Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial

IntroductionEmergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care.Methods and analysisThe Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0–16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age (<1, 1–7 and >7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO2<90% (patient-dependent variable) and (2) first intubation attempt success without hypoxemia (operator-dependent variable). Analyses will be conducted on an intention-to-treat basis.Ethics and disseminationEthics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal.Trial registration numberACTRN12617000147381.

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Study protocol for a randomised controlled trial of Allen Carr’s Easyway programme versus Lambeth and Southwark NHS for smoking cessation

BMJ Open ◽

10.1136/bmjopen-2017-016867 ◽

2017 ◽

Vol 7 (12) ◽

pp. e016867 ◽

Cited By ~ 1

Author(s):

Kerry V Wood ◽

Ian P Albery ◽

Antony C Moss ◽

Sarah White ◽

Daniel Frings

Keyword(s):

Smoking Cessation ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cost Effective ◽

Primary Treatment ◽

Health Condition ◽

Chronic Obstructive ◽

Link Type ◽

Registration Number ◽

Randomised Controlled

IntroductionSmoking is a major cause of ill health and is associated with several diseases including cancer, coronary heart disease and stroke. Many psychological and pharmacological smoking cessation treatments are available and although they are undoubtedly the most cost-effective health interventions available, many people still fail to maintain cessation in the longer term. Recently, National Institute for Health and Care Excellence called for comparative studies to determine the short-term and long-term effectiveness of Allen Carr’s Easyway (ACE) method of stopping smoking. This study will compare the efficacy of the ACE programme and a 1–1 counselling service available via the National Health Service.Methods and analysisA two-arm, parallel-group, blinded, randomised controlled trial will be conducted with people who smoke tobacco cigarettes, are aged ≥18 years and are motivated to quit. Exclusion criteria comprise self-reported mental health condition, pregnancy or respiratory disease such as chronic obstructive pulmonary disease or emphysema. The primary treatment outcome is smoking cessation 26 weeks after treatment. Participants will be analysed on an intention to treat basis at the point of randomisation. Before being randomised, the research team will not inform participants which two treatments are being compared. Once randomised researchers will be blinded to participant condition, and participants will be blinded to the condition they are not assigned to. Logistic regression will be used to estimate the effectiveness of the treatment condition on smoking cessation at 26 weeks. The following covariates will be included: baseline quit efficacy (at inclusion), age (at inclusion), gender and baseline nicotine dependency.Ethics and disseminationApproval was granted by London–Fulham Research Ethics Committee (ref: 16/LO/1657). The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences.Trial registration numberClinicalTrials.gov identifier number: NCT02855255. ISRCTN registration number: ISRCTN23584477; Pre-results.

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Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-039981 ◽

2021 ◽

Vol 11 (1) ◽

pp. e039981

Author(s):

Maleea Denise Holbert ◽

Roy M Kimble ◽

Mark Chatfield ◽

Bronwyn R Griffin

Keyword(s):

Randomised Controlled Trial ◽

Repeated Measures ◽

Controlled Trial ◽

Geometric Mean ◽

First Aid ◽

Self Report ◽

Thermal Burn ◽

Pain Scores ◽

Registration Number ◽

Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

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Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-044045 ◽

2021 ◽

Vol 11 (2) ◽

pp. e044045

Author(s):

Ben Colagiuri ◽

Louise Sharpe ◽

Zahava Ambarchi ◽

Nick Glozier ◽

Delwyn Bartlett ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Treatment Period ◽

Controlled Trial ◽

Severity Index ◽

Open Label ◽

Human Research Ethics ◽

Sleep Parameters ◽

Registration Number ◽

Randomised Controlled ◽

Insomnia Symptoms

IntroductionInsomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown.Methods and analysisThis study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and sixty-seven participants with self-reported insomnia symptoms (Insomnia Severity Index, ISI ≥10) will be recruited into an observational study and have their sleep monitored over a 2-week period. Participants will then be randomised to one of three groups: invite to OLP, invite to CP described deceptively as a new pharmacological agent, or no invite/observational control. Those in OLP and CP accepting the invite receive identical placebos for a 2-week treatment period while sleep is monitored in all participants. The primary outcome is ISI at the end of the treatment period. Secondary outcomes include treatment uptake and clinically significant response rates, objective and subjective sleep parameters, fatigue, mood, expectancy, treatment satisfaction and side effects. Predictors of uptake and responses to OLP and CP will be explored.Ethics and disseminationThe trial has been approved by The University of Sydney Human Research Ethics Committee. Written informed consent is obtained from every participant. OLP and CP participants accepting the invite undergo an additional consent process. Results will be disseminated via peer-reviewed conference proceedings and publications.Trial registration numberACTRN12620001080910.

