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Introduction Learned smoking cues from a smoker’s environment are a major cause of lapse and relapse. Quit Sense, a theory-guided Just-In-Time Adaptive Intervention smartphone app, aims to help smokers learn about their situational smoking cues and provide in-the-moment support to help manage these when quitting. Methods A two-arm feasibility randomized controlled trial (N = 209) to estimate parameters to inform a definitive evaluation. Smoker’s willing to make a quit attempt were recruited using online paid-for adverts and randomized to “usual care” (text message referral to NHS SmokeFree website) or “usual care” plus a text message invitation to install Quit Sense. Procedures, excluding manual follow-up for nonresponders, were automated. Follow-up at 6 weeks and 6 months included feasibility, intervention engagement, smoking-related, and economic outcomes. Abstinence was verified using cotinine assessment from posted saliva samples. Results Self-reported smoking outcome completion rates at 6 months were 77% (95% CI 71%, 82%), viable saliva sample return rate was 39% (95% CI 24%, 54%), and health economic data 70% (95% CI 64%, 77%). Among Quit Sense participants, 75% (95% CI 67%, 83%) installed the app and set a quit date and, of those, 51% engaged for more than one week. The 6-month biochemically verified sustained abstinence rate (anticipated primary outcome for definitive trial), was 11.5% (12/104) among Quit Sense participants and 2.9% (3/105) for usual care (adjusted odds ratio = 4.57, 95% CIs 1.23, 16.94). No evidence of between-group differences in hypothesized mechanisms of action was found. Conclusions Evaluation feasibility was demonstrated alongside evidence supporting the effectiveness potential of Quit Sense. Implications Running a primarily automated trial to initially evaluate Quit Sense was feasible, resulting in modest recruitment costs and researcher time, and high trial engagement. When invited, as part of trial participation, to install a smoking cessation app, most participants are likely to do so, and, for those using Quit Sense, an estimated one-half will engage with it for more than 1 week. Evidence that Quit Sense may increase verified abstinence at 6-month follow-up, relative to usual care, was generated, although low saliva return rates to verify smoking status contributed to considerable imprecision in the effect size estimate.

Background Although cardiometabolic conditions account for over 32% of all global deaths, nearly half of the patients with cardiometabolic conditions do not take medication as prescribed. Remote behavioral interventions have been shown to potentially improve adherence in these patients and further support cost effective clinical practice. Purpose To evaluate the effectiveness of remote behavioral interventions at improving treatment adherence and to explore behavioral intervention components associated with it. Methods We searched MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science in April 2021. Random-effects meta-analyses were utilized. Results In total, 40 studies, including 24,672 participants, were included. The overall quality of evidence, assessed using the RoB2 tool, was low. The intervention had a small (odds ratios [OR] = 1.70, 95% CI: 1.47, 1.96, N = 4823 p < .001) to moderate effect (SMD = 0.57, 95% CI: 0.38, 0.76, N = 20,271, p < .001) on the dichotomous and continuous outcomes, respectively. Systolic blood pressure (SBP) was reduced by 3.71 mmHg (95% CI: 3.99, 3.43, N = 6,527, p < .001) and participants receiving the intervention were twice more likely to achieve blood pressure (BP) control (OR = 2.14, 95% CI: 1.61, 2.84, N = 1,172, p < .001). Generally, HBA1c decreased by 0.25% (95% CI: 0.33, 0.17, N = 6,734, p < .001), whereas low-density lipoprotein (LDL)-cholesterol dropped by 6.82 mg/dL (95% CI: 8.33, 5.30, N = 4,550, p < .001) in favor of the intervention. There was a trend suggesting a potential positive effects on reducing visits to emergency department (OR=0.76, 95% CI: 0.57, 1.01, N = 4,182) and mortality rates (OR=0.78, 95% CI: 0.42, 1.42, N = 1,971), and no risk for hospital readmission (OR=1.00, 95% CI: 0.83, 1.20, N = 5,402), favoring the intervention. Conclusions Despite low quality of evidence, remote consultations are effective at improving medication adherence and clinical indicators, and potentially cost-effective solution for health care services.

