scholarly journals Pharmacological and non-pharmacological interventions for non-respiratory sleep disturbance in children with neurodisabilities: a systematic review

2018 ◽  
Vol 22 (60) ◽  
pp. 1-296 ◽  
Author(s):  
Bryony Beresford ◽  
Catriona McDaid ◽  
Adwoa Parker ◽  
Arabella Scantlebury ◽  
Gemma Spiers ◽  
...  

BackgroundThere is uncertainty about the most appropriate ways to manage non-respiratory sleep disturbances in children with neurodisabilities (NDs).ObjectiveTo assess the clinical effectiveness and safety of NHS-relevant pharmacological and non-pharmacological interventions to manage sleep disturbance in children and young people with NDs, who have non-respiratory sleep disturbance.Data sourcesSixteen databases, including The Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE, were searched up to February 2017, and grey literature searches and hand-searches were conducted.Review methodsFor pharmacological interventions, only randomised controlled trials (RCTs) were included. For non-pharmacological interventions, RCTs, non-randomised controlled studies and before-and-after studies were included. Data were extracted and quality assessed by two researchers. Meta-analysis and narrative synthesis were undertaken. Data on parents’ and children’s experiences of receiving a sleep disturbance intervention were collated into themes and reported narratively.ResultsThirty-nine studies were included. Sample sizes ranged from 5 to 244 participants. Thirteen RCTs evaluated oral melatonin. Twenty-six studies (12 RCTs and 14 before-and-after studies) evaluated non-pharmacological interventions, including comprehensive parent-directed tailored (n = 9) and non-tailored (n = 8) interventions, non-comprehensive parent-directed interventions (n = 2) and other non-pharmacological interventions (n = 7). All but one study were reported as having a high or unclear risk of bias, and studies were generally poorly reported. There was a statistically significant increase in diary-reported total sleep time (TST), which was the most commonly reported outcome for melatonin compared with placebo [pooled mean difference 29.6 minutes, 95% confidence interval (CI) 6.9 to 52.4 minutes;p = 0.01]; however, statistical heterogeneity was extremely high (97%). For the single melatonin study that was rated as having a low risk of bias, the mean increase in TST was 13.2 minutes and the lower CI included the possibility of reduced sleep time (95% CI –13.3 to 39.7 minutes). There was mixed evidence about the clinical effectiveness of the non-pharmacological interventions. Sixteen studies included interventions that investigated the feasibility, acceptability and/or parent or clinician views of sleep disturbance interventions. The majority of these studies reported the ‘family experience’ of non-pharmacological interventions.LimitationsPlanned subgroup analysis was possible in only a small number of melatonin trials.ConclusionsThere is some evidence of benefit for melatonin compared with placebo, but the degree of benefit is uncertain. There are various types of non-pharmacological interventions for managing sleep disturbance; however, clinical and methodological heterogeneity, few RCTs, a lack of standardised outcome measures and risk of bias means that it is not possible to draw conclusions with regard to their effectiveness. Future work should include the development of a core outcome, further evaluation of the clinical effectiveness and cost-effectiveness of pharmacological and non-pharmacological interventions and research exploring the prevention of, and methods for identifying, sleep disturbance. Research mapping current practices and exploring families’ understanding of sleep disturbance and their experiences of obtaining help may facilitate service provision development.Study registrationThis study is registered as PROSPERO CRD42016034067.FundingThe National Institute for Health Research Health Technology Assessment programme.

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S17-S17
Author(s):  
K. Grant ◽  
C. Bayley ◽  
E. Lang ◽  
G. Innes

