scholarly journals Cognitive complexity of clients and counsellors during motivation-based treatment for smoking cessation: an observational study on occasional smokers in a US college sample

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e015849 ◽  
Author(s):  
Lucian Gideon Conway ◽  
Kari Jo Harris ◽  
Delwyn Catley ◽  
Laura Janelle Gornick ◽  
Kathrene Renee Conway ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Observational Study ◽  
Confidence Interval ◽  
Cognitive Complexity ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Secondary Outcome ◽  
Integrative Complexity ◽  
Randomised Controlled

ObjectiveMotivational interviewing (MI) is a widely used and promising treatment approach for aiding in smoking cessation. The present observational study adds to other recent research on why and when MI works by investigating a new potential mechanism: integrative complexity.SettingThe study took place in college fraternity and sorority chapters at one large midwestern university.ParticipantsResearchers transcribed MI counselling sessions from a previous randomised controlled trial focused on tobacco cessation among college students and subsequently scored clients’ and counsellors’ discussions across four counselling sessions for integrative complexity.InterventionsThis is an observational secondary analysis of a randomised controlled trial that tested the effectiveness of MI. We analysed the relationship between integrative complexity and success at quitting smoking in the trial.Primary and secondary outcome measuresSuccess in quitting smoking:Participants were categorised into two outcome groups (successful quitters vs failed attempters), created based on dichotomous outcomes on two standard variables: (1) self-reported attempts to quit and (2) number of days smoked via timeline follow-back assessment procedures that use key events in participants’ lives to prompt their recall of smoking.ResultsWe found (1) significantly higher complexity overall for participants who tried to quit but failed compared with successful quitters (standardised β=0.36, p<0.001, (Lower Confidence Interval.)LCI=0.16, (Upper Confidence Interval)UCI=0.47) and (2) the predictive effect of complexity on outcome remains when controlling for standard motivational and demographic variables (partialr(102)=−0.23, p=0.022).ConclusionsTaken together, these results suggest that cognitive complexity is uniquely associated with successful quitting in MI controlled trials, and thus may be an important variable to more fully explore during treatment.

scholarly journals The skill of tracheal intubation with rigid scopes – a randomised controlled trial comparing learning curves in 740 intubations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lorenz Theiler ◽  
Robert Greif ◽  
Lukas Bütikofer ◽  
Kristopher Arheart ◽  
Maren Kleine-Brueggeney
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Confidence Interval ◽  
Learning Effect ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Success Probability ◽  
Learning Curves ◽  
Secondary Outcome ◽  
Randomised Controlled

Abstract Background Rigid scopes are successfully used for management of difficult airways, but learning curves have not been established. Methods This randomised controlled trial was performed at the University Hospital Bern in Switzerland to establish learning curves for the rigid scopes Bonfils and SensaScope and to assess their performance. Fifteen consultant anaesthetists and 15 anaesthesia registrars performed a total of 740 intubations (10 to 20 intubations with each device per physician) in adult patients without predictors of a difficult airway under general anaesthesia. According to randomisation, physicians intubated the patient’s trachea with either the Bonfils or the SensaScope. A maximum of three intubation attempts was allowed. Primary outcome was overall time to successful intubation. Secondary outcome parameters included first attempt success, first attempt success within 60 s, failures and adverse events. Results A clear learning effect was demonstrated: Over 20 trials, intubations became 2.5-times quicker and first attempt intubation success probability increased by 21–28 percentage points. Fourteen and 20 trials were needed with the Bonfils and the SensaScope, respectively, to reach a 90% first attempt success probability. Intubation times were 23% longer (geometric mean ratio 1.23, 95% confidence interval 1.12–1.36, p < 0.001) and first attempt success was less likely (odds ratio 0.64, 95% confidence interval 0.45–0.92, p = 0.016) with the SensaScope. Consultants showed a tendency for a better first attempt success compared to registrars. Overall, 23 intubations (10 Bonfils, 13 SensaScope) failed. Adverse events were rare and did not differ between devices. Conclusions A clear learning effect was demonstrated for both rigid scopes. Fourteen intubations with the Bonfils and 20 intubations with the SensaScope were required to reach a 90% first attempt success probability. Learning of the technique seemed more complex with the SensaScope compared to the Bonfils. Trial registration Current Controlled Trials, ISRCTN14429285. Registered 28 September 2011, retrospectively registered.

