Ear Acupressure for Smoking Cessation: A Randomised Controlled Trial

This study investigated the efficacy and safety of ear acupressure (EAP) as a stand-alone intervention for smoking cessation and the feasibility of this study design. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a nonspecific EAP (NSEAP) intervention which is not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times daily. Participants were followed up for three months. Primary outcome measures were a 7-day point-prevalence cessation rate confirmed by exhaled carbon monoxide and relief of nicotine withdrawal symptoms (NWS). Intention-to-treat analysis was applied. Forty-three adult smokers were randomly assigned to SSEAP (n=20) or NSEAP (n=23) groups. The dropout rate was high with 19 participants completing the treatments and 12 remaining at followup. One participant from the SSEAP group had confirmed cessation at week 8 and end of followup (5%), but there was no difference between groups for confirmed cessation or NWS. Adverse events were few and minor.

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Relative effectiveness of a full versus reduced version of the ‘Smoke Free’ mobile application for smoking cessation: a randomised controlled trial

F1000Research ◽

10.12688/f1000research.16148.1 ◽

2018 ◽

Vol 7 ◽

pp. 1524 ◽

Cited By ~ 4

Author(s):

David Crane ◽

Harveen Kaur Ubhi ◽

Jamie Brown ◽

Robert West

Keyword(s):

Smoking Cessation ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Relative Effectiveness ◽

Behaviour Change Techniques ◽

Full Version ◽

Intention To Treat ◽

Support Programmes ◽

Randomised Controlled

Background: Smartphone applications (apps) are popular aids for smoking cessation. Smoke Free is an app that delivers behaviour change techniques used in effective face-to-face behavioural support programmes. The aim of this study was to assess whether the full version of Smoke Free is more effective than the reduced version. Methods: This was a two-arm randomised controlled trial. Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included. The full version provided updates on benefits of abstinence, progress (days smoke free), virtual ‘badges’ and daily ‘missions’ with push notifications aimed at preventing and managing cravings. The reduced version did not include the missions. At baseline the app recorded users’: device type (iPhone or Android), age, sex, daily cigarette consumption, time to first cigarette of the day, and educational level. The primary outcome was self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app. Analyses conducted included logistic regressions of outcome on to app version (full versus reduced) with adjustment for baseline variables using both intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses. Results: The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control. A total of 234 participants reported not smoking in the intervention versus 124 in the control, representing 1.6% versus 0.9% in the MES analysis and 19.3% versus 13.8% in the FUO analysis. Adjusted odds ratios were 1.90, 95%CI=1.53-2.37 (p<0.001) and 1.50, 95%CI=1.18-1.91 (p<0.001) in the MES and FUO analyses respectively. Conclusions: Despite very low follow-up rates using in-app follow up, both intention-to-treat/missing equals smoking and follow-up only analyses showed the full version of the Smoke Free app to result in higher self-reported 3-month continuous smoking abstinence rates than the reduced version.

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DHA supplementation in infants born preterm and the effect on attention at 18 months’ corrected age: follow-up of a subset of the N3RO randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114520002500 ◽

2020 ◽

pp. 1-12 ◽

Cited By ~ 2

Author(s):

Erandi Hewawasam ◽

Carmel T. Collins ◽

Beverly S. Muhlhausler ◽

Lisa N. Yelland ◽

Lisa G. Smithers ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

High Dose ◽

Peak Period ◽

Soya Oil ◽

Randomised Controlled ◽

To Receive ◽

The Brain

Abstract Infants born preterm miss out on the peak period of in utero DHA accretion to the brain during the last trimester of pregnancy which is hypothesised to contribute to the increased prevalence of neurodevelopmental deficits in this population. This study aimed to determine whether DHA supplementation in infants born preterm improves attention at 18 months’ corrected age. This is a follow-up of a subset of infants who participated in the N3RO randomised controlled trial. Infants were randomised to receive an enteral emulsion of high-dose DHA (60 mg/kg per d) or no DHA (soya oil – control) from within the first days of birth until 36 weeks’ post-menstrual age. The assessment of attention involved three tasks requiring the child to maintain attention on toy/s in either the presence or absence of competition or a distractor. The primary outcome was the child’s latency of distractibility when attention was focused on a toy. The primary outcome was available for seventy-three of the 120 infants that were eligible to participate. There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0·08 s, 95 % CI –0·81, 0·97; P = 0·86). Enteral DHA supplementation did not result in improved attention in infants born preterm at 18 months’ corrected age.