Objectives The Covid-19 pandemic necessitated a rapid global transition towards telemedicine; yet much remains unknown about telemedicine’s acceptability and safety in rheumatology. To help address this gap and inform practice, this study investigated rheumatology patient and clinician experiences and views of telemedicine. Methods Sequential mixed methodology combined analysis of surveys and in-depth interviews. Between and within-group differences in views of telemedicine were examined for patients and clinicians using t-tests. Results Surveys (patients n = 1340, clinicians n = 111) and interviews (patients n = 31, clinicians n = 29) were completed between April 2021 and July 2021. The majority of patients were from the UK (96%) and had inflammatory arthritis (32%) or lupus (32%). Patients and clinicians rated telemedicine as worse than face-to-face consultations in almost all categories, although >60% found it more convenient. Building trusting medical relationships and assessment accuracy were great concerns (93% of clinicians and 86% of patients rated telemedicine as worse than face-to-face for assessment accuracy). Telemedicine was perceived to have increased misdiagnoses, inequalities and barriers to accessing care. Participants reported highly disparate telemedicine delivery and responsiveness from primary and secondary care. Although rheumatology clinicians highlighted the importance of a quick response to flaring patients, only 55% of patients were confident that their rheumatology department would respond within 48 hours. Conclusion Findings indicate a preference for face-to-face consultations. Some negative experiences may be due to the pandemic rather than telemedicine specifically, although the risk of greater diagnostic inaccuracies using telemedicine is unlikely to be fully resolved. Training, choice, careful patient selection, and further consultation with clinicians and patients is required to increase telemedicine’s acceptability and safety. Trial registration This telemedicine study is part of a pre-registered longitudinal multi-stage trial, the LISTEN study (ISRCTN-14966097), with later Covid-related additions registered in March 2021, including a pre-registered statistical analysis plan.

Objective To better understand rheumatology patient and clinician pandemic-related experiences, medical relationships and behaviours in order to help identify the persisting impacts of the COVID-19 pandemic and inform efforts to ameliorate the negative impacts and build upon the positive ones. Methods Rheumatology patients and clinicians completed surveys (patients n = 1543, clinicians n = 111) and interviews (patients n = 41, clinicians n = 32) between April 2021 and August 2021. A cohort (n = 139) of systemic autoimmune rheumatic disease patients was also followed up from March 2020 to April 2021. Analyses used sequential mixed methods. Pre-specified outcome measures included the Warwick–Edinburgh Mental wellbeing score (WEMWBS), satisfaction with care and healthcare behaviours. Results We identified multiple ongoing pandemic-induced/increased barriers to receiving care. The percentage of patients agreeing they were medically supported reduced from 74.4% pre-pandemic to 39.7% during-pandemic. Ratings for medical support, medical security and trust were significantly (P Conclusion Without concerted action—such as rebuilding trust, improved administrative systems and more support for clinicians—barriers to care and negative impacts of the pandemic on trust, medical relationships, medical security and patient help-seeking may persist in the longer term. Trial registration This study is part of a pre-registered longitudinal multi-stage trial, the LISTEN study (ISRCTN-14966097), with later COVID-related additions registered in March 2021, including a pre-registered statistical analysis plan.

Objectives The aim was to explore patient experiences and views of their symptoms, delays in diagnosis, misdiagnoses and medical support, to identify common experiences, preferences and unmet needs. Methods Following a review of LUPUS UK’s online forum, a questionnaire was posted online during December 2018. This was an exploratory mixed methods study, with qualitative data analysed thematically and combined with descriptive and statistically analysed quantitative data. Results There were 233 eligible respondents. The mean time to diagnosis from first experiencing symptoms was 6 years 11 months. Seventy-six per cent reported at least one misdiagnosis for symptoms subsequently attributed to their systemic autoimmune rheumatic disease. Mental health/non-organic misdiagnoses constituted 47% of reported misdiagnoses and were indicated to have reduced trust in physicians and to have changed future health-care-seeking behaviour. Perceptions of physician knowledge and listening skills were highly correlated with patient ratings of trust. The symptom burden was high. Fatigue had the greatest impact on activities of daily living, yet the majority reported receiving no support or poor support in managing it. Assessing and treating patients holistically and with empathy was strongly felt to increase diagnostic accuracy and improve medical relationships. Conclusion Patient responses indicated that timely diagnosis could be facilitated if physicians had greater knowledge of lupus/related systemic autoimmune diseases and were more amenable to listening to and believing patient reports of their symptoms. Patient priorities included physicians viewing them holistically, with more emotional support and assistance in improving quality of life, especially in relation to fatigue.

