scholarly journals Child outcomes after induction of labour or expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks of gestation: study protocol of the PPROMEXIL Follow-up trial. A long-term follow-up study of the randomised controlled trials PPROMEXIL and PPROMEXIL-2

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046046
Author(s):  
Annemijn A de Ruigh ◽  
Noor E Simons ◽  
Janneke Van ‘t Hooft ◽  
Aleid G van Wassenaer-Leemhuis ◽  
Cornelieke S H Aarnoudse-Moens ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Expectant Management ◽  
Induction Of Labour ◽  
Late Preterm ◽  
Controlled Trials ◽  
Link Type ◽  
Long Term Follow Up ◽  
Randomised Controlled

IntroductionLate preterm prelabour rupture of membranes (PROM between 34+0 and 36+6 weeks gestational age) is an important clinical dilemma. Previously, two large Dutch randomised controlled trials (RCTs) compared induction of labour (IoL) to expectant management (EM). Both trials showed that early delivery does not reduce the risk of neonatal sepsis as compared with EM, although prematurity-related risks might increase. An extensive, structured long-term follow-up of these children has never been performed.Methods and analysisThe PPROMEXIL Follow-up trial (NL6623 (NTR6953)) aims to assess long-term childhood outcomes of the PPROMEXIL (ISRCTN29313500) and PPROMEXIL-2 trial (ISRCTN05689407), two multicentre RCTs using the same protocol, conducted between 2007 and 2010 evaluating IoL versus EM in women with late preterm PROM. The PPROMEXIL Follow-up will analyse children of mothers with a singleton pregnancy (PPROMEXIL trial n=520, PPROMEXIL-2 trial n=191, total IoL n=359; total EM n=352). At 10–12 years of age all surviving children will be invited for a neurodevelopmental assessment using the Wechsler Intelligence Scale for Children-V, Color-Word Interference Test and the Movement Assessment Battery for Children-2. Parents will be asked to fill out questionnaires assessing behaviour, motor function, sensory processing, respiratory problems, general health and need for healthcare services. Teachers will fill out the Teacher Report Form and answer questions regarding school attainment. For all tests means with SDs will be compared, as well as predefined cut-off scores for abnormal outcome. Sensitivity analyses consisting of different imputation techniques will be used to deal with lost to follow-up.Ethics and disseminationThe study has been granted approval by the Medical Centre Amsterdam (MEC) of the AmsterdamUMC (MEC2016_217). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results.Trial registration numberNL6623 (NTR6953).

Effectiveness of exercise-based interventions in reducing depressive symptoms in people without clinical depression: systematic review and meta-analysis of randomised controlled trials

2021 ◽  
pp. 1-10
Author(s):  
Juan Ángel Bellón ◽  
Sonia Conejo-Cerón ◽  
Almudena Sánchez-Calderón ◽  
Beatriz Rodríguez-Martín ◽  
Darío Bellón ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Sample Size ◽  
Randomised Controlled Trials ◽  
Clinical Depression ◽  
Sensitivity Analyses ◽  
Controlled Trials ◽  
Long Term Follow Up ◽  
Randomised Controlled

