scholarly journals N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Lauren Arancini ◽  
Chiara C. Bortolasci ◽  
Seetal Dodd ◽  
Olivia M. Dean ◽  
Michael Berk
Keyword(s):  
Public Health ◽  
Tobacco Smoking ◽  
Rating Scales ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Trial Registration ◽  
Diagnostic Statistics ◽  
Salivary Cotinine ◽  
Randomised Controlled ◽  
Clinical Trials Registry

Abstract Background Tobacco smoking is a highly prevalent, addictive behaviour and a key public health priority. However available cessation therapies have low quit and high relapse rates, indicating an urgent need for more effective treatments. Predicated on promising preclinical and pilot clinical data, this paper presents a rationale and protocol for the trial of N-acetylcysteine (NAC) as a novel anti-craving smoking cessation aid. Methods Current smokers (n = 120) of at least 10 cigarettes a day are recruited through online advertisements, print publications and dissemination of flyers. Participants are randomised on a 1:1 ratio to receive either 16-week treatment of 1.8 g/day of NAC or placebo with all participants receiving quit support from the online QuitCoach tool. Participants are attending visits at baseline, 8 and 16 weeks with a 42-week post-discontinuation follow-up. The primary outcome measure is sustained abstinence at six months after treatment based on self-reported rating scales and confirmed by exhaled carbon monoxide and salivary cotinine levels. Secondary outcomes are timing of the first lapse and relapse, between-group cigarette consumption, withdrawal symptoms, general wellbeing and mood/anxiety symptoms. Between-group differences in adverse events and subgroup analyses for variables including gender and Diagnostic Statistics Manual 5 diagnostics will also be investigated. Discussion The planned trial addresses an issue of major importance to human health and, if an effect is shown, may result in substantial changes to the management of smoking and nicotine addiction with overt public health implications. Trial registration Australian New Zealand Clinical Trials registry (ANZCTR), ACTRN12617001478303. Registered on 19 October 2017.

scholarly journals Metformin reduces 12-month change in body weight among people newly commenced on clozapine: a retrospective naturalistic cohort study

2021 ◽  
Vol 11 ◽  
pp. 204512532110006
Author(s):  
Jessica Spokes ◽  
Samantha Hollingworth ◽  
Karl Winckel ◽  
Steve Kisely ◽  
Andrea Baker ◽  
...  
Keyword(s):  
Cohort Study ◽  
Weight Gain ◽  
Tobacco Smoking ◽  
Digital Health ◽  
Controlled Trial ◽  
Bodyweight Gain ◽  
Metabolic Effects ◽  
Secondary Outcome ◽  
Standard Clinical Practice ◽  
Randomised Controlled

Background: People with schizophrenia have a 15–20-year reduction in life expectancy, driven in part by the metabolic effects of antipsychotics. Clozapine is associated with the highest rates of weight gain. As clozapine remains the most effective antipsychotic for treatment-resistant schizophrenia (TRS), identifying treatments to ameliorate clozapine-induced weight gain (CIWG) is urgently needed to reduce this morality gap. Methods: We retrospectively analysed digital health records of patients with TRS aged 18–65 newly initiated on clozapine at four tertiary hospitals in south-east Queensland from 1 March 2017 to 30 June 2019. Our primary outcome was the effect of metformin on change in percentage bodyweight at 12 months after clozapine initiation, with secondary outcome being proportion with >5% or >7% bodyweight change. We also explored impact on bodyweight change of other variables including sex, tobacco smoking, type 2 diabetes (T2DM), age, clozapine level and dose and clozapine/norclozapine ratio. Results: Among 90 patients initiated on clozapine, metformin use ( n = 48) was associated with a smaller increase in percentage bodyweight (1.32% versus 5.95%, p = 0.031), lower rates of >7% gain in bodyweight (37.8% versus 63.0%, p = 0.025) but not >5% gain in bodyweight. Age below the median (32.0 years) was associated with greater bodyweight gain (5.55% versus 1.22%, p = 0.046). Sex, tobacco smoking, T2DM, clozapine dose and level and clozapine/norclozapine ratio were not associated with differences in change in bodyweight. Conclusion: In this small retrospective cohort study, use of metformin within 12-months of clozapine initiation was associated with a statistically and clinically significant reduction in CIWG. Although there is increasing evidence for the role of metformin to ameliorate bodyweight gain at time of clozapine initiation, our findings need replication and testing in a randomised controlled trial before recommending metformin co-commencement with clozapine as standard clinical practice.