Objective The aim was to explore the impact of patient–physician interactions, pre- and post-diagnosis, on lupus and UCTD patients’ psychological well-being, cognition and health-care-seeking behaviour. Methods Participants were purposively sampled from the 233 responses to a survey on patient experiences of medical support. Twenty-one semi-structured interviews were conducted and themes generated using thematic analysis. Results The study identified six principal themes: (i) the impact of the diagnostic journey; (ii) the influence of key physician(s) on patient trust and security, with most participants reporting at least one positive medical relationship; (iii) disparities in patient–physician priorities, with patients desiring more support with quality-of-life concerns; (iv) persisting insecurity and distrust, which was prevalent and largely influenced by previous and anticipated disproportionate (often perceived as dismissive) physician responses to symptoms and experiences of widespread inadequate physician knowledge of systemic autoimmune diseases; (v) changes to health-care-seeking behaviours, such as curtailing help-seeking or under-reporting symptoms; and (vi) empowerment, including shared medical decision-making and knowledge acquisition, which can mitigate insecurity and improve care. Conclusion Negative medical interactions pre- and post-diagnosis can cause a loss of self-confidence and a loss of confidence and trust in the medical profession. This insecurity can persist even in subsequent positive medical relationships and should be addressed. Key physicians implementing empowering and security-inducing strategies, including being available in times of health crises and validating patient-reported symptoms, might lead to more trusting medical relationships and positive health-care-seeking behaviour.

INTRODUCTION: Smoking remains a significant public health problem and is a leading cause of preventable morbidity and mortality around the world. By combining the behavioral intervention principles used in specialist services with the high reach rates of public health interventions, personal tailored self-help cessation intervention provides a potential economical method for improving reach and effectiveness. METHODS: Cost-effectiveness analysis is performed alongside a randomized controlled trial to compare the computer-tailored self-help intervention with a generic self-help intervention in smoking cessation. A Markov model was developed to extrapolate lifetime cost-effectiveness by combining trial data with estimates from the literature. FINDINGS: In the short term, smokers in the intervention group gained 0.0006 (95% CI = -0.0024 to 0.0036) quality-adjusted life years (QALYs) more than those in the control group at an increased cost of about £9 per person (95% CI = £5-£12). This yielded an incremental cost-effectiveness ratio (ICER) of £14,432/QALY. Precision of the ICER estimates was assessed by 5,000 bootstrapping replications. The probability that the intervention was cost effective was 54% (58%) at a cost-effectiveness threshold of £20,000(£30,000) per QALY. The Markov model showed that simulating lifetime outcomes improved the cost-effectiveness ratio (£9,700/QALY) in favor of the tailored intervention. The intervention would have a 55%-57% chance of being more cost effective than nontailored intervention at the willingness-to-pay threshold of £20,000-30,000/QALY. CONCLUSIONS: The computer-tailored intervention appears slightly more likely to be cost effective than the generic self-help intervention in smoking cessation, in both the short term and the long term, but caution is required given the considerable uncertainty surrounding the estimates.

