Examining the benefit of graduated compression stockings in the prevention of hospital-associated venous thromboembolism in low-risk surgical patients: a multicentre cluster randomised controlled trial (PETS trial).

INTRODUCTION: Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor. METHODS AND ANALYSIS: A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18-59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN13908683.

Long-Term Effectiveness of a Clinician-Assisted Digital Cognitive Behavioral Therapy Intervention for Smoking Cessation: Secondary Outcomes From a Randomized Controlled Trial.

INTRODUCTION: This study evaluated the secondary effectiveness outcomes for Quit Genius, a digital clinician-assisted cognitive behavioral therapy (CBT) intervention for smoking cessation. METHODS: Adult smokers (N = 556) were randomly assigned to Quit Genius (n = 277), a digital, clinician-assisted CBT intervention or very brief advice (VBA) to stop smoking, an evidence-based, 30-s intervention designed to facilitate quit attempts, coupled with referral to a cessation service (n = 279). Participants were offered combination nicotine replacement therapy (patches and gum) tailored to individual nicotine dependence. Analyses (n = 530), by intention-to-treat, compared Quit Genius and VBA at 4, 26, and 52 weeks post-quit date (QD). The primary outcome was self-reported 7-day point prevalence abstinence (PPA) at 4 weeks post-QD. Consecutive 7-day point-prevalence abstinence, defined as abstinent at two or more consecutive timepoints, was examined at weeks 26 and 52 to indicate long-term effectiveness. Abstinence was verified using a random sample of participants with carbon monoxide breath testing of <5 parts per million (n = 280). RESULTS: Self-reported consecutive 7-day PPA at weeks 26 and 52 for Quit Genius was 27.2% and 22.6%, respectively, compared with VBA which was 16.6% and 13.2% (RR = 1.70, 95% CI, 1.22-2.37; p = .003, 26 weeks; RR = 1.71, 95% CI, 1.17-2.50; P = .005, 52 weeks). Biochemically verified abstinence was significantly different at 26- (p = .03) but not 52 weeks (p = .16). Quit Genius participants were more likely to remain abstinent than those who received VBA (RR = 1.71, 95% CI 1.17-2.50; p = .005). CONCLUSIONS: This study provides secondary evidence for the long-term effectiveness of Quit Genius in comparison with VBA. Future trials of digital interventions without clinician support and comparisons with active treatment are needed. IMPLICATIONS: The long-term effectiveness of clinician-assisted digital smoking cessation interventions has not been well studied. This study established the long-term effectiveness of an extended CBT-based intervention; results may inform implementation of scalable approaches to smoking cessation in the health system.

Study protocol for a multicentre, randomised controlled trial to compare the use of the decellularised dermis allograft in addition to standard care versus standard care alone for the treatment of venous leg ulceration: DAVE trial.

INTRODUCTION: Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. METHODS AND ANALYSIS: This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. ETHICS AND DISSEMINATION: Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN21541209.

Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial.

BACKGROUND: Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. OBJECTIVE: Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. METHODS: A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date. RESULTS: A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed. CONCLUSIONS: The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476.

Are 'dual users' who smoke and use e-cigarettes interested in using varenicline to stop smoking altogether, and can they benefit from it? A cohort study of UK vapers.

OBJECTIVES: Smokers who use e-cigarettes (EC) do so mostly to stop smoking, but many continue to use both products. It is not known whether these 'dual users' are interested in stop-smoking medications and whether they can benefit from them. SETTING, PARTICIPANTS AND MEASURES: Dual users were recruited over social media and posted study questionnaire and saliva kits at baseline, 3 and 6 months. Those interested in varenicline were posted the medication and received weekly calls over the first 6 weeks, followed by three calls at fortnightly intervals. RESULTS: Of 204 participants, 124 (61%, CI=54% to 68%) expressed interest in receiving varenicline and 80 (39%, CI=32% to 45%) started varenicline (varenicline users, VU). VU were more dependent smokers (F=6.2, p=0.01) with higher cigarette consumption (F=8.7, p<0.01) who were using stronger nicotine e-liquids (F=13.9, p<0.001) than dual users not opting for varenicline (varenicline non-users, VN). In terms of abstinence for at least 3 months at the 6-month follow-up, VU were more likely than VN to report abstinence from smoking (17.5% vs 4.8%, p=0.006, RR=3.6, CI:1.4 to 9.0), vaping (12.5% vs 1.6%, p=0.007, RR=7.8, CI:1.7 to 34.5) and both smoking and vaping (8.8% vs 0.8%, p=0.02, RR=10.9, CI:1.4 to 86.6). The differences were significant across sensitivity analyses (RRs=4.9 to 14.0; p=0.02 to p<0.001 at 3 months; RRs=3.0 to 14.0; p=0.01 to p<0.001 at 6 months). VU reported a greater reduction in enjoyment of vaping by the end of the varenicline use period (F=4.1, p=0.04) and recorded a significantly greater reduction in nicotine intake than VN at 3 months (F=13.9, p<0.001) and 6 months (F=26.5, p<0.001). CONCLUSION: Varenicline offered to dual users is likely to promote successful abstinence from both smoking and vaping, although a randomised trial is needed to confirm this. Among dual users who want to stop smoking, there seems to be a high level of interest in smoking-cessation treatments.