scholarly journals Recruiting for research on sensitive topics in schools: an experience with Vaxcards, a collectable vaccine card game

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
D. S. Epstein ◽  
J. C. Enticott ◽  
H. J. Larson ◽  
C. Barton
Keyword(s):  
Research Team ◽  
Controlled Trial ◽  
Contact Point ◽  
Research Participation ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Card Game ◽  
Successful Recruitment ◽  
Sensitive Topics ◽  
Randomised Controlled

Abstract Undertaking recruitment for research in schools is an effective way to recruit young people for research participation but it is not without its challenges. Gaining access and coordinating many levels of different organisations and stakeholders whose cooperation and approval are crucial all add time and sometimes logistical challenges for the research team. In addition, recruiting around sensitive research topics can elicit additional barriers to successful research. The research team aimed to conduct a pragmatic cluster randomised controlled trial involving schools in a local government region in Victoria, Australia, to assess the effect of a vaccination-based educational card game called “Vaxcards” on vaccine consent returns. Schools were contacted via phone and email to determine which staff member would best be a contact point for a face-to-face meeting to discuss the methods and purpose of the study. Email follow-ups were scheduled to follow up non-responsive schools and consent forms. The minimum required sample size was 13. Of 31 eligible schools, 13 were recruited. The research team encountered several unanticipated challenges before achieving the recruitment target. The most common reasons for non-participation were being too busy with other commitments, concerns regarding the topic of vaccination being too sensitive, and concerns that key stakeholders in the school would not approve of the research topic of vaccination. One school required a review by a private research ethics board that rejected the study. Significant hesitancy and misinformation about vaccine science was observed that affected engagement with a small number of schools. This paper highlights the challenges of recruiting schools in the context of public anxieties about vaccines and has several important learning lessons for successful recruitment about sensitive topics. This includes navigating approval processes for research in schools, the importance of local champions, dealing with misinformation and the importance of strong relationships and organisational trust. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001753246. Prospectively registered on 25 October 2018 8:24:21 AM

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

scholarly journals An assets-based intervention before and after birth to improve breastfeeding initiation and continuation: the ABA feasibility RCT

2020 ◽  
Vol 8 (7) ◽  
pp. 1-156
Author(s):  
Joanne L Clarke ◽  
Jenny Ingram ◽  
Debbie Johnson ◽  
Gill Thomson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Public Health ◽  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Public Health Research ◽  
Breastfeeding Initiation ◽  
Before And After ◽  
Randomised Controlled

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

scholarly journals Is there an optimal place to hold the endotracheal tube during direct laryngoscopy? Protocol for a Randomised Controlled Trial

2021 ◽  
Author(s):  
Manisha Sahoo ◽  
Swagata Tripathy ◽  
Nitasha Mishra
Keyword(s):  
Endotracheal Tube ◽  
Endotracheal Intubation ◽  
Controlled Trial ◽  
Scientific Evidence ◽  
Intubation Difficulty ◽  
The Mean ◽  
Randomised Controlled ◽  
Difficulty Score ◽  
Clinical Trials Registry ◽  
Rate Of Success