Introduction: Emergency Department (ED) crowding is the primary threat to emergency care quality. Input and outflow factors are important factors, but EDs must optimize throughput efficiency by improving internal processes from triage to disposition, and triage is the first throughput phase. Triage throughput interventions exclude strategies that direct patients away from the ED (these modify input rather than throughput). Previous research has described physicians in triage, team triage, telemedical triage, and nurse practitioner (NP) or physician assistant (PA) led triage, but their impact has never been systematically evaluated. Methods: We conducted systematic database searches in Medline, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials without the use of filters or language restrictions of all triage interventions that effected ED throughput (PROSPERO:CRD42019125651). Two independent reviewers screened studies. Study quality was assessed using the Cochrane Risk of Bias tool (version 2) for randomized controlled trials, and the National Heart, Lung, and Blood Institute quality assessment tool for other designs. Results: 18 studies met inclusion criteria (Cohen's k = 0.69). Study results were not pooled due to high statistical heterogeneity as assessed by chi-squared and I-squared statistics. Studies were grouped into physician led, NP or PA led, and team triage interventions. Six physician in triage interventions reported LOS changes between -82 and + 18 minutes. Five NP/PA led triage interventions resulted in LOS changes of -106 to + 19 minutes. Five team triage interventions reported LOS reductions of 4 to 34 minutes. One telemedicine triage study reported a non-significant 8 minute increase in LOS. Six physician at triage interventions yielded significant LWBS rate improvement (relative risk {RR}= 0.29-0.82). Team triage interventions generated LWBS rate changes ranging from meaningful improvement (RR = 0.58) to substantial deterioration (RR = 1.68). Five studies have low risk of bias, 11 studies have some risk of bias, and 2 studies have high risk of bias (Cohen's kappa = 0.58). Conclusion: Fourteen of 18 triage interventions reduced EDLOS and/or LWBS rate. Physician, NP and PA led triage were the most effective triage interventions. To aid widespread adoption, future research should focus on interrupted time series or RCT designs, and more comprehensive descriptions of the contextual factors affecting implementation of these interventions.


2020 ◽  
Author(s):  
Ilaria Costantini ◽  
Elise Paul ◽  
Deborah M Caldwell ◽  
José A López-López ◽  
Rebecca M Pearson

Abstract Background: Internalising problems, such as depression and anxiety, are common and represent an important economical and societal burden. The effectiveness of parenting interventions in reducing risk of internalising problems in children and adolescents has not yet been summarised. The aims of this review are to:1. assess the effectiveness of parenting interventions in the primary, secondary and tertiary prevention of internalising problems in children and adolescents;2. determine which intervention components and which intervention aspects are most effective for reducing risk of internalising problems in children and adolescents. Methods: Electronic searches in OVID SP versions of Medline, EMBASE and PsycINFO; Cochrane Central Register of Controlled Trials; EBSCO version of ERIC and clinicaltrials.gov have been performed to identify randomised controlled trials or quasi-randomised controlled trials of parenting interventions. At least two independent researchers will assess studies for inclusion and extract data from each paper. The risk of bias assessment will be conducted independently by two reviewers using the Cochrane Collaboration’s Risk of Bias Assessment Tool. Statistical heterogeneity is anticipated given potential variation in participant characteristics, intervention type and mode of delivery, and outcome measures. Random effects models, assuming a common between-study variability, will be used to account for statistical heterogeneity. Results will be analysed using a network meta-analysis (NMA). If appropriate, we will also conduct a component-level NMA, where the ‘active ingredients’ of interventions are modelled using a network meta-regression approach.Discussion: Preventing and reducing internalising problems could have major beneficial effects at the economic and societal level. Informing policy makers on the effectiveness of parenting interventions and on which intervention’s component is driving the effect is important for the development of treatment strategies. Systematic review registration: International Prospective Register for Systematic Reviews (PROSPERO) number CRD42020172251


BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e025145
Author(s):  
Bianca E Kavanagh ◽  
Sharon Lee Brennan-Olsen ◽  
Alyna Turner ◽  
Olivia M Dean ◽  
Michael Berk ◽  
...  

IntroductionRemission rates for mood disorders, including depressive and bipolar disorders, remain relatively low despite available treatments, and many patients fail to respond adequately to these interventions. Evidence suggests that personality disorder may play a role in poor outcomes. Although personality disorders are common in patients with mood disorders, it remains unknown whether personality disorder affects treatment outcomes in mood disorders. We aim to review currently available evidence regarding the role of personality disorder on pharmacological interventions in randomised controlled trials for adults with mood disorders.Methods and analysisA systematic search of Cochrane Central Register of Controlled Clinical Trials (CENTRAL) via cochranelibrary.com, PubMed via PubMed, EMBASE via embase.com, PsycINFO via Ebsco and CINAHL Complete via Ebsco databases will be conducted to identify randomised controlled trials that have investigated pharmacological interventions in participants aged 18 years or older for mood disorders (ie, depressive disorders and bipolar spectrum disorders) and have also included assessment of personality disorder. One reviewer will screen studies against the predetermined eligibility criteria, and a second reviewer will confirm eligible studies. Data will be extracted by two independent reviewers. Methodological quality and risk of bias will be assessed using the Cochrane Risk of Bias tool. A systematic review, and if sufficient evidence is identified, a meta-analysis will be completed. Meta-analysis will be conducted using the standardised mean difference approach and reported with 95% CIs. A random effects model will be employed and statistical heterogeneity will be evaluated using the I2 statistic. Prespecified subgroup analyses will be completed.Ethics and disseminationAs this systematic review will use published data, ethics permission will not be required. The outcomes of this systematic review will be published in a relevant scientific journal and presented at a research conference.Trial registration numberCRD42018089279.


BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e024127 ◽  
Author(s):  
Graham Boniface ◽  
Meriel Norris ◽  
Esther Williamson ◽  
Varsha Gandhi ◽  
Shona Kirtley ◽  
...  

IntroductionHealthcare researchers designing strength-based exercise interventions must choose an appropriate dose to test before evaluating its effect using a definitive/phase-III randomised controlled trial (RCT). Compared with early phase testing employed by pharmaceutical trials, it is questionable whether exercise-based trials employ the same rigour for establishing tolerated dosage. Consequently, it is unclear if participants are initially prescribed optimal doses of exercise, which may potentially impact on study outcomes. Using trials of strength-based exercise interventions in adults with rheumatoid arthritis (RA) as an exemplar, the aims of this review are to (1) identify the proportion of RCTs that use phase I/II trials with dose escalation methodology for setting prescription parameters, (2) determine type and level of evidence used to justify prescription parameters of strength-based exercise interventions evaluated by RCTs, (3) explore consistency and applicability of the evidence underpinning prescription parameters in RCTs and (4) explore if a relationship exists between risk of bias for RCTs evaluating strength-based interventions and the level of evidence used to underpin prescription parameters.Methods and analysisFocusing on RCT’s evaluating strength-based exercise interventions in adults with RA published after 2000, the following databases will be searched: Allied and Complementary Medicine Database, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Excerpta Medica Database, Medline and Physiotherapy Evidence Database. For each RCT, we will identify the evidence used to underpin prescription parameters. Both trial and underpinning evidence will have key information about the intervention extracted using the template for intervention description and replication checklist. Risk of bias will be assessed according to Cochrane. Levels of evidence will be assessed against the Oxford Centre for Evidence-Based Medicine and relationships between RCT and underpinning evidence explored and described narratively. Two independent assessors will be involved throughout data selection and extraction with recourse to a third reviewer should agreement not be reached.Ethics and disseminationNo ethical issues are identified. Dissemination will be via publication.PROSPERO registration numberCRD42018090963.


BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037422
Author(s):  
Lintong Yu ◽  
Xueqian Yu ◽  
Yueyang Li ◽  
Jun Li ◽  
Fang Hua ◽  
...  

IntroductionRegular toothbrushing with fluoride toothpaste is a fundamental intervention for caries prevention. Professional fluoride application (PFA) is widely considered a beneficial supplement to the routine use of fluoride toothpaste. However, some recent studies have failed to demonstrate the preventive effect of PFA. In addition, an increasing number of studies have highlighted the potential adverse effects of fluoride. However, little information exists on the effectiveness of additional PFA. The objective of this review is to systematically analyse the efficacy of PFA in addition to regular fluoride toothpaste among children under the age of 16.Method and analysisWe will search the PubMed, Embase, Google Scholar and Cochrane Central Register of Controlled Trials databases for randomised controlled trials without language or publication date restrictions. Additional studies will be identified by manually searching the reference lists of the included studies and relevant reviews. At least two authors will carry out the selection of studies independently and in duplicate. The Cochrane Risk of Bias tool will be used to assess the risk of bias of the included studies. The random effects model will be used for meta-analyses. The data synthesis will be conducted using Review Manager software (RevMan V.5.3). The Grading of Recommendation, Assessment, Development and Evaluation will be used to assess the quality of supporting evidence for each major comparison.Ethics and disseminationThere is no need for ethical approval. The results of this review will be disseminated through peer-reviewed publications and social networks.PROSPERO registration numberCRD42020165270


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043751
Author(s):  
Lorraine Lau ◽  
Jamie L Benham ◽  
Patricia Lemieux ◽  
Jennifer Yamamoto ◽  
Lois E Donovan