scholarly journals Association of e-cigarette use and smoking cessation among Canadian young adult smokers: secondary analysis of data from a randomised controlled trial

2020 ◽  
Vol 15 (1) ◽  
pp. 50-58
Author(s):  
Arti Saxena ◽  
Neill Bruce Baskerville ◽  
John M. Garcia
Keyword(s):  
Smoking Cessation ◽  
Young Adult ◽  
Randomised Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cessation Rate ◽  
Using Data ◽  
Randomised Controlled

AbstractAimsThis study examined the reasons for e-cigarette (EC) use, changes in self-efficacy and association between EC use and cessation of tobacco among Canadian young adult smokers over a 6-month period.MethodsA secondary analysis was conducted using data from a randomised controlled trial (RCT) of young adult Canadian smokers. EC exposure was defined as persistent, transient and non-use of ECs at baseline and follow-up. The association between EC exposure and cessation was examined using logistic regression and adjusting for co-variates.ResultsAt 6-month follow-up, persistent EC use was associated with a lower cessation rate (13%) than transient (23%) or non-use (29%). After adjusting for covariates, non-use and transient use were associated with higher odds of cessation than persistent use (AOR = 3.23, 95% CI = 1.41–7.40, P < 0.01; AOR = 2.40, 95% CI = 1.01–5.58, P < 0.05). At 6-month follow-up, persistent users (68%) had high self-efficacy as compared to transient (15%) or non-use (12%). Top reasons for EC use included use as a quit aid (67%), perceived use as less harmful (52%) and taste (32%).ConclusionsAmong young adult Canadian smokers enrolled in a RCT of a cessation intervention, persistent and transient use of ECs was associated with a lower smoking cessation rate at 6 months.

scholarly journals Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038351
Author(s):  
Xue Weng ◽  
Man Ping Wang ◽  
Ho Cheung William Li ◽  
Yee Tak Derek Cheung ◽  
Ching Yin Lau ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Hong Kong ◽  
Randomised Controlled Trial ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Reduction Rate ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Smoking Cessation Services ◽  
Randomised Controlled

IntroductionEvidence-based smoking cessation treatments are effective but underutilised, accentuating the need for novel approaches to increase use. This trial investigates the effects of active referral combined with a financial incentive to use smoking cessation services on smoking abstinence among community smokers.Methods and analysisThis ongoing study is a two-arm, assessor-blinded, pragmatic, cluster randomised controlled trial with follow‐ups at 1, 2, 3 and 6 months after randomisation. We aim to enrol 1134 daily smokers from 70 community sites (clusters) in Hong Kong. All participants receive Ask, Warn, Advise, Refer, Do-it-again (AWARD) guided advice and a self-help booklet at baseline. Additionally, participants in the intervention group receive an offer of referral to smoking cessation services at baseline and a small financial incentive (HK$300≈US$38) contingent on using any of such services within 3 months. The primary outcomes are bioverified abstinence (exhaled carbon monoxide <4 ppm and salivary cotinine <10 ng/mL) at 3 and 6 months. Secondary outcomes include self-reported 7-day point prevalence of abstinence, smoking reduction rate, quit attempts and the use of smoking cessation services at 3 and 6 months. Intention-to-treat approach and regression models will be used in primary analyses.Ethics and disseminationThis protocol has been approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-318). The results of this trial will be submitted for publication in peer-reviewed journals, and the key findings will be presented at national and international conferences.Trial registration numberClinicalTrials.gov Registry NCT03565796.

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042365
Author(s):  
Jessica Leight ◽  
Negussie Deyessa ◽  
Vandana Sharma
Keyword(s):  
Intimate Partner Violence ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Partner Violence ◽  
Controlled Trial ◽  
Intimate Partner ◽  
Community Level ◽  
Secondary Outcome ◽  
Randomised Controlled ◽  
The Cost

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)

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