Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study

2021 ◽  
pp. archdischild-2020-319968
Author(s):  
Hadeel Hassan ◽  
Sally Kinsey ◽  
Bob Phillips
Keyword(s):  
Direct Contact ◽  
Randomised Controlled Trials ◽  
Healthcare Professionals ◽  
Meta Analysis ◽  
Paediatric Oncology ◽  
Children With Cancer ◽  
Patient Diary ◽  
Registration Number ◽  
Randomised Controlled ◽  
To Receive

BackgroundA recent systematic review and meta-analysis identified a paucity of randomised-controlled trials (RCTs) investigating the use of probiotics to reduce or prevent mucositis and infection in children with cancer.ObjectiveThis study evaluated the feasibility of undertaking an RCT and investigated the efficacy of probiotics for reducing or preventing mucositis and infection in children with cancers.SettingThe Paediatric Oncology and Haematology department at Leeds Teaching Hospital, UK.PatientsChildren aged 1 year or older, receiving chemotherapies likely to cause mucositis.InterventionsParticipants were randomised to receive the probiotic or placebo on day 1–14 of a chemotherapy cycle. Participants were also required to complete a patient diary for 21 days.Main outcome measuresTo assess whether it is feasible to recruit children diagnosed with cancer who are at risk of developing mucositis to an adequately powered RCT.ResultsBetween May and November 2019, 34 out of 39 eligible participants were approached. Ten patients were recruited (4 probiotic and 6 placebo) of which 2 participants withdrew. Seven participants partially completed the diary but only two participants completed 80% or more. Eligible participants appeared to prefer giving informal verbal feedback when in direct contact with research and healthcare professionals.ConclusionThis study demonstrated that recruitment needs to be improved prior to undertaking an adequately powered RCT.Trial registration numberNCT03785938.

Effectiveness of school-based physical activity programmes on cardiorespiratory fitness in children: a meta-analysis of randomised controlled trials

2017 ◽  
Vol 52 (19) ◽  
pp. 1234-1240 ◽  
Author(s):  
Diana P Pozuelo-Carrascosa ◽  
Antonio García-Hermoso ◽  
Celia Álvarez-Bueno ◽  
Mairena Sánchez-López ◽  
Vicente Martinez-Vizcaino
Keyword(s):  
Physical Activity ◽  
Cardiorespiratory Fitness ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Healthy Children ◽  
Physical Activity Interventions ◽  
School Based ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo conduct a meta-analysis of randomised controlled trials aimed at testing whether school-based physical activity programmes improve cardiorespiratory fitness (CRF) in children.DesignSystematic review with meta-analysis.Data sourcesUsing keywords, we performed a computerised search in five databases: MEDLINE, EMBASE, CINAHL, Web of Science and SportDiscus.Eligibility criteria for selecting studiesStudies that assessed the effectiveness of school-based physical activity programmes on improving CRF in children (3–12 years old). We selected interventions that included an additional physical activity programme and not only a physical activity educational component. The reference lists of selected full-text articles and systematic reviews were also searched for relevant studies. Pooled effect size (Hedges′ g) was calculated assuming a random-effects model.ResultsTwenty trials with 7287 healthy children aged 3–12 years were included in the meta-analysis. School-based physical activity interventions with aerobic games and activities were associated with a significant small increase in CRF (Hedges′ g=0.22; 95% CI 0.14 to 0.30; p<0.001). Based on subgroup analysis, the increase in CRF was significant in girls (Hedges′ g=0.25; 95% CI 0.13 to 0.37; p<0.001), but not in boys (Hedges′ g=0.02; 95% CI −0.10 to 0.14; p=0.731).SummaryModerate quality evidence supports the effectiveness of school-based physical activity interventions on improving CRF in children.Trial registration numberProtocol PROSPERO registration number CRD42016050173.

scholarly journals Feasibility of reporting results of large randomised controlled trials to participants: experience from the Fluoxetine Or Control Under Supervision (FOCUS) trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040492
Author(s):  
Gillian Mead ◽  
Martin Dennis
Keyword(s):  
Randomised Controlled Trials ◽  
Ethical Imperative ◽  
Research Participants ◽  
Email Address ◽  
Telephone Helpline ◽  
Registration Number ◽  
Stroke Services ◽  
Randomised Controlled ◽  
To Receive

