A smoking cessation smartphone app that delivers real-time ‘context aware’ behavioural support: the Quit Sense feasibility RCT

BackgroundDuring a quit attempt, cues from a smoker’s environment are a major cause of brief smoking lapses, which increase the risk of relapse. Quit Sense is a theory-guided Just-In-Time Adaptive Intervention smartphone app, providing smokers with the means to learn about their environmental smoking cues and provides ‘in the moment’ support to help them manage these during a quit attempt.ObjectiveTo undertake a feasibility randomised controlled trial to estimate key parameters to inform a definitive randomised controlled trial of Quit Sense.DesignA parallel, two-arm randomised controlled trial with a qualitative process evaluation and a ‘Study Within A Trial’ evaluating incentives on attrition. The research team were blind to allocation except for the study statistician, database developers and lead researcher. Participants were not blind to allocation.SettingOnline with recruitment, enrolment, randomisation and data collection (excluding manual telephone follow-up) automated through the study website.ParticipantsSmokers (323 screened, 297 eligible, 209 enrolled) recruited via online adverts on Google search, Facebook and Instagram.InterventionsParticipants were allocated to ‘usual care’ arm (n = 105; text message referral to the National Health Service SmokeFree website) or ‘usual care’ plus Quit Sense (n = 104), via a text message invitation to install the Quit Sense app.Main outcome measuresFollow-up at 6 weeks and 6 months post enrolment was undertaken by automated text messages with an online questionnaire link and, for non-responders, by telephone. Definitive trial progression criteria were met if a priori thresholds were included in or lower than the 95% confidence interval of the estimate. Measures included health economic and outcome data completion rates (progression criterion #1 threshold: ≥ 70%), including biochemical validation rates (progression criterion #2 threshold: ≥ 70%), recruitment costs, app installation (progression criterion #3 threshold: ≥ 70%) and engagement rates (progression criterion #4 threshold: ≥ 60%), biochemically verified 6-month abstinence and hypothesised mechanisms of action and participant views of the app (qualitative).ResultsSelf-reported smoking outcome completion rates were 77% (95% confidence interval 71% to 82%) and health economic data (resource use and quality of life) 70% (95% CI 64% to 77%) at 6 months. Return rate of viable saliva samples for abstinence verification was 39% (95% CI 24% to 54%). The per-participant recruitment cost was £19.20, which included advert (£5.82) and running costs (£13.38). In the Quit Sense arm, 75% (95% CI 67% to 83%; 78/104) installed the app and, of these, 100% set a quit date within the app and 51% engaged with it for more than 1 week. The rate of 6-month biochemically verified sustained abstinence, which we anticipated would be used as a primary outcome in a future study, was 11.5% (12/104) in the Quit Sense arm and 2.9% (3/105) in the usual care arm (estimated effect size: adjusted odds ratio = 4.57, 95% CIs 1.23 to 16.94). There was no evidence of between-arm differences in hypothesised mechanisms of action. Three out of four progression criteria were met.The Study Within A Trial analysis found a £20 versus £10 incentive did not significantly increase follow-up rates though reduced the need for manual follow-up and increased response speed. The process evaluation identified several potential pathways to abstinence for Quit Sense, factors which led to disengagement with the app, and app improvement suggestions.LimitationsBiochemical validation rates were lower than anticipated and imbalanced between arms. COVID-19-related restrictions likely limited opportunities for Quit Sense to provide location tailored support.ConclusionsThe trial design and procedures demonstrated feasibility and evidence was generated supporting the efficacy potential of Quit Sense.Future workProgression to a definitive trial is warranted providing improved biochemical validation rates.Trial registrationThis trial is registered as ISRCTN12326962

Multicentre evaluation of two multiplex PCR platforms for the rapid microbiologicalinvestigation of nosocomial pneumonia in UK ICUs: the INHALE WP1 study

Background Culture-based microbiological investigation of hospital-acquired or ventilator-associated pneumonia (HAP or VAP) is insensitive, with aetiological agents often unidentified. This can lead to excess antimicrobial treatment of patients with susceptible pathogens, while those with resistant bacteria are treated inadequately for prolonged periods. Using PCR to seek pathogens and their resistance genes directly from clinical samples may improve therapy and stewardship.Methods Surplus routine lower respiratory tract samples were collected from intensive care unit patients about to receive new or changed antibiotics for hospital-onset lower respiratory tract infections at 15 UK hospitals. Testing was performed using the BioFire FilmArray Pneumonia Panel (bioMérieux) and Unyvero Pneumonia Panel (Curetis). Concordance analysis compared machine and routine microbiology results, while Bayesian latent class (BLC) analysis estimated the sensitivity and specificity of each test, incorporating information from both PCR panels and routine microbiology.Findings In 652 eligible samples; PCR identified pathogens in considerably more samples compared with routine microbiology: 60.4% and 74.2% for Unyvero and FilmArray respectively vs 44.2% by routine microbiology. PCR tests also detected more pathogens per sample than routine microbiology. For common HAP/VAP pathogens, FilmArray had sensitivity of 91.7%–100.0% and specificity of 87.5%–99.5%; Unyvero had sensitivity of 50.0%–100.0%%, and specificity of 89.4%–99.0%. BLC analysis indicated that, compared with PCR, routine microbiology had low sensitivity, ranging from 27.0% to 69.4%.Interpretation Conventional and BLC analysis demonstrated that both platforms performed similarly and were considerably more sensitive than routine microbiology, detecting potential pathogens in patient samples reported as culture negative. The increased sensitivity of detection realised by PCR offers potential for improved antimicrobial prescribing.</p