ObjectiveTo evaluate the effect of levothyroxine therapy on pregnancy outcomes compared with placebo or no treatment in women without overt hypothyroidism with presence of thyroid peroxidase antibodies (TPOAb) and/or thyroglobulin antibodies (TgAb).DesignSystematic review and meta-analysis of randomised controlled trialsStudy eligibility criteriaPrespecified criteria for inclusion were: randomised trials of levothyroxine versus control (placebo or no treatment) among women with positive TPOAb or TgAb who were pregnant or considering conception.Data sourcesOvid MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched from 1980 to 5 November 2020.Outcome measuresPrespecified data elements were extracted and where appropriate, meta-analyses were conducted. Main outcomes include pregnancy achieved, miscarriage, preterm delivery and live birth.Risk of bias assessmentCochrane Risk of Bias Tool for Quality Assessment of Randomised Controlled Trials.ResultsFrom 3023 citations, 79 citations were identified for full-text review. Of these, six trials (total of 2263 women) were included for qualitative and quantitative analyses. Risk of bias was deemed low for only one trial. There was no significant difference in the relative risk (RR) of pregnancy achieved (RR 1.03; 95% CI 0.93 to 1.13), miscarriage (RR 0.93; 95% CI 0.76 to 1.14), preterm delivery (RR 0.66; 95% CI 0.39 to 1.10) or live births (RR 1.01; 95% CI 0.89 to 1.16) in thyroid autoimmune women treated with levothyroxine compared with controls. Sensitivity analyses of preterm birth identified study quality and timing of levothyroxine initiation as sources of heterogeneity.ConclusionsAmong pregnant women or women planning conception, with thyroid autoimmunity, there is a lack of evidence of benefit for levothyroxine use (moderate to high Grading of Recommendations, Assessment, Development and Evaluations). Recommendations to use levothyroxine in this setting need to be reconsidered.PROSPERO registration numberCRD42019130459.


2016 ◽  
Vol 31 (4) ◽  
pp. 444-453 ◽  
Author(s):  
M Nadler ◽  
MMH Pauls

Objectives: To determine whether shoulder orthoses prevent or reduce gleno-humeral subluxation and hemiplegic shoulder pain. Data sources: OVID SP, MEDLINE, AMED, CINAHL, PEDro and the Cochrane Central Register of Controlled Trials. Review methods: We included: randomised or quasi-randomised controlled trials, controlled before and after studies and observational studies. Two reviewers independently screened, critically appraised papers using the PEDro tool, and extracted data. A descriptive synthesis was performed as there were insufficient data for meta-analysis. Results: Eight studies were included, totalling 186 participants: One randomised controlled trial with 41 participants, one quasi-randomised with 14 participants, one before and after controlled study with 40 participants and five observational studies with 91 participants met the inclusion criteria. Findings suggest that applying an orthosis to an already subluxed shoulder immediately reduced vertical subluxation on X-ray but improvements were not maintained when orthosis was removed. Orthoses with both proximal and distal attachments improved shoulder pain in the majority of stroke patients when worn for four weeks (starting several days or weeks post-stroke). There was no increase in adverse effects of contracture, spasticity or hand oedema when compared to no orthosis. Orthoses were generally well-tolerated and most patients rated the orthosis as comfortable to wear. Conclusion: Observational studies suggest that orthoses reduce vertical subluxation whilst in-situ. Available evidence from heterogeneous studies after stroke suggests that orthoses may reduce pain and are well-tolerated with prolonged use. No studies have tested whether subluxation and pain can be prevented by immediate post-stroke application of orthoses.


2019 ◽  
Vol 14 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Morteza Ghojazadeh ◽  
Sakineh Hajebrahimi ◽  
Fatemeh Pournaghi-Azar ◽  
Mohammad Mohseni ◽  
Naser Derakhshani ◽  
...  