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Effectiveness of a Fortified Drink in Improving B Vitamin Biomarkers in Older Adults: A Controlled Intervention Trial

10.21203/rs.3.rs-757573/v1 ◽

2021 ◽

Author(s):

Maria Heffernan ◽

Leanne C Doherty ◽

Roberta Hack Mendes ◽

Michelle Clarke ◽

Stephanie Hodge ◽

...

Keyword(s):

Older Adults ◽

Controlled Trial ◽

Intervention Strategy ◽

B Vitamins ◽

Double Blind ◽

Intention To Treat ◽

Vitamin Status ◽

Randomised Controlled ◽

B Vitamin ◽

To Receive

Abstract BackgroundOlder adults are reported to have sub-optimal B vitamin status; targeted food-based solutions may help to address this. The objectives of the OptiAge food intervention study were to develop and investigate the effectiveness of a B vitamin-fortified drink in improving B vitamin biomarkers in older Irish adults with a primary outcome of change in B vitamin biomarker concentrations.MethodsA multicentre double-blind randomised controlled trial was performed in University College Dublin and Ulster University. Participants aged > 50 years were recruited following screening for exclusion criteria i.e. taking medications known to interfere with B vitamin metabolism, supplements containing B vitamins, consuming >4 portions of B-vitamin fortified foods per week or diagnosed with gastrointestinal, liver or pulmonary disease. Recruited participants were randomised with gender and centre as factors in the randomisation to receive either B vitamin-fortified or placebo drinks (developed by Smartfish, Norway) daily for 16 weeks.ResultsA total of 95 participants were randomised, of which 81 commenced the trial. Of these, 70 completed - 37 in the active and 33 in the placebo groups. Intention to treat (ITT) analysis of the B vitamins demonstrated a significant improvement in all B vitamins biomarkers in the active compared to placebo groups (p<0.01 for Folate, Vitamin B12, Vitamin B6, and Riboflavin). A significant lowering of plasma homocysteine from 11.9 (10.3-15.1) µmol/L to 10.6 (9.4-13.0) µmol/L (functional marker of B vitamin status) was also observed in response to the active treatment (P<0.001). Similar results were seen in a per-protocol analysis.ConclusionsThe results demonstrate that a B vitamin-fortified drink was effective in optimising B vitamin status, making this a useful intervention strategy to improve B vitamin status in older adults. Trial registration: ISRCTN, ISRCTN61709781. - Retrospectively registered, https://www.isrctn.com/ISRCTN61709781

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Presenting a randomised controlled trial

10.1093/med/9780198599661.003.0012 ◽

2013 ◽

Author(s):

Janet L. Peacock ◽

Sally M. Kerry

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Consort Statement ◽

Intention To Treat ◽

The Consort Statement ◽

Randomised Controlled ◽

Treat Analysis

Chapter 12 covers presenting a randomised controlled trial, including the CONSORT statement and checklist, intention to treat analysis, and presenting trials with other designs.

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Efficacy and safety of furosemide for prevention of intradialytic hypotension in haemodialysis patients: protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-048015 ◽

2021 ◽

Vol 11 (7) ◽

pp. e048015

Author(s):

Wenwen Chen ◽

Fang Wang ◽

Yuliang Zhao ◽

Ling Zhang ◽

Zhiwen Chen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Urine Volume ◽

Residual Renal Function ◽

Control Group ◽

Intradialytic Hypotension ◽

Efficacy And Safety ◽

Blank Control Group ◽

Intention To Treat ◽

Randomised Controlled

IntroductionIntradialytic hypotension (IDH) is a frequent and serious complication of maintaining haemodialysis (HD) patients and associated with subsequent cardiovascular events and higher mortality. Furosemide is commonly used in non-dialysis chronic kidney disease patients and can effectively manage the volume and blood pressure. However, these agents are often discontinued on initiation of dialysis. Two large observational studies have demonstrated that furosemide can lower the rate of IDH episodes. However, there is still no randomised controlled trial (RCT) to investigate the efficacy and safety of furosemide for prevention of IDH in HD patients. The purpose of this study was to assess the efficacy of furosemide in reducing IDH in HD patients with residual renal function.Methods and analysisA two-arm, parallel, multicente RCT will be conducted at 12 hospitals in China. An estimated sample of 560 HD patients will be recruited. Eligible patients will be randomly assigned to treatment group (patients receive oral furosemide 80 mg/day; after a 2-week treatment, if their urine volume is less than 400 mL/day, the dose of furosemide is adjusted to 160 mg/day) and blank control group via a central randomisation system using 1:1 ratio. The primary outcome is the occurrence of IDH. Outcome assessors and data analysts will be blinded and participants will be asked not to reveal their allocation to assessors. The outcome analyses will be performed both on the intention-to-treat, which includes all patients randomised, and per-protocol population, which includes eligible patients who adhere to the planned treatment and follow-ups.Ethics and disseminationThe trial protocol has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (2019.385)Results will be presented at national and international conferences and published in peer-reviewed journals.Trial registration numberChiCTR2000039724.