Abstract Background: Laryngoscopic endotracheal intubation (LEI) is a widely performed lifesaving technique. There are evidence and guidelines to help decide the optimal sized endotracheal tube (ET), laryngoscope, depth of insertion, and patient position for successful endotracheal intubation. We hypothesize that after glottic visualization, the point at which the ET is held will affect the time, ease, and success of the technique due to a difference in visualization and torque. We aim to compare two sites of holding the ET after optimal laryngeal-inlet visualization: time to intubation, rate of success of first pass intubation, intubation difficulty and complications.Methods: Supervised intubations on ASA 1-2 patients (>18 years) posted for surgery under general anesthesia performed by anesthesia trainees (experience <18 months) will be included. Patients with an anticipated difficult airway or unanticipated difficulty - CL grade > three or requiring the use of airway adjuncts will be excluded. A computer-generated numbers list will randomize patients; allocation concealed with opaque sealed envelopes. ET marked at the selected site will be handed to the intubator by the theatre-technician once she/he confirms the optimum laryngoscopic view. The entire procedure will be video recorded. Two blinded assessors will independently review the videos to document the time to intubation (TTI defined as the time from holding the ET to the removal of laryngoscope from the mouth after successful intubation) and intubation difficulty score. Postoperative sore throat and hoarseness will be recorded.Sample size: 54 experienced anesthetists were video-recorded during intubating. The site of holding ET and TTI were analyzed. The mean site was 3 SD 2.5 cm from the tip, yielding two sites for the study- 19 cm (Gr 1) and 24 cm (Gr 2). To detect a 20% difference in intubation time between groups, the confidence of 95%, and power 85%, we will need 298 patients: 180 per group after accounting for data loss.Discussion: This will be the first study to assess whether holding the tube at a particular site has any impact on the ease and time taken for intubation. This study's findings will provide the first scientific evidence for an appropriate place for holding the ET during LEI, which we feel will help trainees improve their LEI technique.Trial registration: CTRI/2019/09/021201, Clinical Trials Registry India. http://ctri.nic.in/Clinicaltrials/advsearch.php. Registered 12th September 2019,

scholarly journals Effects of Deqi on Autonomic Balance in Adult Tinnitus Patients: Study Design of a Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Qian-Qian Li ◽  
Guang-Xia Shi ◽  
Xin-Xing Fu ◽  
Li-Li Han ◽  
Li-Ying Liu ◽  
...  
Keyword(s):  
Heart Rate ◽  
Heart Rate Variability ◽  
Nervous System ◽  
Autonomic Nervous System ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Autonomic Nervous ◽  
Nervous System Function ◽  
Acupuncture Effect ◽  
Randomised Controlled

Background. Recent reports suggest that a proportion of tinnitus patients suffer from mental illness. Autonomic nervous system plays a useful role in tinnitus therapy since electrical vagal nerve stimulation (VNS) has been frequently used to alleviate tinnitus-induced depression in clinic. heart rate variability (HRV), which is reflective of autonomic nervous system function, has been proved to be modulated by acupuncture. In the present study, we aim to compare the effect of deqi sensation on heart rate variability in adult tinnitus patients.Methods. Thirty participants are randomly assigned to verum acupuncture (creating deqi) or shallow acupuncture (not creating deqi) at Baihui (Du-20), Shenting (Du-24), Tinghui (GB-2), Waiguan (SJ-5), and Zulinqi (GB-41) for 3 weeks. The primary outcome measure is heart rate variability, which is measured at the first acupuncture, as well as the last acupuncture.Discussion. Completion of this trial will help to identify the role of deqi sensation in acupuncture effect for tinnitus and reveal an autonomic modulation mechanism for acupuncture effect.Trial Registration. This trial is registered with International Standard Randomised Controlled Trial NumberISRCTN58013563.

Process and Resource Assessment in Trials Undertaken in Residential Care Homes: Experiences from the Australian MIDDEL Cluster Randomised Controlled Trial Research Team.