Background In most trials and systematic reviews that evaluate exercise-based interventions in reducing depressive symptoms, it is difficult to separate treatment from prevention. Aims To evaluate the effectiveness of exercise-based interventions in reducing depressive symptoms in people without clinical depression. Method We searched PubMed, PsycINFO, Embase, WOS, SPORTDiscus, CENTRAL, OpenGrey and other sources up to 25 May 2020. We selected randomised controlled trials (RCTs) that compared exclusively exercise-based interventions with control groups, enrolling participants without clinical depression, as measured using validated instruments, and whose outcome was reduction of depressive symptoms and/or incidence of new cases of people with depression. Pooled standardised mean differences (SMDs) were calculated using random-effect models (registration at PROSPERO: CRD42017055726). Results A total of 14 RCTs (18 comparisons) evaluated 1737 adults without clinical depression from eight countries and four continents. The pooled SMD was −0.34 (95% CI −0.51 to −0.17; P < 0.001) and sensitivity analyses confirmed the robustness of this result. We found no statistical evidence of publication bias and heterogeneity was moderate (I2 = 54%; 95% CI 22–73%). Only two RCTs had an overall low risk of bias and three had long-term follow-up. Multivariate meta-regression found that a larger sample size, country (Asia) and selective prevention (i.e. people exposed to risk factors for depression) were associated with lower effectiveness, although only sample size remained significant when adjustment for multiple tests was considered. According to the Grading of Recommendations Assessment, Development and Evaluation tool, the quality of evidence was low. Conclusions Exercise-based interventions have a small effect on the reduction of depressive symptoms in people without clinical depression. It could be an alternative to or complement psychological programmes, although further higher-quality trials with larger samples and long-term follow-up are needed.

scholarly journals Bronchoscopic management of asthma, COPD and emphysema

2021 ◽  
Vol 30 (159) ◽  
pp. 200029
Author(s):  
Jeanne Marie Perotin ◽  
Maxime Dewolf ◽  
Claire Launois ◽  
Valérian Dormoy ◽  
Gaëtan Deslee
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trials ◽  
Inflammatory Diseases ◽  
Chronic Obstructive ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Long Term Follow Up ◽  
Randomised Controlled

In recent years, many bronchoscopic techniques have been developed in chronic obstructive airway inflammatory diseases, including asthma, COPD and emphysema. The main techniques with available data from randomised controlled trials are: 1) bronchial thermoplasty in asthma; 2) valves, coils and thermal vapor ablation in emphysema; and 3) targeted lung denervation in COPD. The objectives of this article are to describe the levels of evidence for efficacy and safety, long-term follow-up results beyond 1 year, and current recommendations for clinical practice from international guidelines for each technique.

scholarly journals New Evidence in the Booming Field of Online Mindfulness: An Updated Meta-Analysis of Randomised Controlled Trials (Preprint)

2021 ◽  
Author(s):  
Marion Sommers-Spijkerman ◽  
Judith Austin ◽  
Ernst Bohlmeijer ◽  
Wendy Pots
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Well Being ◽  
Evidence Base ◽  
Effect Sizes ◽  
Controlled Trials ◽  
Long Term Follow Up ◽  
Randomised Controlled

BACKGROUND There is a need for regularly updating the evidence base on the effectiveness of online mindfulness-based interventions (MBIs), especially considering how fast this field is growing and developing. OBJECTIVE The current study presents an updated meta-analysis of randomised controlled trials assessing the effects of online MBIs on mental health, as well as the potential moderators of those effects. METHODS A systematic literature search was conducted in PsycINFO, PubMed and Web of Science up to July 19th, 2019. Seventy trials totalling 91 comparisons were included. Pre-to-post and pre-to-follow-up between-group effect sizes (Hedges’ g) were calculated for depression, anxiety, stress, well-being and mindfulness, using a random effects model. RESULTS The findings revealed statistically significant moderate pre-to-post effects on stress (g=0.41) and mindfulness (g=0.43) and small effects on depression (g=0.31) and anxiety (g=0.23). For well-being, a significant effect was found only when omitting low quality studies (g=0.34). Significant but small follow-up effects were found for depression (g=0.25), anxiety (g=0.17) and stress (g=-0.11). Subgroup analyses revealed that online MBIs resulted in higher effect sizes for stress when offered with guidance. For stress and mindfulness, studies that used an inactive control condition yielded larger effects. CONCLUSIONS Our findings do not only demonstrate that the field of online MBIs is booming, but also corroborate previous evidence that online MBIs are beneficial for improving mental health outcomes in a broad range of samples. To advance the field of online MBIs, future trials should pay specific attention to methodological quality, adherence and long-term follow-up measurements.

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