ObjectivesInforming research participants of the results of studies in which they took part is viewed as an ethical imperative. However, there is little guidance in the literature about how to do this. The Fluoxetine Or Control Under Supervision trial randomised 3127 patients with a recent acute stroke to 6 months of fluoxetine or placebo and was published in the Lancet on 5 December 2018. The trial team decided to inform the participants of the results at exactly the same time as the Lancet publication, and also whether they had been allocated fluoxetine or placebo. In this report, we describe how we informed participants of the results.DesignIn the 6-month and 12-month follow-up questionnaires, we invited participants to provide an email address if they wished to be informed of the results of the trial. We re-opened our trial telephone helpline between 5 December 2018 and 31 March 2019.SettingUK stroke services.Participants3127 participants were randomised. 2847 returned 6-month follow-up forms and 2703 returned 12-month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond.ResultsOf those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people requested results to be sent by post. Results were sent to all email and postal addresses provided; 309 emails were returned unrecognised. Seventeen people replied, of whom three called the helpline and the rest responded by email.ConclusionIt is feasible to disseminate results of large trials to research participants, though only around 60% of those randomised wanted to receive the results. The system we developed was efficient and required very little resource, and could be replicated by trialists in the future.Trial registration numberISRCTN83290762; Post-results.

scholarly journals Do mobile device apps designed to support medication adherence demonstrate efficacy? A systematic review of randomised controlled trials, with meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e032045 ◽  
Author(s):  
Laura Catherine Armitage ◽  
Aikaterini Kassavou ◽  
Stephen Sutton
Keyword(s):  
Systematic Review ◽  
Medication Adherence ◽  
Effect Size ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Behaviour Change Techniques ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesTo estimate the efficacy of app-based interventions designed to support medication adherence and investigate which behaviour change techniques (BCTs) used by the apps are associated with efficacy.DesignSystematic review of randomised controlled trials (RCTs), with meta-analysis.SettingMedline/PubMed, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Embase and Web of Science were searched from 1990 to November 2018 for RCTs conducted in any healthcare setting.ParticipantsStudies of participants of any age taking prescribed medication for any health condition and for any duration.InterventionAn app-based intervention delivered through a smartphone, tablet computer or personal digital assistant to help, support or advise about medication adherence.ComparatorOne of (1) usual care, (2) a control app which did not use any BCTs to improve medication adherence or (3) a non-app-based comparator.Primary and secondary outcome measuresThe primary outcome was the pooled effect size of changes in medication adherence. The secondary outcome was the association between BCTs used by the apps and the effect size.ResultsThe initial search identified 13 259 citations. After title and abstract screening, full-text articles of 83 studies were screened for eligibility. Nine RCTs with 1159 recruited participants were included. The mean age of participants was >50 years in all but one study. Health conditions of target populations included cardiovascular disease, depression, Parkinson’s disease, psoriasis and multimorbidity. The meta-analysis indicated that patients who use mobile apps to support them in taking medications are more likely to self-report adherence to medications (OR 2.120, 95% CI 1.635 to 2.747, n=988) than those in the comparator groups. Meta-regression of the BCTs did not reveal any significant associations with effect size.ConclusionsApp-based medication adherence interventions may have a positive effect on patient adherence. Larger scale studies are required to further evaluate this effect, including long-term sustainability, and intervention and participant characteristics that are associated with efficacy and app usage.Prospero registration numberPROSPERO Protocol Registration Number: CRD42017080150.

scholarly journals Statin and mortality in COVID-19: a systematic review and meta-analysis of pooled adjusted effect estimates from propensity-matched cohorts

2021 ◽  
pp. postgradmedj-2021-140409
Author(s):  
Ahmad Fariz Malvi Zamzam Zein ◽  
Catur Setiya Sulistiyana ◽  
Uswatun Khasanah ◽  
Arief Wibowo ◽  
Michael Anthonius Lim ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Male Gender ◽  
Effect Estimate ◽  
Inverse Probability ◽  
Risk Of Mortality ◽  
Registration Number ◽  
Multivariable Regression ◽  
Randomised Controlled

PurposeStatin potentially improved outcome in patients with COVID-19. Patients who receive statin generally have a higher proportion of comorbidities than those who did not, which may introduce bias. In this meta-analysis, we aimed to investigate the association between statin use and mortality in patients with COVID-19 by pooling the adjusted effect estimates from propensity-score matching (PSM) matched studies or randomised controlled trials to reduce bias.MethodsA systematic literature search using the PubMed, Scopus and Embase databases were performed up until 1 March 2021. Studies that were designed the study to assess statin and mortality using PSM with the addition of Inverse Probability Treatment Weighting or multivariable regression analysis on top of PSM-matched cohorts were included. The effect estimate was reported in term of relative risk (RR).Results14 446 patients were included in the eight PSM-matched studies. Statin was associated with decreased mortality in patients with COVID-19 (RR 0.72 (0.55, 0.95), p=0.018; I2: 84.3%, p<0.001). Subgroup analysis in patients receiving statin in-hospital showed that it was associated with lower mortality (RR 0.71 (0.54, 0.94), p=0.030; I2: 64.1%, p<0.025). The association of statin and mortality was not significantly affected by age (coefficient: −0.04, p=0.382), male gender (RR 0.96 (0.95, 1.02), p=0.456), diabetes (RR 1.02 (0.99, 1.04), p=0.271) and hypertension (RR 1.01 (0.97, 1.04), p=0.732) in this pooled analysis.ConclusionIn this meta-analysis of PSM-matched cohorts with adjusted analysis, statin was shown to decrease the risk of mortality in patients with COVID-19.PROSPERO registration numberCRD42021240137.