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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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Involving clinical experts in prioritising topics for health technology assessment: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-016104 ◽

2017 ◽

Vol 7 (8) ◽

pp. e016104 ◽

Cited By ~ 1

Author(s):

Andrew Cook ◽

Elke Streit ◽

Gill Davage

Keyword(s):

Controlled Trial ◽

Free Text ◽

Intention To Treat ◽

Cohen’S D ◽

Registration Number ◽

Review Form ◽

Response Modes ◽

Randomised Controlled ◽

Scoring Tool ◽

Cohen's D

ObjectivesThe objective of this study was to explore whether reducing the material supplied to external experts during peer review and decreasing the burden of response would maintain review quality into prioritising research questions for a major research funder.Methods and analysisClinical experts who agreed to review documents outlining research for potential commissioning were screened for eligibility and randomised in a factorial design to two types of review materials (long document versus short document) and response modes (structured review form versus free text email response). Previous and current members of the funder’s programme groups were excluded. Response quality was assessed by use of a four-point scoring tool and analysed by intention to treat.Results554 consecutive experts were screened for eligibility and 460 were randomised (232 and 228 to long document or short document, respectively; 230 each to structured response or free text). 356 participants provided reviews, 90 did not respond and 14 were excluded after randomisation as not eligible.The pooled mean quality score was 2.4 (SD=0.95). The short document scored 0.037 (Cohen’s d=0.039) extra quality points over the long document arm, and the structured response scored 0.335 (Cohen’s d=0.353) over free text. The allocation did not appear to have any effect on the experts' willingness to engage with the task.ConclusionsNeither providing a short or a long document outlining suggested research was shown to be superior. However, providing a structured form to guide the expert response provided more useful information than allowing free text. The funder should continue to use a structured form to gather responses. It would be acceptable to provide shorter documents to reviewers, if there were reasons to do so.Trial registration numberANZCTR12614000167662.

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Using feeding to reduce pain during vaccination of formula-fed infants: a randomised controlled trial

Archives of Disease in Childhood ◽

10.1136/archdischild-2017-313488 ◽

2018 ◽

Vol 103 (12) ◽

pp. 1132-1137 ◽

Cited By ~ 3

Author(s):

Netty G P Bos-Veneman ◽

Marrit Otter ◽

Sijmen A Reijneveld

Keyword(s):

Side Effects ◽

Controlled Trial ◽

Recovery Phase ◽

Pain Scale ◽

Formula Feeding ◽

Full Term ◽

Intention To Treat ◽

Registration Number ◽

The Face ◽

Randomised Controlled

ObjectivesTo assess the effectiveness and potential side effects of formula feeding to reduce pain during vaccination among infants.Study designIn the setting of well-baby clinics we recruited a community-based sample of full-term born infants who were already formula fed by the choice of the parents (n=48, aged 4–10 weeks) and received their first DTaP-IPV-HepB-Hib and pneumococcal vaccinations and randomised them into two groups. To evaluate pain experienced during vaccination we compared infants who drank formula feeding before, during and after vaccination with infants who did not. Outcomes were observed cry duration and pain scores measured by means of the Neonatal Infant Pain Scale (NIPS) and the Face, Legs, Activity, Cry and Consolability (FLACC) scale. Side effects of drinking during vaccination were recorded. We performed intention-to-treat analyses using regression models, crude and adjusted for sex and age of the infant.ResultsPain at the moment of the second injection did not differ between groups. Drinking infants cried 33.5 s shorter (−56.6; −10.3). In the first minute after injection drinking infants experienced a faster pain reduction on the NIPSΔt: regression coefficient 3.86 (95% CI 2.70 to 5.02) and FLACCΔt: 4.42 (95% CI 2.85 to 5.99).ConclusionsIn line with findings of previous studies regarding breast feeding, formula feeding reduced vaccination pain in the recovery phase in full-term born infants receiving their first vaccinations between ages 4 and 10 weeks with no adverse effects. Professionals should discuss this non-costly and feasible pain-reducing intervention with parents of infants who receive vaccinations.Trial registration numberIRCTN 31383, post-results

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Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017511 ◽

2018 ◽

Vol 8 (8) ◽

pp. e017511 ◽

Cited By ~ 1

Author(s):

Nishma Patel ◽

Rebecca J Beeken ◽

Baptiste Leurent ◽

Rumana Z Omar ◽

Irwin Nazareth ◽

...