Introduction: Smoking cessation support is increasingly delivered in primary care by auxiliary healthcare workers in place of healthcare professionals. However, it is unknown whether this shift might affect the quality and impact of the support delivered. Methods: Data from the iQuit in Practice randomized control trial of cessation support in General Practice was used (N = 602). Analyses assessed whether cessation advisor type (nurse or healthcare assistant [HCA]) was associated with abstinence (primary outcome: self-reported 2-week point prevalence abstinence at 8 weeks follow-up), the advice delivered during the initial consultation, pharmacotherapies prescribed, patient satisfaction, initial consultation length, and the number and type of interim contacts. Results: There were no statistically significant differences in abstinence for support delivered by HCAs versus nurses at 8 weeks (HCAs 42.8%, nurses 42.6%; unadjusted odds ratio [OR] = 1.01, 95% confidence interval [CI] = 0.73 to 1.40), or at 4 weeks or 6 months follow-up. There were no statistically significant differences in advice delivered, the types of pharmacotherapies prescribed or patient satisfaction. Compared with nurses, HCA consultations were longer on average (HCAs 23.6 minutes, nurses 20.8 minutes; P = .002) and they undertook more interim contacts (HCAs median 2, nurses median 1; P < .001), with contact more likely to be face-to-face than phone call (HCAs 91.2%, nurses 70.9%; OR = 4.23, 95% CI = 2.86 to 6.26). Conclusions: HCAs appear equally effective as nurses in supporting smoking cessation, although they do this with greater patient contact. Using auxiliary practitioners to deliver cessation support could free up nurse time and reduce costs. Implications: This study found that primary care patients receiving smoking cessation support from auxiliary healthcare workers were just as likely to be abstinent up to 6 months later as those patients seen by nurses. While the auxiliary healthcare workers achieved this with slightly increased patient contact time, the advice delivered, pharmacotherapies provided and patient satisfaction were similar to that of nurses. Expanding the auxiliary healthcare worker role to include smoking cessation support could increase role satisfaction and reduce the costs of cessation support delivery in primary care.

Introduction: Nicotine replacement therapy (NRT) medications have been shown to be effective in increasing smoking cessation rates. There is, however, a lack of good evidence describing how individuals in primary care use these medications and which factors are likely to affect this. The study objectives are to describe adherence and consumption, examine key factors that may determine use, and examine the relationship between consumption of NRT and abstinence from smoking. Methods: Secondary analysis of data from a randomized controlled trial conducted in smoking cessation services in primary care. Adult smokers (n = 633) starting a quit attempt within smoking cessation clinics were followed for 6 months, with NRT use closely monitored for an initial treatment period of 4 weeks. The main outcomes were 4-week adherence to prescribed NRT, mean daily consumption of NRT over the 4-week period, and abstinence from smoking at 4 weeks. Results: Levels of adherence to prescribed NRT were high: more than 94% in participants who completed the treatment period. After controlling for possible confounders, prescribing higher doses of patch and oral NRT was associated with higher mean daily consumption of NRT. Using an inhalator to deliver oral NRT was associated with both higher adherence and higher consumption. The amount of NRT consumed predicted future abstinence when reverse causation was accounted for. Conclusions: Most individuals within a clinical trial in primary care who persisted with a quit attempt adhered closely to their prescription. Prescribing higher doses of NRT led to higher consumption and higher consumption to higher abstinence. © The Author 2013. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.

Introduction: Smokers receiving support in specialist centres tend to have a higher short-term quit rate, compared with those receiving support in other settings from professionals for whom smoking cessation is only a part of their work. We investigated the difference in longer-term abstinence after short-term smoking cessation treatment from specialist and non-specialist smoking cessation services. Methods: We conducted a secondary analysis of data from a randomised controlled trial of self-help booklets for the prevention of smoking relapse. The trial included 1,088 short-term quitters from specialist stop smoking clinics and 316 from non-specialist cessation services (such as general practice, pharmacies, and health trainer services). The difference in prolonged smoking abstinence from months four to 12 between specialist and non-specialist services was compared. Multivariable logistic regression analyses were conducted to investigate the association between continuous smoking abstinence and the type of smoking cessation services, adjusted for possible confounding factors (including demographic, socioeconomic, and smoking history variables). Results: The proportion of continuous abstinence from four to 12 months was higher in short-term quitters from specialist services compared with those from non-specialist services (39% vs. 32%; P=0.023). After adjusting for a range of participant characteristics and smoking variables, the specialist service was significantly associated with a higher rate of longer-term smoking abstinence (odds ratio 1.48, 95% CI: 1.09 to 2.00; P=0.011). Conclusions: People who receive support to stop smoking from a specialist appear to be at lower risk of relapse than those receiving support from a non-specialist advisor.