scholarly journals Interventions by healthcare professionals to improve management of physical long-term conditions in adults who are homeless: a systematic review protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016756 ◽  
Author(s):  
Peter Hanlon ◽  
Lynsey Yeoman ◽  
Regina Esiovwa ◽  
Lauren Gibson ◽  
Andrea E Williamson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Healthcare Professional ◽  
Randomised Controlled Trials ◽  
Healthcare Professionals ◽  
Controlled Trials ◽  
Long Term Conditions ◽  
Homeless Adults ◽  
Registration Number ◽  
Randomised Controlled

IntroductionPeople experiencing homelessness are at increased risk of, and have poorer outcomes from, a range of physical long-term conditions (LTCs). It is increasingly recognised that interventions targeting people who are homeless should be tailored to the specific needs of this population. This systematic review aims to identify, describe and appraise trials of interventions that aim to manage physical LTCs in homeless adults and are delivered by healthcare professionals.Methods and analysisSeven electronic databases (Medline, EMBASE, Cochrane Central Register of Controlled Trials, Assia, Scopus, PsycINFO and CINAHL) will be searched from 1960 (or inception) to October 2016 and supplemented by forward citation searching, handsearching of reference lists and searching grey literature. Two reviewers will independently review titles, abstract and full-texts using DistillerSR software. Inclusion criteria include (1) homeless adults with any physical LTC, (2) interventions delivered by a healthcare professional (any professional trained to provide any form of healthcare, but excluding social workers and professionals without health-related training), (3) comparison with usual care or an alternative intervention, (4) report outcomes such as healthcare usage, physical and psychological health or well-being or cost-effectiveness, (5) randomised controlled trials, non-randomised controlled trials, controlled before-after studies. Quality will be assessed using the Cochrane EPOC Risk of Bias Tool. A meta-analysis will be performed if sufficient data are identified; however, we anticipate a narrative synthesis will be performed.Ethics and disseminationThis review will synthesise existing evidence for interventions delivered by healthcare professionals to manage physical LTCs in adults who are homeless. The findings will inform the development of future interventions and research aiming to improve the management of LTCs for people experiencing homelessness. Ethical approval will not be required for this systematic review as it does not contain individual patient data. We will disseminate the results of this systematic review via conference presentations, healthcare professional networks, social media and peer-reviewed publication.Trial registration numberPROSPERO registration number: CRD42016046183.

scholarly journals Smoking cessation in individuals who use vaping as compared with traditional nicotine replacement therapies: a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e044222
Author(s):  
Catherine M Pound ◽  
Jennifer Zhe Zhang ◽  
Ama Tweneboa Kodua ◽  
Margaret Sampson
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Cigarette Smoking ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Smoking Reduction ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesDespite the aggressive marketing of electronic nicotine device systems (ENDS) as smoking cessation tools, the evidence of their effectiveness is mixed. We conducted a systematic review of randomised controlled trials to determine the effect of ENDS on cigarette smoking cessation, as compared with other types of nicotine replacement therapies (NRT).DesignSystematic review and meta-analysis using the Grading of Recommendations Assessment, Development and Evaluation approach.Data sourcesMEDLINE, Embase, the CENTRAL Trials Registry of the Cochrane Collaboration using the Ovid interface, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform trials registries were searched through 17 June 2020.Eligibility criteria for studiesRandomised controlled trials in which any type of ENDS was compared with any type of NRT, in traditional cigarette users.Data extraction and synthesisThe primary outcome was smoking cessation, defined as abstinence from traditional cigarette smoking for any time period, as reported in each included study, regardless of whether abstinence is self-reported or biochemically validated. Secondary outcomes included smoking reduction, harms, withdrawal and acceptance of therapy. A random-effect model was used, and data were pooled in meta-analyses where appropriate.ResultsSix studies were retained from 270. Most outcomes were judged to be at high risk of bias. The overall quality of evidence was graded as ‘low’ or ‘very low’. Pooled results showed no difference in smoking cessation (rate ratio (RR) 1.42, 95% CI 0.97 to 2.09), proportion of participants reducing smoking consumption (RR 1.25, 95% CI 0.79 to 1.98), mean reduction in cigarettes smoked per day (mean difference 1.11, 95% CI −0.41 to 2.63), or harms (RR 0.96, 95% CI 0.76 to 1.20), between groups.ConclusionWe found no difference in smoking cessation, harms and smoking reduction between e-cigarette and NRT users. However, the quality of the evidence was low. Further research is needed before widespread recommendations are made with regard to the use of ENDS.PROSPERO registration numberSystematic review registration number: protocol registered with the International Prospective Register of Systematic Reviews (PROSPERO) on February 27th, 2020; CRD42020169416.

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