scholarly journals Process evaluations of a web-based intervention to increase handwashing during a pandemic: Moving Germ Defence from a randomised controlled trial to public dissemination (Preprint)

2020 ◽  
Author(s):  
Sascha Miller ◽  
Ben Ainsworth ◽  
Mark Weal ◽  
Peter Smith ◽  
Paul Little ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
General Public ◽  
Controlled Trial ◽  
Swine Flu ◽  
Global Pandemic ◽  
Core Section ◽  
In The Wild ◽  
Randomised Controlled ◽  
Tract Infections ◽  
Process Evaluations

BACKGROUND Washing hands helps prevent transmission of seasonal and pandemic respiratory viruses. The PRIMIT study developed a fully automated, digital intervention to promote handwashing. In a randomised controlled trial during the Swine Flu outbreak, participants who had access to the intervention reported washing their hands more and experienced less respiratory tract infections than those without access. Using these findings, the intervention was subsequently adapted, renamed ‘Germ Defence’, and a study designed to assess a preliminary dissemination of the intervention to the general public to help prevent the spread of seasonal colds and flu. OBJECTIVE This paper compares process evaluations of the PRIMIT trial and Germ Defence dissemination to examine: 1) how online research enrollment procedures impacted on who used the intervention; 2) intervention usage in the two contexts; 3) whether increased intentions to wash hands are replicated once disseminated. The purpose of this paper is to provide insight so that the Germ Defence intervention could be optimized for wide-scale dissemination in the event of a global pandemic. METHODS The PRIMIT trial ran between 2010 and 2012 recruiting participants offline from General Practices, with restricted access to the intervention (N=9155). Germ Defence was disseminated as an open access website for use by the general public from 2016 to 2019 (N=624). The process evaluation plan was developed using Medical Research Council guidance and the framework for Analysing and Measuring Usage and Engagement Data. Both interventions contained a goal-setting section where users self-reported current and intended handwashing behaviour across seven situations. RESULTS During online enrolment, 54.30% (n=17,511) of PRIMIT study participants dropped out of the study compared to 36.46% (n=358) of Germ Defence users. Having reached the intervention, 93.79% (n=8586) of PRIMIT users completed the core section, whereas 65.06% (n=406) of Germ Defence users reached the same point. Users across both studies selected to increase their handwashing in five out of seven situations, including before eating snacks (PRIMIT MD=1.040 [CI 1.016, 1.063], Germ Defence MD=.949 [CI 766, 1.132]) and after blowing their nose, sneezing or coughing (PRIMIT MD=.995 [CI .972, 1.019], Germ Defence MD=.842 [CI .675, 1.008]). CONCLUSIONS By comparing a preliminary dissemination of Germ Defence to the PRIMIT trial we have been able to examine the potential effects of research procedures on uptake and attrition, such as the sizeable dropout during the PRIMIT trial enrolment procedure that may have led to a more motivated sample. The Germ Defence study highlighted points of attrition within the intervention. Despite sample bias in the trial context, the intervention replicated increases in intentions to handwash when used ‘in the wild’. This preliminary dissemination study informed the adaptation of the intervention for the COVID-19 health emergency, and it has now been disseminated globally. CLINICALTRIAL ISRCTN75058295

scholarly journals Quick-Wee versus bladder stimulation to collect midstream urine from precontinent infants under 1 year of age: a study protocol for a randomised controlled trial (ES.Stimquick.U)

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e046324
Author(s):  
Sarah Marchal ◽  
Jade Janicot ◽  
Julie Salicis ◽  
Diane Demonchy ◽  
Anne-Laure Herisse ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Urine Analysis ◽  
Controlled Trial ◽  
Contamination Rate ◽  
Minimal Invasiveness ◽  
Registration Number ◽  
Randomised Controlled ◽  
Tract Infections ◽  
Clinical Trials Registry

IntroductionUrinary tract infections occur in around 1%–4% of boys and 3%–8% of girls under 2 years old. Diagnosis is difficult because of non-specific symptoms and the risk of urine analysis contamination depending on the sampling method used for precontinent infants. The American Academy of Pediatrics recommend transurethral catheterisation and suprapubic aspiration because of a low contamination rate but these techniques are invasive. On the other hand, while the National Institute for Health and Care Excellence advocate clean catch urine for its minimal invasiveness and acceptable contamination rate, it is difficult to accomplish in precontinent infants. Two recent methods have been described: the Quick-Wee method by Kaufman et al (suprapubic stimulation with cold saline-soaked gauze); and bladder stimulation by Herreros et al then by Tran et al (pubic tapping alternating with lumbar massage). This study aims to compare the effectiveness in collecting midstream urine by bladder stimulation vs the Quick-Wee method in infants under 1 year, before walking.Methods and analysisThis study is a multicentre randomised controlled trial of 230 infants under 1 year and before walking who need urine analysis, conducted in four paediatric emergency departments in France. Patients will be randomised into two groups: bladder stimulation and Quick-Wee method.The primary endpoint will be the success rate of voiding at least 2 mL of urine in less than 5 min.Secondary outcomes are the time to collect at least 2 mL of urine, comfort, quality of urine and the risk factors associated with failure of the two techniques.Ethics and disseminationThe study protocol was approved by the French national ethic committee (consultative committee of the protection of persons). The results of the study will be published in a peer-reviewed journal.Trial registration numberClinical Trials Registry - NCT04587999.Date and protocol version identifierOctober 2020, V.1.

scholarly journals Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo as a prophylaxis for recurrence urinary tract infections in children: a study protocol for a randomised controlled trial

BMC Urology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Maria Daniel ◽  
Hanna Szymanik-Grzelak ◽  
Agnieszka Turczyn ◽  
Małgorzata Pańczyk-Tomaszewska
Keyword(s):  
Urinary Tract ◽  
Randomised Controlled Trial ◽  
Lactobacillus Plantarum ◽  
Urinary Tract Infections ◽  
Acute Pyelonephritis ◽  
Controlled Trial ◽  
Lactobacillus Rhamnosus ◽  
Recurrent Utis ◽  
Randomised Controlled ◽  
Tract Infections

Abstract Background Urinary tract infections (UTIs) are one of the most common bacterial infections in children. In children < 7 years of age, the prevalence of one episode of symptomatic UTI has been estimated at 3–7% in girls and 1–2% in boys, whereas 8–30% of them will have one or more episodes of UTI. The use of some probiotics appears to reduce the risk of recurrence of UTIs. Since the effects of probiotics are strain-specific, the efficacy and safety of each strain has to be assessed. The main aim of this study is to determine whether probiotics (containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1) therapy are effective in preventing UTI in children compared to placebo. Method A superiority, double-blind, randomised, controlled trial is being conducted. One hundred and six patients aged 3 to 18 years with recurrent UTIs in last year (defined as: ≥ 2 episodes of UTI with acute pyelonephritis/upper UTI; or 1 episode of UTI with acute pyelonephritis and ≥ 1 episodes of UTI with cystitis/lower UTI; or ≥ 3 episodes of UTI with cystitis/lower UTI) or children with ≥ 1 infection in the upper urinary tract and ≥ 1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-day prophylaxis arm (probiotic containing L. rhamnosus PL1 and L. plantarum PM1) or a 90-day placebo arm. The primary outcome measure will be the frequency of recurrence of UTI during the intervention and in the period 9 months after the intervention. Discussion The findings of this randomised controlled trial (RCT), whether positive or negative, will contribute to the formulation of further recommendations on prevention of recurrent UTIs in children. Trial registration number NCT03462160, date of trial registration 12th March 2018.

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