scholarly journals Feasibility Study for a Randomised Controlled Trial for the Topical Treatment of Impetigo in Australian General Practice

2021 ◽  
Vol 6 (4) ◽  
pp. 197
Author(s):  
Hilary Gorges ◽  
Leanne Hall ◽  
Clare Heal
Keyword(s):  
General Practice ◽  
Randomised Controlled Trial ◽  
Topical Treatment ◽  
Controlled Trial ◽  
Severe Infection ◽  
Recruitment Rate ◽  
Valuable Insight ◽  
Randomised Controlled ◽  
Recruitment Barriers ◽  
At Home

Impetigo affects millions of children worldwide. Most guidelines recommend antibiotics as first-line treatment; however, topical antiseptics present a potentially valuable, understudied, antibiotic-sparing treatment for mild impetigo. We aimed to determine the feasibility of a randomised controlled trial (RCT) comparing efficacy of soft white paraffin (SWP), hydrogen peroxide (H2O2) and mupirocin for mild impetigo. Participants were recruited from general practices and randomly assigned one of three treatments. Size and number of lesions were measured at the initial consultation and day six. Post-recruitment, interviews with general practitioners were transcribed and themes identified to determine protocol acceptability, recruitment barriers and avenues to improve delivery. Two participants received SWP (n = 1) and mupirocin (n = 1). Both commenced oral antibiotics following failure of assigned topical treatment in which lesions increased in size or number. Recruitment barriers included reduced presentation of impetigo due to COVID-19, pre-treatment with existing at-home medications and moderate/severe infection. Childcare centers and pharmacies were identified as alternative venues to improve the recruitment rate. Valuable insight was gained into the practicality of conducting a RCT of impetigo treatments in general practice. Future trials should consider recruiting outside of general practice clinics to capture patients at earlier, more mild stages of infection. Further investigation into the prevalence and impact of use of at-home expired antibiotics may be beneficial.

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 Protocol for a factorial randomised controlled trial, embedded within WHiTE 8 COPAL, of an Enhanced Trainee Principal Investigator Package and Additional Digital Nudge to increase recruitment rates

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1153 ◽  
Author(s):  
Nickil Agni ◽  
Caroline Fairhurst ◽  
Catriona McDaid ◽  
Mike Reed ◽  
David Torgerson
Keyword(s):  
Randomised Controlled Trial ◽  
Positive Reinforcement ◽  
Controlled Trial ◽  
Significant Proportion ◽  
Educational Programme ◽  
Primary Objective ◽  
Recruitment Rate ◽  
Principal Investigators ◽  
Link Type ◽  
Randomised Controlled

Recruitment remains an issue when conducting randomised controlled trials (RCTs) with a significant proportion of studies failing to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. This factorial RCT will evaluate the effectiveness of an educational intervention to trainee principal investigators and a positive reinforcement intervention via an email nudge on increasing recruitment. The targeted recruiters will be in 20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL. Centres will be randomised via minimisation to one of four groups. The primary outcome is recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model. Results will be presented as adjusted incidence rate ratios with 95% confidence intervals. Secondary outcomes relate to the feasibility and logistics of running the interventions.  We will also collect feedback regarding the educational programme set out for the trainee principal investigators. The study started in August 2018 with the anticipation of the primary objective endpoint by October 2019. The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. Trial registration: 11600053, ISRCTN, 20/08/2018; SWAT 67, Northern Ireland Hub for Trials Methodology Research SWAT repository, 01/10/2017.

scholarly journals The effect of alcohol strength on alcohol consumption: findings from a randomised controlled cross-over pilot trial.

2021 ◽  
Author(s):  
Parvati Rose Perman-Howe ◽  
Emma L Davies ◽  
David R Foxcroft
Keyword(s):  
Randomised Controlled Trial ◽  
Alcohol Consumption ◽  
Sample Size ◽  
Study Protocol ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Participant Recruitment ◽  
Licensed Premises ◽  
Randomised Controlled

Abstract Background Reducing the alcohol content of drinks has the potential to reduce alcohol consumption. Aims: (1) test the feasibility of a randomised controlled trial (RCT) to assess the effect of alcohol strength on alcohol consumption within licensed premises in the United Kingdom (UK), (2) provide data to estimate key parameters for a RCT. Methods Double-blind randomised controlled cross-over pilot trial based within four licensed premises in the UK. Participants (n=36) purchased and consumed ad libitum a 3.5% lager and a 4.8% lager during two separate study sessions. Descriptive statistics reported the efficacy and efficiency of the study processes, and the rates of licensed premises recruitment, and participant recruitment and attrition. Mean and the 95% confidence interval (CI) compared alcohol consumption between conditions. The mean, standard deviation (SD) and CI of UK units of alcohol consumed were used to calculate a sample size for a RCT. Responses to participant questionnaires and duration of participation in study sessions between conditions were analysed.Results Components of the study protocol were effective and efficient. The venue recruitment rate was less than anticipated. The participant recruitment rate was greater than anticipated. The rate of attrition was 23% and varied by less than 1% according to the arm of the trial. There was a reduction of alcohol consumed under the intervention conditions. Estimated mean difference, and 95% CI (UK units): -3.76 (-5.01 to -2.52).The sample size required for a RCT is 53. Participants did not find one lager more pleasant in taste: (on a scale of one to 10) -0.95 (-2.11 to 0.21). Participants found the reduced-strength lager less enjoyable: (on a scale of one to 10) -1.44 (-2.64 to -0.24) and they perceived themselves to be less intoxicated after consuming it: (on a scale of one to 10) -1.00 (-1.61 to -0.40).Conclusion A RCT is feasible with minor alterations to the study protocol and scoping work to establish different brands of alcohol that are more alike and more enjoyable than the products used in the pilot trial. Trial registration Registered in the American Economic Association (AEA) Randomised Controlled Trial (RCT) Registry as of 16 June 2017: https://www.socialscienceregistry.org/trials/2266. Unique identifying number: AEARCTR-0002266.

Informal caregiver strain, preference and satisfaction in hospital-at-home and usual hospital care for COPD exacerbations: Results of a randomised controlled trial

2014 ◽  
Vol 51 (8) ◽  
pp. 1093-1102 ◽  
Author(s):  
Cecile M.A. Utens ◽  
Onno C.P. van Schayck ◽  
Lucas M.A. Goossens ◽  
Maureen P.H.M. Rutten-van Mölken ◽  
Dirk R.A.J. DeMunck ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Care ◽  
Informal Caregiver ◽  
Controlled Trial ◽  
Caregiver Strain ◽  
Copd Exacerbations ◽  
Hospital At Home ◽  
Randomised Controlled ◽  
At Home

scholarly journals 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 ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e017511 ◽  
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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