Keyword(s):

General Practice ◽

Economic Evaluation ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Health Service ◽

Usual Care ◽

Controlled Trial ◽

Cost Effective ◽

The Mean ◽

Randomised Controlled

ObjectiveTen Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.DesignAn economic evaluation was conducted alongside an individually randomised controlled trial.Setting14 general practitioner practices in England.ParticipantsAll patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention.Outcomes measuresHealth service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation.ResultsOver a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of −£36 (95% CI −£512 to £441) and a mean QALY difference of 0.001 (95% CI −0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI −£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold.ConclusionsCosts and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations.Trial registration numberISRCTN16347068; Post-results.

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Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-033150 ◽

2019 ◽

Vol 9 (9) ◽

pp. e033150 ◽

Cited By ~ 2

Author(s):

Flavia K Borges ◽

P J Devereaux ◽

Meaghan Cuerden ◽

Mohit Bhandari ◽

Ernesto Guerra-Farfán ◽

...

Keyword(s):

Acute Kidney Injury ◽

Surgical Treatment ◽

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Kidney Injury ◽

Registration Number ◽

Randomised Controlled ◽

Care Surgery

IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.

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A Comparison of Caudal Epidural Bupivacaine with Adrenaline and Bupivacaine with Adrenaline and Pethidine for Operative and Postoperative Analgesia in Infants and Children

Anaesthesia and Intensive Care ◽

10.1177/0310057x9302100410 ◽

1993 ◽

Vol 21 (4) ◽

pp. 424-428 ◽

Cited By ~ 7

Author(s):

T. P. Santhosh Kumar ◽

R. Jacob

Keyword(s):

Randomised Controlled Trial ◽

Pain Relief ◽

Controlled Trial ◽

Infants And Children ◽

Epidural Bupivacaine ◽

High Incidence ◽

Randomised Controlled ◽

Very High ◽

In Infants And Children ◽

Caudal Epidural

This study compares the effectiveness of two drug combinations–010-(010a) bupivacaine with adrenaline and (b) bupivacaine with adrenaline and pethidine — on operative and postoperative pain relief when administered by the caudal route in infants and children. A randomised controlled trial was conducted on fifty children below the age of twelve years: 25 children were randomly allocated to each group. Both groups had a significant period of analgesia in the postoperative period. None of the children in either group required parenteral analgesia. Though the group with pethidine had a longer duration of analgesia and sedation, the very high incidence of vomiting and delay in urination observed in this group would preclude the use of pethidine routinely. No respiratory depression was seen in either group.

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Home treatment of COPD exacerbation selected by DECAF score: a non-inferiority, randomised controlled trial and economic evaluation

Thorax ◽

10.1136/thoraxjnl-2017-211197 ◽

2018 ◽

Vol 73 (8) ◽

pp. 713-722 ◽

Cited By ~ 12

Author(s):

Carlos Echevarria ◽

Joanne Gray ◽

Tom Hartley ◽

John Steer ◽

Jonathan Miller ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Length Of Stay ◽

Controlled Trial ◽

Prognostic Score ◽

Cost Effective ◽

Low Risk ◽

Copd Exacerbation ◽

Hospitalised Patients ◽

Life Years ◽

Randomised Controlled

BackgroundPrevious models of Hospital at Home (HAH) for COPD exacerbation (ECOPD) were limited by the lack of a reliable prognostic score to guide patient selection. Approximately 50% of hospitalised patients have a low mortality risk by DECAF, thus are potentially suitable.MethodsIn a non-inferiority randomised controlled trial, 118 patients admitted with a low-risk ECOPD (DECAF 0 or 1) were recruited to HAH or usual care (UC). The primary outcome was health and social costs at 90 days.ResultsMean 90-day costs were £1016 lower in HAH, but the one-sided 95% CI crossed the non-inferiority limit of £150 (CI −2343 to 312). Savings were primarily due to reduced hospital bed days: HAH=1 (IQR 1–7), UC=5 (IQR 2–12) (P=0.001). Length of stay during the index admission in UC was only 3 days, which was 2 days shorter than expected. Based on quality-adjusted life years, the probability of HAH being cost-effective was 90%. There was one death within 90 days in each arm, readmission rates were similar and 90% of patients preferred HAH for subsequent ECOPD.ConclusionHAH selected by low-risk DECAF score was safe, clinically effective, cost-effective, and preferred by most patients. Compared with earlier models, selection is simpler and approximately twice as many patients are eligible. The introduction of DECAF was associated with a fall in UC length of stay without adverse outcome, supporting use of DECAF to direct early discharge.Trial registration numberRegistered prospectively ISRCTN29082260.

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