2020 ◽  
Author(s):  
Felicity Anne Baker ◽  
Phoebe Stretton-Smith ◽  
Tanara Vieira Sousa ◽  
Imogen Clark ◽  
Alice Cotton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Resource Assessment ◽  
Trial Registration ◽  
Residential Aged Care ◽  
Cluster Randomised ◽  
Intervention Adherence ◽  
Randomised Controlled

Abstract Background: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. The main aim of this paper is to describe process and resource assessment during recruitment, collection of outcome measures and intervention delivery and present learnings and considerations for conducting trials in RACFs with people living with dementia. Methods: We collected data across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as data on reasons for participant non-attendance at the interventions. Results: Results show that time between contacting next of kin and receiving formal consent often exceeded 45 days and the ratio of time between direct and indirect research activity is approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Conclusions: Researchers planning studies within RACFs should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. This study provides specific data on resource assessment and intervention adherence that could be beneficial for future researchers planning to conduct trials in RACFs with people with dementia. Trial registration: Australian and New Zealand Clinical Trial Registry: ANZCTR12618000156280, 1/02/2018, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280

scholarly journals Temporal features of sitting, standing and stepping changes in a cluster-randomised controlled trial of a workplace sitting-reduction intervention

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Samantha K. Stephens ◽  
Elisabeth A. H. Winkler ◽  
Elizabeth G. Eakin ◽  
Bronwyn K. Clark ◽  
Neville Owen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Work Hours ◽  
Trial Registration ◽  
Sitting Time ◽  
Work Time ◽  
Prolonged Sitting ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background There is now a body of evidence on the effectiveness of interventions to reduce workplace sitting time. However, there has been limited reporting of how such interventions may impact behaviour both during and outside of work. Sitting, standing and stepping changes following a workplace intervention were examined across five timeframes (work time on work days; non-work time on work days; work days; non-work days; overall (i.e. work and non-work time on all days)), and the relationships between changes during and outside of work was assessed. Methods The cluster-randomised controlled trial, ‘Stand Up Victoria’, delivered a multi-component workplace-delivered intervention that successfully reduced workplace and overall sitting time (relative to controls). Separately, over the five timeframes, changes in device (activPAL3)-assessed outcomes — sitting; prolonged sitting (≥30 min bouts); standing; and, stepping — were compared between intervention (n = 114) and controls (n = 84), along with the time-course of sitting changes during work hours, using mixed models. The potential relationships of changes during work with changes outside of work were examined using compositional data analysis. Results On workdays, intervention participants significantly (p < 0.05) improved their activity profile relative to controls, with reduced sitting (− 117 min/8-h workday, 95% CI: − 141, − 93) and prolonged sitting (− 77 min/8 h workday, 95% CI: − 101, − 52); increased standing (114 min/8 h workday, 95% CI: 92, 136) and maintenance of stepping (3 min/8 h workday, 95% CI: − 7, 11, p = 0.576). Effects were nearly identical for time at work; similar but slightly weaker for overall; and, small and non-significant outside of work on workdays and non-work days. Improvements occurred at all times, but not equally, during work hours (p < 0.001). Correlations between changes during and outside of work on workdays were very weak in both the intervention group (r = − 0.07) and controls (r = − 0.09). Conclusions Sitting time was reduced almost exclusively during work hours (via replacement with standing), with reductions evident during all working hours, to varying degrees. There was no evidence of compensation, with minimal change in activity outside of work, in response to changes in activity at work. Future interventions may benefit from exploring how best to elicit change throughout the whole day, and across work and non-work domains. Trial registration This trial was prospectively registered with the Australian New Zealand Clinical Trials register (ACTRN12611000742976) on 15 July 2011

scholarly journals Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Meg Wiggins ◽  
Mary Sawtell ◽  
Octavia Wiseman ◽  
Christine McCourt ◽  
Sandra Eldridge ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Antenatal Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
The World ◽  
Randomised Controlled

Abstract Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

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