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Protocol for a randomised controlled trial comparing two CPAP levels to prevent extubation failure in extremely preterm infants

BMJ Open ◽

10.1136/bmjopen-2020-045897 ◽

2021 ◽

Vol 11 (6) ◽

pp. e045897

Author(s):

Anna Madeline Kidman ◽

Brett James Manley ◽

Rosemarie Anne Boland ◽

Atul Malhotra ◽

Susan M Donath ◽

...

Keyword(s):

Mechanical Ventilation ◽

Randomised Controlled Trial ◽

Preterm Infants ◽

Primary Outcome ◽

Controlled Trial ◽

Extubation Failure ◽

Intention To Treat ◽

Extremely Preterm ◽

Extremely Preterm Infants ◽

Randomised Controlled

IntroductionRespiratory distress syndrome is a complication of prematurity and extremely preterm infants born before 28 weeks’ gestation often require endotracheal intubation and mechanical ventilation. In this high-risk population, mechanical ventilation is associated with lung injury and contributes to bronchopulmonary dysplasia. Therefore, clinicians attempt to extubate infants as quickly and use non-invasive respiratory support such as nasal continuous positive airway pressure (CPAP) to facilitate the transition. However, approximately 60% of extremely preterm infants experience ‘extubation failure’ and require reintubation. While CPAP pressures of 5–8 cm H2O are commonly used, the optimal CPAP pressure is unknown, and higher pressures may be beneficial in avoiding extubation failure. Our trial is the Extubation CPAP Level Assessment Trial (ÉCLAT). The aim of this trial is to compare higher CPAP pressures 9–11 cm H2O with a current standard pressures of 6–8 cmH2O on extubation failure in extremely preterm infants.Methods and analysis200 extremely preterm infants will be recruited prior to their first extubation from mechanical ventilation to CPAP. This is a parallel group randomised controlled trial. Infants will be randomised to one of two set CPAP pressures: CPAP 10 cmH2O (intervention) or CPAP 7 cmH2O (control). The primary outcome will be extubation failure (reintubation) within 7 days. Statistical analysis will follow standard methods for randomised trials on an intention to treat basis. For the primary outcome, this will be by intention to treat, adjusted for the prerandomisation strata (GA and centre). We will use the appropriate parametric and non-parametric statistical tests.Ethics and disseminationEthics approval has been granted by the Monash Health Human Research Ethics Committees. Amendments to the trial protocol will be submitted for approval. The findings of this study will be written into a clinical trial report manuscript and disseminated via peer-reviewed journals (on-line or in press) and presented at national and international conferences.Trial registration numberACTRN12618001638224; pre-results.

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Relative effectiveness of a full versus reduced version of the ‘Smoke Free’ mobile application for smoking cessation: an exploratory randomised controlled trial

F1000Research ◽

10.12688/f1000research.16148.2 ◽

2019 ◽

Vol 7 ◽

pp. 1524 ◽

Cited By ~ 10

Author(s):

David Crane ◽

Harveen Kaur Ubhi ◽

Jamie Brown ◽

Robert West

Keyword(s):

Smoking Cessation ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Relative Effectiveness ◽