Objective Community pharmacists are in an optimal position to provide smoking-cessation services. Computer-based interventions that generate behavioural feedback materials designed to encourage and help smokers to quit can complement existing services and ensure that smoking-cessation advice is reliably delivered. This study aimed to assess the feasibility of offering a system of computer-generated individually tailored behavioural feedback for smoking cessation in community pharmacy. Method The setting was community pharmacies in North London. Pharmacists, already offering cessation advice routinely in the pharmacy, were trained to use a computer-based system generating a feedback report containing highly tailored behavioural advice about quitting. Pharmacists' advice was structured around the report, which was printed for the participant. Pharmacists were interviewed after recruitment ended, and participants were sent a follow-up questionnaire 4 weeks after baseline. Key findings Pharmacists felt they had benefited from taking part in the study and were more confident in their management of, and advice to, smokers. All agreed that the computer program was an acceptable and valuable tool to aid smoking-cessation advice in pharmacies. Eleven smokers were recruited; five completed the follow-up, four of whom reported 4-week prolonged abstinence. Reaction to the feedback report from participants was positive. Conclusions The feedback from both pharmacists and participants demonstrates that use of this computer system to structure and standardise delivery of smoking-cessation advice in community pharmacy is feasible and acceptable. The study suggests that the use of this system could increase pharmacists' confidence and the quality of the advice they give, leading to improved outcomes. However, a randomised controlled trial to fully evaluate the effectiveness of the system is needed.

Theory-based intervention programmes to support health-related behaviour change aim to increase health impact and improve understanding of mechanisms of behaviour change. However, the science of intervention development remains at an early stage. We present a causal modelling approach to developing complex interventions for evaluation in randomized trials. In this approach a generic model links behavioural determinants, causally through behaviour, to physiological and biochemical variables, and health outcomes. It is tailored to context, target population, behaviours and health outcomes. The development of a specific causal model based on theory and evidence is illustrated by the ProActive programme, supporting increased physical activity among individuals at risk of Type 2 diabetes. The model provides a rational guide to appropriate measures, intervention points and intervention techniques, and can be tested quantitatively. Causal modelling is critically compared to other approaches to intervention development and evaluation, and research directions are indicated.

BACKGROUND Computer decision support systems have been proposed as a suitable method to enable primary care practitioners to manage familial cancer and advise about other developments in clinical genetics. OBJECTIVE To investigate GPs' preferences, attitudes and intentions regarding the use of Genetic Risk Assessment on the Internet and Decision Support (GRAIDS) in clinical practice. METHODS GPs were recruited through a physician Internet portal for UK GPs (www.ukpractice.net). Electronic questionnaires assessed the respondents' current practice regarding family history taking and risk assessment, preferences about particular attributes of GRAIDS, intentions to use GRAIDS for familial cancer management and factors associated with these intentions. RESULTS Two hundred and sixty-eight GPs completed the electronic survey (adjusted response rate = 51.2%). Seventy-two GPs participated in a telephone survey of non-respondents (adjusted response rate = 63%). Ninety-two per cent of respondents in the electronic survey and 68% in the telephone survey stated that they would be either extremely or fairly likely to use GRAIDS. Intentions were associated with positive attitudes toward GRAIDS, beliefs that colleagues and patients would find the tool acceptable, perceived control and perceived confidence about conducting risk assessment and making appropriate decisions about patient management. Key attributes for the implementation of GRAIDS in practice were the authoritativeness of the guideline, easy user interface, the validity and reliability of risk estimation and specific advice about patient management. CONCLUSION GP users of the physician portal www.ukpractice.net value GRAIDS as an aid for the management of familial cancer in primary care. These Internet-literate GPs are likely to be early adopters of GRAIDS in clinical practice and could be important in promoting the use of such technology to support high quality advice about genetic issues in primary care.