Autonomic Management of Large Clusters and Their Integration into the Grid

We present a framework for the co-ordinated, autonomic management of multiple clusters in a compute center and their integration into a Grid environment. Site autonomy and the automation of administrative tasks are prime aspects in this framework. The system behavior is continuously monitored in a steering cycle and appropriate actions are taken to resolve any problems. All presented components have been implemented in the course of the EU project DataGrid: The Lemon monitoring components, the FT fault-tolerance mechanism, the quattor system for software installation and configuration, the RMS job and resource management system, and the Gridification scheme that integrates clusters into the Grid

Human biomonitoring from an environmental justice perspective: supporting study participation of women of Turkish and Moroccan descent

Environmental justice research shows how socially disadvantaged groups are more exposed and more vulnerable to environmental pollution. At the same time, these groups are less represented and, thus, less visible in biomedical studies. This socioeconomic participation bias is a form of environmental injustice within research practice itself.status: publishe

Human biomonitoring from an environmental justice perspective: supporting study participation of women of Turkish and Moroccan descent

Abstract Background Environmental justice research shows how socially disadvantaged groups are more exposed and more vulnerable to environmental pollution. At the same time, these groups are less represented and, thus, less visible in biomedical studies. This socioeconomic participation bias is a form of environmental injustice within research practice itself. Methods We designed, implemented and evaluated a targeted recruitment strategy to enhance the participation of socially disadvantaged pregnant women in a human biomonitoring study in Belgium. We focused on women of Turkish and Moroccan descent and developed a setup using personal buddies that enabled information transfer about study conditions in the pre-parturition period as well as support and follow-up with questionnaires in the post-parturition period. Results We identified four barriers to the participation of women with a vulnerable social and ethnic background which were related to psychosocial and situational factors. Lack of trust in researchers and no perceived study benefits were important personal barriers; the complex study design and difficult self-administered questionnaires were equally significant barriers. Conclusion By investing in direct, person-to-person contact with trusted buddies and supported by practical advice about cultural and linguistic sensitivity, it was possible to increase study participation of socially disadvantaged people. Above all, this required openness and flexibility in the mind-set of researchers so that study design and procedures could be better grounded in the experiences and circumstances of underprivileged groups

Participant Experiences in a Human Biomonitoring Study: Follow-Up Interviews with Participants of the Flemish Environment and Health Study

Communicating individual human biomonitoring results to study participants has been the subject of debate for some time. This debate is dominated by ethical considerations from a researchers’ perspective on whether or not to communicate, thereby overlooking more practice-based questions from a participants’ perspective on what and how to communicate. We conducted a small scale follow-up study based on eleven face-to-face interviews with mothers participating in the third cycle of the Flemish Environment and Health Study (FLEHS III 2012–2015) to investigate how they experienced and interpreted individual biomonitoring results. Key findings indicate that respondents were generally satisfied with participating in the biomonitoring study, but the report-back process especially lacked contextualized information and interactive communication options to better comprehend and cope with personal results. These findings also argue in favor of a more tailored approach in which report-back methods, formats and content are diversified according to the type of results and the preferences of participants. A reflexive research practice with active engagement in follow-up research is crucial to improve participants’ understanding and use of personal biomonitoring results.</jats:p

Participant Experiences in a Human Biomonitoring Study: Follow-Up Interviews with Participants of the Flemish Environment and Health Study

Communicating individual human biomonitoring results to study participants has been the subject of debate for some time. This debate is dominated by ethical considerations from a researchers’ perspective on whether or not to communicate, thereby overlooking more practice-based questions from a participants’ perspective on what and how to communicate. We conducted a small scale follow-up study based on eleven face-to-face interviews with mothers participating in the third cycle of the Flemish Environment and Health Study (FLEHS III 2012–2015) to investigate how they experienced and interpreted individual biomonitoring results. Key findings indicate that respondents were generally satisfied with participating in the biomonitoring study, but the report-back process especially lacked contextualized information and interactive communication options to better comprehend and cope with personal results. These findings also argue in favor of a more tailored approach in which report-back methods, formats and content are diversified according to the type of results and the preferences of participants. A reflexive research practice with active engagement in follow-up research is crucial to improve participants’ understanding and use of personal biomonitoring results

Participant experiences in a human biomonitoring study : follow-up interviews with participants of the Flemish environment and health study

Communicating individual human biomonitoring results to study participants has been the subject of debate for some time. This debate is dominated by ethical considerations from a researchers’ perspective on whether or not to communicate, thereby overlooking more practice-based questions from a participants’ perspective on what and how to communicate. We conducted a small scale follow-up study based on eleven face-to-face interviews with mothers participating in the third cycle of the Flemish Environment and Health Study (FLEHS III 2012–2015) to investigate how they experienced and interpreted individual biomonitoring results. Key findings indicate that respondents were generally satisfied with participating in the biomonitoring study, but the report-back process especially lacked contextualized information and interactive communication options to better comprehend and cope with personal results. These findings also argue in favor of a more tailored approach in which report-back methods, formats and content are diversified according to the type of results and the preferences of participants. A reflexive research practice with active engagement in follow-up research is crucial to improve participants’ understanding and use of personal biomonitoring&nbsp;results.</p