Behaviour Change Techniques ◽

Full Version ◽

Intention To Treat ◽

Support Programmes ◽

Randomised Controlled

Background: Smartphone applications (apps) are popular aids for smoking cessation. Smoke Free is an app that delivers behaviour change techniques used in effective face-to-face behavioural support programmes. The aim of this study was to assess whether the full version of Smoke Free is more effective than the reduced version. Methods: This was a two-arm exploratory randomised controlled trial. Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included. The full version provided updates on benefits of abstinence, progress (days smoke free), virtual ‘badges’ and daily ‘missions’ with push notifications aimed at preventing and managing cravings. The reduced version did not include the missions. At baseline the app recorded users’: device type (iPhone or Android), age, sex, daily cigarette consumption, time to first cigarette of the day, and educational level. The primary outcome was self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app. Analyses conducted included logistic regressions of outcome on to app version (full versus reduced) with adjustment for baseline variables using both intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses. Results: The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control. A total of 234 participants reported not smoking in the intervention versus 124 in the control, representing 1.6% versus 0.9% in the MES analysis and 19.3% versus 13.8% in the FUO analysis. Adjusted odds ratios were 1.90, 95%CI=1.53-2.37 (p<0.001) and 1.50, 95%CI=1.18-1.91 (p<0.001) in the MES and FUO analyses respectively. Conclusions: Despite very low follow-up rates using in-app follow up, both intention-to-treat/missing equals smoking and follow-up only analyses showed the full version of the Smoke Free app to result in higher self-reported 3-month continuous smoking abstinence rates than the reduced version.

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

10.2196/preprints.22833 ◽

2020 ◽

Author(s):

Jamie Webb ◽

Sarrah Peerbux ◽

Peter Smittenaar ◽

Sarim Siddiqui ◽

Yusuf Sherwani ◽

...

Keyword(s):

Carbon Monoxide ◽

Randomized Controlled Trial ◽

Smoking Cessation ◽

Therapeutic Intervention ◽

Primary Outcome ◽

Controlled Trial ◽

Promising Alternative ◽

Intention To Treat ◽

Randomized Controlled ◽

Brief Advice

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; <i>P</i><.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. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476

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Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial

Infectious Diseases in Obstetrics and Gynecology ◽

10.1155/2012/921519 ◽

2012 ◽

Vol 2012 ◽

pp. 1-8 ◽

Cited By ~ 2

Author(s):

Craig R. Cohen ◽

Su-Chun Cheng ◽

Stephen Shiboski ◽

Tsungai Chipato ◽

Martin Matu ◽

...

Keyword(s):

Bacterial Vaginosis ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Vaginal Swab ◽

Intention To Treat ◽

Hiv Acquisition ◽

And Control ◽

Treat Analysis

Background. Bacterial vaginosis (BV) has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial.Methods. We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent’s criteria; women with BV (score 7–10) were compared to those with intermediate (score 4–6) and normal flora (score 0–3). During quarterly follow-up visits over 12–24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup.Results. 528 participants were enrolled; 213 (40%) had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR=0.4, 95% CI 0.29–.56) but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR=1.01, 95% CI 0.52–1.94) or for those who did not have BV (OR=1.21, 95% CI 0.65–2.27) at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5–16%) were reported using anything else but water to cleanse the vagina over the course of the trial.Conclusions. Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.

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PROphylactic MESH (PROMESH) for stoma closure: does it reduce the incidence of incisional hernia? Protocol for a triple-blinded randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-053751 ◽

2021 ◽

Vol 11 (12) ◽

pp. e053751

Author(s):

Jeremy Meyer ◽

Vaihere Delaune ◽

Ziad Abbassi ◽

Jonathan Douissard ◽

Christian Toso ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Incisional Hernia ◽

Primary Outcome ◽

Controlled Trial ◽

Group Analysis ◽

Stoma Closure ◽

Digestive Cancer ◽

Prophylactic Mesh ◽

Intention To Treat ◽

Randomised Controlled

IntroductionApplication of a prophylactic mesh during stoma closure was shown to reduce the incidence of incisional hernia at the site of stoma closure. Our objective is to provide high quality evidence to validate this finding.Methods and analysisThe study will be a randomised controlled triple-blinded superiority parallel monocentric trial. Patients undergoing elective ileostomy or colostomy closure after surgery for digestive cancer will be eligible for inclusion. Patients allergic to the mesh, immunosuppressed or refusing to participate will be excluded. Randomisation will be performed based on a 1:1 allocation ratio between stoma closure with application of a non-absorbable mesh in the sublay position (intervention) and stoma closure without a mesh (control). The primary outcome will be the 1-year incidence of incisional hernia at the site of stoma closure, determined clinically and by CT. Secondary outcomes will be the 31-day incidence of surgical site infection and the modified Carolinas Comfort Scale. Patients, radiologists and investigators performing the assessment at 1 year will be blinded for the allocated study group. Analysis will be performed in intention-to-treat. The trial will include 68 patients (34 with mesh, 34 without mesh).Ethics and disseminationThe present randomised controlled trial was registered into clinicaltrials.gov (NCT 04510558) and was accepted by the local ethic committee (Geneva, Switzerland: CCER 2021-00053). The results will be presented at national and international congresses in the fields of colorectal surgery and general surgery, and published in a peer-reviewed journal.

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