assignment. SMC was delivered by specialist doctors but was not standardised; GES consisted of a self-help booklet describing a six-step graded exercise programme that would take roughly 12 weeks to complete, and up to four guidance sessions with a physiotherapist over 8 weeks (maximum 90 min in total). Primary outcomes were fatigue (measured by the Chalder Fatigue Questionnaire) and physical function (assessed by the Short Form-36 physical function subscale); both were self-rated by patients at 12 weeks after randomisation and analysed in all randomised patients with outcome data at follow-up (ie, by modified intention to treat). We recorded adverse events, including serious adverse reactions to trial interventions. We used multiple linear regression analysis to compare SMC with GES, adjusting for baseline and stratification factors. This trial is registered at ISRCTN, number ISRCTN22975026.Findings: Between May 15, 2012, and Dec 24, 2014, we recruited 211 eligible patients, of whom 107 were assigned to the GES group and 104 to the control group. At 12 weeks, compared with the control group, mean fatigue score was 19·1 (SD 7·6) in the GES group and 22·9 (6·9) in the control group (adjusted difference -4·2 points, 95% CI -6·1 to -2·3, p<0·0001; effect size 0·53) and mean physical function score was 55·7 (23·3) in the GES group and 50·8 (25·3) in the control group (adjusted difference 6·3 points, 1·8 to 10·8, p=0·006; 0·20). No serious adverse reactions were recorded and other safety measures did not differ between the groups, after allowing for missing data.Interpretation: GES is a safe intervention that might reduce fatigue and, to a lesser extent, physical disability for patients with chronic fatigue syndrome. These findings need confirmation and extension to other health-care settings.Funding: UK National Institute for Health Research Research for Patient Benefit Programme and the Sue Estermann Fund. [ABSTRACT FROM AUTHOR]

Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. [ABSTRACT FROM AUTHOR]

Background: Supporting recovery is the aim of national mental health policy in many countries. However, only one measure of recovery has been developed in England: the Questionnaire about the Process of Recovery (QPR), which measures recovery from the perspective of adult mental health service users with a psychosis diagnosis.Aims: To independently evaluate the psychometric properties of the 15- and 22-item versions of the QPR.Method: Two samples were used: data-set 1 (n = 88) involved assessment of the QPR at baseline, 2 weeks and 3 months. Data-set 2 (n = 399; trial registration: ISRCTN02507940) involved assessment of the QPR at baseline and 1 year.Results: For the 15-item version, internal consistency was 0.89, convergent validity was 0.73, test-retest reliability was 0.74 and sensitivity to change was 0.40. Confirmatory factor analysis showed the 15-item version offered a good fit. For the 22-item version, the interpersonal subscale was found to underperform and the intrapersonal subscale overlaps substantially with the 15-item version.Conclusions: Both the 15-item and the intrapersonal subscale of the 22-item versions of the QPR demonstrated satisfactory psychometric properties. The 15-item version is slightly more robust and also less burdensome, so it can be recommended for use in research and clinical practice. [ABSTRACT FROM AUTHOR]

Objective: The GETSET trial found that guided graded exercise self-help (GES) improved fatigue and physical functioning more than specialist medical care (SMC) alone in adults with chronic fatigue syndrome (CFS) 12 weeks after randomisation. In this paper, we assess the longer-term clinical and health economic outcomes.Methods: GETSET was a randomised controlled trial of 211 UK secondary care patients with CFS. Primary outcomes were the Chalder fatigue questionnaire and the physical functioning subscale of the short-form-36 survey. Postal questionnaires assessed the primary outcomes and cost-effectiveness of the intervention 12 months after randomisation. Service costs and quality-adjusted life years (QALYs) were combined in a cost-effectiveness analysis.Results: Between January 2014 and March 2016, 164 (78%) participants returned questionnaires 15 months after randomisation. Results showed no main effect of intervention arm on fatigue (chi2(1) = 4.8, p = 0.03) or physical functioning (chi2(1) = 1.3, p = 0.25), adjusting for multiplicity. No other intervention arm or time*arm effect was significant. The short-term fatigue reduction was maintained at long-term follow-up for participants assigned to GES, with improved fatigue from short- to long-term follow up after SMC, such that the groups no longer differed. Healthcare costs were £85 higher for GES and produced more QALYs. The incremental cost-effectiveness ratio was £4802 per QALY.Conclusions: The short-term improvements after GES were maintained at long-term follow-up, with further improvement in the SMC group such that the groups no longer differed at long-term follow-up. The cost per QALY for GES compared to SMC alone was below the usual threshold indicating cost-effectiveness, but with uncertainty around the result. [ABSTRACT FROM AUTHOR]