Tackling obesity in areas of high social deprivation: clinical effectiveness and cost-effectiveness of a task-based weight management group programme - a randomised controlled trial and economic evaluation.

BACKGROUND: An increasing number of people require help to manage their weight. The NHS recommends weight loss advice by general practitioners and/or a referral to a practice nurse. Although this is helpful for some, more effective approaches that can be disseminated economically on a large scale are needed. OBJECTIVE: To assess whether or not a task-based weight management programme [Weight Action Programme (WAP)] has better long-term effects than a 'best practice' intervention provided in primary care by practice nurses. DESIGN: Randomised controlled trial with cost-effectiveness analysis. SETTING: General practices in east London, UK. PARTICIPANTS: Three hundred and thirty adults with a body mass index (BMI) of ≥ 30 kg/m2 or a BMI of ≥ 28 kg/m2 plus comorbidities were recruited from local general practices and via media publicity. Those who had a BMI of > 45 kg/m2, had lost > 5% of their body weight in the previous 6 months, were currently pregnant or taking psychiatric medications were excluded. Participants were randomised (2 : 1) to the WAP or nurse arms. INTERVENTIONS: The WAP intervention was delivered in eight weekly group sessions that combined dietary and physical activity, advice and self-monitoring in a group-oriented intervention. The initial course was followed by 10 monthly group maintenance sessions open to all participants in this study arm. The practice nurse intervention (best usual care) consisted of four one-to-one sessions delivered over 8 weeks, and included standard advice on diet and physical activity based on NHS 'Change4Life' materials and motivational support. MAIN OUTCOME MEASURES: The primary outcome measure was weight change at 12 months. Secondary outcome measures included change in BMI, waist circumference and blood pressure, and proportion of participants losing at least 5% and 10% of baseline body weight. Staff collecting measurements at the 6- and 12-month follow-ups were blinded to treatment allocation. The primary outcome measure was analysed according to the intention-to-treat principle, and included all participants with at least one recorded outcome at either 1, 2, 6 or 12 months. The analysis employed a mixed-effects linear regression model, adjusted for baseline weight, age, sex, ethnicity, smoking status and general practice. The European Quality of Life-5 Dimensions-5 Levels questionnaire was completed and used to estimate quality-adjusted life-years (QALYs) within the cost-effectiveness analysis. RESULTS: There were 330 participants (WAP arm, n = 221; nurse arm, n = 109; 72% women). A total of 291 (88%) participants (WAP arm, n = 194; nurse arm, n = 97) were included in the main analysis for the primary outcome. Weight loss at 12 months was greater in the WAP arm than in the nurse intervention arm [-4.2 kg vs. -2.3 kg; difference -1.9 kg, 95% confidence interval (CI) -3.7 to -0.1 kg; p = 0.04]. Participants in the WAP arm were more likely than participants in the nurse arm to have lost at least 5% of their baseline body weight at 12 months (41% vs. 27%; odds ratio 14.61, 95% CI 2.32 to 91.96; p = 0.004). The incremental cost-effectiveness ratio for WAP over and above the nurse arm is £7742 per QALY. CONCLUSIONS: A WAP delivered in general practice better promotes weight loss over 12 months than a best usual practice nurse-led weight loss programme. LIMITATIONS: The trial recruited mostly women. Research is needed into factors that would make weight loss programmes more attractive to men. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45820471. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 79. See the NIHR Journals Library website for further project information.