Background & Aims: Evaluating the effect of Kangaroo Mother Care (KMC) on breastfeeding success shows conflicting results. Regarding the importance of breastfeeding and uncertainties about its effect, this study intended to conduct a systematic review and meta-analysis of randomised controlled trials on the effect of KMC on success of breastfeeding. </P><P> Methods: In this systematic review and meta-analysis study, required data were collected by searching the following keywords: breastfeeding, Breast-Feeding, “skin-to-skin”, “Kangaroo Mother Care”, randomized clinical trial. The following databases were searched: Google Scholar, PubMed, EMBASE, Scopus, and Cochrane Central Register of Controlled Trials. Two authors independently extracted the data. To estimate the Breast-Feeding outcome variables, CMA2 software was used. The risk of bias of studies was assessed with the criteria developed in the Cochrane Handbook. Results: Twenty articles were included. In the KMC and CNC groups, 1,432 and 1,410 neonates were examined. Breastfeeding success rate was higher in the KMC group within different time slots, however this difference was not statistically significant (RR=1.11(95CI, 0.93-1.34) and RR=1.13(95%CI, 0.92-1.34) based on the time slot and birth weight, respectively). The inter-groups differences in the mean scores of Infant Breast-Feeding Assessment Tool (IBFAT) were statistically significant (P<0.05). Breastfeeding was initiated very sooner in the KMC group, suggesting a statistically significant inter-groups difference -0.72(95%CI, from -0.92 to -0.53) (P<0.05). Majority of the studies had a high risk of bias. Conclusion: Findings indicated a superiority of KMC over CNC in terms of breastfeeding success. Assessment of the complications and costs of KMC implementation is recommended.


BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034424 ◽  
Author(s):  
Carmen Martín-Gómez ◽  
Patricia Moreno-Peral ◽  
Juan A Bellón ◽  
Sonia Conejo Cerón ◽  
Henar Campos-Paino ◽  
...  

IntroductionThe prevalence of postpartum depression (PPD) is 17%, and the incidence is 12% worldwide. Adverse consequences for mothers and babies have been associated with this disease. To assess the effectiveness of psychological, psychoeducational and psychosocial interventions in preventing PPD, a systematic review and meta-analysis (SR/MA) will be conducted.Methods and analysisA SR/MA will be performed following the indications of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies will be identified through MEDLINE (Ovid and PubMed), PsycINFO, Web of Science, Scopus, CINAHL, Cochrane Central Register of Controlled Trials, OpenGrey, Australian New Zealand Clinical Trial Registry, ClinicalTrials.gov and evidencebasedtherapy.org from inception until 31 January 2020. Bridging searches will be also conducted until the review is completed. The selection criteria will be as follows: (1) subjects will be pregnant females or females who have given birth in the last 12 months and who were non-depressive at baseline; (2) psychological, psychoeducational and psychosocial interventions; (3) comparator will be usual care, attention control, waiting list or no intervention; (4) outcomes will be specific results on PPD; and (5) the design of the studies will be randomised controlled trials. No restrictions regarding the year of publication, the setting of the intervention or the language of publication will be considered. Pooled standardised mean differences and 95% CIs will be calculated. The risk of bias of the studies will be assessed through the Cochrane Collaboration risk of bias tool. Heterogeneity between the studies will be determined by the I2 and Cochran’s Q statistics. Sensitivity and subgroup analyses will also be performed. Publication bias will be checked with funnel plots and Egger’s test. Heterogeneity will be explored by random-effects meta-regression analysis.Ethics and disseminationThe ethical assessment was not required. The results will be presented at conferences and disseminated through publications.PROSPERO registration numberCRD42018109981.


2021 ◽  
Author(s):  
Mats Baxter ◽  
Jurgen Schwarze ◽  
Andrew Bush ◽  
Aziz Sheikh

Abstract IntroductionMobile health (mHealth) is a potential tool to improve nasal corticosteroid (NCS) adherence in allergic rhinitis (AR), which remains largely poor and inconsistent for many. We plan to undertake a systematic review to synthesise the evidence on the efficacy of mHealth interventions to improve NCS adherence in AR. Methods and analysisA systematic search will be conducted in the electronic databases MEDLINE, EMBASE and CENTRAL (Cochrane Central Register of Controlled Trials), filtered for publication dates between January 2010 and August 2020. The search is scheduled to commence in August 2020. We will scan reference lists of included studies for additional eligible papers. Relevant unpublished or in-progress trials will be searched for through trial registries. Randomised controlled trials that examine the efficacy of mHealth interventions to improve NCS adherence in AR are to be included. Two reviewers will independently screen and extract relevant data from the included studies and perform a risk-of-bias assessment using the Cochrane risk of bias tool 2.0. We will perform a narrative synthesis with relevant data tables and, if deemed clinically relevant and statistically adequate, meta-analyses using random-effects modelling. The Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) statement will be used to help guide the reporting of this review. Ethics and disseminationSince this systematic review will be exclusively based on published and retrievable literature, no ethics approval will be sought. The findings of this systematic review will be disseminated at appropriate conferences/webinars while being published in an open access peer-reviewed journal.Registration: In accordance with the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 27th August 2020. PROSPERO registration number CRD42020198879.


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